Injections in Aesthetic Medicine Atlas of Full-face and Full-body Treatment 9788847053618, 8847053617

Table of contents :
Preface
Contents
Contributors
Part IGeneral Aspects
1 Fillers in Aesthetic Medicine
1.1…Permanent Fillers
1.1.1 Liquid Silicone
1.2…Collagen
1.2.1 Heterologous Collagen
1.2.2 Human Collagen
1.2.3 Autogenic Human Collagen
1.2.4 Isogenic Human Collagen
1.3…Hyaluronic Acid
1.3.1 What is Hyaluronic Acid?
1.3.2 What is Cross-Linked Hyaluronic Acid?
1.3.3 History of Hyaluronic Acid in Aesthetic Medicine
1.4…Macrofillers: Hyaluronic Acid for Body Modelling
1.5…Calcium Hydroxylapatite
1.5.1 Injection Technique
1.6…Botulin
1.6.1 History
1.6.2 Different Toxins
1.6.3 Use in Clinical Practice and Aesthetic Medicine
1.6.4 Clinical Evaluation of the Patient
1.6.5 Contraindications to Treatment
1.6.6 Informed Consent
1.6.7 Safety of Botulinum: Open Questions and State of the Art
1.7…Platelet-Rich Plasma
1.7.1 Mechanism of Action
1.7.2 Indications
1.7.3 How To
1.7.4 Methods
1.8…Combining PRP with Calcium Hydroxylapatite (Radiessereg) as a Filler
1.8.1 How To
1.9…Summary
Acknowledgement
References
2 Aesthetic Analysis of the Face: The Maxillofacial Deformity
2.1…Facial Analysis
2.2…What’s Beauty?
2.2.1 Surgical Options: The Orthognathic Surgery
References
3 Standard Evaluation of the Patient: The Merz Scale
3.1…Application of the Merz Scale
References
Part IIFace and Body Treatments
4 Temporal Fossa
4.1…Anatomy
4.2…Pitfalls
4.3…Augmentation of the Temporal Fossa
4.4…Augmentation of the Temporal Fossa with Calcium Hydroxylapatite
4.4.1 Indications
4.4.2 Contraindications
4.4.3 Operating Time
4.4.4 Materials
4.4.5 Material Choice
4.4.6 Methods
4.4.7 Complications and Management
4.5…Augmentation of the Temporal Fossa with Hyaluronic Acid
4.5.1 Indications
4.5.2 Contraindications
4.5.3 Operating Time
4.5.4 Materials
4.5.5 Material Choice
4.5.6 Methods
4.6…Summary: Treatment Options
5 Forehead, Glabella, and Crow’s-Feet
5.1…Anatomy
5.2…Correction of Forehead and Glabella Wrinkles and Crow’s-feet with Botulinum Toxin
5.2.1 Pitfalls
5.2.2 Indications
5.2.3 Contraindications
5.2.4 Case 1: Treatment with Bocouture in a Young Simmetric Patient
5.2.5 Case 2: Treatment with Azzalure in a Case of Facial Asymmetry
5.2.6 Complications and Management of Botulin Toxin Injection
5.3…Correction of the Forehead Wrinkles with Hyaluronic Acid
5.3.1 Pitfalls
5.3.2 Indication
5.3.3 Contraindications
5.3.4 Case 3
5.4…Summary: Treatment Options
6 Malar Area
6.1…Anatomy
6.2…Pitfalls
6.3…Indications
6.4…Contraindications
6.5…Augmentation of the Malar Arch with Calcium Hydroxylapatite and Cannula
6.5.1 Operating Time
6.5.2 Materials (Fig. 6.5)
6.5.3 Material Choice
6.5.4 Methods
6.5.5 Considerations About Malar Arch Augmentation
6.6…Augmentation of the Body of the Malar Bone with Calcium Hydroxylapatite with Standard Needle
6.6.1 Pitfalls
6.6.2 Operating Time
6.6.3 Materials
6.6.4 Material Choice
6.6.5 Methods
6.7…Augmentation of the Malar Area with Calcium Hydroxylapatite and Platelet Enriched Plasma
6.7.1 Indications
6.7.2 Pitfalls
6.7.3 Contraindications
6.7.4 Operating Time
6.7.5 Materials
6.7.6 Material Choice
6.7.7 Methods
6.8…Malar Body Augmentation with HA Using Standard Needle
6.8.1 Pitfalls
6.8.2 Operating Time
6.8.3 Materials
6.8.4 Material Choice
6.8.5 Method
6.9…Complications and Management
6.10…Calcium Hydroxylapatite Versus HA
6.11…Summary: Treatment Options
Acknowledgment
Reference
7 Tear Trough
7.1…Anatomy
7.2…Pitfalls
7.3…Correction of Tear Trough Deformity with HA and Blunt Tip Cannule
7.3.1 Indications
7.3.2 Contraindications
7.3.3 Materials
7.3.4 Material Choice
7.3.5 Operating Time
7.3.6 Method
7.4…Complications and Management
Summary: Treatment Options
8 Nasolabial Folds
8.1…Anatomy
8.2…Pitfalls
8.3…Correction of Nasolabial Folds with HA and Cannula
8.3.1 Indications
8.3.2 Contraindications
8.3.3 Materials
8.3.4 Material Choice
8.3.5 Operating Time
8.3.6 Method
8.4…Correction of Nasolabial Folds with HA and Standard Needle
8.4.1 Indications
8.4.2 Contraindications
8.4.3 Materials
8.4.4 Material Choice
8.4.5 Operating Time
8.4.6 Method
8.5…Complications and Management
8.6…Summary: Treatment Options
9 Medical Rhinoplasty
9.1…Anatomy
9.2…Pitfalls
9.3…Indications
9.4…Contraindications
9.5…Medical Rhinoplasty with Botulinum and HA
9.5.1 Operating Time
9.5.2 Materials
9.5.3 Material Choice
9.5.4 Method
9.6…Medical Rhinoplasty with Calcium Hydroxylapatite and Botulin Toxin
9.6.1 Operating Time
9.6.2 Materials
9.6.3 Material Choice
9.6.4 Method
9.7…Complications and Management
9.8…Summary: Treatment Options
10 Marionette Lines
10.1…Anatomy
10.1.1 Facial Vessels
10.2…Marginal Mandibular Branch of the Facial Nerve
10.3…Pitfalls
10.4…Marionette Line Correction with Hydroxylapatite and Blunt-tip Cannula
10.4.1 Indications
10.4.2 Contraindications
10.4.3 Operating Time
10.4.4 Materials
10.4.5 Material Choice
10.4.6 Methods
10.5…Marionette Line Correction with HA and Blunt-tip Cannula
10.5.1 Indications
10.5.2 Contraindications
10.5.3 Operating Time
10.5.4 Materials
10.5.5 Material Choice
10.5.6 Methods
10.6…Marionette Line Correction with HA and Standard Needle
10.6.1 Indications
10.6.2 Contraindications
10.6.3 Operating Time
10.6.4 Materials
10.6.5 Material Choice
10.6.6 Method
10.7…Complications and Management
10.8…Summary: Treatment Options
11 Lips
11.1…Anatomy
11.2…Pitfalls
11.3…Lips Recontouring with Hyaluronic Acid and Blunt Cannula
11.3.1 Indications
11.3.2 Contraindications
11.3.3 Materials
11.3.4 Material Choice
11.3.5 Operating Time
11.3.6 Method
11.4…Lips Augmentation with Hyaluronic Acid and Standard Needle
11.4.1 Materials
11.4.2 Material Choice
11.4.3 Operating Time
11.4.4 Method
11.5…‘‘Bar Code’’ Wrinkles (Cutaneous Upper Lip)
11.5.1 Materials
11.5.2 Our Material Choice
11.5.3 Operating Time
11.5.4 Method
11.6…Complications and Management
11.7…Summary: Treatment Options
12 Chin
12.1…Anatomy
12.2…Pitfalls
12.3…Augmentation of the Chin
12.4…Augmentation of the Chin with Calcium Hydroxylapatite
12.4.1 Indications
12.4.2 Contraindications
12.4.3 Operating Time
12.4.4 Materials
12.4.5 Material Choice
12.4.6 Methods
12.5…Augmentation of the Chin with Hyaluronic Acid
12.5.1 Indications
12.5.2 Operating Time
12.5.3 Materials
12.5.4 Material Choice
12.5.5 Methods
12.6…Complications and Management
12.7…Summary: Treatment Options
13 Neck and Décolleté
13.1…Anatomy
13.2…Pitfalls
13.3…Bio-rejuvenation Technique for the Treatment of Neck and Décolleté
13.3.1 Indications
13.3.2 Contraindications
13.3.3 Operating Time
13.3.4 Materials
13.3.5 Material Choice
13.3.6 Methods
13.4…Treatment of Décolleté Using HA Injected with Blunt-tip Cannula
13.4.1 Indications
13.4.2 Contraindications
13.4.3 Materials
13.4.4 Material: Our Choice
13.4.5 Operating Time
13.4.6 Method
13.5…PRP in the Treatment of Neck and Décolleté
13.5.1 Indications
13.5.2 Contraindications
13.5.3 Operating Time
13.5.4 Materials
13.5.5 Method
13.6…Complications and Management
13.7…Summary: Treatment Options
14 Arms
14.1…Anatomy
14.2…Pitfalls
14.3…Arm’s Treatment with Low-density HA
14.3.1 Indications
14.3.2 Contraindications
14.3.3 Materials
14.3.4 Material Choice
14.3.5 Method
14.4…Complications
14.5…Summary: Treatment Options
15 Hands
15.1…Anatomy
15.2…Pitfalls
15.3…Hand Filling with Calcium Hydroxylapatite and Blunt-tip Cannula
15.3.1 Indications
15.3.2 Contraindications
15.3.3 Materials
15.3.4 Material Choice
15.3.5 Operating Time
15.3.6 Method
15.4…Hand Filling with Hyaluronic Acid and Blunt-tip Cannula
15.4.1 Indications
15.4.2 Contraindications
15.4.3 Materials
15.4.4 Material Choice
15.4.5 Operating Time
15.4.6 Method
15.5…Hand Treatment with Low-density HA
15.5.1 Indications
15.5.2 Contraindications
15.5.3 Materials
15.6…Material Choice
15.6.1 Method
15.6.2 Complications and Management
15.7…Summary: Treatment Options
16 Breast Augmentation
16.1…Anatomy
16.2…Has Hyaluronic Acid Still a Role in Breast Augmentation?
16.3…Macrolane for Breast Augmentation: Clinical Experience and Future Perspectives
16.4…Results
16.4.1 NASHA-Based Gel Injected Without Ultrasonography Guidance
16.4.2 NASHA-Based Gel Injected Under Ultrasonography Guidance
17 Gluteal Augmentation and Remodeling
17.1…Anatomy
17.2…Pitfalls
17.3…Buttock Augmentation by Hyaluronic Acid
17.3.1 Indications
17.3.2 Contraindications
17.3.3 Operating Time
17.3.4 Materials
17.3.5 Material choice
17.3.6 Methods
17.4…Complications and Management
17.5…Summary: Treatment Options
18 Calf Augmentation and Remodeling
18.1…Anatomy
18.2…Pitfalls
18.3…Calves Augmentation with Hyaluronic Acid
18.3.1 Indications
18.3.2 Contraindications
18.3.3 Operating Time
18.3.4 Materials
18.3.5 Material Choice
18.3.6 Methods
18.3.7 Complications and Management
18.4…Summary: Treatment Options
19 Scar Revision
19.1…Correction of Scars with Hyaluronic Acid
19.1.1 Indications
19.1.2 Contraindications
19.1.3 Operating Time
19.1.4 Materials
19.1.5 Methods
19.2…Complications and Management
19.3…Summary: Treatment Options
20 Full-body and Full-face Treatment
20.1…From the Full Body to the Full Face: The Sense of Multiple Treatments in the Same Day in Aesthetic Medicine
20.2…Surgery or Not Surgery?
21 Complications in Aesthetic Medicine
21.1…Hyaluronic Acid
21.2…Macrofiller
21.3…Calcium Hydroxylapatite (Radiesse)
21.4…Classification of Complications
21.5…Immediate Complications
21.6…Transient Erythema, Edema, and Pruritus
21.7…Induration
21.8…Ecchymosis and Hematoma
21.9…Bacterial Infections
21.10…Biofilm
21.11…Herpes Reactivation
21.11.1 Herpes Zoster
21.11.2 Herpes Labialis
21.12…Overcorrection
21.13…Migration
21.14…Inflammation
21.15…Foreign-Body Granulomas
21.16…Discoloration
21.17…Skin Necrosis
21.18…Rapid Resorption
21.19…Radiological Problems
21.19.1 Radiographic Problems Due to Radiesse
21.20…Incorrect Placement of Macrofillers
21.21…Defensive Aesthetic Medicine
References
Part IIIMiscellany
22 Quality Standards in Aesthetic Medicine
22.1…The AQ Standard for Aesthetic Medicine
22.2…The Quality Protocol for Patient Management and for Registration of Products
22.3…Customer Relationship Management or PRM
22.3.1 Key Points of PRM
22.4…Quality Standards of Marketing in Aesthetic Medicine
22.4.1 Marketing Campaigns
22.4.2 Coupon or not Coupon: The Profitability of Large Discounts in Aesthetic Medicine
22.5…Standard for Qualification of Medical Doctors
References
23 Complementary Treatments
23.1…Radiofrequency for Nonablative Skin Rejuvenation
23.2…Mechanical Stimulation of the Skin
23.3…Acoustic Waves
References
24 Products
Sec1
Sec2
Sec3
24.2.2 Belotero Soft Filler
24.2.3 Belotero Intense Filler
Sec6
Sec7
Sec8
Sec9
Sec10
24.5.2 Glytone 2 Filler
24.5.3 Glytone 3 Filler
24.5.4 Glytone 4 Filler
Sec14
Sec15
24.7…Juvédermreg Hydratetrade
24.8…Juvedermreg ULTRAtrade RANGE
Sec18
Sec19
Sec20
24.12…Juvédermreg Volumatrade with Lidocaine (2 ml)
24.13…Juvedermreg Volifttrade with Lidocaine
24.14…Haequeo Range
24.15…Macrolane VRF 20 and Macrolane VRF 30
24.16…NEWESTreg: Skin Biorevitalization
24.17…PLINESTreg: Skin Biorevitalization
24.18…PLINESTreg fast: Skin Biorevitalization
24.19…IALESTreg: Skin Biorevitalization
24.20…Radiesse
24.20.1 Radiesse Filler
Sec30
Sec31
24.22…Range Restylane Vital
24.22.2 Surgidermreg 24XP
24.22.3 Surgidermreg 30XP
24.22.4 Surgidermreg 30
Sec33
Sec34
Sec35
Sec36
24.24…Vistabexreg
Sec37
24.25…Summary

Citation preview

Mario Goisis Editor

Injections in Aesthetic Medicine Atlas of Full-face and Full-body Treatment

Injections in Aesthetic Medicine

Mario Goisis Editor

Injections in Aesthetic Medicine Atlas of Full-face and Full-body Treatment

123

Editor Mario Goisis Maxillo-Facial and Aesthetic Surgeon Doctor’s Equipe Milan Italy

ISBN 978-88-470-5360-1 ISBN 978-88-470-5361-8 DOI 10.1007/978-88-470-5361-8

(eBook)

Springer Milan Heidelberg New York Dordrecht London Library of Congress Control Number: 2013953897  Springer-Verlag Italia 2014 This work is subject to copyright. All rights are reserved by the Publisher, whether the whole or part of the material is concerned, specifically the rights of translation, reprinting, reuse of illustrations, recitation, broadcasting, reproduction on microfilms or in any other physical way, and transmission or information storage and retrieval, electronic adaptation, computer software, or by similar or dissimilar methodology now known or hereafter developed. Exempted from this legal reservation are brief excerpts in connection with reviews or scholarly analysis or material supplied specifically for the purpose of being entered and executed on a computer system, for exclusive use by the purchaser of the work. Duplication of this publication or parts thereof is permitted only under the provisions of the Copyright Law of the Publisher’s location, in its current version, and permission for use must always be obtained from Springer. Permissions for use may be obtained through RightsLink at the Copyright Clearance Center. Violations are liable to prosecution under the respective Copyright Law. The use of general descriptive names, registered names, trademarks, service marks, etc. in this publication does not imply, even in the absence of a specific statement, that such names are exempt from the relevant protective laws and regulations and therefore free for general use. While the advice and information in this book are believed to be true and accurate at the date of publication, neither the authors nor the editors nor the publisher can accept any legal responsibility for any errors or omissions that may be made. The publisher makes no warranty, express or implied, with respect to the material contained herein. Printed on acid-free paper Springer is part of Springer Science+Business Media (www.springer.com)

Affectionately dedicated to my father Gianandrea

Preface

The Concept of Beauty Beauty has a key role in human history. In ancient times Greeks held regularly beauty contests for both male and female. Beauty was greatly admired and competitions were serious. Annual contests were held at Lesbos, at Elis and in Arcadia. But the first beauty contest in history was described in the Iliad. The marriage of Peleus and Thetis was celebrated with a big banquet on Mount Olympus, home of the gods. All the gods and goddesses were invited, except one, Eris, the Goddess of Strife and Discord, in order to avoid problems. For this offense, Eris placed on the table, in the middle of the banqueting hall, a golden apple with the inscription ‘‘For the Fairest’’. All the three most important goddesses, Hera, Athena and Aphrodite had their eyes on the apple, each wanting it for herself. They began to quarrel. Paris, the son of Priam, King of Troy, was asked to judge. The three goddesses were involved in the final round in what would become known as the World’s First Ever Beauty Contest! Hera promised Paris dominions, wealth and power. Athena promised victory in battle. Aphrodite promised the most beautiful woman in the world, Helen. Paris gave the Golden Apple to Aphrodite, and that was the initial cause of Trojan War. The beauty was a key concept in human history. In particular, Piero della Francesca was one of the most original men of Italian renaissance. Piero had two passions—art and geometry—and he integrated the two in the definition of beauty. In fact, renaissance education placed exceptional value on mathematic rule of proportion. Luca Bartolomeo Pacioli (c.1445–1517) was tutored in mathematics by Piero. Both were born in Borgo San Sepolcro, and Luca even posed for Piero in the mid-1470s for Madonna and Child with Saints and Angels. He published the Summa de arithmetica, geometrica, proportioni et proportionalita (1494) a summary of arithmetic, geometry, and algebra. It contains the first mention of double-entry book-keeping, for which Luca is now known as the ‘‘Father of Accounting.’’ Accounting has a great importance in management of the aesthetic medicine office, but that’s not the reason of introducing Pacioli. In fact, in his De divina Proportione published in 1509 he described the golden ratio ‘‘dal ciel mandata’’—heavensent. He was inspired by the Platonic solids, and he related the Platonic solids to the golden ratio: As God created the four solids . . . earth, air, water, and fire … so our sacred proportion gave shape to heaven itself. The concept of divine proportion and the concept of perfect beauty was one of the most important concept in art, and it inspired Leonardo, Durer and many others artists. The research of ideal proportion and ideal beauty changes over time and in different centuries people have different options for becoming beautiful. In Shakespearean times, a woman was considered ideally beautiful if she had pale skin, light hair, intense eyes, and red lips and cheeks [1]. Women went to extreme measures to have these

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characteristics, plastering their faces with white cream and coloring their cheeks red. Shakespeare criticises ‘‘ideal’’ beauty in one of his sonnets, Sonnet 130: My mistress’ eyes are nothing like the sun; Coral is far more red than her lips’ red: If snow be white, why then her breasts are dun; If hairs be wires, black wires grow on her head. As creams at time of Shakespeare, aesthetic medicine and aesthetic surgery involves techniques intended for the ‘‘enhancement’’ of beauty. In fact, the aim of aesthetic medicine and surgery is to change a part of the face and body through surgical and medical techniques in order to increase beauty. Beauty is the key concept: the use of aesthetic surgery and medicine must not be in contrast with this principle, also in case of restoring or to maintaining youth. In fact, even though beauty is a complex concept, the standards of attractiveness are similar across different genders and cultures [2, 3]. As described by Piero della Francesca and Pacioli, beauty is harmony of form and proportions. Injecting an enormous amount of filler in the face of an old patient can result in correction of wrinkles. But this correction is associated with an unnatural result: in fact, the ‘‘pillow face’’ that we can obtain has probably a younger appearance, but at the end there is not beauty in our result. In this book are described many techniques: these techniques must be the instrument to obtain a natural result. Avoiding excess is the key to success in aesthetic medicine. Mario Goisis

References 1. Barroll JL (1984) Shakespearean tragedy: genre, tradition, and change in Antony and Cleopatra. Folger Books, Washington D.C 2. Rhodes G (2006) The evolutionary psychology of facial beauty. Annu Rev Psychol 57:199–226 3. Zecchi S (2007) Le promesse della bellezza. Oscar Mondadori

Contents

Part I

General Aspects

1

Fillers in Aesthetic Medicine. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Mario Goisis, Alessandro Di Petrillo, Claudio Rinna, Chiara Brillante, Magda Guareschi, and Doris Ali Youssef

3

2

Aesthetic Analysis of the Face: The Maxillofacial Deformity . . . . . . . . . . . Giada Anna Beltramini, Francesco Laganà, Alessandro Baj, Michele Romano, Antonio Russillo, and Aldo Bruno Giannì

25

3

Standard Evaluation of the Patient: The Merz Scale . . . . . . . . . . . . . . . . . Enrica Stella and Alessandro Di Petrillo

33

Part II

Face and Body Treatments

4

Temporal Fossa . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Mario Goisis and Alessandro Di Petrillo

53

5

Forehead, Glabella, and Crow’s-Feet . . . . . . . . . . . . . . . . . . . . . . . . . . . . Alessandro Di Petrillo and Magda Guareschi

61

6

Malar Area . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Mario Goisis, Enrica Stella, and Alessandro Di Petrillo

73

7

Tear Trough . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Mario Goisis and Enrica Stella

89

8

Nasolabial Folds . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Enrica Stella and Magda Guareschi

95

9

Medical Rhinoplasty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Mario Goisis

101

10

Marionette Lines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Enrica Stella, Alessandro Di Petrillo, and Mario Goisis

113

11

Lips . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Magda Guareschi and Enrica Stella

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12

Chin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Magda Guareschi and Mario Goisis

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13

Neck and Décolleté . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Enrica Stella and Mario Goisis

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14

Arms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Enrica Stella and Alessandro Di Petrillo

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15

Hands . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Mario Goisis and Alessandro Di Petrillo

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16

Breast Augmentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Mario Goisis

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17

Gluteal Augmentation and Remodeling . . . . . . . . . . . . . . . . . . . . . . . . . . . Mario Goisis and Magda Guareschi

185

18

Calf Augmentation and Remodeling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Mario Goisis and Enrica Stella

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19

Scar Revision . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Mario Goisis and Magda Guareschi

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20

Full-body and Full-face Treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Mario Goisis

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21

Complications in Aesthetic Medicine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Enrica Stella, Mario Goisis, and Mariangela Giarda

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Part III

Miscellany

22

Quality Standards in Aesthetic Medicine . . . . . . . . . . . . . . . . . . . . . . . . . . Mario Goisis and Andrea Goisis

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23

Complementary Treatments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Mario Goisis

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24

Products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Magda Guareschi

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Contributors

Editor Mario Goisis Maxillo-facial and Aesthetic Surgeon, Doctor’s Equipe, Milan, Italy

Authors Alessandro Di Petrillo, Maxillo-facial Surgeon, Doctor’s Equipe, Bologna, Italy Bruno Giannì, Maxillo-facial Surgeon, University of Milan, Italy Magda Guareschi, Ophthalmologist and Aesthetic Doctor, Doctor’s Equipe, Milan, Italy Claudio Rinna, Maxillo-facial Surgeon, Doctor’s Equipe, Rome, Italy Enrica Stella, Aesthetic Doctor, Doctor’s Equipe, Genova, Italy Contributors Alessandro Baj Maxillo-facial Surgeon, University of Milan, Italy Giulia Beltrami Aesthetic Doctor, Doctor’s Equipe, Asti, Italy Giada Anna Beltramini Maxillo-facial Surgeon, University of Milan, Italy Gina Bianco Aesthetic Doctor, Doctor’s Equipe, Bologna, Italy Chiara Brillante Ophthalmologist, Sapienza University, Rome, Italy Doris Ali Youssef Maxillo-facial Surgeon, University of Milan, Italy Andrea Goisis Software manager, Milan, Italy Francesco Goisis Lawyer, University of Milan, Italy Valentina Isgro` Aesthetic Doctor, Doctor’s Equipe, Rome, Italy Francesco Lagana` Maxillo-facial Surgeon, University of Milan, Italy Chiara Lumini Aesthetic Doctor, Doctor’s Equipe, Torino, Italy Giorgio Persichetti Aesthetic Doctor, Doctor’s Equipe, Rome, Italy Michele Romano Maxillo-facial Surgeon, University of Milan, Italy Antonio Russillo Maxillo-facial Surgeon, University of Milan, Italy

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Part I

General Aspects

1

Fillers in Aesthetic Medicine Mario Goisis, Alessandro Di Petrillo, Claudio Rinna, Chiara Brillante, Magda Guareschi, and Doris Ali Youssef

1.1

Permanent Fillers

Doris Ali Youssef The pursuit of beauty and the effort to reverse the effects of ageing dates back to many centuries. Facial volume depletion and facial rhytids are a natural and inevitable part of ageing. Over the last 100 years, various attempts to restore volume to the face with the use of injectable devices have been described. The prologue to this story must start with the development of the appropriate technology, namely the syringe. The hollow needle was invented in 1844 by Irish physician Francis Rynd [1]. The fillers history begins in 1830, when a German chemist, Baron Karl Ludwig von Reichenbach, discovered a material created by the dry distillation of beech-wood tar. He noted this substance to be very unreactive and named it paraffin, from the Latin parum (barely) and affinis (affinity). The first reported use of a material injected into the body for ‘cosmetic’ purposes was by Robert Gersuny (1844–1924) [2]; Gersuny injected mineral oil (liquid paraffin) to create a testicular prosthesis in a patient with tuberculous epididymitis who had been treated by castration. Paraffin was enthusiastically embraced by the medical community and became the treatment of choice for nasal augmentation. However, in 1901, a case was reported of a 39-year-old woman who underwent paraffin injection for urinary incontinence and developed pulmonary and cerebral paraffin emboli [3]. The sequelae associated with paraffin injections were outlined in 1911 by Kolle [4], who described inflammation, infection, embolism, and yellowish skin plaques at the site of the injection. In the following years, the term paraffinoma was used to describe the

M. Goisis (&)  A. Di Petrillo  C. Rinna  C. Brillante  M. Guareschi  D. A. Youssef Doctor’s Equipe, via Carducci 19, 20123 Milan, Italy e-mail: [email protected]

M. Goisis (ed.), Injections in Aesthetic Medicine, DOI: 10.1007/978-88-470-5361-8_1,  Springer-Verlag Italia 2014

granulomatous foreign-body reaction that developed as a result of paraffin injection. The most famous account of the complications of paraffin injection was that of the Duchess of Marlborough [5]. This American-born, dazzling beauty was preoccupied with the ‘kink’ of her nose and underwent paraffin injections to her nasal dorsum. The paraffin subsequently migrated into her chin producing paraffinomas throughout her face. She became so disfigured she did not permit mirrors in her house, and she died a recluse in 1977. The biology of injected paraffin is now well understood. There is an initial inflammatory phase, followed by a latent phase that can last for decades [6] Over time, the fatty tissue calcifies and develops hyaline sclerosis, producing yellowish skin nodules. These lesions can become infected or fistulize. Because the paraffin is inert, it remains completely unchanged in the body and can migrate through the fatty tissue, stopped only by fascial planes. Over the subsequent years, similar injectables such as vegetable oil, mineral oil, lanolin and beeswax have been used for cosmetic injections but were abandoned due to undesirable complications including migration, granuloma formation and scarring. A tragic example of such injections was described in the London Daily Telegraph (November 11, 2008). A Korean woman received silicone injections from a physician who also gave her syringes to selfadminister. After she ran out of silicone, she substituted cooking oil for self-injection and ultimately became severely disfigured.

1.1.1

Liquid Silicone

In the 1960s, liquid silicone injection became a popular cosmetic treatment [7–10]. Like paraffin, silicone is an inert, clear, oily substance that is easily injected and, unfortunately, had similar disastrous sequelae. Silicone, a polymer of dimethylsiloxanes, was first used in Japan during the 1940s for breast augmentation. This practice spread to the

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United States (California, Texas and Nevada), in 1965, Dow Corning developed a purified silicone that could be used for injection, called MDX4–4011. In subsequent years, it was noted that the injected silicone would migrate and fistulize, and it had resulted in several deaths. Some patients with severe complications required mastectomies. Because of the complications encountered in the Las Vegas showgirls injected with silicone, Nevada was the first state to ban the use of injectable silicone. In 1964, Weiner coined the term siliconoma to describe the soft tissue granuloma that developed from injected silicone. These disfiguring inflammatory responses could sometimes be seen decades after silicone had been injected. Although medical-grade silicone was also used to treat facial wrinkles and augment the lips, the U.S. Food and Drug Administration (FDA) considered it an investigational device and never approved silicone for cosmetic use. In 1964, the FDA regulated the use of injectable silicone as a drug, and the Medical Device Amendments of 1976 restricted the use of silicone as a device. After reports of the sequelae of injected silicone, in 1979, the FDA and the American Medical Association condemned the use of injectable liquid silicone. Although today medical-grade silicone is available for ophthalmic use in the treatment of detached retinas, its cosmetic use is considered illegal in some states. In spite of the problems encountered with injectable liquid silicone, silicone injections are still performed in Europe, Canada, Mexico and by some physicians in the United States. Since 1994, two medical-grade silicone products were available to treat detached retinas, and use of these products cosmetically is considered ‘off-label’. Even though the use of injectable silicone for cosmetic purposes is federally banned and illegal in some states, some physicians feel that in the hands of experienced surgeons, injections can be extremely efficacious. They purport the ‘microdroplet’ injection technique using a small needle and deep injection into the dermis and subcutaneous fat. These injections are performed in multiple treatments over 1- to 3-month intervals. The authors strongly suggest not to use liquid silicon and to consider this use illegal.

1.2

Collagen

1.2.1

Heterologous Collagen

Giorgio Persichetti, Valentina Isgrò Bovine collagen has been the most widely used filler material in the early 2000s (See Table 1.2). Three products have been manufactured and distributed by Inamed:

Zyderm I, Zyderm II, and Zyplast. Inamed has been acquired by Allergan at the end of 2005. Allergan continued marketing these products until the end of 2010. In June 2008, Johnson & Johnson patented their own product, Evolence, derived from porcine collagen. The production of Evolence has been suddenly discontinued in November 2009. Zyderm I corrected fine lines quite well, particularly fine perioral and crow’s-feet lines. Zyderm II, designed to correct average lines, offers an average duration of 3–6 months. Zyplast was designed to correct deep wrinkles in thick skin and to restore facial volume (lips and outline of the face). It generally lasted 6–12 months [11]. Evolence has been recommended for the treatment of moderate to deep wrinkles, fold and lines, including hardto-treat nasolabial folds. Due to the possible allergic reactions concerning the use of heterologous collagen, a preliminary test was mandatory before injection. A double test was recommended because positive reactions to treatment have been reported in 0.3–1.5 % of patients even after clinical selection and initial testing [12, 13]. Pons-Guiraud [14] recommends the following protocol, which can take up to 7 weeks to complete. The first injection (0.1 mL) is given in the anterior aspect of the forearm, followed by a reading at 72 h. A positive reaction is characterized by a change in the contour of the injected implant, erythema, oedema, occasionally pruritus and, rarely, by an indurated papule or inflamed dermal nodule. All positive reactions contraindicate collagen injections. A second injection is given 15 days later, followed by readings 3 days and 4 weeks later. Any positive reaction to the test or double test contraindicates the collagen injection. If there is any doubt, bovine (ACACB) and human (ACACH) anticollagen antibodies must be measured. Concerning complications, a study performed by Castrow and Krull [15] on behalf of 316 practitioners, covering approximately 7,000 patients who demonstrated negative test results revealed a side-effect rate at the injection site of 1.5 %. The reactions were mostly limited to the injection site: erythema, induration, itching, and pain. In general, these reactions lasted 4–6 months; in a few cases, they lasted more than 1 year. Other reactions included arthralgia (6.5 %) and local granulomas (5 %, confirmed in 4 of 5 cases through biopsy). In rare cases, severe allergic reaction (anaphylactic shock) that requires immediate emergency medical assistance occurred. Abscesses were reported at a frequency of 4 cases per 10,000 patients [16]. These reactions develop, on average, 8–12 weeks after the injection, after 1 or more collagen injections. They are characterized by a nodule or papule at the injection site, severe swelling, erythema and induration

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Table 1.1 ASAPS member statistics year on year comparisons for dermal filler products 2006 versus 2007 (%)

2005 versus 2006 (%)

2004 versus 2005 (%)

Collagen

-60

-27

-72

Hyaluronic acids

-9

+33

+35

of the surrounding tissues. The abscess is different from the collagen hypersensitivity reaction, which is also characterized by induration and erythema but is not fluctuant. Cases of necrosis have been reported at a rate of 9 per 10,000 [16]. The local necrosis reaction after injection of collagen is not related to the implant itself but to obstruction of a blood vessel or ischaemic necrosis. According to ASAPS member statistics, use of heterologous collagen decreased starting from 2004 (Table 1.1). During 2009, law firm McPhadden Samac Tuovi announced a proposed class action against Johnson & Johnson and related companies relative to the injectable collagen dermal filler Evolence. It is alleged that Johnson & Johnson and related companies failed to warn the public about the potential of these adverse effects. Exactly, during November 2009, Johnson & Johnson announced that it would be discontinuing the porcine collagen product. The need of a double test and relative waiting time together with the risk of side effects are probably the main reasons leading to a gradual decrease in the mid of 2000s and a definitive loss of popularity of heterologous collagen between 2008 and 2010.

1.2.2

Human Collagen

Implantable materials containing autogenous or isogenous human collagen have a limited presence because preparation of the injectable solutions is relatively difficult, and the cost of these products is relatively high.

1.2.3

Autogenic Human Collagen

Introduced at the end of the 1980s, Autologen (Collagenesis, Inc., Beverly, MA) was the first autologous injectable agent on the market. Autologen is a dispersion of intact collagen fibres and a matrix of collagen tissue obtained from the clean skin of the patient during a plastic surgery procedure (mammaplasty, abdominoplasty, facelift and blepharoplasty). A skin biopsy is inadequate. Because the injected material is autologous and no allergic reactions were reported in a sufficient number of patients, the United States Food and Drug Administration (FDA) does not consider it necessary to perform a test before Autologen injection. The skin excision, placed in a sterile container, is

sent to the manufacturer’s laboratory for treatment. As a general rule, 10–13 cm2 of excised skin is required to produce 1 mL of Autologen 5 %. At least 3 injections, a few weeks apart, are needed to obtain a satisfactory result, provided that each treatment is overcorrected by 30 % [17]. The duration of treatment depends on the region treated, the injection technique and the volume of Autologen administered. No significant side effects have been reported. It must be noted, however, that moderately severe erythema may last for 48 h after the injection [18, 19]. Preparation of the autologous collagen from a patienttissue sample is expensive, and yield varies, depending on the individual and the anatomic areas from which collagen is harvested. Since 1998, autologous fibroblast cultures have been used to correct wrinkles, scars and other skin defects. Boss et al. [20] described a method of injecting autologous fibroblasts obtained from a 3-mm skin excision from the retroauricular area, an area protected from UV light. The sample is immediately placed in a culture medium provided by Isolagen Laboratories (Houston, TX) and must reach the laboratory by the day after sampling in an isothermic container. Six weeks after sampling, an injection test (0.1 mL) is administered to the patient in the forearm; any sign of an allergic reaction is recorded. Two weeks after the test, approximately 1 mL of the autologous material is available for implantation. Overcorrection of 300 % is recommended for suitable aesthetic results [21, 22]. The level of correction achieved depends on the defect, the patient’s age, and the ability of the patient’s fibroblasts to create collagen. Patients older than 60 years are not good candidates for this technique. This technique has several disadvantages. The Isolagen preparation must be injected within 48 h. It offers more effective correction of periorbital wrinkles or perioral wrinkles than of deep furrows [23]. The improvement obtained is poor compared with that of other techniques, such as hyaluronic acid, and correction is not immediate. Fagien and Elson [24] concluded that the results obtained with this technique were rather disappointing. In addition, Isolagen is expensive.

1.2.4

Isogenic Human Collagen

Alloderm (LifeCell, Branchburg, NJ) has been used in the treatment of burns and for transplantation in periodontal surgery. In aesthetic surgery, it is used to increase lip volume, to correct nasolabial folds and to treat scars. Alloderm

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is an acellular dermal graft material obtained from cadavers or from a tissue bank that provides an acellular matrix of dermal components, including collagen, elastin and glycosaminoglycans. The dermis skin is examined in accordance with FDA requirements and regulations relating to human tissue. No cases of transmissible viral disease have been reported in patients who have received this treatment since its introduction in 1992. Alloderm is offered in the form of sheets that are implanted through an incision in the treatment area. Infection of the incised/sutured sites has been attributed to abscess formation around the suture rather than to the graft itself. Cases of labial herpes have also been reported; prophylactic antiviral therapy must be prescribed for patients with a history of labial herpes. Alloderm is also available in a micronized injectable form, marketed under the name Cymetra (average particle size 123 lm). Cymetra is provided in the form of an aseptic powder reconstituted with lidocaine 0.5 % with 1: 200,000 epinephrine immediately before injection. It is injected with a 26-gauge needle [25]. Dermalogen (Collagenesis Corp., Beverly, MA) is obtained from cadaver tissues that have been carefully selected to help eliminate the risks of viral and bacterial infection. Clinical indications for the use of Dermalogen include correction of obvious nasolabial folds, perioral wrinkles, glabellar wrinkles and depressed scars, as well as increasing lip volume. The injection technique for Dermalogen is the same one used for Autologen: injection into the middle dermis/deep dermis with a 30-gauge needle. Because the injection is painful, use of a local anaesthetic is recommended [26]. Overcorrection of 20–30 % is recommended at each session. An average of 3 injection sessions is required for satisfactory correction. Prolonged erythema and acneiform rashes were noted in 10 % of patients in a study of 130 patients. The manufacturer does not recommend a pretreatment allergy test, although 1 case of foreign-body reaction 4 weeks after a test injection of 1 mL of Dermalogen in the forearm has been described by Moody and Sengelmann [27]. Klein [28] also reported several positive skin tests with Dermalogen and 1 case of secondary reaction characterized by redness, swelling, and hyperpigmentation of the treated sites after Dermalogen implantation.

1.3

Hyaluronic Acid

Chiara Lumini Hyaluronic acid is a natural substance in the body that was first described in 1934 by John Palmer and Karl Meyer at Columbia University, New York. It was isolated from a cow’s eye, and the name comes from hyalos (Greek word for glass) and the uronic sugar found in the substance.

Hyaluronic acid is produced by the cells in the human body, and it plays a key role in numerous functions. It facilitates the cell-division process, it makes the skin elastic and it lubricates the joints. In 2003, the U.S. Food and Drug Administration (FDA) approved the first hyaluronic acid dermal filler for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds. In the last ten years, numerous products for therapeutic and aesthetic uses have been developed for this versatile natural substance.

1.3.1

What is Hyaluronic Acid?

Hyaluronic acid is a natural complex sugar found in all living animals. It is one of the few elements that is virtually identical in all living organisms. Hyaluronic acid has the capacity to bind great quantities of water, absorbing more than 1,000 times its weight In addition, hyaluronic acid combines with collagen and elastin. The triple binding of elastin, collagen and hyaluronic acid provides elasticity and volume to the skin. The body’s amount of hyaluronic acid is metabolized quickly and must be newly produced constantly by the cells. The ageing of the skin, and the exposure to oxidants, to pollutants and to ultraviolet rays, reduce the ability of the cells to produce hyaluronic acid. As a result, the skin begins to reduce its volume, with subsequent formation of facial wrinkles and folds.

1.3.2

What is Cross-Linked Hyaluronic Acid?

In its natural form, hyaluronic acid is a liquid composed of individual polymers (chains) that are broken down in the body in just 12 h. Cross-linking is a process in which the individual chains of hyaluronic acid are cross-linked (chemically bound) together, converting the liquid hyaluronic acid into a gel, a soft solid. The hardness of the gel depends on the degree of cross-linking of the individual hyaluronic acid chains. The body metabolizes cross-linked hyaluronic acid more slowly than the natural individual chains, resulting in a longer duration of effect. For this reason, dermal fillers composed of cross-linked hyaluronic acid are used in aesthetic medicine to temporarily replace lost hyaluronic acid and to restore volume of the face and of the body. Fillers are reticulated hyaluronic acid-based medical devices. They are made of stabilized non-animal hyaluronic acid obtained from bacterial fermentation of_Streptococcus equi strains. The cross-linking agent generally used for fillers is 1.4butanediol diglycidyl ether (BDDE), a small molecule that

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binds to two ends of an HA chain, generating a threedimensional structure. The various HA-based fillers on the market have different chemico-physical characteristics, such as particle size, the cross-linking agent used, the degree of cross-linking, the quantity of free HA and the elastic modulus G. The quantity of hyaluronic acid in a product affects its consistency and longevity. However, it is also important to take into account the quantity of reticulated HA, the quantity of non-reticulated HA and the degree of crosslinking to consider the HA as fully or partially linked. Often, some quantities of free hyaluronic acid are added to increase its ease of injection as it functions as a lubricant. The cohesive property of the gel depends on the elastic modulus G which measures its resistance to deformation and, therefore, the strength of the gel. Fillers with a high G are considered cohesive gels and are indicated for correction of deeper wrinkles, such as naso-labial folds or for marionette lines, whereas fillers with a lower G0 are indicated for the treatment of larger areas such as the cheekbones and cheeks (See Table 1.2). Different properties of hyaluronic acid can be resumed in a simple classification: – low viscosity hyaluronic acid, useful for revitalization and small wrinkles – medium viscosity hyaluronic acid: useful for deeper wrinkles, lines and lips – high viscosity hyaluronic acid: useful for larger areas as malar areas.

1.3.3

History of Hyaluronic Acid in Aesthetic Medicine

1987 Q-Med was founded by Bengt Ågerup with a view to commercializing the research that he had carried out around hyaluronic acid. 1996 Restylane obtained marketing authorization in Europe for use as filler for wrinkles and lip augmentation. 2003 Restylane is approved in the US. 2003 Corneal group introduces Juvaderm in Europe and Canada. In 2006, Q-Med launches a new product for lip enhancement treatment, Restylane LippTM, Q-Med’s first product in the field of body augmentations, MacrolaneTM, is approved in Europe. The JUVÉDERMTM dermal filler family of products is approved by the FDA. 2007 Restylane PerlaneTM approved for sale in the USA. 2008 Q-Med’s Restylane VitalTM and Restylane VitalTM Light—were launched in Europe.

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Allergan introduces in Europe Juvederm Ultra 2, 3 and 4. 2009 Restylane obtained registration approval in China and became the first injectable non-animal hyaluronic acid product on the Chinese market. Q-Med introduced Restylane Lidocaine and Restylane PerlaneTM Lidocaine. Allergan introduces Juvaderm Voluma. 2010 By the beginning of 2010 FDA approved Restylane and Restylane Perlane with added lidocaine in USA. 2011 Belotero Balance has been approved by FDA to treat moderate to severe facial wrinkles and folds. De-listing of Q-Med AB (publ) from NASDAQ OMX Stockholm. Q-med is acquired by Galderma. CE-approval of Restylane SubQ lidocaine. 2012 Glytone Range of Injectable Hyaluronic Acid Products of Pierre Fabre Group was acquired by Merz Aesthetics Inc. Allergan introduces the new filler Juvederm Volbella with lidocaine.

1.4

Macrofillers: Hyaluronic Acid for Body Modelling

Giulia Beltrami The use of liquid filler for body enhancement was first described in 1899 by Gersuny, who injected silicone into the scrotum of a patient in order to reconstruct a testicle after an orchiectomy [29, 30]. Since then, there has been a steady increase in the use of implants and filler substances to reshape body defects. In particular, many permanent liquids and gels have been injected for breast augmentation (e.g. silicone, paraffin, polyalkylimide and polyacrylamide hydrogel). However, the use of these materials has been hampered by complications, such as chronic inflammatory reactions, palpable nodule formation, granuloma formation, and migration [29, 31–33]. As a consequence of these complications, new materials on the market can face scepticism, even if they are biocompatible and non-permanent. Hyaluronic acid specifically produced for body remodelling was introduced in 2009, in particular Macrolane, a new formulation of injectable stabilized hyaluronic acid– based gel of non-animal origin (NASHA-based gel; Q-Med AB, Uppsala, Sweden) have been developed for use in breast enhancement, volume restoration and contouring body surfaces [31, 34]. Since larger volumes are required for body enhancement than for facial augmentation, the Macrolane formulation has increased viscosity (i.e. a thicker gel). With a high resistance to deformation, hyaluronic acid gel augments body tissue simply by occupying space (in a similar manner to permanent implants).

8

In 2010, Bioscence (Bioscence, Germany) introduced Hyacorp for body enhancement, with exclusion of breasts. Hyacorp is a specially designed cross-linked HA gel which becomes less viscous under pressure (injecting force) and returns immediately to the original viscosity upon pressure release (injecting force). This is a characteristic of a system (advanced thixotropic technology = ATT technique) exhibiting a decrease in viscosity with an increase in the rate of shear, usually a function of time. Breast augmentation was Macrolane major indication. Many women have undergone breast augmentation with Macrolane in Europe and Asia. It has never been approved for breast augmentation by the Food and Drug Administration [31, 34]. In January 2010 Goisis et al. wrote a contribution to Aesthetic Plastic Surgery [35]. Three major questions were examined in this paragraph. The first question is related to the duration and cost of Macrolane. Macrolane is a resorbable material, and the study of P. Heden et al. published in 2009 showed 30–50 % resorption at 12 months [31]. The echographic measurements in the study of Goisis et al. [35] showed a 60 % rate of resorption after one year. Consequently, a second treatment was usually done 9 months after the first. The necessity of a touchup increases the cost of breast augmentation with NASHA gel, which is as expensive as a single surgical treatment with a prosthesis after three or four touch-ups. The second problem is related to the radiological evaluation of patients. Macrolane is a new material and it constitutes a diagnostic challenge for radiologists. Indeed, the appearance of NASHA gel may mimic a cyst on mammography and sonography [31]. Therefore, it is important that radiologists become familiar with the spectrum of imaging findings of Macrolane. In particular, in order to make an accurate diagnosis in these patients, it is important to send them to specialized radiological centres. The last open question is related to post-treatment adverse events. Goisis et al. had a high rate of minor complications. Goisis et al. concluded in this study that NASHA gel for breast volume augmentation was an interesting treatment, although the three open questions require more studies. P. Heden et al. answered this paper with a letter, writing that Macrolane injection did not reduce sensitivity and specificity in breast cancer screenings [36]. After the paper of Goisis et al, some other authors reported complications associated with the procedure [32, 37]. In 2011, Goisis et al. wrote two papers about difficulties on breast imaging, which were described by manyauthors as the most important problem of breast augmentation by hyaluronic acid [38–40]. To reduce these problems, Goisis et al. stressed the importance to carry out the injections under ultrasound guidance. In particular, they suggested to inject a single deposit of hyaluronic acid gel.

M. Goisis et al.

A cavity with a uniform symmetrical globular shape must be created in the space under the deep fascia of the breast, anterior to pectoralis muscle. The gel can be also placed posterior to the pectoralis muscle (submuscular plane) or inside the pectoralis muscle (intramuscular plane) in order to minimize visibility and palpability. In fact, in Goisis et al. published experience, the overall incidence of complications among patients receiving submuscular or dual-plane or intramuscular injection appeared lower than in patients receiving subglandular injection. Injection of gel into the space between the glandular tissue and the deep fascia of the breast may be related to a higher risk of displacement into the gland tissue and into the subcutaneous fat, especially if multi-pocket injection is performed without ultrasonography guidance [41]. In April 2012, after reviewing the current situation and in consultation with the regulatory authorities, Q-Med has decided to discontinue the indication for breast augmentation until consensus for best practices in breast radiology examination following Macrolane treatment has been reached. Q-Med announced that a safety reporting system has been in place since launch and no safety concerns have been identified. Despite this, Macrolane can interfere with the reading of mammograms. Since no safety concerns have been identified with the product itself, Q-Med suggested that women who have undergone breast augmentation with Macrolane do not need to take any additional actions other than the routine follow-up consultations or as directed by their doctors. As with any other breast prosthesis, it is important to inform the healthcare professional of previous Macrolane treatment before any breast assessment is carried out.

1.5

Calcium Hydroxylapatite

Gina Bianco Initially launched in the US in 2000 as Radiance FN, this dermal filler was introduced in Europe in June 2004 under the name RadiesseTM. RadiesseTM is a medical device developed by Bristol-Myers Squibb and BioForm Medical (since acquired by Merz Aesthetics). Radiesse is an injectable filler material composed of synthetic calcium hydroxylapatite microspheres (30 %) suspended in an aqueous carrier gel (70 %). These uniform microspheres (25–45 m) are smooth in shape and are identical in composition to the mineral portion of human bone and teeth [42]. Radiesse injectable implant is a steam sterilized, latexfree, non-pyrogenic, semi-solid, cohesive completely biodegradable deep and sub-dermal implant. The principle

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component is synthetic calcium hydroxylapatite. Calcium hydroxylapatite is the primary mineral constituent of bone and teeth. The semi-solid nature of the implant is created by suspending calcium hydroxylapatite in a gel carrier that consists primarily of water and glycerine. The gel structure is formed by the addition of a small amount of sodium carboxymethyl cellulose. It does not contain any animal- or human-derived components. The gel is dissipated in vivo and replaced with soft-tissue growth, while the calcium hydroxylapatite remains at the site of injection. Results from extensive in vitro and in vivo safety studies and in several retrospective physician reports, including toxicology assessments, standardized biocompatibility testing, and a 3-year animal study, demonstrate that injectable calcium hydroxylapatite is biocompatible, nontoxic, non-irritating and non-antigenic. Patient sensitivity testing is not required before use [43]. Calcium hydroxylapatite has been used for more than 20 years in various forms in surgery and dentistry. In the United States, injectable calcium hydroxylapatite has been used for several years for the correction of oral/maxillofacial defects, for vocal fold augmentation and as a radiographic tissue marker. In 2006, Radiesse was approved in the United States for the correction of moderate to severe facial wrinkles and folds, including the nasolabial folds, and restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus. In Europe, RadiesseTM is approved for plastic and reconstructive surgery, including deep-dermal and sub-dermal soft-tissue augmentation of the facial area. When placed into soft-tissue, Radiesse provides immediate correction. Over time, the carrier gel is gradually absorbed and the calcium hydroxylapatite particles remain (Figs. 1.1, 1.2, 1.3). Local histiocytic and fibroblastic response at the site appears to result in the production of new collagen around the microspheres [44]. Preclinical canine studies (Fig. 1.4, above) have demonstrated histologically progressive integration of collagen fibres in and around the calcium hydroxylapatite microspheres up to 78 weeks after implantation (Fig. 1.4, centre and below). Over time, calcium hydroxylapatite particles are broken down into calcium and phosphate ions via normal metabolic processes and eliminated through the body’s normal excretory processes. In one long-term animal study in the bladder neck, the particles remained intact at the site of injection throughout the entire 3-year study period [45]. Our experience with calcium hydroxylapatite use for facial soft-tissue augmentation has shown results lasting an average period of a year or more in most patients. In vivo, durability depends on factors such as injection technique, site of material

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Fig. 1.1 When injected into soft-tissue, Calcium hydroxylapatite provides immediate correction

placement and patient age and metabolism. The study was conducted on 357 patients and is not yet published.

1.5.1

Injection Technique

Due to its relatively low viscosity, calcium hydroxylapatite is delivered with a small (e.g., 27-gauge) needle and local anaesthesia improves patients’ comfort during procedures. The choice of infiltration, nerve block anaesthesia, topical anaesthesia, infiltration of tiny amounts of local anaesthetic directly into the area, or some combination thereof depends on the preferences of the operator and the patient [46, 47]. When needed, the treatment site should be marked before administration of anaesthetic, as infiltration may distort the skin surface. Practical skill: to reduce post-treatment pain, you can mix radiesse with local anaesthesia (Figs. 1.5a, b, 1.6a, b). Calcium hydroxylapatite should ordinarily be injected at the sub-dermal plane, especially when filling creases, wrinkles and deep lines. Injection depth can be just in the subcutaneous space but superior to the periosteum. The

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Fig. 1.2 Over time, the carrier gel is gradually absorbed and the calcium hydroxylapatite particles remain

injection can also be placed on the periosteum if the intent is to augment the facial bony skeleton. Placement on the periosteum will not stimulate bone growth in the area. Depending on the area being treated, calcium hydroxylapatite may be injected in a retrograde fashion using a linear, threading, fanning and/or crosshatching technique. Massage or moulding of material follows injection to desired effect. Post-treatment care involves immediate placement of ice onto the injected areas to reduce and limit tissue oedema and ecchymosis. Practical skill: a lesser volume of calcium hydroxylapatite is required to provide the same degree of correction as hyaluronic acid and collagen Two studies support the finding of smaller volumes in calcium hydroxylapatite than in several other soft-tissue fillers. For example, in a split-face study of calcium hydroxylapatite versus collagen for the nasolabial folds, on average, the collagen-treated side of the face required twice the volume of material (2.35 ml) to produce optimal correction as compared with the calcium hydroxylapatite– treated side 1.22 ml) (p 0.0001) [48]. In another study, approximately 30 % less volume of calcium hydroxylapatite was required than hyaluronic acid for full correction of the nasolabial folds [49].

M. Goisis et al.

Fig. 1.3 Local histiocytic and fibroblastic response at the site appears to result in the production of new collagen around the microspheres

1.6

Botulin

Claudio Rinna, Chiara Brillante

1.6.1

History

Botulinum toxin (BoNT) is a neurotoxin. The symptoms of intoxication by botulinum were first described two centuries ago by Justinus Kerner [50, 51]. He observed these symptoms after eating sausages, and the term botulism derived from the latin botul (sausage). BoNT is produced by the anaerobic micro-organism Clostridium botulinum. There are 7 different known serological types, indicated with the letters from A to G [51]. In 1937, the ophthalmologist Alan B. Scott used for the first time the botulinum toxin A (BTXA) in experiments on monkeys. In 1946, Edward Schantz in Fort Detrick produced the first botulin toxin in crystals [50]. Only in the 1970s, it was approved as a therapeutic agent [51], and in 1989, the BTX-A was approved by the Food and Drug Administration for the treatment of strabismus, blepharospasm and hemifacial spasm in patients over the age of 12. In 1991, it was used to treat spasticity, both in

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Fig. 1.4 Scanning electron photomicrographs of (above, left) calcium hydroxylapatite microspheres in sodium carboxymethylcellulose gel. Note the consistent, smooth, round shape (500 magnification). Above, right Calcium hydroxylapatite microspheres 30 months after implantation into bladder neck (350 magnification). Note the slowly dissolving particles. Centre and below Histological evaluation of calcium hydroxylapatite gel injected intradermally into canine skin over a period of 4–78 weeks. Sections stained with picrosirius red denote progressive collagen integration in and around the white spherule calcium hydroxylapatite particles. Collagen deposition (centre, right) 16 weeks, (below, left) 32 weeks, and (below, right) 78 weeks after calcium hydroxylapatite injection (Photographs and illustrations courtesy of BioForm Medical, Inc.)

Fig. 1.5 a, b 0, 5 cc of local anesthetic (2% lidocaine or 2% mepivacaine) are inspired in a 2, 5 cc syringe

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Fig. 1.6 a, b 1, 5 cc of Radiesse is mixed with the anaesthetic solution

adults and in children and in 2000 for the treatment of cervical dystonia. Jean Carruthers first describes in 1996 the use of botulin toxin for aesthetic treatment of the face. In 2002, the use of BTX-A in aesthetic medicine was approved for the temporary improvement of glabellar frown lines [52]. The use of BoNT, which has been approved, varies widely depending on the type of toxin, the type of marketed product and the country, even within the European Union. This means that, in some cases, its clinical use is off-label, even if supported by scientific literature. BTXA is marketed in the form of various pharmaceutical products: Botox, Dysport, Xeomin, Vistabex, Bocoture, etc. BoNT B is instead marketed under the name of Neurobloc or myobloc.

1.6.2

Different Toxins

Botulinum neurotoxins are synthesized together with different haemagglutinins and/or non-toxic non-haemagglutinin proteins that form a protein complex called progenitor toxin (See Table 1.2). The protein complex is used to stabilize and protect neurotoxin from degradation. The size and composition of nontoxic proteins in the complex vary depending on the bacterial strain. Different bacterial strains also produce different serotypes of boluninum toxin, known as types A, B, C1, D, E, F and G. The various serotypes form protein complexes of different sizes, in which only the type A forms the larger complex of approximately 900 kd. In all complexes, the portion of active neurotoxin is approximately the same size (150 kd) [53].

The neurotoxin is first synthesized as a single-chain protein that, in order to be active, must be cleaved or affected by the protease. The proteolytic cleavage yields a double-chain active molecule consisting of a heavy chain (approx. 100 kd) and a light chain (approx. 50 kd). At present, different medicinal products are registered and marketed and although they are all based on type A BoNT, they are manufactured according to different biological processes and obtained through different isolation and purification processes. Each type of BoNT has its own unit of measurement and the different units of measurement are not interchangeable. In 2009, the US Food and Drug Administration established that BoNTs should be identified unequivocally by means of a specific common denomination for each medicinal product marketed in the United States [52]. BoNTs have been named as follows: • onabotulinumtoxin A (equivalent to the medicinal product BOTOX or Vistabex); • abobotulinumtoxin A (equivalent to the medicinal product Dysport or Azzalure); • incobotulinumtoxin A (equivalent to the medicinal product Xeomin or Bocouture); • rimabotulinumtoxin B (equivalent to the medicinal product Myobloc or Neurobloc in Europe). This need arose from the consideration that, since BoNT is a product of biological origin, its biological activity, defined potency, cannot be determined with a standard methodology. In fact, potency should be determined for each product lot and, due to its high sensitivity, must be precisely

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determined and calculated during the entire production process of the toxin itself, from the bulk to the final lot. Potency is measured as units of biological activity using the test lethal dose 50 (DL50) defined as the quantity of a substance, per unit of body weight, that will kill 50 % of test animals. In recent years, Allergan Inc. has announced the approval of a test based on in vitro cells to be used for testing the stability and potency of the Allergan BoNT, thereby eliminating the need to perform tests on animals. This new assay is the first to be developed and approved and specifically applies to the type A BoNT manufactured by Allergan. A different name allows to confirm that the BoNTs are manufactured according to different biological processes, are obtained with different isolation and purification techniques and derive from different strains of the C. Botulinum. The different formulation and molecular structure can affect both the local diffusion of the toxin from the inoculation site and its potency characteristics which may affect its efficacy, safety profile as well as the antigenic potential of the product. The BoNT produced by Allergan derives from the clostridium strain called ‘Hall’ which undergoes several purification and crystallization steps (using the method developed by Schantz) which allow to obtain a homogenous neurotoxin complex with a molecular weight of 900kDA given by the presence of auxiliary proteins (haemagglutinins and non-haemagglutinins) that form complexes with the neurotoxin and are used to stabilize and protect the toxin from degradation [54]. As regards the other available preparations, one derives from the clostridium strain called NCTC 2916 which undergoes purification steps using chromatography, a technique that has been proven to generate a more heterogeneous compound, while the other contains pure neurotoxin with a molecular weight of 150Kda, free from complexing proteins [55, 56].

1.6.3

Use in Clinical Practice and Aesthetic Medicine

BoNTs used in aesthetic medicine are of type A and are indicated for the treatment of expression wrinkles (dynamic wrinkles). The effect of proper treatment with BoNT is to mitigate these signs at rest without affecting the mimicry of the patient or inhibiting muscles contraction.

1.6.4

Clinical Evaluation of the Patient

Before the injection of the toxin it is important to perform a careful physical examination of the upper third of the face

13

considering asymmetries, position of the eyelids and the presence of ptosis produced by the levator muscle of the eyelid. To exclude a ptosis, ask the patient to look forward, to put a hand on his forehead to block the frontal muscle in order to evaluate the actual activity of the levator muscle of the eyelid. The next step is to assess wrinkles in a sitting position and during mimic efforts look for possible contraindications. Once the suitability of the subject to injection has been established, photograph the face both in static and dynamic position to have a documentation prior to treatment. To proceed with the injection, it is necessary to inform the patient of the possible risks of side effects and let him/ her sign an informed consent to treatment.

1.6.5

Contraindications to Treatment

Contraindications to treatment with BoNT -A are: • diseases of the neuromuscular junction (myasthenia gravis, Lambert–Eaton syndrome); • allergy to human albumin and sodium chloride; • skin lesions of treated areas; • infection of the planned site for the injections; • recent surgical treatments; • pregnancy and lactation; • recent use of aminoglycoside antibiotics or other agents that interfere with neuromuscular transmission (spectinomycin, tubocurarin-type muscle relaxants).

1.6.6

Informed Consent

It is important to inform the patient about the good rules to follow during the hours after treatment, such as avoiding alcohol, avoiding excessive pressure on the affected area and exposure to excessive heat. The patient should be informed of possible side effects from the injection of BoNT, such as pain, weakness, itching, swelling or bruising at the injection site. The patient should be informed of the side effects that may occur in the hours following the treatment to enable him to associate the disorder to treatment and inform their doctor if necessary. These effects are divided into categories based on the frequency with which they occur: • Very common (1 in 10 patients): headache, local muscle movement disorders and feeling of heaviness in the upper part of the face; • Common (1–10 in 100 patients): eyelid oedema, eyelid ptosis, eyelid inflammation, eye pain, blurred vision, nausea, dizziness, dry mouth, cramps and muscle contraction, flu-like symptoms, itching and burning sensation

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in the treated area, infection, sensitivity to light, bronchitis, dry skin, fatigue, insomnia, depression; • Rare (1–10 in 10,000 patients): swelling, redness or rash and allergic reaction to the product; • Very rare (less than one in 10,000 patients): excessive muscle weakness, difficulty swallowing, and difficulty swallowing after inhalation of foreign bodies or inhaled irritants. The practitioner must also be aware of the possible reaction of the patient caused by fear, such as lightheadedness, nausea and ringing in the ears. The practitioner must compulsorily check the patient after about one week in order to evaluate the response to the toxin and any asymmetries correctable with a second injection.

1.6.7

Safety of Botulinum: Open Questions and State of the Art

Does botulinum toxin migrate to the brain? BoNT relaxes muscles peripherally, its direct effect on the brain has not been demonstrated. Some experimental data [57–59], concerning animal studies, assume a possible migration effect of the toxin. However, this effect is observed if using massive doses of toxin well above the therapeutic doses that are commonly used and recommended. As of today, this data have not been confirmed by clinical studies on humans. Does botulinum toxin determine distant effects from the injection site? BoNT sometimes can diffuse distally from the injection site [60] according to some investigations. However, this does not determine significant clinical consequences. Clinical symptoms that might be observed and attributed to the diffusion phenomena are mainly fatigability and asthenia [61, 62]. However, at the standard recommended doses, the diffusion has been observed only very rarely and has never resulted in serious consequences [63]. Does botulinum toxin block muscles and cause neuronal damages? BoNT blocks muscles since this represents its therapeutic effect inducing a temporary chemical denervation. This determines a muscle relaxation whose entity might be modulated according to the dose, the targeted muscles and desired therapeutic and aesthetic effect. The key benefit of the toxin is based on its temporary and totally reversible effects [64–66] and thus it cannot provoke either neurologic permanent or long-term damages. Does botulinum toxin cause undesired/side effects that are irreversible? No. Actually, due to its mechanism of action and its pharmacological characteristics, the side effects that have been observed are totally reversible and temporary [67, 68].

Does botulinum toxin freeze the expression of the face? No, if the toxin is administered according to the appropriate dosage and after an accurate preliminary evaluation [69]. A frozen expression might be observed if the toxin is used at high doses/dilutions or if the injection is not properly done. Is botulinum toxin a poison? ‘All things are poisons and there is nothing that is harmless, the dose alone decides that something is no poison’—Paracelsus (1493–1541). Yes, it is commercially available as a pharmaceutical product, and a pharmaceutical product is, at the end, a poison [70]. Can botulinum toxin kill? A review of scientific literature shows that death after Botox administration for cosmetic indications had never been documented with standard approved formulations. Li et al. [71] reported the first death associated with a Botox–lidocaine mixture given to a woman for chronic neck and back pain. The cause of death was determined to be anaphylaxis to the Botox–lidocaine mixture. Chertow et al. [72] described botulism after cosmetic injections of BoNT in four patients. An unlicensed and highly concentrated preparation was used with Doses 2,857 times the estimated human lethal dose of BoNT. Pretreatment serum toxin levels in 3 of the 4 case-patients were equivalent to 21–43 times the estimated human lethal dose, a box of toxin taken from the same manufacturer’s lot contained a toxin amount sufficient to kill approximately 14,286 adults. The obvious alert is that botulin toxin is a drug and that black or grey market products can kill!

1.7

Platelet-Rich Plasma

Alessandro Di Petrillo Platelet-rich plasma (PRP) is an autologous concentration of human platelets in a small volume of plasma. Since it is a concentration of platelets, it is also a concentration of the protein growth factors contained in platelets. Those factors are proven to be important to initiate all wound healing [73].

Table 1.2 Definition of PRP—FDA specified standards for PRP pH over 6.2 Mean platelet recovery C50 % The platelet viability and integrity must be demonstrated by the ability to: ••Express P-selectin upon specific ADP stimulation ••Resist to a hypotonic stress ••Aggregate in response to collagen

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15

Table 1.3 Comparison of medical devices for PRP preparation Technology

Device name

Concentration factor

Platelet recovery (%)

Blood vol. (ml)

Vol. of PRP (ml)

Specific apparatus

Product

Floating buoy or shelf

Biomet

6-9 X

70

27

3

Yes

Buffy coat product: concentrated platelets, concentrated white blood cells and variable amount of red blood cells

4X

70

18

3

Yes

4X

70

40

4

Yes

5X

65

26

6

Yes

1.2 X

65

8

4.5

No

RegenTHT

1.7 X

>95

8

4.5

No

RegenBCT

1.6 X

>80

8

4.5

No

Arthrex ACP

2X

\60

10

3

Yes

BTI PRGF

2-3 X

\50

8

4

No

GPS III Harvest SmartPrep2

Computer aided systems

Cytomedix Angel Arteriocyte Magellan

Separating gel

Cascade Fibrinet Selphyl

Centrifugation and manual aspiration

Platelet suspension in plasma, physiological or lower value of white blood cells, very low contamination of red blood cells

No physical separation of red blood cells. Operator dependant results

Endoret

PRP is more than just a platelet concentrate (Table 1.2), and it also contains proteins in plasma known to act as a matrix for bone, connective tissue and epithelial migration (fibrin itself, fibronectin and vitronectin) (Table 1.3). There are many different PRP kits. A brief revision of the main commercially available kits is reported. It should be noted that really high platelet concentrations are not necessarily associated with better results. Some studies demonstrated that not so high concentration PRP show better results for wound healing than too highly concentrated PRP, with better results when platelets where 2.5 times more concentrated than physiologically [74–77]. Therefore preparation devices that yield higher concentrations should be avoided. Devices containing separating gel allow regulation of concentration. Results are probably more associated with the total number of available platelets recovered then with their concentration.

1.7.1

Mechanism of Action

PRP works trough the degranulation of the granules contained in platelets (Table 1.4). The active secretion of these growth factors is initiated by the clotting process of blood and begins within 10 min after clotting. More than 95 % of the pre-synthesized growth factors are secreted within 1 h. Therefore, PRP must be developed in an anticoagulated state and should be used within 10 min of clot initiation (Fig. 1.7).

Table 1.4 Growth factors in PRP TGFbeta

Transforming growth factor b

Stimulates cell proliferation

PDGFAB

Platelet-derived growth factor

Stimulates cell proliferation

bFGF

Fibroblast growth factor

Stimulates fibroblasts proliferation

IGF

Insulin-like growth factor

Stimulates cell proliferation

Promotes extracellular matrix production Stimulates angiogenesis Stimulates fibroblasts chemotaxis

Promotes collagen synthesis Stimulates fibroblasts migration

VEGF

Vascular endothelial growth factor

Stimulates endothelial cell proliferation and migration

EGF

Epidermal growth factor

Stimulates angiogenesis Regulates extra cellular matrix turnover Stimulates fibroblasts migration and proliferation

After the initial burst of PRP-related growth factors, the platelets synthesize and secrete additional growth factors for the remaining 7 days of their life span. Once the platelet is exhausted and dies off, the macrophage, which has reached the region via the vascular in-growth stimulated by the platelets, assumes the function of wound healing regulation by secreting some of the same growth factors as well

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Fig. 1.7 Process of wound healing

as others. Therefore, the number of platelets in the blood clot within the graft sets the rate of wound healing. PRP merely increases this number. Pro-inflammatory and growth factors also contained in white blood cells play an important role. In particular, monocytes and lymphocytes are capable of producing growth factors (VEGF and TGFb) and other proangiogenic factors that play an essential role in neo vascularization and granulation tissue formation. They are also involved in matrix remodelling and resolution of fibrosis. Neutrophils are instead associated with tissue damage, delayed rates of healing and increased risk of scar.

1.7.2

Indications

In Aesthetic Medicine and surgery PRP is indicated for: • Biorejuvenation of the skin, when injected intradermally. • Hair regrowth in male and female with alopecia androgenetica. • Hair thickening in both sexes. • Mixed with fillers and graft of alloplastic biomaterials. • Mixed with fat graft in lipo-sculpturing.

1.7.3

1.7.4

Methods

Step 1: Collecting whole blood Perform a venous puncture using the butterfly needle connected to the collection holder. Wait for the presence of blood in the flexible tube, under the yellow plastic section (the blood is visible over 1–2 mm). Pierce the stopper of the tube to fill with the whole blood using the internal needle of the collection system. The vacuum within the tube will enable automatic collection of the necessary volume of blood (about 8 ml). Carefully turn the tube upside down several times (Figs. 1.8, 1.9, 1.10, 1.11, 1.12). Step 2: Centrifugation It is essential to always correctly balance the centrifuge before starting it. If necessary, fill a counterbalance tube with water until it reaches the same volume as the blood in the collecting tube. Insert the filled tubes into the centrifuge facing each other to balance the machine.

How To

Important tip: the patient should be asked to interrupt any Non-Steroideal Anti-Inflammatory Drugs (NSAIDs) for at least 3 days before the treatment (7 days would be better) since this drugs inhibit Platlet Activation and hence PRP effect. Atypical NSAIDs such as Acetaminophene (Paracetamol) or Metamizole (Noramidopirine) can be used instead if necessary. In this section, we explain how to obtain a PRP. RegenLab RegenACR EXTRA Kit were used.

Fig. 1.8 Picture of the kit

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Fig. 1.9 Illustration of the content of the kit

Fig. 1.10 Instructions for whole blood collection and centrifugation

Fig. 1.11 Picture of venous access

Fig. 1.12 Venous blood collection

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Fig. 1.13 Centrifugation Fig. 1.14 Results of centrifugation

Centrifuge for 5–10 min at 1,500 g. Pay attention: centrifugation speed (expressed in Revolutions Per Minute, rpm) does not match with the centrifugation power (expressed in g). Check your centrifuge manual to find the correspondence (Fig. 1.13). Step 3: Centrifugation results After centrifugation, the blood is fractionated; the red blood cells are trapped under the gel, and cellular elements settle on the surface of the gel (Fig. 1.14). Step 4: Homogeneization By gently inverting the Regen BCT tubes several times, proceed to the re-suspension of the cellular deposit in the supernatant. About 4 ml of PRP will be obtained for each tube (Fig. 1.15). Step 5: Collecting the (PRP) in a syringe Collect the desired quantity of PRP with a 5-ml LuerLock syringe previously screwed to the transfer device (Fig. 1.16a, b). Step 6: (Optional): Addition of Calium Gluconate: Calcium gluconate is a pro-coagulant and inhibits the effects of the sodium citrate anticoagulant used in the tube. Theoretically, calcium gluconate should enhance PRP effects by inducing a fast clotting formation.

Calcium gluconate is sold as a 10 % sterile solution or can be found in commercial kits. Calcium gluconate is preferable to calcium chloride (10 %) since it contains 3 times less calcium per mL and is much easier to calibrate. An excess of calcium in the solution inhibits the clotting formation, hence the PRP effect. Stimulating the clotting formation through calcium should instead enhance the platelet activation and create a solution that will coagulate immediately after the injection. Clotting formation in dermis creates a ‘growth factor richmatrix’ which must be reabsorbed through granulation tissue formation and monocyte activation, multiplying the effect of the PRP. The maximum calcium gluconate addition should be 0.1 mL for each millilitre of PRP obtained (Fig. 1.17) (Table 1.5). This ‘calcium gluconate/PRP’ ratio yields the fastest clotting formation, obtaining a clot in 3–10 min depending on individual factors. This time is sometimes is too short and implies intra-syringe clotting formation and loss of the product contained in the syringe. Hence, lower ratios are recommended, such as 0.05 mL calcium gluconate per millilitre of PRP, which results in a 10–20 min clotting formation time (Figs. 1.17, 1.18, 1.19).

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19

Fig. 1.15 Platelets and plasma homogeneization

Fig. 1.16 a, b Collecting the (PRP) in a syringe

Fig. 1.17 Aspiration of 0.09 mL of CaGlu in a 1 mL syringe

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Fig. 1.18 Transfer of 0.91 mL of PRP in the previously CaGlu loaded 1 mL syringe

Fig. 1.19 The 1 mL syringe is loaded with 0.09 mL of CaGlu and 0.91 mL of PRP

Table 1.5 Calcium gluconate Calcium gluconate 10 % (mL)/ PRP (mL) ratio

Mean empiric coagulation time (min)

[0.1

Massive uncontrolled clotting formation

0.1 (0.1 mL CaGlu per mL PRP)

3–10 min

0.05 (0.05 mL CaGlu per mL PRP)

10–20 min

Step 7: Injection PRP can be used on scalp for hair regrowth, intradermally for skin rejuvenation, or as filler when mixed with calcium hydroxylapatite. For biorejuvenation With or without calcium gluconate addition, injected superficially, in the dermis. Multiple small injections, picottage technique. For scalp With or without calcium gluconate addition, injected superficially, in the dermis. Multiple small injections, picottage technique (Fig. 1.20).

Fig. 1.20 Injection in the scalp

The combination of calcium hydroxylapatite (Radiesse) with PRP has the aim inducing collagen formation. Due to the elevated content of growth factors, PRP should induce new collagen matrix formation and possibly transform a filler in a cell-populated autologous tissue [85].

1.8.1

1.8

Combining PRP with Calcium Hydroxylapatite (Radiesse) as a Filler

A large number of publications document the efficacy of PRP, especially on bone graft transplantation. Several studies, especially those conducted by Marx et al., document a reduced healing time and a better engraftment in alveolar bone grafting using auto-transplantation, xeno-transplantation, Porous polyethylene [Medpor] or the use of heterologous calcium hydroxylapatite sponge matrix [78–84].

How To

A detailed discussion on how to perform a malar area augmentation with this technique is reported in Chap. 6.7.

1.9

Summary

An overview of the materials most commonly used in aesthetic medicine is given in Table 1.6, with some examples of their trademarks and the areas where they are commercialized.

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21

Table 1.6 Overview of the most common materials used in aesthetic medicine as fillers and some examples of their commercial name class

Commercial name

Company

Commercialization

Chapter

PARAFFIN

Liquid paraffin

No company

Do not use

1.1

SILICONE

Liquid silicone

No company

Do not use

1.1.1

BOVINE COLLAGENE

Zyderm I, II and Zyplast

Inamed an Allergan division

not available

1.2.1

PORCINE COLLAGENE

Evolence

Johnson and Johnson

not available

1.2.1

AUTOGENIC HUMAN COLLAGEN

Autologen

Collagenesis

USA

1.2.3

ISOGENIC HUMAN COLLAGEN

Alloderm, Cymetra

Lifecell

USA, European Union

1.2.4

Isogenic human collagen

Dermalogen

Collagenesis

USA

1.2.4

Low viscosity Hyaluronic Acid

Medium viscosity HA

Hight viscosity HA

Belotero soft

Merz

Europe

24.2

Emervel touch

Galderma

Europe

24.4

Glytone 1 and 2 filler

MerzPharma

Europe

24.5

Hyacorp fine

BioSience GmbH

Europe, Japan and Middle East

24.6

Ephyal

BioSience GmbH

Italy, Russia, Ukraine

24.6

Juvederm Hydrate

ALLERGAN

Europe

24.7

NEWEST and IALEST

MASTELLI SRL

Europe and Russia

24.15 and 24.18

Restylane Vital and Vital Light

Galderma

Europe

24.21

Surgiderm 18XP

Allergan

Europe

24.22

Belotero basic and B.intense

Merz

Europe

24.2

Emervel classic, deep, and lips

Galderma

Europe

24.4

Glytone 3 amd 4 filler

MerzPharma

Europe

24.5

Hyacorp face and lips

BioSience GmbH

Europe, Japan and Middle East

24.6

Juvederm ULTRA 2 ,3 and 4, ultra smile,VolbellaamdVolift

ALLERGAN

Europe

24.8- 24.12

Haequo and haequo plus

Genethia

Europe

24.13

Restylane, R. Perlane, R.Lip volume and R.Refresh

Q-med a Galderma division

Europe and USA

24.20

Surgiderm 24XP and 30XP

Allergan

Europe

24.22

Emervel Volume

Galderma

Europe

24.4

Hyacorp H/S 500 and Hyacorp L

BioSience GmbH

Europe, Japan and Middle East

24.6

JuvedermVoluma

ALLERGAN

Europe

24.10- 12

Restylane Sub Q

Q-med a Galderma division

Europe and USA

24.20

Glytone 4 Filler

MerzPharma

Europe

24.5 (continued)

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M. Goisis et al.

Table 1.6 (continued) class MACROFILLERS

Commercial name

Company

Commercialization

Chapter

MacrolaneVrf 20 and Vrf 30

Q-med a Galderma division

Europe

24.14

Hyacorp H 1000

BioSience GmbH

Europe, Japan and Middle East

24.6

Calcium Hydroxylapatite

Radiesse

MerzPharma

Europe, Asia/South Pacific, Africa, Latin America, Middle East and North America

24.19

BOTULINUM TOXIN (BoNT)

Bocoture (Xeomin, Xeemin)

Merz

Europe and USA

24.23 and 1.6

Dysport

Medicis

USA

1.6 and 24.1

Vistabex Vistabel (Botox)

Allergan

Europe, USA, Asia

1.6 and 24.23

Azzalure

Galderma

Europe

24.1 and 1.6

Acknowledgement Heartfelt thanks go to Marco Zoccolan of Regen Lab

References 1. Murray CA, Zloty D, Warshawski L (2005) The evolution of soft tissue fillers in clinical practice. Dermatol Clin 23:343–363 2. Feldmann H (2000) History of injections. Pictures from the history of otorhinolaryngology highlighted by exhibits of the German History of Medicine Museum in Ingolstadt. Laryngorhinootologie 79:239–246 3. Goldwyn RM (1980) The paraffin story. Plast Reconstr Surg 65:517–524 4. Glicenstein J (2007) The first ‘‘fillers,’’ vaseline and paraffin: from miracle to disaster [in French]. Ann Chir Plast Esthet 52:157–161 5. Uchida Y, Yoshii N, Kubo H et al (2007) Facial paraffinoma after cosmetic paraffin injection. J Dermatol 34:798–800 6. Di Benedetto G, Pierangeli M, Scalise A, Bertani A (2002) Paraffin oil injection in the body: an obsolete and destructive procedure. Ann Plast Surg 49:391–396 7. Humble G, Mest D (2004) Soft tissue augmentation using silicone: an historical review. Facial Plast Surg 20:181–184 8. Ficarra G, Mosqueda-Taylor A, Carlos R (2002) Silicone granuloma of the facial tissues: a report of seven cases. Oral Surg Oral Med Oral Pathol Oral Radiol Endod 94:65–73 9. Orentreich DS, Orentreich N (1989) Injectable fluid silicone. In: Roenigk RK, Roenigk HH Jr (eds) Dermatologic surgery: principles and practice. Marcel Dekker, New York, pp 1349–1395 10. Webster RC, Fuleihan NS, Gaunt JM et al (1984) Injectable silicone for small augmentations: twenty-year experience in humans. Am J Cosm Surg 1:1–7 11. Fagien S, Elson ML (2001) Facial soft-tissue augmentation with allogeneic human tissue collagen matrix (Dermalogen and Dermaplant). Clin Past Surg 28:63–81 12. Klein AW (1989) In favor of double testing. (Editorial). J Dermatol Surg Oncol 15:263 13. Bejot M, Schnitzler I, Hartmann DJ, Charrière G (1988) Implant de collagène bovin: étude clinique et immunologique. J Méd ESTU Chir Derm 15:337–342 14. Pons-Guiraud A (1992) Réactions d’hypersensitivité retardée aux implants de collagène bovin. Etude sur 810 patients. Nouv Dermatol 11:422–432

15. Castrow FF 2nd, Krull EA (1983) Injectable collagen implant— update. J Am Acad Dermatol 9:889–893 16. Hanke CW, Higley HR, Jolivette DM, Swanson NA, Stegman SJ (1991) Abscess formation and local necrosis after treatment with Zyderm or Zyplast collagen implant. J Am Acad Dermatol 25:319–326 17. Fagien S (2000) Facial soft-tissue augmentation with injectable autologous and allogeneic human tissue collagen matrix (Autologen and Dermalogen). Plast Reconstr Surg 105:362–373 18. DeVore DP, Kelman CD, Fagien S, Casson P (1996) Autologen: autologous, injectable dermal collagen. In: Bosniak S (ed) Principles and practice of ophthalmic plastic and reconstructive surgery. Saunders, Philadelphia, pp 670–675 19. Beran SJ, Rohrich RJ (1997) The potential role of autologous, injectable, dermal collagen (Autologen) and acellular dermal homograft (AlloDerm) in facial soft tissue augmentation. Aesthetic Surg J 17:420–422 20. Boss WK Jr, Usal H, Chernoff G et al (2000) Autologous cultured fibroblasts: a protein repair system. Ann Plast Surg 44:536–542 21. Alster TS, West TB (2000) Human-derived and new synthetic injectable materials for soft-tissue augmentation: current status and role in cosmetic surgery. Plast Reconstr Surg 105:2515–2525 22. Ellis DA, Makdessian AS, Brown DJ (2001) Survey of future injectables. Facial Plast Surg Clin North Am 9:405–411 23. Alkek DS (1998) Isolagen: a new autologous collagen technique. Am J Cosm Surg 18:325–328 24. Fagien S, Elson ML (2001) Facial soft-tissue augmentation with allogeneic human tissue collagen matrix (Dermalogen and Dermaplant). Clin Past Surg 28:63–81 25. Sclafani AP, Romo T 3rd, Jacono AA (2002) Rejuvenation of the aging lip with an injectable acellular dermal graft (Cymetra). Arch Facial Plas Surg 4:252–257 26. Sclafani AP, Romo T 3rd, Parker A et al (2002) Homologous collagen dispersion (Dermalogen) as a dermal filler: persistence and histology compared with bovine collagen. Ann Plast Surg 49:181–188 27. Elson ML (1999) Human tissue collagen matrix vs bovine collagen: a side-byside same patient comparison. Cosm Dermatol 9 28. Moody BR, Sengelmann RD (2000) Self-limited adverse reaction to human derived collagen injectable product. Dermatol Surg 26:936–938 29. Gomez-de la Fuente E, Alvarez-Fernandez JG, Pinedo F, Naz E, Gamo R, Vicente-Martin FJ, Lopez-Estebaranz JL (2007)

1

30.

31.

32.

33.

34. 35.

36.

37.

38.

39.

40.

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42. 43. 44.

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Fillers in Aesthetic Medicine Cutaneous adverse reaction to bio-alcamid implant. Actas Dermosifiliogr 98(4):271–275. doi:13102006 Klein AW, Elson ML (2000) The history of substances for soft tissue augmentation. Dermatol Surg 26(12):1096–1105. doi: dsu00512 Heden P, Sellman G, von Wachenfeldt M, Olenius M, Fagrell D (2009) Body shaping and volume restoration: the role of hyaluronic acid. Aesthetic Plast Surg 33(3):274–282. doi: 10.1007/s00266-008-9303-y McCleave MJ (2010) Is breast augmentation using hyaluronic acid safe? Aesthetic Plast Surg 34(1):65–68. doi:10.1007/ s00266-009-9450-9 (discussion 69–70) Broder KW, Cohen SR (2006) An overview of permanent and semipermanent fillers. Plast Reconstr Surg 118(3 Suppl):7S–14S. doi:10.1097/01.prs.0000234900.26676.0b Fumihiko I, Toshiya H, Kazuaki S (2006) Hyaluronic acid breast augmentation. Jap J Plast Reconstr Surg 49:1335–1341 Goisis M, Savoldi A, Guareschi M (2011) Is hyaluronic acid gel a good option for breast augmentation? Aesthetic Plast Surg 35(1):134–136 (Feb) Goisis M, Savoldi A, Guareschi M (2011) Is hyaluronic acid gel a good option for breast augmentation? Aesthetic Plast Surg 35(1): author reply 137 (Feb) McCleave MJ, Grover R, Jones BM (2010) Breast enhancement using macrolane: a report of complications in three patients and a review of this new product. J Plast Reconstr Aesthet Surg. doi: 10.1016/j.bjps.2010.02.021 Goisis M, Yoshimura K, Heden P (2011) Breast augmentation after macrolane filler injection. Aesthetic Plast Surg. 35(4):684–686 (Aug) Goisis M, Casale A, Guareschi M (2011) Hyaluronic acid breast injections: difficulties for mammographic monitoring. Cir Esp 89(2):125 (Feb) Pienaar WE, McWilliams S, Wilding LJ, Perera IT (2011) The imaging features of MACROLANETM in breast augmentation. Clin Radiol 66(10):977–983 Goisis M (2011) Macrolane complications after breast augmentantion: treatment and prevention. Eur J Plast Surg 35(1):65–71 (Jan 2012) Goldberg DJ (2006) Calcium hydroxylapatite. Fillers in cosmetic dermatology. Informa UK Ltd, Abingdon Hubbard W (2003) BioForm implants: biocompatibility. Bioform, Inc. Franksville, Wis Marmur ES, Phelps R, Goldberg DJ (2004) Clinical, histologic, and electron microscopic findings after injection of a calcium hydroxylapatite filler. J Cosmet Laser Ther 6:223 Hubbard W (2002) BioForm implants: durability. Franksville, Wis.: Bioform, Inc. http://www.radiesse.com/pdf/Durability.pdf. Accessed June 10 2007 Jones JK (2006) Patient safety considerations regarding dermal filler injections. Plast Surg Nurs 26:156 Ahn MS (2007) Calcium hydroxylapatite: radiesse. Facial Plast Surg Clin North Am 15:85 Smith S, Busso M, McClaren M et al (2005) A six-month randomized, bilateral, prospective comparison of calcium hydroxylapatite microspheres in a gel carrier versus human based collagen for the correction of nasolabial folds. Poster presented at the American Society for Dermatologic Surgery (ASDS) meeting, Atlanta, Ga., Oct 27–30 Moers-Carpi MM, Tufet JO (2008) Calcium hydroxylapatite versus nonanimal stabilized hyaluronic acid for the correction of nasolabial folds: a 12-month, multi-center, prospective, randomized, controlled split-face trial. Dermatol Surg 34(2):210–215

23 50. Brin MF et al (2004) Pharmacology of Botulinum Toxin Therapy. In: Dystonia: etiology, clinical features, and treatment. Lippincott Williams & Williams, pp 93–112 51. Kopera D (2011) Botulinum toxin historical aspects: from food poisoning to pharmaceutical. Int J Dermatol 50:976–980 52. Albanese A (2011) Terminology for preparations of botulinum neurotoxins: what a difference a name makes. JAMA 305(1): 89–90 (Jan 5) 53. Aoki KR (2005) Pharmacology and immunology of botulinum neurotoxins. Int Ophtalmol Clinics 45(3):25–37 54. Schantz EJ et al (1992) Properties and use of botulinum toxin and other microbial neurotoxins in medicines. Microbiol Rev 56:80–99 55. Inoue K et al (1996) Molecular composition of Clostridium botulinum type A progenitor toxins. Infect Immun 1589–1594 56. Hambleton P et al (1981) Production, purification and toxoiding of Clostridium botulinum type A toxin. In: Lewis GE (ed) Biomedical aspects of botulinum. Academy Press, New York, pp 247–260 57. Antonucci F et al (2008) Long-distance retrograde effects of botulinum neurotoxin A. J Neurosci 28(14):3689–3696 58. Restani L et al (2011) Evidence for anterograde transport and transcytosis of botulinum neurotoxin A (BoNT/A). J Neurosci 31(44):15650–15659 59. Wiegand et al. 1976–1977 60. Frick CG et al (2012) A single injection of botulinum toxin decreases the margin of safety of neurotransmission at local and distant sites. Anesth Analg 114:102–109 61. Vistabex Summary of product characteristics 62. Botox Summary of product characteristics 63. Currà A, Berardelli A (2009) Do the unintended actions of botulinum toxin at distant sites have clinical implications? Neurology 72(12):1095 64. Cobb DB et al (2000) Botulism-like syndrome after injections of botulinum toxin. Vet Hum Toxicol 42(3):163 65. Huang W et al (2000) Pharmacology of botulinum toxin. J Am Acad Dermatol 43(2 Part 1):249–259 66. Borodic GE, Ferrante RJ (1992) Effects of repeated botulinum toxin injections on orbicularis oculi muscle. Clin Neuroophthalmol 12:121–127 67. Brin MF, Boodhoo TI, Pogoda JM et al (2009) Safety and tolerability of onabotulinumtoxinA in the treatment of facial lines: a meta-analysis of individual patient data from global clinical registration studies in 1678 participants. J Am Acad Dermatol 61:961–970 68. Carruthers A, Carruthers J, Lowe NJ et al (2004) One-year, randomized, multicenter, two-period study of the safety and efficacy of repeated treatments with botulinum toxin type A in patients with glabellar lines. J Clin Res 7:1–20 69. Carruthers JA et al (2002) A multicenter, double-blind, randomized, placebo-controlled study of the efficacy and safety of botulinum toxin type A in the treatment of glabellar lines. J Am Acad Dermatol 46(6):840 70. Heckmann M, Breit S (2000) Botulinum toxin. A neurotoxin for dermatologic therapy (article in German). Hautartz 51(11): 874–889 71. Li M, Goldberger BA, Hopkins C (2005) Fatal case of BOTOXrelated anaphylaxis? J Forensic Sci 50:1 72. Chertow DS, Tan ET, Maslanka SE, Schulte J, Bresnitz EA, Weisman RS, Bernstein J, Marcus SM, Kumar S, Malecki J, Sobel J, Braden CR (2006) Botulism in 4 adults following cosmetic injections with an unlicensed, highly concentrated botulinum preparation. JAMA 296:2476 73. Marx RE (2004) Platelet-rich plasma: evidence to support its use. J Oral Maxillofac Surg 62:489–496

24 74. Rappl LM et al (2011) Effect of platelet-rich plasma gel in a physiologically relevant platelet concentration on wounds in persons with spinal cord injury. Int Wound J 8:187–195 75. Weibrich G et al (2004) Effect of platelet concentration in plateletrich plasma on peri-implant bone regeneration. Bone 34:665–671 76. Yamaguchi R et al (2012) Effects of platelet-rich plasma on intestinal anastomotic healing in rats: PRP concentration is a key factor. J Surg Res 173(2):258–266 77. Graziani F et al (2006) The in vitro effect of different PRP concentrations on osteoblasts and fibroblasts. Clin Oral Impl Res 17:212–219 78. Marx RE, Carlson ER, Eichstaedt R et al (1998) Platelet rich plasma: growth factor enhancement for bone grafts. Oral Surg Oral Med Oral Pathol Oral Radiol Endod 85:638 79. Garg AK (2000) The use of platelet rich plasma to enhance the success of bone grafts around dental implants. Dent Implantol Update 11:17 80. Adler SC, Kent KJ (2002) Enhancing healing with growth factors. Facial Plast Surg Clin North Am 10:129

M. Goisis et al. 81. Camargo PM, Lekovic V, Weinlander M et al (2002) Platelet rich plasma and bovine porous bone mineral combined with guided tissue regeneration in the treatment of intrabony defects in humans. J Periodont Res 37:300 82. Kim SG, Chung CH, Kim YK et al (2002) Use of particulate dentinplaster of Paris combination with/without platelet rich plasma in the treatment of bone defects around implants. Int J Oral Maxillofac Implant 17:86 83. Kassolis JD, Rosen PS, Reynolds MA (2000) Alveolar ridge and sinus augmentation utilizing platelet rich plasma in combination with freeze-dried bone allograft. Case series. J Periodont 71: 1654 84. Froum SJ, Wallace SS, Tarnow DP et al (2002) Effect of platelet rich plasma on bone growth and osseointegration in human maxillary sinus grafts: three bilateral case reports. Int J Periodont Restor Dent 22:45 85. Slater M, Patava J, Kingham K et al (1995) Involvement of platelets in stimulating osteogenic activity. J Orthop Res 13:655

2

Aesthetic Analysis of the Face: The Maxillofacial Deformity Giada Anna Beltramini, Francesco Lagana`, Alessandro Baj, Michele Romano, Antonio Russillo, and Aldo Bruno Giannı`

2.1

Facial Analysis

Facial analysis involves evaluation of functional and aesthetic disharmonies. It is important to appreciate what constitutes ones own perceptions of beauty and how the clinician can translate this into successful clinical results [1–4]. Facial analysis together with clinical bite examination should provide good diagnosis and treatment plan. Facial analysis identifies positive and negative facial traits and dictates how the bite will be corrected to optimize aesthetic facial goals. ‘The bite indicates a problem; the face indicates how to treat the bite’ Arnett affirms [5]. Ideal occlusal harmony is achieved with the desired cosmetic facial changes. These facial changes dictate what orthodontic or surgical procedures or medical aesthetic treatment should be chosen [6]. Natural head position, centric relation, first tooth contact and relaxed lip position are necessary to accurately assess the face. The patient should be in relaxed lip position to demonstrate the relationship of soft tissues relative to hard tissues without muscular compensation for dentoskeletal abnormalities. The clinical examination starts from the oral cavity: the occlusal classification is determined, and the degrees of incisor overlap and overjet are quantified (Table 2.1), (Figs. 2.1, 2.2, 2.3). The maxillary and mandibular dental midlines are assessed to determine whether they are congruent with each other and with the facial midline. Deviations are noted and quantified. The presence and degree of dental compensation is also recorded. Dental compensation is the tendency of teeth to tilt in a direction that minimizes the dental mal-

Table 2.1 Occlusal classifications and orthodontic terminology Class I occlusion

The mesiobuccal cusp of the first permanent maxillary molar occludes in the buccal groove of the permanent mandibular first molar

Class II malocclusion

The mesiobuccal cusp of the first permanent maxillary molar occludes mesial to the buccal groove of the permanent mandibular first molar

Class III malocclusion

The mesiobuccal cusp of the first permanent maxillary molar occludes distal to the buccal groove of the permanent mandibular first molar

Overjet

Overjet is a horizontal (anterior-posterior) distance, of the upper incisors ahead of the lower incisors. Normal overjet is between 1 and 3 mm

Negative overjet

Negative overjet or reverse overjet is where the upper incisors are behind the lower incisors

Overbite

Overbite is a vertical distance, the maxillary incisors overlap the mandibular incisors. Normal overbite is between 3 and 5 mm

Open bite or apertognathia

Overbite B0 mm. Is a type of malocclusion characterized by the occlusion of posterior teeth without anterior occlusion

See Fig. 2.1

See Fig. 2.2

See Fig. 2.3

See Fig. 2.3

See Fig. 2.5 Deep bite

Deep bite is an increase of the overbite ([5 mm)

Crossbite

Crossbite is an occlusal irregularity where a tooth (or teeth) has a more vestibular or lingual position than its corresponding antagonist tooth in the upper or lower arcade

See Fig. 2.7

See Fig. 2.5

G. A. Beltramini  F. Laganà  A. Baj  M. Romano  A. Russillo  A. B. Giannì (&) Maxillofacial Surgery, Ospedale Maggiore Policlinico, via Sforza 35, 20123 Milan, Italy e-mail: [email protected]

M. Goisis (ed.), Injections in Aesthetic Medicine, DOI: 10.1007/978-88-470-5361-8_2,  Springer-Verlag Italia 2014

occlusion. Compensation will camouflage the deformity and restore proper overjet and overlap. If orthodontic tooth movement cannot produce the necessary facial changes, then surgery should be indicated.

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Fig. 2.3 Class III malocclusion

which artist were inspired in every period of history for their representations (Da Vinci, Vitruvio, Botticelli). Some features symbolize an idea or feeling and inspire emotions absolutely unique in the observer. ‘Regions of Interest’, or ‘facial points of interest’, theorized from Yarbus, are angles, maximal curvature points and unpredictable curve of the outline (curve that change in the different positions of vision): the lip commissure and the lateral and medial Fig. 2.1 Intraoral photograph of Class I occlusion (a). Despite normal interdental relationships, the aesthetical examination of the same patient (b) documents a jaws biprotrusion. The surgical correction consisted of superior and inferior dentoalveolar osteotomies. (c) Postoperative lateral view

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Fig. 2.2 Class II malocclusion 1/3

2.2

What’s Beauty?

Clinical facial analysis [7] defines appearance, proportions, volumes, symmetry and visible deformities; it is a crucial phase of surgical planning that can visualize, evaluate and prioritize existing problems. But what determines beauty? The canons of beauty have changed over time. The harmony of shapes related to ‘gold number’ or ‘divine proportion’ to

Fig. 2.4 Frontal facial analysis. The ideal face is vertically divided into equal thirds by horizontal lines adjacent to trichion, glabella, nasal base, and menton. The lower third is divided into two parts: the upper lip makes up the upper third, and the lower lip and chin compose the lower two-thirds

2

Aesthetic Analysis of the Face: The Maxillofacial Deformity

Fig. 2.5 Long face syndrome. A ‘long face’ is a long, narrow face, with anterior and posterior maxillary overgrowth, a narrow alar base and lip incompetence. Cephalometric analysis demonstrates steep mandibular and occlusal planes in relationship to the cranial base, and increase in facial height and retroposition of the mandible. Evaluation of study models exhibits increased alveolar bone height, a high palatal vault, and a narrow maxillary arch. The dental relationship may be Class I, II or III (with Class II being the most common), with or without open bite. Clinical (a) and intraoral (b) views of long face, II class, transversalmaxillaryhypoplasia. The treatment plan is divided in two steps: first an orthosurgical expansion, second a Le Fort I maxillary osteotomy for superior repositioning of the maxilla, BSSO and mentoplasty. c and d pictures show the aesthetic and occlusal improvements after surgery

canthus are angular points of interest; the root of the nose and the labial-mental furrow are concavities and the tip of the nose, superior and inferior lip and chin are convexities. In the past, notions of beauty were envisaged as arbitrary cultural conventions with no uniformly accepted standard of what constitutes an attractive face. However, during the last decade, a greater understanding of the shared preferences for attractive faces has led researchers to regard certain aspects of facial attraction as inherent and definable, transcending social and cultural fashions. Some studies suggested that female face attractiveness is greater when the face is symmetrical, is close to the average, and has certain features (e.g. large eyes, prominent cheekbones, thick lips, thin eyebrows and small nose and chin) [8, 9]. Symmetry is a characteristic of attractive faces, but there are some exceptions to the rule. Under certain conditions, symmetry can be completely unattractive; the visual impact of symmetry on the perception of beauty increases significantly when approaching the midline [10]. The frontal facial view (Fig. 2.4) [11] provides information on the midlines, levels, outline and heights of the face. In particular, orbital rim, subpupil and alar base contours are noted. Vertical facial planning of facial or occlusal cants, midline deviations and

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Fig. 2.6 Short face syndrome. A ‘short face’ is marked by Class II malocclusions with skeletal deep bite and reduced facial height. Treatment is aimed at establishing a proper lip–incisor relationship. The facial skeleton should be expanded to the degree that provides optimal soft-tissue aesthetics. Inferior repositioning of the maxilla and clockwise mandibular rotation is indicated to improve facial aesthetics and function. Clockwise mandibular rotation leads to posterior positioning of the chin; the surgeon needs to assess the new chin position on the cephalometric tracing to determine whether an advancement genioplasty is necessary. Pre-operative facial (a) and occlusal (b) analysis of a short face syndrome. Frontal (c) and intraoral (d) appearance after a two-jaw surgery

general facial outline is determined by information gained from the clinical facial examination. The facial evaluation begins with assessment of these vertical facial thirds: trichion to glabella, glabella to subnasale, and subnasale to menton; each of these facial thirds should be about equal (Figs. 2.5, 2.6). The most important factor in assessing the vertical height of the maxilla is the degree of incisor showing while the patient’s lips are in repose. A man should show at least 2–3 mm, whereas as much as 4–5 mm is considered attractive in a woman. If the patient shows the correct degree of incisor in repose, but shows excessive gingival in full smile, the maxilla should not be impacted (Fig. 2.7). The intercanthal distance should be the same as the distance between the medial and lateral canthus of each eye. The inferior orbital rims, malar eminence, and piriform areas are evaluated for the degree of projection. If these regions appear deficient, maxillary advancement is indicated. The alar base width should also be assessed prior to surgery since Le Fort I osteotomy may alter the width. Asymmetries of the maxilla and mandible are documented on physical examination, and the degree of deviation from the facial midline is noted. The soft-tissue envelope of the upper face is evaluated for descent of the malar fat pads, the severity of the nasolabial creases and folds. These changes are associated with aging; however, skeletal movements of the maxilla will affect these areas. It is important for the

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Fig. 2.7 Gummy smile. Clinical views of a patient who presents a severe lip incompetence and accentuation of perialar areas. She sustained superior repositioning of the maxilla, counter clockwise mandibular rotation and chin advancement. The treatment approach is

to impact the maxilla to achieve the proper incisor show with the lips in repose. a Pre-operative facial appearance. b One-year postoperative facial views

surgeon to realize that skeletal expansion (anterior or inferior repositioning of the jaws) will improve the creases and folds, whereas skeletal contraction (posterior or superior movements of the jaws) will accentuate these aspects and appearance of premature aging. The surgeon can frequently take advantage of skeletal expansion to reduce some of these soft-tissue creases, giving the patient a youthful appearance and reducing the signs of aging (Fig. 2.8). In evaluating the chin, the clinician assesses the labiomental angle. An acute angle may indicate a short or prominent chin, and effacement of the crease typically excessive vertical length or insufficient anterior projection. The profile view is used to assess the projections of the face (Figs. 2.9, 2.10). Projections analysis is divided into high midface, maxillary and mandibular areas. An experienced clinician can usually determine whether the deformity is caused by the maxilla, the mandible, or both just by looking at the patient. This assessment is made clinically and verified radiographically with cephalometry. Holdaway describes a ‘harmony line’ or H line that extend from pogonion to the most prominent part of the upper lip. The line that runs from the soft-tissue nasion to the pogonion meets the H line to create the H angle. An average H angle is 10 degrees; a larger angle relates to increasing soft-tissue profile convexity. The proper position of the nose relates to the upper lip, which is supported by the maxillary incisors, and the chin. Because both of these structures may be altered by orthognathic surgery, it is important to predict how the dimensions of the nose will fit into the new facial proportions. The soft tissues of the neck are also assessed. The patient with submental laxity will not benefit aesthetically

from posterior positioning of the mandible. Mandibular advancement, however, will improve the laxity and the cervicomental angle.

2.2.1

Surgical Options: The Orthognathic Surgery

In orthognathic surgery one or more segments of the jaws can be simultaneously repositioned to treat various types of malocclusion and craniofacial deformities [1]. All clinical and radiographic findings are analyzed and pre-surgical model surgery performed. Maxillary advancement improves the facial contour and normalizes dental occlusion when there is a relative deficiency of the midface region. Maxilla movements require Le Fort I osteotomy (Fig. 2.11). The vertical position of the maxilla is recorded by measuring the distance between the medial canthus and the orthodontic arch wire. An incision is made 5 mm above the mucogingival junction from first molar to first molar. A periosteal elevator is used to expose the maxilla around the piriform rim and infraorbital nerve and complete the dissection of the nasal floor and lateral nasal wall. A reciprocating saw or a fissure burr is used to make a transverse osteotomy from the piriform aperture laterally until the maxillary tuberosity; the cut should be made at least 5 mm above the apices of the teeth. A double-balled osteotome is used to release the septum from the maxilla. The Kawamoto-Tessier osteotome is used between the tuberosity of the maxilla and the pterygoid plate of the sphenoid bone to pterygomaxillary disjunction. The maxilla is down fractured with manual pressure or with disimpaction forceps. A splint, obtained

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Aesthetic Analysis of the Face: The Maxillofacial Deformity

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H

PF

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b 90°- 110°

75°- 85°

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30° a PFP

PFA

Fig. 2.9 Analysis of the facial profile. Four horizontal lines divide the face into three-thirds. These lines are also used for the Frankfurt plane (PF), the front frontal plane (PFA), the rear frontal plane (PFP), the H line (H): this line with the PF form an angle of between 75 and 85, while a plane passing through the nasion (a) with the PFA form an angle of approximately 30. Finally, a plane passing through the major axis of the nostril (b) with PFP form an angle of approximately 90 and 110, respectively in males and females

Fig. 2.8 Pre-operative and post-operative frontal (a) and lateral (b) views in a case of skeletal expansion with facial rejuvenation after orthognathic surgery (Le Fort I osteotomy, Bilateral Sagittal Split Osteotomy, mentoplasty and mandibular angles remodeling—see ‘Surgical Options’)

during the pre-surgical planning on dental models, is used to place the maxilla in its proper position. Intermaxillary fixation is then applied with 26-gauge wires around the surgical lugs. The amount the maxilla will be impacted or elongated and/or advanced was determined in the treatment plan. Two plates on each side, usually L-shaped, can be used to secure the maxilla. The mandibulomaxillary fixation is released and occlusion verified prior to closure. If the alar base is wide, an alar cinch can be performed to normalize the width. Lip shortening may also result from closure; A V-Y closure at the central incisor can help alleviate this effect. Finally, if simultaneous expansion of the maxilla is necessary, the maxilla can be split into two or more pieces to allow simultaneous expansion. Depending on severity of the occlusal discrepancy and soft tissues profile, problems in the lower face may require surgery on mandible. This can be done in conjunction with or separate to maxillary surgery. The mandible can be advanced, set back and tilted. A combination of these

procedures may be necessary. Bilateral sagittal split osteotomy (Fig. 2.12) begins from an incision made about 1 cm from the lateral aspect of the molars and extended from midramus to the region of the second molar. A periosteal elevator is used to expose the lateral mandible and the anterior coronoid process in a subperiosteal plane. The medial aspect of the ramus is also dissected subperiosteally and the mandibular nerve should be identified. A Lindemann side-cutting burr is used to make a cut on the medial ramus that is parallel to the occlusal plane and extends about two-thirds of the distance to the posterior ramus. The cut extends from medial to lateral until the burr is in the cancellous portion of the ramus. A fissure burr or a reciprocating saw is used to make a cut from the midramus down along the external oblique ridge, gently curving to the inferior border of the mandible. The cuts are verified with an osteotome, and then large osteotomes are inserted and rotated to gently separate the segments. The tooth-bearing segment is referred to as the distal segment, and the condylar portion as the proximal segment. The distal segment is placed into occlusion and secured by tightening 26-gauge wire loops around the surgical lugs. If a surgical splint is necessary to establish the required occlusion, it is placed between the teeth prior to intermaxillary wiring. The proximal segment is then gently rotated to ensure it is seated

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(b)

(c)

Fig. 2.10 a Clinical views of a III Class with a disharmonic concave profile. b Facial convexity angle is the intersection of a line drawn from the forehand to the chin and a line drawn from the bottom of the

nose to the chin (glabella—SN—pogonion, 165–175). c The patient sustained posterior impaction and advancement of the maxilla and mandible set back

Fig. 2.11 Le Fort I osteotomy. The LeFort I osteotomy is designed to separate the tooth-bearing maxillary component from the superior part of the maxilla. The fracture line extends from the piriform aperture through the lateral maxillary and lateral nasal walls to the posterior region and will often include a segment of pterygoid plates

Fig. 2.12 Sagittal split osteotomy of the mandible, mandibular osteotomic lines of the obwegeser/dal pont osteotomy; it is a bilateral sagittal split osteotomy of the mandible, ramus and angle, which can be extended into the posterior body. It divides the mandible into two smaller condyle-bearing segments and a large segment consisting of the mandibular body including the teeth and chin

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Aesthetic Analysis of the Face: The Maxillofacial Deformity

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Fig. 2.13 A case of simultaneous surgical procedure in a female patient with skeletal Class III, nasal deformity, facial asymmetry, zygoma hypoplasia. a–b–c: Pre-surgical frontal, lateral and oblique view. d–e–f Post-surgical result after LeFort I osteotomy, mandibular sagittal split osteotomy, mentoplasty, rhynoseptoplasy and lipostructure of the malar area

within the glenoid fossa. Rigid fixation is performed with one or two 2.0 mm plates on each side of the mandible. In a patient with prominent submental fat in whom mandibular advancement is contraindicated, suction-assisted lipectomy is helpful in removing the adipose deposits. The chin is an important component of the facial profile as well as the aesthetic balance. Osseous genioplasty, surgical correction of chin abnormalities by skeletal modification, has the potential of causing refreshing changes in facial harmony. In adult patients, orthognathic surgery can be combined with soft tissues contouring and ancillary procedures to improve aesthetic results. Lipostructure (also known as structural fat grafts, lipofilling, or fat grafting) is a technique with reproducible results. Lipofilling is a safe, long-lasting method of recontouring, filling and supporting the face using intricate layering of infiltrated autologous tissue. This method allows the tissues to be sculpted to enact threedimensional augmentation of facial elements. To successfully use fatty tissue as such a graft, attention must be paid to the nature of fatty tissue, to the methods of harvesting, transfer and placement and to the preparation of the patient. Successful, three-dimensional sculpting requires attention to patient evaluation and meticulous planning. In 1988, the Coleman personally developed a technique called structural fat grafting (SFG), which allows the fat to be harvested and

injected with minimal risk of necrosis and reabsorption [12– 14]. Simultaneous fat injection and orthognathic surgery allow a natural correction of malar hypoplasia, mandibular angle irregularities, or asymmetries. Patients requiring surgical correction of skeletal deformities and malocclusion often present a coexisting functional and/or aesthetic nasal deformity. The nose has a prominent place in the face, so should ideally be corrected at the same time as the dentofacial disharmonies to achieve an attractive profile [15]. This is in line with Obwegeser’s philosophy of ‘profile before occlusion’ [16]. There are two groups of patients with dentofacial abnormalities who will benefit from rhinoplasty: those with inherent nasal deformities and those who acquired deformities from the orthognathic surgery [17]. Some nasal deformities can be corrected by maxillary osteotomies: a narrow alar base, a slight droopy nasal tip and a mild dorsal hump, which can be corrected by Le Fort I advancement and impaction. Nasal deformities that cannot be improved by maxillary osteotomies include wide alar base, moderate to prominent dorsal hump, saddle nose, broad nasal base, and deformities of the tip and columella. Maxillary advancement can result in raising the tip with an increase in the supratip break depression, widening the alar base, and lowering the columella. Maxillary impaction can result in raising the nasal tip

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and upper lip, widening the alar base and retracting the columella at the subnasal. Maxillary setback can result in widening the nasal bridge, an obtuse nasolabial angle and decreased projection of the nasal tip; maxillary downgraft can result in inferior positioning of the alar base and columella, a droopy nasal tip, and an obtuse nasolabial angle. Several advantages of simultaneous rhinoplasty and orthognathic surgery have been described by different authors: a single procedure, one general anaesthesia and stay in hospital for the patient, less post-operative discomfort from infraorbital hypoaesthesia and poor nasal outcome after orthognathic surgery can be corrected immediately, which avoids the prospect of dealing with an unhappy patient. Technically, the maxillary downfracture allows easier septoplasty, harvesting of the nasal septum, and resection of enlarged inferior turbinates. Surgeons who prefer to make the nasal infracture with guarded osteotomes can do so easily at the exposed piriform rim. Simultaneous rhinoplasty and orthognathic surgery minimize pre-operative, perioperative and post-operative problems. Good preoperative planning is important for a successful outcome. Nasal changes that accompany maxillary osteotomies are taken into consideration when planning a rhinoplasty. Perioperatively, changing the nasotracheal to endotracheal intubation requires an experienced anaesthetist. While surgical oedema is inevitable, it can be reduced by a combination of pre-operative and perioperative steroids and hypotensive anaesthesia with effective surgery. Simultaneous correction of nasal, malar and angular deformities allows a major patient satisfaction (Fig. 2.13).

References 1. Proffit WR, White RP, Sarver DM (2003) Contemporary treatment of dentofacial deformities. Mosby, St. Louis

G. A. Beltramini et al. 2. Proffit WR, Turvey TA, Phillips C (2007) The hierarchy of stability and predictability in orthognathic surgery with rigid fixation: an update and extension. Head Face Med 3:21. doi: 10.1186/1746-160X-3-21 3. Mendelson BC, Hartley W, Scott M et al (2007) Age related changes of the orbit and midcheek and the implications for facial rejuvenation. Aesthetic Plast Surg 31:419–423 4. O’Ryan F, Lassetter J (2011) Optimizing facial esthetics in the orthognathic surgery patient. J Oral Maxillofac Surg 69: 702–715 5. Arnett GW, Gunson MJ (2010) Esthetic treatment planning for orthognathic surgery. J Clin Orthod 44:196–200 6. Arnett GW, Gunson MJ (2004) Facial planning for orthodontists and oral surgeons. Am J Orthod Dentofacial Orthop 126: 290–295 7. Meneghini F, Biondi P (2012) Clinical facial analysis. Springer, Berlin 8. Baudouin JY, Tiberghien G (2004) Symmetry, averageness, and feature size in the facial attractiveness of women. Acta Psychol 117:313–332 9. Springer IN, Wannike B, Warnke PH et al (2007) Facial attractiveness: visual impact of symmetry increases significantly towards the midline. Ann Plast Surg 59:156–162 10. Zaidel DW, Cohen JA (2005) The face, beauty, and symmetry: perceiving asymmetry in beautiful faces. Int J Neurosci 115: 1165–1173 11. Larrabee WF Jr, Makielski K, Henderson JL (2004) Surgical anatomy of the face. Lippincott Williams & Wilkins, Philadelphia 12. Coleman SR (2001) Structural fat grafts: the ideal filler? Clin Plast Surg 28:111–119 13. Coleman SR (1998) Structural fat grafting. Aesthet Surg J 18:386–388 14. Coleman SR (1997) Facial recontouring with lipostructure. Clin Plast Surg 24:347–367 15. Cottrell DA, Wolford LM (1993) Factors influencing combined orthognathic and rhinoplastic surgery. Int J Adult Orthodon Orthognath Surg 8:265–276 16. Seah TE, Bellis H, Ilankovan V (2012) Orthognathic patients with nasal deformities: case for simultaneous orthognathic surgery and rhinoplasty. Br J Oral Maxillofac Surg 50:55–59 17. Obwegeser HL (2000) Mandibular growth anomalies. Terminology, aetiology, diagnosis, and treatment. Springer, Berlin

3

Standard Evaluation of the Patient: The Merz Scale Enrica Stella and Alessandro Di Petrillo

Age may affect quality of life and psychological well-being. The development of globally accepted tools to assess these changes objectively is an essential contribution to aesthetic research and routine clinical medicine. Upper face changes such as wrinkles, lines, volume loss, and anatomical alterations are important indicators of age and have an important role in aesthetic aspect of the patient [1, 2].

The Merz Scale is a validated and globally accepted tool for proper assessment of the forehead lines, glabellar lines, crow’s feet (at rest and dynamic), and brow positioning (Fig. 3.1a, b, c, d, e, f, g). The upper face rating scales are reliable tools for valid and reproducible assessment of the ageing process.

E. Stella (&)  A. Di Petrillo Doctor’s Equipe, via Carducci 19, 20123, Milan, Italy e-mail: [email protected] A. Di Petrillo e-mail: [email protected]

M. Goisis (ed.), Injections in Aesthetic Medicine, DOI: 10.1007/978-88-470-5361-8_3,  Springer-Verlag Italia 2014

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E. Stella and A. Di Petrillo

Scales_Crows-Feet_At-Rest

Scales_Crows-Feet_Dynamic

Scales_Brow-Positioning

Scales_Forhead-lines_at-rest

Fig. 3.1 a–g The Merz scale: upper part of the face

3

Standard Evaluation of the Patient: The Merz Scale

Scales_Forhead-Lines_Dynamic

Scales_Glabella-Lines_at rest.

Scales_Glabella-Lines_Dynamic.

Fig. 3.1 (continued)

35

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E. Stella and A. Di Petrillo

Volume loss of the mid face: The Merz Scale is a validated [3] and globally accepted tool for proper assessment

of the infraorbital hollow, upper and lower cheek fullness, and nasolabial lines (Fig. 3.2a–d).

Scales_Infra-Orbital-Hollow_At-Rest

Scales_Upper-Cheek-Fullness_At-Rest

Scales_Lower-Cheek-Fullness_At-Rest

Fig. 3.2 a–d The Merz scale: mid face

3

Standard Evaluation of the Patient: The Merz Scale

37

Scales_Nasolabial-Folds_At-Rest

Fig. 3.2 (continued)

Lines, wrinkles, depression of the corners of the mouth, and changes in lip volume and lip shape, with increased sagging of the skin of the jawline, are important indicators of age and have an important role in aesthetic aspect of the

Fig. 3.3 The Merz scale: lower part of the face

patient [4]. The Merz Scale is a validated and globally accepted tool for proper assessment of jaw lines, lip wrinkles, lip volume, marionette lines and oral commissures. (Fig. 3.3a–g)

38

E. Stella and A. Di Petrillo

Scales_Upper-Lip-Fullness_At-Rest

Scales_Marionette-Lines_At-Rest

Fig. 3.3 (continued)

3

Standard Evaluation of the Patient: The Merz Scale

39

Oral-Commissures_At-Rest

Fig. 3.3 (continued)

Sagging of the neck is an important indicator of age and has an important role in aesthetic aspect of the patient [5].

The Merz Scale is a validated and globally accepted tool for proper assessment of the change in neck volume (Fig. 3.4).

Scales_Neck-Volume_At-Rest

Fig. 3.4 The Merz scale: neck

40

Irregular surface pigmentation, prominence of superficial veins and tendons, thinning of the dermis, and loss of subcutaneous fat are important indicators of age of the hand [6].

Fig. 3.5 The Merz scale: hands

E. Stella and A. Di Petrillo

The Merz Scale is a validated and globally accepted tool for proper assessment of the change in ageing of the hand (Fig. 3.5).

3

Standard Evaluation of the Patient: The Merz Scale

3.1

Application of the Merz Scale

In these pictures is shown a good improvement of the infraorbital hollow obtained with injection of 0.05 cc of hyaluronic acid along the tear trough (Fig. 3.6a, b, c, d), (Fig. 3.7a,

Fig. 3.6 A good improvement of the infra-orbital hollow obtained by injecting 0.05 cc of Ha along the tear trough. a Merz scale for infra-orbital hollow at rest; b pre-treatment evaluation: grade 3;

41

b, c), (Fig. 3.8a, b, c, d, e), (Fig. 3.9a, b, c, d), (Fig. 3.10a, b, c, d, e, f, g, h), (Fig. 3.11a, b, c, d, e, f), (Fig. 3.12, a, b, c, d, e, f), (Fig. 3.13a, b, c, d, e) and (Fig. 3.14a, b, c, d, e).

c post-treatment evaluation: grade 1; d closer comparison between pre-treatment and post-treatment

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Fig. 3.7 A good improvement of the infra-orbital hollow obtained by injecting 0.1 cc of Ha along the tear trough. a Pre-treatment

E. Stella and A. Di Petrillo

evaluation: grade 3; b post-treatment evaluation: grade 1; c closer comparison between pre-treatment and post-treatment

3

Standard Evaluation of the Patient: The Merz Scale

Fig. 3.8 Correction of malar hypoplasia obtained by adding 1.5 cc calcium hydroxylapatite to PRP in a single bolus on the zygomatic bone on a periosteal plane. a Merz scale for upper cheek fullness at

43

rest; b pre-treatment evaluation: grade 4; c treatment; d post-treatment evaluation: grade 1; e closer comparison between pre-treatment and post-treatment

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Fig. 3.9 Improvement of malar projection obtained by injecting calcium hydroxylapatite with a blunt-tip cannula. a Pre-treatment

E. Stella and A. Di Petrillo

evaluation: grade 4; b treatment; c post-treatment evaluation: grade 0; d closer comparison between pre-treatment and post-treatment

3

Standard Evaluation of the Patient: The Merz Scale

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Scales_Lower-Cheek-Fullness_At-Rest

Fig. 3.10 Fullness of the lower cheek is restored by injecting calcium hydroxylapatite on a fan-shaped area on the whole cheek; this improves face sagging. a Merz scale for lower cheek fullness at rest; b-

d pre-treatment evaluation: grade 4; e fan-shaped area for injection; fh post-treatment evaluation: grade 2

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Fig. 3.10 continued

E. Stella and A. Di Petrillo

3

Standard Evaluation of the Patient: The Merz Scale

47

Scales_Upper-Lip-Fullness_At-Rest

Scales_Upper-Lip-Fullness_At-Rest

Fig. 3.11 Augmentation of the lip is obtained by injecting 0.8 cc of Ha spread between the upper and the lower lip and along the vermillion border. a Merz scale for upper lip fullness at rest; b and

Scales_Upper-Lip-Fullness_At-Rest

d pre- and post-treatment evaluation: from grade 3 to grade 4; c application; e, f closer comparison between pre-treatment and posttreatment

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E. Stella and A. Di Petrillo

Scales_Marionette-Lines_At-Rest

(c)

Mandible Augmentation with Radiesse 1,5cc

Fig. 3.12 Example of improvement of marionette lines obtained by injecting 1.5 cc calcium hydroxylapatite in the lower cheek area, in order to have a lifting effect. a Merz Scale; b pre-treatment evaluation:

grade 3; c, d Treatment with Radiesse; e post-treatment evaluation: grade 1; closer comparison between pre-treatment f and posttreatment g

3

Standard Evaluation of the Patient: The Merz Scale

Fig. 3.13 Example of amelioration of hands; both hands were injected with 1,5 cc of calcium hydroxylapatite using a blunt-tip cannula. a Merz Scale for hand; b pre-treatment evaluation: grade 3;

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c treatment with Radiesse; d closer comparison between pre-treatment and post-treatment; e post-treatment evaluation: grade 1

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E. Stella and A. Di Petrillo

Scales_Forhead-lines_at-rest

Fig. 3.14 Improvement of forehead wrinkles obtained by injecting hyaluronic acid; 0.8 cc hyaluronic acid is injected along the wrinkles with a blunt-tip cannula. a Merz Scale; b pre-treatment evaluation:

References 1. Flynn T, Carruthers A, Carruthers J et al (2012) Validated assessment scales for the upper face. Dermatol Surg 38:309–319 2. Rzany B, Carruthers A, Carruthers J et al (2012) Validated composite assessment scales for the global face. Dermatol Surg 38:294–308 3. Carruthers J, Flynn T, Geister T et al (2012) Validated assessment scales for the mid face. Dermatol Surg 38:320–332

grade 4; c treatment with hyaluronic acid; d post-treatment evaluation: grade 2; e closer comparison between pre-treatment and posttreatment

4. Narins R, Carruthers J, Flynn T et al (2012) Validated assessment scales for the lower face. Dermatol Surg 38:333–342 5. Sattler G, Carruthers A, Carruthers J et al (2012) Validated assessment scales for neck volume. Dermatol Surg 38:343–350 6. Carruthers A, Carruthers J, Hardas B, Kaur M, Goertelmeyer R, Jones D, Rzany B, Cohen J, Kerscher M, Flynn TC, Maas C, Sattler G, Gebauer A, Pooth R, McClure K, Simone-Korbel U, Buchner L (2008) A validated hand grading scale. Dermatol Surg 34(2):S179–S183. doi:10.1111/j.1524-4725.2008.34368.x

Part II

Face and Body Treatments

4

Temporal Fossa Mario Goisis and Alessandro Di Petrillo

The depression of the temporal area tends to become much more visible with aging. This is due in part to fat atrophy and in part to temporal muscle atrophy. In some subjects, the depression is visible already at a young age. Excavation in that area is often associated with a ‘‘skull aspect.’’ Temporal excavation can be intended as one of the worst anti-esthetic signs of aging in upper-face approach.

4.1

Anatomy

The temporal fossa is a depression on each side of the skull bounded superiorly by the insertion of the temporal muscle and terminating inferiorly on the level of the zygomatic arch. The anterior boundary is constituted by the posterior surface of the frontal process of the zygomatic bone and the posterior surface of the zygomatic process of the frontal bone. Superiorly, the fossa is delimited by a line that arches across the skull from the zygomatic process of the frontal bone to the supra-mastoid crest of the temporal bone. The inferior boundary is represented by the zygomatic arch and medially by the infratemporal crest of the greater wing of the sphenoid (Fig. 4.1). Noble structures that are contained in fossa temporalis and that need to be preserved during the treatment are as follows: • Superficial temporal artery is a major artery of the head. It arises from the external carotid artery when it bifurcates into the superficial temporal artery and maxillary

M. Goisis (&)  A. Di Petrillo Doctor’s Equipe, via Carducci 19, 20123 Milan, Italy e-mail: [email protected]

M. Goisis (ed.), Injections in Aesthetic Medicine, DOI: 10.1007/978-88-470-5361-8_4,  Springer-Verlag Italia 2014

artery. It begins in the parotid gland, behind the neck of the mandible, and passes superficially over the posterior root of the zygomatic process of the temporal bone; about 5 cm above this process, it divides into two branches, a frontal and a parietal. Its pulse is palpable superior to the zygomatic arch, around 1 cm anterior and superior to the tragus (Fig. 4.2, blue arrow). • The most superior branches of the seventh cranial nerve, also known as the frontal branch of the facial nerve, cross the zygomatic arch to the temporal region, supplying the superior and anterior auricular muscles. The more anterior branches supply the frontalis, the orbicularis oculi, and corrugator supercilii. The branch crosses the zygomatic arch 3–4 cm anteriorly to the tragus and enters the temporal fossa decurring just under the auriculotemporal fascia. Accidental lesion of the temporal branch leads to

Fig. 4.1 Bone anatomy of temporal fossa. Reproduction of a lithograph plate from Gray’s anatomy (Henry Gray, Anatomy: Descriptive and Surgical)

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M. Goisis and A. Di Petrillo

Fig. 4.2 Superficial temporal artery arises from the external carotid artery. It originates in the parotid gland, behind the neck of the mandible. Its pulse is palpable superiorly to the zygomatic arch, around 1 cm anteriorly and superiorly to the tragus (blue arrow)

Fig. 4.3 a, b The frontal branch of the facial nerve crosses the zygomatic arch to the temporal region, supplying the superior and anterior auricular muscles. Most of the anterior branches (blue arrow) cross the zygomatic arch 3–4 cm anteriorly to the tragus and enters the temporal fossa spreading just under the auriculotemporal fascia

(a)

facial asymmetry due to monolateral insufficient function of frontalis muscle and corrugator supercilii (Fig. 4.3a, b blue arrow).

4.2

Pitfalls

The noble structures, such as temporal artery and nerve, can be preserved using the correct point of injection (safe point). Safe point is located 2.5 cm laterally from the lateral margin of the orbital cavity (Fig. 4.4a, c) and 2.5 cm superiorly from the superior border of zygomatic arch (Fig. 4.4b, c).

(b)

The temporal artery can be touched with the finger. Its pulse can be retrieved anteriorly to the tragus, followed in the temporal area. The safe point is usually at least 2 cm anterior to this vessel (Fig. 4.4a, c). The facial nerve is usually located at least 2 cm below the safe point (Fig. 4.4a, c).

4.3

Augmentation of the Temporal Fossa

Correction of temporal excavation can lead to substantial improvement in the appearance of the face, giving a younger look to the patient.

4

Temporal Fossa

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4.4

Augmentation of the Temporal Fossa with Calcium Hydroxylapatite

4.4.1

Indications

• Marked excavation of the temporal area.

4.4.2

Contraindications

• Anatomical alterations due to previous trauma or surgical intervention (neurosurgery). Scarring often induces a displacement of the noble structures and can lead to temporal artery perforation or nerve section. It can also induce retracting scars that can cause asymmetry and unequal filling of the part treated. • The filler should not be injected in areas that lack sufficient blood supply or that have an infection or inflammation. • No injection should be done if the hand has been previously treated with liquid silicone or other permanent fillers because new injection could lead to inflammation or infection of the implants. • Any hypersensitivity to any components of the filler obviously constitutes a contraindication for the treatment.

4.4.3

Operating Time

The procedure usually takes from 10 to 15 min.

4.4.4

Materials

• 1.5 cc of Calcium Hydroxylapatite. • Needle 28G.

Fig. 4.4 The injection is administered in a single point. Safe point of injection is located 2.5 cm laterally from the lateral margin of the orbital cavity and 2.5 cm superiorly from the superior border of zygomatic arch

Augmentation of the temporal area is a simple procedure, performable in office under local anesthesia. Few noble structures need to be preserved, but this can be accomplished simply.

Fig. 4.5 Materials

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M. Goisis and A. Di Petrillo

Fig. 4.6 0.5 cc of anesthetic solution is injected 5 min before the treatment. The injection is performed in the supra-periosteal and subcutaneous layers, in order to reduce pain and bleeding

Fig. 4.7 On each side 0.75 cc of Radiesse is injected into the supraperiosteal layer as a bolus

• 0.2 cc of Local anesthetic (2% lidocaine or 2% mepivacaine) with epinephrine 1:100000. • Bandages and antiseptic solution. (Fig. 4.5)

4.4.5

Material Choice

In Europe, Asia, and America, Radiesse can be used.

4.4.6

Methods

Procedure is shown in Figs. 4.4a, b, 4.5, 4.6, 4.7, 4.8a, b.

4.4.7

Complications and Management

Immediate complications (within 72 hours after injection) immediate hypersensitivity reaction, transient erythema, edema, induration, pruritus and ecchymosis. Eventual perforation of the superficial temporal artery leads to sudden bleeding. Treatment should be stopped immediately. Bleeding is arrested with anintense pressure with the finger for 5 min. If the bleeding does not stop, a large-volume injection of diluted adrenaline in the proximity of the arterial wall can be effective. Early complications (days to weeks after injection) include overcorrection, local infection, skin necrosis, herpes reactivation, discoloration and persistent local symptoms (erythema, edema, induration, pruritus and hyperpigmentation).

Fig. 4.8 The product is spread in the temporal fossa with a vigorous massage (a,b). The most important noble structure, the temporal branch of the facial nerve, which innervates the frontalis muscle, will be dislocated and not be damaged by the increased volume of the filler

4

Temporal Fossa

Late complications include infection, filler migration, delayed hypersensitivity reaction, foreign-body granuloma and scarring.

4.5

Augmentation of the Temporal Fossa with Hyaluronic Acid

4.5.1

Indications

• Marked excavation of the temporal area.

4.5.2

4.5.5

Material Choice

In Europe • Glytone 4 • Belotero intense • Juvederm Voluma lidocaine In Asia • Juvederm Voluma lidocaine • Restylane Sub-Q In America • Belotero intense • Juvederm Voluma XC

Contraindications

• Anatomical alterations due to previous trauma or surgical intervention (neurosurgery contraindicate augmentation of the temporal fossa). Scarring often induces a displacement of the noble structures, which can lead to temporal artery perforation or nerve section. It can also induce retracting scars that can lead to asymmetry and unequal filling of the part treated.

4.5.3

57

4.5.6

Methods

Pre-treatment images are shown in Fig. 4.10a. The area of interest is illustrated in the Fig. 4.11. Procedure is shown in Figs. 4.12, 4.13, 4.14, 4.15a, b 4.16.

Operating Time

The procedure usually takes from 10 to 15 min.

4.5.4

Materials

• • • •

2 cc of high-viscosity hyaluronic acid. 2.5 cc syringe with Luer lock. 22 G needle. 0.2 cc of Local anesthetic (2% lidocaine or 2% mepivacaine) with epinephrine 1:100000. • Bandages and antiseptic solution. (Fig. 4.9).

Fig. 4.9 Materials

Fig. 4.10 a, b pre-treatment images. Marked excavation of the temporal area is observed

58

Fig. 4.11 The area of interest is illustrated. Marked excavation of the temporal area is observed

M. Goisis and A. Di Petrillo

Fig. 4.14 A tampon is applied to the area for 60 s

Fig. 4.12 0.5 cc of the anesthetic solution is injected 5 min before the treatment. The injection is performed in the supra-periosteal and subcutaneous layers, in order to reduce pain and bleeding

Fig. 4.13 1 cc of hyaluronic acid is then injected into the supraperiosteal layer as a bolus

Fig. 4.15 a, b The product is spread in the temporal fossa by a vigorous massage. The most important noble structure, the temporal branch of the facial nerve, which innervates the frontalis muscle, will be dislocated and not be damaged by the increased volume of the filler

4

Temporal Fossa

59

4.6

Summary: Treatment Options

Indications Temporal fossa augmentation Temporal fossa augmentation

Fig. 4.16 Pre-treatment image (on the left) compared with posttreatment image (on the right)

Material

Needle or cannula

Chapter

Needle 28 G

4.4

Needle 22 G

4.5

Calcium Hydroxylapatite High density hyaluronic acid

5

Forehead, Glabella, and Crow’s-Feet Alessandro Di Petrillo and Magda Guareschi

5.1

Anatomy

Careful identification of supraorbital foramen in the medial third of the superior orbital rim is useful to avoid damage to supraorbital nerve and vessel which direct upward to frontal area starting from the foramen (Figs. 5.1, 5.2, 5.3). Medially to supraorbital nerve and vessels, the supratrochlear vessels arise from the medial part of the superior orbital rim and direct vertically to the medial part of the frontal region (Figs. 5.2, 5.3).

Fig. 5.2 Supraorbital nerve and vessels and supratrochlear nerve are shown during the dissection (source: wikipedia, www. anatomyumftm.com)

Fig. 5.1 Supraorbital foramen. Reproduction of a lithograph plate from Gray’s anatomy (Henry Gray, Anatomy: Descriptive and Surgical)

A. Di Petrillo (&)  M. Guareschi Doctor’s Equipe, via Carducci 19, 20123 Milan, Italy e-mail: [email protected]

M. Goisis (ed.), Injections in Aesthetic Medicine, DOI: 10.1007/978-88-470-5361-8_5,  Springer-Verlag Italia 2014

Fig. 5.3 Supratrochlear (yellow arrow) and supraorbital (green arrow) nerves and vessels have been schematically drown on the patient. Reproduction of a lithograph plate from Gray’s anatomy (Henry Gray, Anatomy: Descriptive and Surgical)

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A. Di Petrillo and M. Guareschi

Fig. 5.4 Frontalis muscle. Reproduction of a lithograph plate from Gray’s anatomy (Henry Gray, Anatomy: Descriptive and Surgical)

Knowledge of mimic muscle of glabellar and frontal area together with their function is of capital importance to correct esthetic issues in this region. The frontalis muscle (Fig. 5.4) is thin, of a quadrilateral form, and intimately adherent to the superficial fascia. It has no bony attachments. Its medial fibers are continuous with those of the procerus; its immediate fibers blend with the corrugator and orbicularis oculi, thus attached to the skin of the eyebrows; and its lateral fibers are also blended with the latter muscle over the zygomatic process of the frontal bone. In the eyebrows, its primary function is to lift them (Fig. 5.5) (thus opposing the orbital portion of the orbicularis), especially when looking up. From these attachments, the fibers are directed upward and join the galea aponeurotica below the coronal suture. The medial margins of the frontalis are joined together for some distance above the root of the nose. The procerus (Fig. 5.6) is a small pyramidal slip of muscle which arises by tendinous fibers from the fascia covering the lower part of the nasal bone and upper part of the lateral nasal cartilage. It is inserted into the skin in the lower part of the forehead between the two eyebrows on either side of the midline, its fibers merging with those of the frontalis. It helps to pull that part of the skin between the eyebrows downwards, which assists in flaring the nostrils. It can also contribute to an expression of anger (Fig. 5.8). The corrugator supercilii (Fig. 5.7) is a small, narrow, pyramidal muscle, placed at the medial end of the eyebrow, beneath the frontalis and just above orbicularis oculi. It arises from the medial end of the superciliary arch, and its fibers pass upward and laterally, between the palpebral and orbital portions of the orbicularis oculi, and are inserted into the deep surface of the skin, above the middle of the

Fig. 5.5 Frontalis muscle (green) in function

orbital arch. The corrugator draws the eyebrow downward and medially, producing the vertical wrinkles of the forehead (Fig. 5.8). It is the ‘‘frowning’’ muscle and may be regarded as the principal muscle in the expression of suffering. The orbicularis oculi is a muscle in the face that closes the eyelids (Fig. 5.9, 5.10). It arises from the nasal part of the frontal bone, from the frontal process of the maxilla in front of the lacrimal groove, and from the anterior surface and borders of a short fibrous band, the medial palpebral ligament. From this origin, the fibers are directed lateralward, forming a broad and thin layer, which occupies the eyelids or palpebrae, surrounds the circumference of the orbit, and spreads over the temple, and downward on the cheek. The lateral part of orbicularis functionally responsible of the crow’s-feet lies above the lateral orbital rim and superficially to the temporalis muscle.

5

Forehead, Glabella, and Crow’s-Feet

63

Fig. 5.6 Procerus muscle Fig. 5.9 Orbicular oculis

Fig. 5.7 Corrugator supercilii

Fig. 5.8 Procerus and corrugator supercilii in action; they are usually activated in the same time

Fig. 5.10 Orbicular oculis in function

5.2

Correction of Forehead and Glabella Wrinkles and Crow’s-feet with Botulinum Toxin

5.2.1

Pitfalls

Technical skill: The goal is to inject orbicularis muscle to correct crow’s-feet. For this reason, injection should be administered immediately under the epidermis because the orbicularis muscles addressed are extremely superficial at this site. Deeper infiltration will lead to reach the layer of temporalis muscles that lies underneath the orbicolaris muscle, with consequent waste of product and insufficient esthetic result (Fig. 5.11a, b).

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A. Di Petrillo and M. Guareschi

Fig. 5.11 a, b It is always useful to determine the anatomic boundaries individuating the muscles before injecting: the patient may be asked to contract frontalis muscle, procerus, corrugator, and orbicularis oculi to tailor the treatment to the anatomic features. Since the patient is young, a small quantity of toxin is injected. Six points of injection are administered on both side plus one central point as shown by the pictures. In the central point, 0.05 cc of bocouture is injected, while in all the other points just 0.5 of the solution contained in the syringe is delivered: in terms of units, 4 units in the central point

and 2 units in all the other points. The other six points are: an ideal point corresponding vertically to the internal canthus placed 0.5 cm above the superior orbital rim; an ideal point corresponding vertically to the centre of the pupil placed 1 cm above the superior orbital rim; the superomedial part of frontalis muscle; the superolateral part of frontalis muscle. The orbicularis oculi is injected into three points keeping a distance of 1 cm from the lateral orbital rim. The described safepoints are indicated as yellow circles on patient’s face

Safe points: While injecting, a good manner is to touch with the hand that does not handle the syringe the bone rim of the orbit, ensuring this way that botulinum is delivered in the safe points: in particular, one should never inject to close to the eyebrows (0.5 cm distance at least, 1 cm in the medium part of the eyebrows) to avoid the possibility of diffusion to levator muscle and subsequent upper eyelid ptosis.

• • • • • •

5.2.2

allergy to human albumin and sodium chloride; skin lesions of treated areas; infection of the planned site for the injections; recent surgical treatments; pregnancy and lactation; recent use of aminoglycoside antibiotics or other agents that interfere with neuromuscular transmission (spectinomycin, tubocurarine-type muscle relaxants).

Indications 5.2.4

Official indication for aesthetic use of botulin toxin is the temporary improvement in the appearance of moderate to severe glabellar lines (vertical lines between the eyebrows) seen at frown, in adult patients under 65 years, when the severity of these lines has an important psychological impact on the patient. Other indications are off label, and these are the temporary improvement of crown feet and of forehead lines at rest and in motion.

5.2.3

Contraindications

Contraindications to treatment with BoNT/A are as follows: • diseases of the neuromuscular junction (myasthenia gravis, Lambert–Eaton syndrome);

Case 1: Treatment with Bocouture in a Young Simmetric Patient

Materials (Fig. 5.12). • Botulinum toxin A: in this case Bocouture (packs of 50 units; 4 units/0.1 ml) • 1-cc syringe • 1.25 ml of sodium chloride • Bandages and antiseptic solution The botulinum toxin A is in powder form and so needs to be diluted with physiological solution. Bocouture standard dilution is prepared by mixing 1.25 cc of saline in the vial containing the toxin. In the vial, there is a vacuum and therefore the aspiration of the liquid should be automatic. The bottle should not be agitated. Once the dilution is performed, it is better to wait one minute before drawing it into the syringe (Fig. 5.12).

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Fig. 5.14 1 cc of physiological solution is slowly injected into the glass tube containing botulinum

Fig. 5.12 Case 1 materials: Botulinum toxin A: in this case Bocouture (packs of 50 units; 4 units/0.1 ml); 1-cc syringe; 1.25 ml of sodium chloride; bandages and antiseptic solution. The botulinum toxin A is in powder form and needs to be diluted with physiological solution. Bocouture standard dilution is prepared by mixing 1.25 cc of saline in the vial containing the toxin. In the vial there is a vacuum and therefore the aspiration of the liquid should be automatic. The bottle should not be shaken. Once the dilution is performed, it is better to wait one minute before drawing it into the syringe Fig. 5.15 0.25 cc of physiological solution is taken with 1-cc syringe

Fig. 5.13 1 cc of physiological solution is taken to fill the 1-cc syringe

Fig. 5.16 0.25 cc of physiological solution is slowly injected into the glass tube containing botulinum

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Fig. 5.17 32 units of Bocouture or Vistabex are used to treat patient’s forehead, glabella, and crow’s-feet, in order to achieve a natural result in this young patient: As with this dilution (1.25) we have 4 units in 0.1 cc, the syringe is filled with 0.8 cc

A. Di Petrillo and M. Guareschi

Fig. 5.19 0.05 cc (2 units) is injected 0.5 cm above the superior orbital rim on an imaginary axis passing through the internal canthus

Fig. 5.20 0.05 cc (2 units) is delivered 1 cm above the superior orbital rim on an imaginary axis passing through the pupil

Fig. 5.18 G.B., 31 years old. 0.1 cc (4 units) is injected into the center of the glabella

Material Choice In Europe • Bocouture • Vistabex • Vistabel • Azzalure In Asia • Xeomin • Neuronox

• Azzalure • Botox In America • Xeomin • Xeemin • Neuronox (Brasil) • Botox • Azzalure Operating time 10 min Method Procedure is shown in Figs. 5.13, 5.14, 5.15, 5.16, 5.17, 5.18, 5.19, 5.20, 5.21, 5.22, and 5.23a, b, c.

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Fig. 5.21 0.05 cc (2 units) is injected into the superomedial part of the frontalis muscle

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Fig. 5.22 0.05 cc (2 units) is injected into the superolateral part of frontalis muscle

Fig. 5.23 a, b, c The orbicular oculi is injected into three points 1 cm from the lateral orbital rim; 0.05 cc (2 units) is injected into each of the three points chosen

5.2.5

Case 2: Treatment with Azzalure in a Case of Facial Asymmetry

Materials (Fig. 5.24) • Botulinum toxin A: in this case Azzalure (pack of 125 Speywood units; 10 Spaywood units/0.05 ml) • 0.5-cc syringe • 0.625 ml sodium chloride • Bandages and antiseptic solution The botulinum toxin A needs to be diluted with physiological solution. Azzalure standard dilution is prepared by mixing 0.625 cc of physiological solution in the glass tube containing the toxin. Once the dilution is performed, it is better to wait for one minute before drawing it into the syringe. Operating time 10 min

Method As shown in Figures 5.25, 5.26, 5.27, 5.28a, b, c, 5.29, 5.30, 5.31, 5.32a, b, and 5.33, the botulinum toxin A needs to be diluted with physiological solution. Azzalure standard dilution is prepared by mixing 0.625 cc of physiological solution in the glass tube containing the toxin.

5.2.6

Complications and Management of Botulin Toxin Injection

• Very common (1 in 10 patients): headache, local muscle movement disorders and feeling of heaviness in the upper part of the face. • Common (1–10 in 100 patients): eyelid oedema, eyelid ptosis, eyelid inflammation, eye pain, blurred vision, nausea, dizziness, dry mouth, cramps and muscle con-traction,

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Fig. 5.24 Case 2 materials

Fig. 5.26 0.125 cc of physiological solution is taken with the 0.5-cc syringe

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Fig. 5.25 0.5 cc of physiological solution is taken to fill the 0.5-cc syringe and is slowly injected into the glass tube containing botulinum

Fig. 5.27 0.625 cc of physiological solution is slowly injected into the glass tube containing botulinum

Fig. 5.28 a, b, c a.s, 39 years old. With botulinum injection, we can also enhance facial symmetry providing a weakening of certain muscles on one side of the face in contrast to the same muscles on the other half of the face. Since the patient is young, a small quantity of toxin is injected. The patient is studied and the points of injection chosen to help correct the asymmetry. The amount of botulin toxin injected in each site does not change: 0.025 cc (5 Spaywood units) in each injection point is delivered. It is the choice of different points that leads to the esthetic correction. In this case, due to a physiological asymmetry of the patient, in the left side of the frontalis (the side with the upper eyebrow), the injections are done more laterally, and in the right side (the side with the lower eyebrow), the injections are done more medially in order to correct the asymmetry

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Fig. 5.29 0.05 cc are injected in two points into the center of the glabella (0.025cc in every point)

Fig. 5.32 a, b Left orbicular oculi is injected into just two points with 0.025 cc Right orbicular oculi is injected into four points with 0.025 cc introduced in each of the four points chosen Fig. 5.30 0.025 cc is injected 0.5 cm above the superior orbital rim on an imaginary axis passing through the internal canthus

Fig. 5.31 0.025 cc is delivered in the superolateral part of frontalis muscle. The injection is performed more laterally in the left side, more centrally in the right side in order to lift the eyebrow up

flu-like symptoms, itching and burning sensation in the treated area, infection, sensitivity to light, bron-chitis, dry skin, fatigue, insomnia, depression. • Rare (1–10 in 10,000 patients): swelling, redness or rash and allergic reaction to the product. • Very rare (less than one in 10,000 patients): excessive muscle weakness, difficulty swallowing, and difficulty swallowing after inhalation of foreign bodies or inhaled irritants. The practitioner must also be aware of the possible reaction of the patient caused by fear, such as light-head-edness, nausea and ringing in the ears. The practitioner must compulsorily check the patient after about one week in order to evaluate the response to the toxin and any asymmetries correctable with a second injection. Anti-inflammatory supplements can help reduce inflammation and pain without using drugs with potentially serious side effects. One tablet of anti-inflammatory supplements is recommended 2 times a day for 15 days (the composition is reported in Chap. 21.6).

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5.3.3

Contraindications

Anatomical alterations due to previous trauma or surgical intervention (neurosurgery). Scarring often induces a displacement of the noble structures and can lead to vessel perforation or nerve section. It can also induce retracting scars that can cause asymmetry and unequal filling of the part treated. – The filler should not be injected in areas that lack sufficient blood supply or that have an infection or inflammation. – No injection should be done if the area has been previously treated with liquid silicone or other permanent fillers because new injection could lead to inflammation or infection of the implants. – Any hypersensitivity to any components of the filler obviously constitutes a contraindication for the treatment.

5.3.4

Fig. 5.33 Pictures before and after treatment showing the improvement in the symmetry of eyebrows

5.3

Correction of the Forehead Wrinkles with Hyaluronic Acid

5.3.1

Pitfalls

Wrinkles in the frontal area can be corrected even by means of hyaluronic acid, filling longitudinally each wrinkle or filling the whole frontal subdermal plane in a fanlike fashion starting just above the lateral third of the eyebrow. If the latter option is chosen, we recommend using a blunt-tip cannula to avoid undesired damage to supraorbital nerve and vessel reaching frontal area from the medial third of the superior orbital rim.

5.3.2

Indication

– Patients who can’t or don’t want to be treated with botulin toxin – Amelioration of previuos treatment with botulin toxin

Case 3

Materials (Fig. 5.34) • 0.8 cc of medium viscosity Ha • Blunt-tip cannula 27 G, 37 mm length • Needle 30 G, 13 mm length • 0.2 cc of Local anesthetic (2% lidocaine, 2% mepivacaine) with epinephrine 1:100000 • Bandages and antiseptic solution Materials: Our Choice In Europe • Glytone 2 • Belotero Basic • Belotero Soft • Surgiderm 24XP • Surgiderm 18 • Volbella • Haequeo In Asia • Juvederm Refine • Juvederm Ultra XC In America • Belotero Basic • Juvederm Ultra XC Operating time The procedure usually takes 15 min. Method Figures 5.35, 5.36a, b, c, d 5.37a, b, c, d, e, f, g 5.38

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Fig. 5.34 Case 3 materials

Fig. 5.35 M.M. 53 years old, before treatment

Fig. 5.36 The insertion points and pattern of the cannula are designed on patient’s glabella and forehead. Anesthesia should be performed before starting the treatment. Correction of frontal wrinkles is not really a painful treatment, but anesthesia can increase significantly the compliance of patients with low level of pain tolerance. 0.2 cc of Mepivacaine with Adrenaline solution can be used

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(a)

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Fig. 5.37 a, b, c, d, e, f, g Hyaluronic acid is injected beneath the wrinkles

5.4

Fig. 5.38 Pre- and post-treatment: closer comparison

Summary: Treatment Options

Indication

Material

Needle or Cannula

Chapter

Correction of Forehead and Glabella Wrinkles and Crow’s-feet

Botulinum Toxin

1 cc syringe (Bocouture), 0.5 cc syringe (Azzalure)

5.2

Correction of the Forehead Wrinkles

Medium density Hyaluronic Acid

Cannula 27 G, 37 mm lenght

5.3

6

Malar Area Mario Goisis, Enrica Stella, and Alessandro Di Petrillo

Augmentation of the malar area is a simple procedure, than can be carried out in the office under local anesthesia. Augmentation of the malar area is one of the best treatments in the mid-face approach for the quality of results.

6.1

Anatomy

The zygomatic bone, or malar bone, is a paired bone which articulates with the maxilla, the temporal bone, the sphenoid bone, and the frontal bone. It creates the prominence of the cheek and takes part in the formation of the lateral wall and floor of the orbit and in that of the temporal and infratemporal fossa (Fig. 6.1a, b). Few noble structures have to be preserved during this procedure: • The zygomatic nerve, also named temporomalar nerve or orbital nerve, is a branch of the maxillary nerve (a trigeminal nerve branch) that enters the orbit and helps to give sensitivity to the skin over the zygomatic and temporal bones (Fig. 6.2a, b blue arrow). The zygomatic nerve is not to be confused with the zygomatic branches of the facial nerve. • In correspondence with the exit of the nerve, a little artery (zygomatic artery) is present. • The zygomatic branches of the facial nerve run across the zygomatic bone to the lateral angle of the orbit, where they supply the orbicularis oculi and join with filaments from the lacrimal nerve and the zygomaticofacial branch of the maxillary nerve.

E. Stella (&)  A. Di Petrillo Doctor’s Equipe, via Carducci 19, 20123 Milan, Italy e-mail: [email protected]

• The infraorbital nerve exits the infraorbital foramen of the maxilla and is a branch of the maxillary nerve. This nerve innervates the lower eyelid, upper lip, and part of the nasal vestibule Fig. 6.2a, b yellow arrow). • The infraorbital foramen is an opening in the skull located below the infraorbital margin of the orbit. It allows passage for the infraorbital artery, vein, and nerve. The infraorbital foramen distance varies between 6.10 and 10.9 mm from the inferior orbital margin. It is often palpable 1 cm below the lower orbit margin, on the pupil axis (Fig. 6.3).

6.2

Pitfalls

While injecting this area it is important to avoid the damage of the infraorbital nerve with the needle or compromise this noble structure injecting the material in the foramen, leading to nerve compression. A correct planning of the treatment is essential: traditionally, a set of easy lines define the areas without risk of damaging the infraorbital nerve. Those lines are called Hinderer’s lines (Fig. 6.4). The practitioner should paint on the patient’s face a first line joining the external cantus of the eye to the lateral rim of the mouth and a second line going from the nasal wing to the tragus. The intersection of the two lines delineates four quadrants. The superomedial quadrant represents the highrisk area. The superolateral quadrant is that usually chosen to perform the injection. In the superolateral quadrant, we can eventually come in contact with the zygomatic nerve, but this event does not lead to any severe clinical consequences: just pain during the treatment. Safe point: the point of injections is in the superolateral quadrant individuated with Hinderer’s lines.

M. Goisis Doctors Equipe, via Carducci 19, 20123 Milan, Italy e-mail: [email protected]

M. Goisis (ed.), Injections in Aesthetic Medicine, DOI: 10.1007/978-88-470-5361-8_6,  Springer-Verlag Italia 2014

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Fig. 6.1a, b : Zygomatic body (green circle) and zygomatic arch (red signs). Reproduction of a lithograph plate from Gray’s anatomy (Henry Gray, Anatomy: Descriptive and Surgical)

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Fig. 6.2 The blue arrow indicates the zygomatic nerve at its exit point on the bone. The zygomatic nerve is a branch of the maxillary nerve (a trigeminal nerve branch) that helps to give sensitivity to the skin over the zygomatic and temporal bones. The yellow arrow shows the infraorbital nerve coming out from the infraorbital foramen. The infraorbital foramen is an opening in the skull located below the

6.3

(b)

Indications

Malar atrophy is often congenital but can be also age related. It has been calculated that the malar area loses approximately 3 mm of lateral thickness due to bone reabsorption from 25- to 60-year old. This causes soft tissues of the medium part of the face to collapse, due to

infraorbital margin of the orbit. It allows passage for the infraorbital artery, vein, and nerve. The infraorbital foramen distance varies between 6.10 and 10.9 mm from the inferior orbital margin. It is often palpable 1 cm below the lower orbit margin, on the pupil axis. Reproduction of a lithograph plate from Gray’s anatomy (Henry Gray, Anatomy: Descriptive and Surgical)

gravity. Comparing patient’s old pictures with recent ones, this phenomenon can often be emphasized. Collapse of the mid-face tissues is responsible for the formation of nasolabial folds, marionette lines and prejowl sulcus. Correction of the age-related malar atrophy is often the best treatment to perform in a patient with mid-face tissue fall, often representing a unique treatment that can resolve

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nasolabial folds. Correction of asymmetries consequent can also benefit from malar augmentation.

6.4

Contraindications

– The filler should not be injected in areas that lack sufficient blood supply or that have an infection or inflammation. – No injection should be done if the area that has been previously treated with liquid silicone or other permanent fillers because new injection could lead to inflammation or infection of the implants. – Hypersensitivity to any components of the filler obviously constitutes a contraindication for the treatment. Fig. 6.3 The green arrow shows the safe point of injection. The blue arrow shows the zygomatic nerve, and the yellow arrow the infra orbital nerve.

6.5

Augmentation of the Malar Arch with Calcium Hydroxylapatite and Cannula

6.5.1

Operating Time

The procedure usually takes from 10 to 15 min.

6.5.2

Materials (Fig. 6.5)

• 1.5 cc of Calcium Hydroxylapatite. • Cannule 27G. • 37mm length Needle 26G, 13mm length.

Fig. 6.4 Hinderer’s lines. A first line joining the external cantus of the eye to the lateral rim of the mouth and a second line going from the nasal wing to the tragus. Reproduced with permission from Woffles et al. [1]

this important problem in only one session, with very little pain, excellent results and great satisfaction for the patient and the surgeon. The most important conditions that are suitable for this treatment are: reduced trophism and reduced lateral projection of the malar area, correction of the prejowl sulcus, correction of the marionette lines, correction of the

Fig. 6.5 Materials for augmentation of malar area

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Fig. 6.6 Hinderer lines designed on patient’s face

Fig. 6.8 Anesthesia should be performed before starting the treatment. Malar area augmentation is not really a painful treatment, but anesthesia can increase significantly the compliance of patients with low level of pain tolerance. 0.5 cc of Mepivacaine with Adrenaline solution can be used. The anesthetic injection can be made in the riskfree area obtaining a plexical anesthesia, but we can obtain a better anesthetic effect performing a troncular anesthesia: in this case, we have to inject directly near the infra orbital nerve area paying attention to inject very slowly

Fig. 6.7 The point of introduction of the cannula and its pattern during the treatment is shown

• 0.2 cc of local anesthetic (2% lidocaine or 2% mepivacaine) with epinephrine 1:100 000. • Bandages and antiseptic solution.

6.5.3

Material Choice

In Europe, Asia, and America Radiesse can be used.

Fig. 6.9 An initial opening is made right above the Hinderer’s lines intersection point with a small and thin needle of 26 G

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Fig. 6.10 A 27-G cannula 40 mm length is introduced perpendicularly to the skin plane through the hole created with the needle

Fig. 6.12 A fan of 3 concentric lines can be disposed beneath the skin of the malar area with the retrograde injection technique

Fig. 6.11 The cannula will then slide in the subcutaneous tissue proceeding from the medial entering overture in a upper lateral direction. The cannula slides in a natural plane so no hard resistance should be perceived by the practitioner. It is useful to keep in mind where the tip of the cannula is located touching it with the finger through the skin in order to check the position reached

6.5.4

Methods

Procedure is shown in Figs. 6.6, 6.7, 6.8, 6.9, 6.10, 6.11, 6.12 and 6.13a, b

6.5.5

Considerations About Malar Arch Augmentation

Injection with the microcannula is designed to be really superficial, in a subdermal plane. Advantages of using the cannula are as follows: reduced probability of bruising and of pain perceived by the patient; limited tenderness and post-treatment swelling. However, superficial injection does not give a big support to the jowl.

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Fig. 6.14 Materials: 1.5 cc of Calcium Hydroxylapatite Needle 30G, 13mm length 0.2 cc of Local anesthetic (2% lidocaine or 2% mepivacaine) with epinephrine 1:100000 Bandages and antiseptic solution

• The product can be diffused during the injection or aftertreatment massage along the lateral orbit margin. This is not a serious side effect but can be anti-esthetic. If the product tends to migrate superiorly, the surgeon should block the migration of the product with the finger, by compressing the lateral margin of the orbit.

6.6.2 Fig. 6.13 The treatment has to be concluded by massaging the part treated and exercising a good pressure laterally and upwards

Operating Time

The procedure usually takes from 10 to 15 min.

6.6.3

Materials

6.6

Augmentation of the Body of the Malar • 1.5 cc of Calcium Hydroxylapatite. Bone with Calcium Hydroxylapatite • Needle 30G, 13mm lenght. with Standard Needle

6.6.1

Pitfalls

• If a sudden pain is felt in the area of the skin innerved by the infraorbital nerve during needle insertion or product injection, treatment should be immediately stopped, no product should be further injected in order to avoid possible compression of the infraorbital nerve. • The product has to be injected deeply in a sovra-periosteal space. The product has to be injected slowly. The fingers of the free hand have to be positioned in a way that allows to feel the product under the tip of the fingers while it is being injected.

• 0.2 cc of Local anesthetic (2% lidocaine or 2% mepivacaine) with epinephrine 1:100000 • Bandages and alcohol (Fig. 6.14).

6.6.4

Material Choice

In Europe, Asia, and America Radiesse can be used.

6.6.5

Methods

The procedure is shown in Figs. 6.15a, b, 6.16, 6.17, 6.18.

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Fig. 6.17 After anesthesia, the practitioner should inject the calcium hydroxylapatite as a single bolus very deeply in the malar area. To find the right location, it is useful to touch with the tip of the needle the malar bone and then start to inject slowly

Fig. 6.15 The area to be corrected is drawn (yellow circle) and the point in which the injection should be made is shown: this point is right above the Hinderer’s lines intersection. Calcium hydroxylapatite will be injected with a 28-G needle in a single-point injection. Multiples injections can also be used: 2 or 3 points along the arrow moving upwards and laterally from the circle drawn on the patient’s face

Fig. 6.16 Anesthesia should be performed before starting the treatment, and 0.5 cc of Mepivacaine with Adrenaline solution can be used

Fig. 6.18 The treatment has to be concluded massaging the part treated exercising a good pressure with the palm of the hand laterally and upwards

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6.7

Augmentation of the Malar Area with Calcium Hydroxylapatite and Platelet Enriched Plasma

6.7.1

Indications

• • • •

Corticosteroid injection at treatment site within 1 month Systemic use of coriticosteroids within 2 weeks Cancer- especially hematopoetic or of bone HIV, HCV

Correction of the age-related malar atrophy.

6.7.4

6.7.2

The procedure usually takes 45 min, most of the time employed to obtain the platelet-enriched plasma (PRP).

Pitfalls

• If an sudden pain is felt in the area of the skin innerved by the infraorbital nerve during needle insertion or product injection, treatment should be immediately stopped, no product should be further injected in order to avoid possible compression of the infraorbital nerve. • The product has to be injected deeply in a sovra-periosteal space. The product has to be injected slowly. The fingers of the free hand have to be positioned in order to feel the product under the tip of the fingers while it is being injected. • The product can be diffused during the injection or aftertreatment massage along the lateral orbit margin. This is not a serious side effect but can be anti-esthetic. If the product tends to migrate superiorly, the surgeon should block the migration of the product with the finger, compressing the lateral margin of the orbit.

6.7.5

• • • •

Contraindications

Platelet dysfunction syndrome Critical thrombocytopenia Local infection at the site of the procedure Consistent use of NSAIDs within 48 hours of procedure

Fig. 6.19 Kit for PRP: in this case, we use REGEN kit

Materials

We use REGEN kit (Figs. 6.19, 6.20) • 1.5 calcium hydroxylapatite. • 28-G Needle. • 22-G Needle. • 2 cc of local anesthetic (2% lidocaine or 2% mepivacaine) with epinephrine 1:100000. • Calcium gluconate (10% solution). • 1-ml syringe. • 3-ml Luer lock syringe. • Connector for Luer lock syringes. • Bandages and alcohol.

6.7.6 6.7.3

Operating Time

Material Choice

In Europe, Asia, and America Radiesse can be used

6.7.7

Methods

The procedure is shown in Figs. 6.21, 6.22, 6.23, 6.24, 6.25, 6.26, 6.27, 6.28, 6.29, 6.30, 6.31, 6.32, 6.33, 6.34.

Fig. 6.20 Regen Lab PRP kit

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Fig. 6.23 Whole blood sample collected in an appropriate tube

Fig. 6.21 The patient is evaluated from three different views to show the hypoplasia of the mascellar bone that has to be corrected

Fig. 6.24 The blood sample is collected in two tubes that can undergo centrifugation for 15 min at a 1,500 G speed

Fig. 6.22 An ultrasound evaluation is performed, in order to compare the part before and after the treatment

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Fig. 6.27 0.05 ml of calcium gluconate are first aspirated in a 1-ml syringe an then added to 1.5 ml of PRP

Fig. 6.25 Result of the separation of the PRP from the red blood cells

Fig. 6.28 0.5 ml of local anesthetic (lidocaine, mepivacaine) with Adrenaline are aspired in a 3-ml syringe

Fig. 6.26 PRP is transferred in a 3-ml syringe leaving the red blood cells in the tube thanks to the specific gel that during the centrifugation has allowed good separation

Fig. 6.29 1.5 cc of calcium hydroxylapatite is mixed with the 0.5 ml of local anesthetic

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Fig. 6.31 The product is ready, composed of 0,05cc of calcium gluconate, 1,5 ml of PRP, o,5cc of local anesthesia, 1,5 cc of calcium hydroxylapatite

Fig. 6.30 PRP plus calcium gluconate is mixed with calcium hydroxylapatite plus anesthesia

After the injection, the surgeon should firmly massage the area of injection (Fig. a, b). The massage should be made from the medial to the lateral part of the malar bone.

Attention has to be paid to possible migration of the material along the lateral margin of the orbit during vigorous massage. This should be avoided with a firm pressure of the lateral margin of the orbit with the finger Fig. 6.34. Mild tenderness and discrete swelling on the malar area is expected in the following week and should not worry the patient or the surgeon.

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Fig. 6.32 After preparing the material, the needle has to be inserted deep in the malar area. The surgeon should touch the malar bone with the tip of the needle. Half of the syringe (1.5 cc of the 3 cc in the

syringe) is slowly injected as a bolus in the risk-free area previously delimited (safe point right above the Hinderer’s lines intersection)

Fig. 6.33 After the injection, the surgeon should firmly massage the area of injection. The massage should be made from the medial to the lateral part of the malar bone. Attention has to be paid to possible migration of the material along the lateral margin of the orbit during

vigorous massage. This should be avoided with a firm pressure of the lateral margin of the orbit with the finger. Mild tenderness and discrete swelling on the malar area is expected in the following week and should not worry the patient or the surgeon

6.8

Malar Body Augmentation with HA Using Standard Needle

6.8.1

Pitfalls

In case sudden pain is felt in the area of the skin innerved by the infraorbital nerve during needle insertion or product injection, treatment should be immediately stopped, no HA should be further injected in order to avoid possible compression of the infraorbital nerve. If pain persists for some minutes, Hyaluronidase should be immediately injected in the site of treatment.

Fig. 6.34 Pretreatment picture (on the left) and post-treatment picture on the right

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6.8.4

Material Choice

In Europe • Glytone 4 • Belotero intense • Juvederm voluma lidocaine. • Hyacorp 500 • Restylane sub-Q In Asia • Juvederm voluma xc. In America • Belotero intense • Juvederm volum xc. Fig. 6.35 Materials

6.8.5 • Product has to be injected deeply, in a supra-periosteal space and has to be injected slowly. The fingers of the free hand have to be positioned in order to feel the product under the tip of the fingers while it is injected. • HA can diffuse during the injection or during the aftertreatment massage along the lateral orbit margin. This is not a serious side effect, but can be anti-aesthetic. If the product tends to migrate superiorly, the surgeon should block the migration of the product with the finger, compressing the lateral margin of the orbit. The syringe can be connected with a 22-G needle. Smaller needles should be avoided, as they increase greatly the pressure needed for the injection and make the treatment uncomfortable for the surgeon. Non-Luer-Lock syringes should be avoided, as it is possible, during injection, that the high pressure generated causes a detachment of the needle from the syringe, causing a sudden leak of the material.

6.8.2

Method

Procedure is shown in Figs. 6.36, 6.37, 6.38, 6.39a, b, 6.40.

Operating Time

The procedure usually takes 10–15 min.

6.8.3

Materials

– – – – –

2 cc of high viscosity hyaluronic acid. 2.5-cc syringe with Luer Lock. 22-G Needle. 1-cc syringe. 0.2 cc of local anesthetic (2% lidocaine or 2% mepivacaine) with epinephrine 1:100000. – Bandages and disinfectant (Fig. 6.35).

Fig. 6.36 The syringe can be connected with a 22-G needle. Smaller needles should be avoided, as they increase greatly the pressure needed for the injection and make the treatment uncomfortable for the surgeon. Non-Luer-Lock syringes should be avoided, as it might happen during injection, that the high pressure generated causes a detachment of the needle from the syringe, causing a sudden leak of the material

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Fig. 6.37 Pretreatment imagines showing loss of volume in soft tissues

Fig. 6.38 Anesthesia

Fig. 6.39 a A single bolus of material is injected in the safe point and then distributed with a vigorous massage (yellow circle). The safe point is right above the Hinderer’s lines intersection. b The needle is inserted deeply and injection is made in a supra-periosteal space, touching the malar bone with the tip of the needle. 1 cc of HA is injected slowly as a unique bolus. The area is then vigorously massaged as the product, has to be distributed along the zygomatic body

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vigorous massage. This should be avoided with a firm pressure of the lateral margin of the orbit with the finger. Early complications (days to weeks after injection) include overcorrection, local infection, skin necrosis, herpes reactivation, discoloration and persistent local symptoms (erythema, edema, induration, pruritus and hyperpigmentation). Late complications include infection, filler migration, delayed hypersensitivity reaction, foreign-body granuloma and scarring. Anti-inflammatory supplements can help reduce inflammation and pain without using drugs with potentially serious side effects. One tablet of anti-inflammatory supplements is recommended 2 times a day for 15 days (the composition is reported in Chap. 21.6). Several factors such as stress, smoking, diet, lifestyle and exposure to natural or artificial UV light can increase the production of free radicals that cause ‘‘oxidative stress’’, a process that can trigger cell damage and decrease the duration of soft-lifting sponsored by the HA fillers. One tablet of antioxidant supplement is recommended 2 times a day for 15 days, then 1 times for 60 days (the composition is reported in Chap. 21.18).

6.10

Fig. 6.40 Pre- (left) and post-treatment (right)

6.9

Complications and Management

Immediate complications (within 72 hours after injection) immediate hypersensitivity reaction, transient erythema, edema, induration, pruritus and ecchymosis. Attention has to be paid to possible migration of the material along the lateral margin of the orbit during

Calcium Hydroxylapatite Versus HA

Radiesse has some advantages and some disadvantages compared with hyaluronic acid. The first advantage is the life of the product. Generally, results are visible for 12–18 months, compared with 6–9 months of HA. Secondarily, calcium hydroxylapatite has better physical endurance. Late-migration of the product due to gravity is reduced, obtaining better results also months after the treatment. Furthermore, the higher consistence of the product gives to the injected material a consistency much more similar to that of the malar bone. Finally, Radiesse can be used with thinner (28 G 9 00 ) needles, contained in the commercial available Box. The main disadvantage is constituted by the limited quantity of product contained in a commercially available syringe, equal to 1.5 cc. Larger corrections need the use of more than one syringe and doubles the cost of the treatment. For this reason, the cost of the treatment is higher with Radiesse than with HA.

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Summary: Treatment Options

Indication Malar arch Augmentation

Material Calcium Hydroxylapatite

Malar body Augmentation

Calcium Hydroxylapatite

Malar body Augmentation

Calcium Hydroxylapatite + PRP

Malar body Augmentation

High density hyaluronic acid

Reference

Needle or Cannula

Chapter

Cannule 27 G, 37MM Length

6.5

Needle 28G

6.6

Needle 22G

6.7

Needle 28G

6.8

Acknowledgment Heartfelt thanks go to Marco Zoccolan of Regen Lab.

1. Woffles W et al (2010) Novel administration technique for largeparticle stabilized hyaluronic acid-based gel of nonanimal origin in facial tissue augmentation. Aesthetic Plast Surg 34:88–95

7

Tear Trough Mario Goisis and Enrica Stella

7.1

Anatomy

On the nasal surface of the body of the maxilla, in front of the opening of the sinus is a deep groove, the lacrimal groove (or tear trough) which is converted into the nasolacrimal canal, by the lacrimal bone and inferior nasal concha; this canal opens into the inferior meatus of the nose and transmits the nasolacrimal duct. The lateral margin of the lacrimal fossa is named the anterior lacrimal crest (Fig. 7.1) and continues below with the inferior orbital rim.

The eyelid is made up of several layers, from superficial to deep, which are skin, subcutaneous tissue, orbicularis oculi, orbital septum and tarsal plates, and palpebral conjunctiva. The skin is similar to areas elsewhere, but is relatively thin and has more pigment cells. It contains sweat glands and hairs, the latter becoming eyelashes as they meet the border of the eyelid. The orbital septum is a membranous sheet that acts as the anterior boundary of the orbit. It extends from the orbital rims to the eyelids. It forms the fibrous portion of the eyelids. Few noble structures have to be preserved during this procedure: • The angular artery is the terminal part of the facial artery; it ascends to the medial angle of the eye’s orbit, imbedded in the fibers of the angular head of the quadratus labii superioris, and accompanied by the angular vein (Fig. 7.2 blue arrows).

Fig. 7.1 Lacrimal crest in red. Reproduction of a lithograph plate from Gray’s anatomy (Henry Gray, Anatomy: Descriptive and Surgical)

M. Goisis  E. Stella (&) Doctor»CPÖs Equipe, via Carducci 19, 20123, Milan, Italy e-mail: [email protected]

M. Goisis (ed.), Injections in Aesthetic Medicine, DOI: 10.1007/978-88-470-5361-8_7,  Springer-Verlag Italia 2014

Fig. 7.2 Angular veins and arteries are indicated by the arrows. Infraorbital foramen is indicated by a yellow circle

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• Orbicularis Oculi: The orbicularis oculi is a muscle in the face that closes the eyelids. It arises from the nasal part of the frontal bone, from the frontal process of the maxilla in front of the lacrimal groove, and from the anterior surface and borders of a short fibrous band, the medial palpebral ligament. From this origin, the fibers are directed lateralward, forming a broad and thin layer, which occupies the eyelids or palpebrae, surrounds the circumference of the orbit, and spreads over the temple, and downward on the cheek. This muscle is thin and pale, forms a series of concentric curves, and is inserted into the lateral palpebral. The lacrimal part (tensor tarsi) is a small, thin muscle, about 6 mm in breadth, and 12 mm in length, situated behind the medial palpebral ligament and lacrimal sac. It arises from the posterior crest and adjacent part of the orbital surface of the lacrimal bone, and passing behind the lacrimal sac, divides into two slips, upper and lower, which are inserted into the superior and inferior tarsi medial to the puncta lacrimalia. The muscle acts to close the eye and is the only muscle capable of doing so. • The infraorbital nerve exits the infraorbital foramen of the maxilla and is a branch of the maxillary nerve. This nerve innervates the lower eyelid, upper lip, and part of the nasal vestibule. The infraorbital foramen (Fig. 7.2 yellow circle) is an opening in the skull located below the infraorbital margin of the orbit. It allows the passage for the infraorbital artery, vein, and nerve. The infraorbital foramen distance varies between 6.10 and 10.9 mm from the infraorbital margin. It is often palpable 1 cm below the lower orbit margin, on the pupil axis.

7.2

Pitfalls

The skin in this area is really thin, and for this reason, any irregularity of the filler injected becomes very evident. Any overcorrection with HA products in the periorbital area may cause an edematous and puffy appearance of the lower eyelids. To avoid these bad outcomes, the injections must be at a supra-periosteal level of the orbital rim: Superficial injection may lead to bad results with even a Tyndall effect. A little amount of HA should be injected: 0.05–0.1 cc of low/medium viscosity HA. Most of the times, better results can be achieved if the patient is reexamined in two weeks and then additional treatment is performed, if needed: in this area is always better a poor correction that an overcorrection with a swelling lasting for months. The HA filler should be gently massaged right after the injection to smooth down any irregularity and obtain the best distribution under the trough.

Overcorrection or irregularity with HA fillers can be corrected by off-label use of hyaluronidase. Caution should be paid around the infraorbital foramen: It is useful to locate it with the finger before performing the pinch. The periorbital area is prone to bruising, and in the main structures, we have to pay attention to the angular vein and arteries. The safer technique is to use a blunt-tipped cannula, diminishing in this way the chance of injuring the vessels.

7.3

Correction of Tear Trough Deformity with HA and Blunt Tip Cannule

7.3.1

Indications

The correction of the tear trough deformity is addressed to those people having a dip under the eye that casts a shadow and gives them a tired look. This condition can be part of the normal aging process, or following lower eyelid surgery when too much fat has been removed.

7.3.2

Contraindications

• Anatomical malformations of lacrimal ducts. • Presence of severe skin laxity or atrophy and large bulgy fat pads will lead to unsatisfactory results. • Anatomical alterations due to previous trauma or surgical intervention (maxillo-facial surgery, titanuom plates). Scarring often induces a displacement of the noble structures. It can also induce retracting scars that can cause asymmetry and unequal filling of the part treated. • No injection should be done if the hand has been previously treated with liquid silicone or other permanent fillers because new injection could lead to inflammation or infection of the implants. • Hypersensitivity to any component of the filler obviously constitutes a contraindication for the treatment.

7.3.3

• • • •

Materials

0.8 cc of medium or low viscosity HA Cannule 27G, 37mm length Needle 26G,13mm lenght 0.2 cc of Local anesthetic (2% lidocaine, 2% mepivacaine) with epinephrine 1:100 000 • Bandages and antiseptic solution (Fig. 7.3).

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Tear Trough

Fig. 7.3 Materials

7.3.4

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Fig. 7.4 To see better tear trough deformity, the patient should be kept in an semi-seated position rather than laid down. The point of insertion of the needle is about 1 cm below the orbital rim in line with the midpupillary line and the pattern of the cannula follows the dip

Material Choice

In Europe • Glytone 2 • Belotero Basic • Belotero Soft • Surgiderm 18. • surgiderm 24xp • Restylane vital In Asia • Juvederm Refine. In America • Belotero Basic • Juvederm Ultra XC.

7.3.5

Operating Time

The procedure usually takes from 10 to 15 min.

7.3.6

Method

Procedure is shown in Figures 7.4, 7.5, 7.6, 7.7, 7.8, 7.9, 7.10, 7.11.

Fig. 7.5 Before the procedure, an anesthesia should be performed in correspondence of the entrance point. Local anesthetic (lidocaine, mepivacaine) with adrenaline 1:200,000 (equal to 1 mg/40 mL of solution) can be used. Taking this precaution, the treatment with the blunt tip cannula will not give any pain to the patient

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Fig. 7.6 A little hole is created around 1 cm below the orbital rim with the midpupillary A 26-G needle is used for this purpose

Fig. 7.7 Perpendicular insertion of a 27-G blunt tip cannula. The cannula is plunged deep into the skin through the orbicular muscle, advancing to the periosteum

Fig. 7.8 The cannula is then directed diagonally up toward the medial cantus of the eye and made it slide forward to the top of the tear trough

M. Goisis and E. Stella

Fig. 7.9 The tip of the cannula is showed through the skin to be just above the lacrimal crest. In fact, the tip of the cannula should be positioned over the lacrimal crest, touching the bone

Fig. 7.10 0.05–0.1 cc of HA are injected with a retrograde technique along the dip

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Fig. 7.11 a, b The trough is gently massaged to smooth down lumps and irregularities of the filler

7.4

Complications and Management

Immediate complications (within 72 hours after injection) include immediate hypersensitivity reaction, transient erythema, edema, induration, pruritus and ecchymosis. The periorbital area is prone to bruising. The safer technique is to use a blunt-tipped cannula, placing ice on the area 5 minutes before injection. Early complications (days to weeks after injection) include overcorrection, local infection, skin necrosis, herpes reactivation, discoloration and persistent local symptoms (erythema, edema, induration, pruritus and hyperpigmentation) and parestesia due to nerve lesion. In particular, caution should be paid around the infraorbital foramen: It is necessary to locate it with the finger before performing the pinch in order to avoid nerve lesions. Late complications include infection, filler migration, delayed hypersensitivity reaction, foreign-body granuloma and scarring. Anti-inflammatory supplements can help reduce inflammation and pain without using drugs with potentially serious side effects. One tablet of anti-inflammatory

supplements is recommended 2 times a day for 15 days (the composition is reported in Chap. 21.6). Several factors such as stress, smoking, diet, lifestyle and exposure to natural or artificial UV light can increase the production of free radicals that cause ‘‘oxidative stress’’, a process that can trigger cell damage and decrease the duration of soft-lifting sponsored by the HA fillers. One tablet of antioxidant supplement is recommended 2 times a day for 15 days, then 1 times for 60 days (the composition is reported in Chap. 21.18).

Summary: Treatment Options

Indications

Material

Needle or cannula

Chapter

Correction of tear throught deformity

Low or Medium viscosity hyaluronic acid

Cannule 27G, 37 mm length

7.3

8

Nasolabial Folds Enrica Stella and Magda Guareschi

Nasolabial folds often deepen with aging, and give the face a tired and sagging appearance. The most significant factor that contributes to the prominence of the folds is the loss of facial volume and skin elasticity as we age. Facial structure and genetic factors also give a contribution to determine the depth of these wrinkles. The best way to give a better appearance to the patient’s face is often to address the overall volume loss and not just treating an individual fold. In this section, we will concentrate on the nasolabial folds by themselves.

8.1

Anatomy

Nasolabial folds area creases on the sides of the nose that extends to the corners of the mouth. They separate the cheeks from the upper lip. Anatomically, the folds are the peripheral margin of the orbicular oris muscle at the fusion of levator labii superioris medially and the zygomatic major muscle laterally (Fig. 8.1).

8.2

Fig. 8.1 Levator labii superioris medially and the zygomatic major muscle. Reproduction of a lithograph plate from Gray’s anatomy (Henry Gray, Anatomy: Descriptive and Surgical)

Pitfalls

Injection should be done in the mid-deep dermis: not too superficially to avoid the creation of lumps or Tyndall effect, not too deep as no fold correction would be noticed. A linear threading retrograde technique along the nasolabial fold can be used, concentrating on the upper triangularshaped area below the nostrils and lateral to the ala. The correction of this little area will produce a more youthful appearance because here usually the problem is the deepening related to age—induced loss of fat: Usually, it is the first part of the crease that has to be filled. When

E. Stella (&)  M. Guareschi Doctor’s Equipe, Via Carducci 19, 20123, Milan, Italy e-mail: [email protected]

M. Goisis (ed.), Injections in Aesthetic Medicine, DOI: 10.1007/978-88-470-5361-8_8,  Springer-Verlag Italia 2014

injecting the Y-shaped area avoid injecting just beneath the nostrils: Penetration of the needle should be stopped at the corner of the ala nasi without going under nostrils. This mistake may eventually lead to esthetical bad results with flaring of the nostrils or even ischemic evolution. The material should be injected symmetrically in the two nasolabial folds leaving a certain amount in the syringe. In the majority of cases, the largest amount of product can be injected in the Y-shaped area that needs a good volume addiction, diminishing the quantity of filler injecting moving down along the fold. Technical skill: particularly attention should be paid in injecting the crease near the mouth corner: here just minute volume of filler should be delivered because of the dynamical feature of this area. These in fact are known as

95

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smile lines, and overcorrection will result in unattractive lumps at both sides of the mouth. Safe point of injection: there are not particular dangerous anatomical structures in the nasolabial crease area. For this reason, there are not particular safe points to pay attention to.

8.3

Correction of Nasolabial Folds with HA and Cannula

8.3.1

Indications

Evident nasolabial folds. The cannula technique permits to avoid bruising but at the same time is less accurate. Normally is useful when also bar code correction is performed with blunt cannula: In this situation thanks to a unique entrance point all the area located between the upper lip and the nasolabial folds, it can be filled by just rotating the cannula.

8.3.2

Contraindications

Fig. 8.2 Materials for correction of nasolabial folds with HA and cannula

Attention should be paid if the area had been previously treated with permanent fillers. The filler should not be injected in areas that lack sufficient blood supply or that have an infection or inflammation.

In Asia • Juvederm Ultra Plus XC • Restylane. In America • Juvederm Ultra Plus XC • Restylane.

8.3.3

8.3.5

Materials

• • • •

0.4–0.8 cc of medium viscosity HA (Fig. 8.2). Blunt-tip cannula 27 G, 37 mm length. Entrance needle 26 G, 13 mm length. Local anesthetic (lidocaine, mepivacaine) with adrenaline 1:200,000 (equal to 1 mg/40 mL of solution). • Bandages and antiseptic solution.

Operating Time

The procedure usually takes from 10 to 15 min.

8.3.6

Method

Procedure is shown in Figs. 8.3, 8.4, 8.5, 8.6, 8.7, 8.8.

8.3.4

Material Choice

In Europe • Surgiderm 24XP • Surgiderm 30XP • Juviderm Ultra 3 and 4 • Juvederm Volift • Restylane • Perlane.

8

Nasolabial Folds

Fig. 8.3 The procedure is shown

Fig. 8.4 Anesthesia is performed in the entrance point at the base of the nasolabial fold with 0.2 cc of local anesthetic (lidocaine, mepivacaine) with adrenaline

Fig. 8.5 An opening is created with a 26-G needle at the base of the nasolabial fold

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Fig. 8.6 A 26-G blunt-tip cannula is inserted perpendicularly to skin surface

Fig. 8.7 The cannula is then pivoted parallel to the skin plane and slid toward the top of the nasolabial fold

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Fig. 8.9 Materials for correction of nasolabial folds with HA and standard needle

8.4.3 • • • •

0.4–0.8 cc of medium viscosity HA (Fig. 8.9). 30 G needle. Topical anesthetic (lidocaine, mepivacaine). Bandages and antiseptic solution.

8.4.4

Fig. 8.8 The filler is delivered slowly while the cannula is withdrawn with retrograde injection. At the end of the treatment, a massage is applied over the area injected

8.4

Correction of Nasolabial Folds with HA and Standard Needle

8.4.1

Indications

Medium and severe nasolabial folds. The technique is very accurate.

8.4.2

Materials

Material Choice

In Europe • Surgiderm 24XP • Surgiderm 30Xp • Juviderm Ultra 3 and 4 • Juvederm Volift • Restylane • Perlane. In Asia • Juvederm Ultra Plus XC • Restylane. In America • Juvederm Ultra Plus XC • Restylane.

8.4.5

Operating Time

The procedure usually takes from 10 to 15 min.

Contraindications 8.4.6

Attention should be paid if the area had been previously treated with permanent fillers.

Method

Procedure is shown in Fig. 8.10.

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Nasolabial Folds

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(a)

(b)

(c)

(d)

(e)

(f)

Fig. 8.10 a: Injecting filler into the nasolabial folds causes often discomfort to the patient. It is better to avoid injection of anesthetic into the area to be treated because this can distort the volume. A topical anesthetic product can be used and placed over the area at least 20 min before starting the procedure. The first part of the nasolabial fold to be approached is the Y-shaped area just below the nostrils. b-c: The procedure is shown. The needle enters the skin at a 30–45 angle in a point located 1 cm below the nasal ala and advanced parallel to the skin surface in the dermal subcutaneous space. The needle is inserted through a single entry point and then pivoted to create a series of linear tunnels in a fanlike pattern. This means that just before the needle exits the skin, it is reoriented medially and advanced; the same is done placing the needle laterally, thus achieving the filling of a triangular-

shaped area. d: A retrograde thread of filler is placed within each tunnel, stopping the injection as the needle approaches the entrance point to avoid excess accumulation at the pivot point. e: The needle is then withdrawn completely, reinserted 1 cm lower to the previous entrance point along the nasal crease and advanced to just beyond the previous insertion point. 8.10. f: The filler is then uniformly delivered into the created tunnel as the needle is slowly withdrawn from the skin: retrograde injection technique. The injection of filler should be stopped before completely withdrawal of the needle to avoid superficial implantation of the product. The procedure is repeated inserting the needle at the base of the nasal fold near the mouth corner. A firm massage of the injected sites is performed to smooth the irregularities. The result can be immediately seen

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E. Stella and M. Guareschi

Complications and Management

Immediate complications (within 72 hours after injection): include immediate hypersensitivity reaction, transient erythema, edema, induration, pruritus and ecchymosis. Early complications (days to weeks after injection) include overcorrection, local infection, skin necrosis, herpes reactivation, discoloration and persistent local symptoms (erythema, edema, induration, pruritus and hyperpigmentation). Late complications include infection, filler migration, delayed hypersensitivity reaction, foreign-body granuloma and scarring. Anti-inflammatory supplements can help reduce inflammation and pain without using drugs with potentially serious side effects. One tablet of anti-inflammatory supplements is recommended 2 times a day for 15 days (the composition is reported in Chap. 21.6).

Several factors such as stress, smoking, diet, lifestyle and exposure to natural or artificial UV light can increase the production of free radicals that cause ‘‘oxidative stress’’, a process that can trigger cell damage and decrease the duration of soft-lifting sponsored by the HA fillers. One tablet of antioxidant supplement is recommended 2 times a day for 15 days, then 1 times for 60 days (the composition is reported in Chap. 21.18).

8.6

Summary: Treatment Options

Indication

Material

Needle or Cannula

Chapter

Correction of nasolabial folds

Medium density hyaluronic acid

Cannula 27 G, 37mm lenght

8.3

Correction of nasolabial folds

Medium density hyaluronic acid

Needle 30 G

8.4

9

Medical Rhinoplasty Mario Goisis

9.1

Anatomy

The nose occupies the middle third of the face. In the upper portion of the nose, the paired nasal bones attach to the frontal bone. Above and to the side (superolaterally), the paired nasal bones connect to the lacrimal bones, and below and to the side (inferolaterally), they attach to the ascending processes of the maxilla (upper jaw). The nasal root is the top of the nose, forming an indentation at the suture where the nasal bones meet the frontal bone. The anterior nasal spine is the thin projection of bone at the midline on the lower nasal margin, holding the cartilaginous center of the nose. The cartilaginous septum (septum nasi) extends from the nasal bones in the midline (above) to the bony septum in the midline (posteriorly), then down along the bony floor (Fig. 9.1). The septum is quadrangular; the upper half is flanked by two triangular-to-trapezoidal cartilages: the upper lateral cartilages, which are fused to the dorsal septum in the midline, and laterally attached, with loose ligaments, to the bony margin of the pyriform (pear-shaped)

M. Goisis (&) Maxillo-facial and Aesthetic Surgeon, Doctor’s Equipe, Milan, Italy e-mail: [email protected]

M. Goisis (ed.), Injections in Aesthetic Medicine, DOI: 10.1007/978-88-470-5361-8_9,  Springer-Verlag Italia 2014

Fig. 9.1 Bony part of the nose is formed by the bony nasal septum, the nasal bones, and medial parts of the maxillae, palatine, and frontal bones; cartilaginous part is formed by two lateral cartilages, two alar cartilages, and a septal cartilage. Reproduction of a lithograph plate from Gray’s anatomy (Henry Gray, Anatomy: Descriptive and Surgical)

Fig. 9.2 Angular artery and lateral nasal artery. Reproduction of a lithograph plate from Gray’s anatomy (Henry Gray, Anatomy: Descriptive and Surgical)

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Fig. 9.3 Muscular fibers of depressor septi nasi are oriented upwards and are inserted into the nasal septum and in the back part of the alar part of nasalis muscle. Reproduction of a lithograph plate from Gray’s anatomy (Henry Gray, Anatomy: Descriptive and Surgical)

aperture, while the inferior ends of the upper lateral cartilages are free (unattached). The internal area (angle), formed by the septum and upper lateral cartilage, constitutes the internal valve of the nose; the sesamoid cartilages are adjacent to the upper lateral cartilages in the fibroareolar connective tissue. Blood supply for nose tip and alar wings is granted by a terminal branch of angular artery named lateral nasal artery (Fig. 9.2). The depressor septi nasi muscle is a mimic muscle that arises from the incisive fossa of the maxilla (Fig. 9.3). Muscular fibers of depressor septi nasi direct upward to be inserted into the nasal septum and back part of the alar part of nasalis muscle. The depressor septi draws the ala of the nose downward.

9.2

Before injecting, patient’s nose profile is carefully evaluated paying attention to the nasofrontal and nasolabial angles; the right dimensions should be the following: • the nasofrontal angle: between 115 and 135, • the dorsal angle, normally straight, • the nasolabial angle, between 90 and 110.

9.3

Indications

Medical rhinoplasty can be employed in those cases where patients are reluctant to undergo surgery, or for correction of minor nose defects. The patients that can benefit from botulinum injections are those with a fall in the nasal tip due to hyperactivity of the depressor septi nasi.

Pitfalls

Filling with hyaluronic acid, the nasal dorsum allows the modification of the nasofrontal angle and slightly models the dorsum itself. This procedure has to be performed by injecting the filler very slowly in order to prevent arteries compression and ischemic injury. The injections in the nasal root should be done by introducing the needle until it touches the bone and then delivering the filler just superficial to the periosteum.

9.4

Contraindications

Severe malformations which require surgical intervention; Patients with recognized vasculopathies due to the terminal nature of parts of nasal irriration. Patients who underwent surgical rhinoplasty or with a previous trauma history should be carefully evaluated before receiving any medical treatment.

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9.5

Medical Rhinoplasty with Botulinum and HA

9.5.1

Operating Time

20 minutes.

9.5.2

Materials

• 0.4 cc of Ha medium viscosity. • Botulinum toxin type A. • Local anesthetic (lidocaine, mepivacaine) with adrenaline 1:200000 (equal to 1 mg/40 mL of solution). • 30 G needle. • 1 cc syringe. • Sodium chloride. • Bandages and antiseptic solution (Fig. 9.4).

9.5.3

Material Choice

Botulinum toxin

Hyaluronic acid

In Europe Bocouture

Surgiderm 30 XP

Vistabex

Juvederm Ultra 4

Vistabel

Juvederm volift

Azzalure

Restylane

In Asia Xeomin

Juvederm Ultra Plus XC

Neuronox

Restylane

Azzalure Botox In America Fig. 9.4 Materials for medical Rhinoplasty with botulinum and HA

Xeomin Xeemin

Juvederm Ultra Plus XC

Neuronox (Brasil)

Restylane

Botox Azzalure

9.5.4

Method

Procedure is shown in Figs. 9.5, 9.6, 9.7, 9.8a–c, 9.9a, b, 9.10, 9.11a, b, 9.12a, b.

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Fig. 9.5 The patient profile is carefully evaluated paying attention to the nasofrontal and nasolabial angles

Fig. 9.6 Areas of correction are marked. The injection of HA in the area designed on the patient’s nasal root improves the dorsum profile and the nasofrontal angle, while botulinum injection addresses depressor septi nasi muscle to contrast the fall of the nasal tip

M. Goisis

Fig. 9.7 Truncal anesthesia at the level of infraorbital nerve is obtained; 0.5 cc of local anesthetic (lidocaine or mepivacaine) may be used

9

Medical Rhinoplasty

Fig. 9.8 a–c Small quantity of anesthetic (0.2 cc in each point) is injected in three point in the area of the nasal root chosen for the filling

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Fig. 9.9 a, b 0.05 cc of botulinum toxin (125 Spaywood unites of Azzalure diluted with 0.625 cc of sodium chloride) is injected in the depressor nasi muscle in two sites (0,025cc for site) of injection located bilaterally to the columella

Fig. 9.10 Injection of the nasal root to refine the nasofrontal angle and improve the nasal dorsum’s line is performed. The needle is introduced with obliquity of 45 right in contact with the bone, delivering the filler just superficial to the periosteum with retrograde technique. The nose should be held in the centre of the root in order to prevent the product from spreading laterally

M. Goisis

Fig. 9.11 a, b Immediately after injection, digital pressure is applied and the implant molded into position

9

Medical Rhinoplasty

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(a)

(b)

Fig. 9.12 a, b While HA injection results can be seen immediately, in case of botulinum injections, at least 5 days are needed; the pretreatment picture on the left and 2 weeks after the procedure on the right

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9.6 9.6.1

M. Goisis

Medical Rhinoplasty with Calcium Hydroxylapatite and Botulin Toxin Operating Time

20 minutes.

9.6.2

Materials

• 0.2 cc of calcium hydroxylapatite. • Botulinum toxin type A (in this case Bocouture, packs of 50 units). • Local anesthetic (lidocaine, mepivacaine) with adrenaline 1:200000 (equal to 1 mg/40 mL of solution). • 30 G needle. • 1 cc syringe. • Sodium chloride. • Bandages and antiseptic solution (Fig. 9.13).

Fig. 9.13 Materials

9.6.3

Material Choice

In Europe, Asia and America Radiesse can be used. Some examples of botulinum toxin that could be used. In Europe • Bocouture. • Vistabex. • Vistabel. • Azzalure. In Asia • Xeomin. • Neuronox. • Azzalure. • Botox. In America • Xeomin. • Xeemin. • Neuronox (Brasil). • Botox. • Azzalure.

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Medical Rhinoplasty

9.6.4

109

Method

Procedure is shown in Figs. 9.14, 9.15, 9.16, 9.17, 9.18, 9.19, 9.20a, b.

Fig. 9.14 The area of injection is drawn

Fig. 9.15 Local anesthesia is performed. Small quantity of anesthetic (0.2 cc in each point) is injected in three point in the area of the nasal root chosen

Fig. 9.16 Injection of the nasal root to refine the nasofrontal angle and improve the nasal dorsum’s line is performed. The needle is introduced with obliquity of 45 right in contact with the bone, delivering the filler just superficially to the periosteum with retrograde technique. The nose should be held in the centre of the root to prevent the product from spreading laterally. Radiesse injection is performed in the area previously drawn

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Fig. 9.18 4 UI of Bocouture, botulinum toxin, is being aspirated into a 1 mL syringe (50 U diluted with 1.25 cc saline)

Fig. 9.17 Digital pressure

Fig. 9.19 Injection in depressor septi is performed. 0.1 cc of botulinum toxin is injected in the depressor nasi muscle in two sites of injection located bilaterally to the columella (0.05cc for side)

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Medical Rhinoplasty

Fig. 9.20 a, b Pretreatment pictures on the left and post treatment pictures on the right

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(b)

9.7

Complications and Management

Immediate complications (within 72 hours after injection) immediate hypersensitivity reaction, transient erythema, edema, induration, pruritus and ecchymosis. Early complications (days to weeks after injection) include overcorrection, local infection, skin necrosis, herpes reactivation, discoloration and persistent local symptoms (erythema, edema, induration, pruritus and hyperpigmentation). Late complications include infection, filler migration, delayed hypersensitivity reaction, foreign-body granuloma and scarring.

Anti-inflammatory supplements can help reduce inflammation and pain without using drugs with potentially serious side effects. One tablet of anti-inflammatory supplements is recommended 2 times a day for 15 days (the composition is reported in Chap. 21.6). Several factors such as stress, smoking, diet, lifestyle and exposure to natural or artificial UV light can increase the production of free radicals that cause ‘‘oxidative stress’’, a process that can trigger cell damage and decrease the duration of soft-lifting sponsored by the HA fillers. One tablet of antioxidant supplement is recommended 2 times a day for 15 days, then 1 times for 60 days (the composition is reported in Chap. 21.18).

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Summary: Treatment Options

Indication

Material

Needle or Cannula

Chapter

Medical Rhinoplasty

Medium density hyaluronic acid

Needle 30 G

9.5

Medical Rhinoplasty

Calcium Hydroxylapatite

Needle 28 G

9.6

Medical Rhinoplasty

Azzalure

0.5 cc syringe

9.5

Medical Rhinoplasty

Vistabex, Bocouture

1cc syringe

9.6

10

Marionette Lines Enrica Stella, Alessandro Di Petrillo, and Mario Goisis

Marionette lines are the result of loss of support normally provided by the soft tissue of the cheek. To improve the appearance this area, it is important to give back the right support to the cheek using a filler. The best choice is the use of CaHA while also HA may be used. Once CaHA particles placed in fact form, a ‘‘scaffold’’ to support and stimulate the production of the body’s own collagen providing a long-lasting result that tends to improve during the months after the treatment.

10.1

Anatomy

Placing fillers in the lower third of the face needs anatomical knowledge of the region, including two important structures: the facial vessels and the marginalis mandibulae branch of facial nerve (VII). Fig. 10.1 Facial artery and vein are indicated by the arrow

10.1.1 Facial Vessels The facial artery, together with anterior facial vein crosses the inferior mandibular border just anteriorly to the masseter muscle (Figs. 10.1, 10.2 and 10.4 blue arrow). The vessels continue in superiorly and anteriorly, lying just superficially to buccinators muscle.

E. Stella (&)  A. Di Petrillo Doctor’s Equipe, via Carducci 19, 20123 Milan, Italy e-mail: [email protected] M. Goisis Doctor’s Equipe, via Carducci 19, 20123 Milan, Italy e-mail: [email protected]

M. Goisis (ed.), Injections in Aesthetic Medicine, DOI: 10.1007/978-88-470-5361-8_10,  Springer-Verlag Italia 2014

Fig. 10.2 In the anatomic dissection, facial vein and artery are evident

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periostal plane, crossing over the facial vessels. The nerve is surrounded by a quite fibrous connective layer.

10.3

Pitfalls

When approaching the lower cheek with filler injections, the use of a blunt-tip needle can help avoiding bruising and injuries to any structure as an undesired damage to the anterior facial vein can hesitate in noticeable hematomas. Placing an implant in the mandibular border area is important to use a blunt-tip needle and to avoid to push the head of the needle directly to the fibrous plane surrounding the periosteum.

10.4 Fig. 10.3 Marginal mandibular branch of the facial nerve is indicated by the yellow arrow

Marionette Line Correction with Hydroxylapatite and Blunt-tip Cannula

10.4.1 Indications Correction of marionette lines obtained by strengthening the support provided by the cheek. The use of the blunt-tip cannula allows for an atraumatic dissection of the tissue with the placement of the implant superficially to buccinator muscle, and permits to obtain fewer needle entry marks and significantly less pain and bruising.

10.4.2 Contraindications

Fig. 10.4 Marginal branch of facial nerve is individuated by yellow arrow and facial vessels are individuated by blue arrow on the patient’s face

10.2

• The filler should not be injected in areas that lack sufficient blood supply or have an infection or inflammation. • No injection should be done if the hand has been previously treated with liquid silicone or other permanent fillers because a new injection could lead to inflammation or infection of the implants. • Hypersensitivity to any component of the filler obviously constitutes a contraindication for the treatment.

Marginal Mandibular Branch of the Facial Nerve 10.4.3 Operating Time

The marginal mandibular branch of the facial nerve passes forward beneath the platysma and triangularis, supplying the muscles of the lower lip and chin, and communicating with the mental branch of the inferior alveolar nerve (yellow arrow in Fig. 10.3 and 10.4). The marginalis branch innervates mentalis muscle, depressor labii inferioris muscle and depressor anguli oris muscle. Injuries to marginalis branch of facial nerve can result in asymmetry of oral rim, more evident during facial expressions. Anteriorly to masseter muscle the nerve remains some millimeters over the

The procedure usually takes from 10 to 15 min.

10.4.4 Materials • 0.8 cc of Radiesse • Cannule 27 G, 37 mm length • Needle 26 G, 13 mm length

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Fig. 10.5 Materials

• 0.2 cc of Local anesthetic (2 % Lidocaine, 2 % mepivacaine) with epinephrine 1:100 000 • Bandages and antiseptic solution (Fig. 10.5).

10.4.5 Material Choice In Europe, Asia, and America Radiesse can be used.

10.4.6 Methods The procedure is described in (Figs. 10.6–10.12).

Fig. 10.7 a–c The calcium hydroxylapatite is injected with a blunttip cannula along into the subcutaneous tissue with a fan-shaped technique using a single entrance point. The point of introduction of the cannula and its pattern during the treatment is shown

Fig. 10.6 The area of injection is designed on patient’s face (green arrows)

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Fig. 10.8 Anesthesia is injected subdermally with an insulin syringe and microfine needle to numb the insertion point of the cannula. 0.2 cc of mepivacaine with Adrenaline solution can be used

Fig. 10.9 An insertion point for the introduction of the blunt-tip cannula is made with a small and thin needle of 26 G; the entrance point is located 1 cm laterally and 2 cm below the oral rim

Fig. 10.10 a A 27-G cannula 40 mm length is introduced perpendicularly to the skin plane through the hole created with the needle; b The cannula will then slide in the subcutaneous tissue; c The cannula is inserted in order to be almost parallel to the skin plane and slowly introduced under the skin proceeding from the medial entering overture in a upper lateral direction reaching the furthest point

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Marionette Lines

Fig. 10.11 a The cannula slides in a natural plane so no hard resistance should be perceived by the practitioner. It is useful to mind where the tip of the cannula is located touching it with the finger through the skin in order to check the position reached. b Multiple

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threads are disposed beneath the skin of the cheek area sing a fanning technique in a retrograde manner from the same port of entry. c 0.8 of calcium hydroxylapatite is then spread in every cheek in a sort of triangular area with the retrograde injection technique

Fig. 10.12 a, b The treatment has to be concluded by massaging the treated part exercising a good pressure laterally and upward in order to mold the product for the desired effect

10.5.4 Materials

10.5

Marionette Line Correction with HA and Blunt-tip Cannula

10.5.1 Indications Correction of marionette lines obtained by increasing of support provided by the cheek.

10.5.2 Contraindications • The filler should not be injected in areas that lack sufficient blood supply or have an infection or inflammation. • No injection should be done if the hand has been previously treated with liquid silicone or other permanent fillers because a new injection could lead to inflammation or infection of the implants. • Any hypersensitivity to any components of the filler obviously constitutes a contraindication for the treatment.

10.5.3 Operating Time The procedure usually takes from 10 to 15 min.

• • • •

0.8 cc of HA. Cannulae 27 G, 37 mm length. Needle 26 G,13 mm length. Local anesthetic (lidocaine, mepivacaine) with Adrenaline 1:200000 (equal to 1 mg/40 mL of solution). • Bandages and antiseptic solution (Fig. 10.13).

10.5.5 Material Choice In Europe • Glytone 3. • Surgiderm 24 xp. • Juvederm ultra 3. • Juvederm volift. • Restylane. In Asia • Juvederm ultra plus xc. • Restylane. In America • Belotero intense. • Juvederm ultra plus xc. • Restylane.

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Fig. 10.13 Materials

Fig. 10.14 The cheek augmentation performed only on one side is useful to help correcting the evident asymmetry of the patient

Fig. 10.16 a–c The HA will be injected with a blunt-tip cannula along into the subcutaneous tissue with a fan-shaped technique using a unique entrance point

10.5.6 Methods Fig. 10.15 The green arrows represent the pattern of the cannula in the subcutaneous tissue. The area of injection of the cannula in the subcutaneous tissue is designed on patient’s face (red arrows)

Procedures is shown in Figs. 10.14, 10.15, 10.16, 10.17, 10.18, 10.19 and 10.20.

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Fig. 10.17 Anesthesia is injected subdermally with an insulin syringe and microfine needle to numb the insertion point of the cannula. 0.2 cc of Mepivacaine with Adrenaline solution can be used. The anesthetic injection is made in the needle entrance point: 1 cm laterally and 2 cm below the oral rim

Fig. 10.18 An insertion point for the introduction of the blunt-tip cannula is made with a small and thin needle of 26 G; the entrance point is located 1 cm laterally and 2 cm below the oral rim

Fig. 10.19 A 27-G cannula 40 mm length is introduced perpendicularly to the skin plane through the hole created with the needle; the cannula is inclined in order to be almost parallel to the skin plane and slowly introduced under the skin

Fig. 10.20 a–c A 27-G cannula is then inserted vertically through the hole obtained and made it slide in the subcutaneous tissue proceeding from the medial entering overture in a upper lateral direction reaching the furthest point (Fig. 10.19). The cannula slides in a natural plane so no hard resistance should be perceived by the practitioner. It is useful to mind where the tip of the cannula is located touching it with the finger through the skin in order to check the position reached. Multiple threads are disposed beneath the skin of the cheek area using a fanning technique in a retrograde manner from the same point of entry. 0.8 of HA is spread in a sort of triangular area with a retrograde injection technique. The treatment has to be concluding massaging the part treated exercising a good pressure laterally and upward in order to mold the product for the desired effect

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Marionette Line Correction with HA and Standard Needle

10.6.1 Indications

10.6.4 Materials • 0.8 cc of medium density HA. • Needle 30 G, 13 mm length

Camouflage of marionette lines can be obtained by augmenting of soft tissues around them. When approaching directly the marionette lines, it is essential to lend support to the whole area and not just to fill the wrinkle itself. The depressed area that needs to be filled can be imagined has a triangle where the marionette line represents just one of the three sides and the lateral oral commissure is the apex.

10.6.2 Contraindications • The filler should not be injected in areas that lack sufficient blood supply or have an infection or inflammation. • No injection should be done if the hand has been previously treated with liquid silicone or other permanent fillers because a new injection could lead to inflammation or infection of the implants. • Any hypersensitivity to any components of the filler obviously constitutes a contraindication for the treatment.

10.6.3 Operating Time The procedure usually takes 5 min.

Fig. 10.21 Materials

Fig. 10.22 a–c Steps of the treatment: three entrance points are shown. The depressed area that needs to be filled can be imagined as a triangle where the marionette line represents just one of the three sides and the lateral oral commissure constitutes the apex

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Fig. 10.23 Anesthesia performed in the entrance point; 0.2 cc of mepivacaine ? adrenaline solution can be used

Fig. 10.24 The needle is inserted along the marionette line 1 cm below the oral rim. The injection is performed using a fanning technique with retrograde threading. The filler is released in deep dermis plane

• 0.2 cc of Local anesthetic (2% lidocaine, 2% mepivacaine) with epinephrine 1:100 000 • Bandages and antiseptic solution

10.6.5 Material Choice In Europe • Glytone 3. • Surgiderm 24 xp. • Juvederm ultra 3. • Juvederm volift. • Restylane.

Fig. 10.25 a The injection is then repeated choosing a second entrance point located immediately below the previous one along the base of the ideal triangular area. The needle is directed always toward the oral rim and then moved. b A third injection point ends the treatment resulting in crosshatching of material

In Asia • Juvederm ultra plus xc. • Restylane. In America • Belotero intense. • Juvederm ultra plus xc. • Restylane

10.6.6 Method Procedures is shown in Figs. 10.21, 10.22a–c, 10.23, 10.24, 10.25a, b, 10.26a, b and 10.27.

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10.7

Complications and Management

Immediate complications (within 72 hours after injection) immediate hypersensitivity reaction, transient erythema, edema, induration, pruritus and ecchymosis. Injuries to marginalis branch of facial nerve can result in asymmetry of oral rim, more evident during facial expressions. Early complications (days to weeks after injection) include overcorrection, local infection, skin necrosis, herpes reactivation, discoloration and persistent local symptoms (erythema, edema, induration, pruritus and hyperpigmentation). Late complications include infection, filler migration, delayed hypersensitivity reaction, foreign-body granuloma and scarring (See Chap. 21). Anti-inflammatory supplements can help reduce inflammation and pain without using drugs with potentially serious side effects. One tablet of anti-inflammatory supplements is recommended 2 times a day for 15 days (the composition is reported in Chap. 21.6). Several factors such as stress, smoking, diet, lifestyle and exposure to natural or artificial UV light can increase the production of free radicals that cause ‘‘oxidative stress’’, a process that can trigger cell damage and decrease the duration of soft-lifting sponsored by the HA fillers. One tablet of antioxidant supplement is recommended 2 times a day for 15 days, then 1 times for 60 days (the composition is reported in Chap. 21.18).

Fig. 10.26 a, b The treated area is massaged to smoothen any unevenness Fig. 10.27 Images pre- and post-treatment

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10.8

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Summary: Treatment Options

Indications

Material

Needle or cannula

Chapter

Marionette Line Correction

Calcium Hydroxylapatite

Cannule 27 G, 37 mm length

12.5

Marionette Line Correction

medium viscosity hyaluronic acid

Cannule 27 G, 37 mm length

12.6

Marionette Line camoufflage

medium viscosity hyaluronic acid

Needle 30 G, 13 mm length

10.7

11

Lips Magda Guareschi and Enrica Stella

Lips are a tactile organ with an essential role in human anatomy and function. Lips, among other face features, contribute to what is perceived as beautiful.

11.1

From superficial to deep, the layers of the upper and lower lips include the epidermis, subcutaneous tissue, orbicularis oris muscle fibers, and mucosa (Fig. 11.1a, b).

Anatomy

The upper lip extends between the nasolabial folds and from the base of the nose to the free edge of the vermilion border inferiorly. The lower lip extends between the oral commissures and from the superior free vermilion edge to the mandible inferiorly. The vermilion is composed of nonkeratinized squamous epithelium that covers numerous capillaries, which give the vermilion its characteristic color. All around the vermilion–skin border, a fine line of pale skin accentuates the chromatic difference between the vermilion and the surrounding skin. Two paramedian elevating curves of the vermilion form the Cupid’s bow along the upper vermilion–skin border. A midline depression called the philtrum is placed between two raised vertical columns of tissue made up by decussating fibers of orbicularis oris. The philtrum is located between the columella and the paramedian elevations of the vermilion. The labiomental crease describes an inverted Ushape horizontally across the lower lip. In cross-section, the orbicularis oris is composed of a long, vertical segment that curls outward at the superior and inferior free margins to form a marginal protrusion. The buccal and marginal mandibular nerves provide motor innervation to the orbicularis oris from its deep surface. In the upper lip, the orbicularis oris fibers decussate in the midline and have dermal insertions approximately 4–5 mm lateral from the midline, sparing the central region. This serves to pull the skin medially at these dermal insertion points, forming the philtral columns. M. Guareschi (&)  E. Stella Doctor’s Equipe, via Carducci 19, 20123 Milan, Italy e-mail: [email protected]

M. Goisis (ed.), Injections in Aesthetic Medicine, DOI: 10.1007/978-88-470-5361-8_11,  Springer-Verlag Italia 2014

Fig. 11.1 a, b Vascular supply of the lips. Reproduction of a lithograph plate from Gray’s anatomy (Henry Gray, Anatomy: Descriptive and Surgical)

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Pitfalls

Injecting filler in the lips can easily activate the dormant herpes simplex virus in those predisposed: The patients that are prone to reactivations of this infection should be on antiviral prophylaxis medication when doing the treatment (see Chap. 21.1). Every lip injection has to be differently tailored to the patient. Injections along the vermillion border typically enhance the projection of the lip. Injections in the red lip enhance volume. When injecting, it’s important to avoid an unnatural look (duckbill like look) or an unbalanced lip. With respect to ‘‘central or outer,’’ it is better to inject more centrally than laterally. This is because overzealous injections laterally can make lips look very unnatural, almost sausagelike. Overfill or overcorrection of the vermilion border is not recommended. This creates an acute angle at the mucocutaneous junction that appears unnatural.

11.3

Lips Recontouring with Hyaluronic Acid and Blunt Cannula

11.3.1 Indications Lips can be recontoured to bring the youthful look back by placing gel along the lip borders (vermillion). Redefining this edge with natural fillers leads to a more youthful and appealing look.

11.3.3 Materials

Fig. 11.2 Materials

• • • •

0.8 cc of HA Cannule 27G, 37mm length Needle 26G, 13mm length 0,2 cc of local anesthetic (2% lidocaine, 2% mepivacaine) with epinephrine 1:100 000 • Bandages and antiseptic solution (Fig. 11.2)

11.3.4 Material Choice 11.3.2 Contraindications • The filler should not be injected in areas that lack sufficient blood supply or that have an infection or inflammation. • No injection should be done if the hand has been previously treated with liquid silicone or other permanent fillers because new injection could lead to inflammation or infection of the implants. • Any hypersensitivity to any components of the filler obviously constitutes a contraindication for the treatment. • Anatomical alterations due to previous trauma or surgical intervention (cleft lip). Scarring often induce retracting scars that can cause asymmetry and unequal filling of the part treated.

In Europe • Glytone 3. • Belotero basic. • Belotero intense. • Restylane lip volume. • Restylane lip refresh. • Emervel lip. • Restylane. • Surgiderm 24 xp. • Juvederm ultra smile. • Juvederm volbella. In Asia • Juvederm refine. • Restylane.

11

Lips

Fig. 11.3 The procedure is shown

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Fig. 11.6 An opening is created with a 26-G needle

Fig. 11.4 Vestibular injection of 0.2 cc per side of local anesthetic (lidocaine, mepivacaine) will provide good anesthesia for the upper lip Fig. 11.7 A 27-G, 37 mm length blunt cannula is inserted perpendicularly to the skin surface through the hole created

• • • •

In America Belotero basic. Belotero intense. Restylane. Juvederm ultra XC.

11.3.5 Operating Time The procedure usually takes 10 min.

11.3.6 Method Fig. 11.5 Anesthesia is performed in the entrance point located in correspondence with the labial commissure at the corner of the mouth with 0.1 ccoflocalanesthetic(lidocaine,mepivacaine)withepinephrine

Procedure is shown in Figs. 11.3, 11.4, 11.5, 11.6, 11.7, 11.8a, b and 11.9.

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11.4

Lips Augmentation with Hyaluronic Acid and Standard Needle

11.4.1 Materials • 0.8 cc of HA • Needle 30G, 13mm length • 0.2 cc of local anesthetic (2% lidocaine, 2% mepivacaine) with epinephrine 1:100 000 • Bandages and antiseptic solution Fig. 11.10

11.4.2 Material Choice In Europe • Glytone 3. • Glytone 4. • Belotero basic. • Belotero intense. • Restylane lip volume. • Restylane lip refresh. • Emervel lip. • Restylane. • Surgiderm 24 xp. • Juvederm ultra smile. • Juvederm volbella. In Asia • Juvederm refine. • Restylane. Fig. 11.8 a, b The cannula is then pivoted parallel to the skin plane and made to slide with precision into the deep dermis along the vermillion border; we recommend touching the tip of the cannula to establish the position reached

Fig. 11.9 0,4 cc of filler is delivered slowly, while the cannula is withdrawn (retrograde injection); the injection is done from the lateral end of the Cupid’s bow to the entrance point of the cannula

Fig. 11.10 Materials

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Fig. 11.11 a–h All the steps are shown; lip recontouring followed by lip augmentation in both upper and lower lips

• • • •

In America Belotero basic. Belotero intense. Restylane. Juvederm ultra XC.

11.4.3 Operating Time The procedure usually takes 15 min (Fig. 11.11 a–h).

11.4.4 Method Procedure is shown in Figs. 11.11–11.23

Fig. 11.12 Topical anesthesia. Injecting filler into the lips causes great pain to the patient. A topical anesthetic product can be used and placed over the part at least 20 min before staring the procedure

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Fig. 11.13 a, b Vestibular injection of 0.2 cc for side of local anesthetic (lidocaine, mepivacaine) will provide good anesthesia for the upper lip

Fig. 11.14 a, b Lower lip mental block will provide good anesthesia for lower lip; 0.2 cc per side of local anesthetic (lidocaine, mepivacaine) can be used

Fig. 11.15 Linear threading with serial puncture technique. Redefinition of the vermillion border begins just laterally to the Cupid’s bow with full insertion of the needle to submucosal layer

Fig. 11.16 HA is injected in a medial-to-lateral fashion, from the Cupid’s bow to the oral commissure

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Fig. 11.17 The needle is reinserted 1 cm from the previous entrance point

Fig. 11.18 The needle is reinserted 1 cm from the previous entrance point along the vermillion border

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Fig. 11.19 The volume of the upper lip body is augmented by intramuscular injection of HA

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Fig. 11.20 a The same procedure is repeated for the lower lip. A redefinition of the vermillion border is performed with full insertion of the needle to submucosal layer. b Retrograde injection of HA is

Fig. 11.21 Augmentation of the volume of the lower lip body is performed injecting one or two bolus of HA directly in the lip

M. Guareschi and E. Stella

performed. c The needle is reinserted 1 cm medially from the previous entrance point along the vermillion border. d Retrograde injection

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Fig. 11.24 Materials

Fig. 11.22 Pretreatment pictures (a), ten minutes after the treatment (b), and one week after the treatment (c)

Fig. 11.23 One week after the treatment (b) is compared with pretreatment pictures (a)

11.5

‘‘Bar Code’’ Wrinkles (Cutaneous Upper Lip)

11.5.1 Materials • 0.8 cc of HA • Cannule 27G, 37mm length • Needle 26G, 13mm length

Fig. 11.25 Before treatment the patient shows severe vertical lip rhytids on the cutaneous upper lip

• 0.2 cc of Local anesthetic (2% lidocaine, 2% mepivacaine) with epinephrine 1:100 000 • Bandages and antiseptic solution (Fig. 11.24)

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Fig. 11.27 Anesthesia in the entrance point is performed; 0.2 cc of local anesthetic (lidocaine, mepivacaine) is used

Fig. 11.28 An opening is created with a 26-G needle; the point is located just 0.5 mm above the oral commissure

Fig. 11.26 a–c The procedure is shown, and the bar code area is refreshed with HA using a fan-shaped technique

Fig. 11.29 A 27G, 37mm length, blunt-tip cannula is inserted perpendicularly to the skin surface through the hole created

11

Lips

Fig. 11.30 The cannula is then pivoted parallel to the skin plane and slid with precision into the deep dermis; the cannula slides perpendicularly to the wrinkle line; we recommend touching the tip of the cannula to establish the position reached

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Fig. 11.32 A gentle massage is performed to spread the filler in the whole area

Fig. 11.31 0.4 cc of filler is delivered slowly, while the cannula is withdrawn (retrograde injection); the cannula is slid right superiorly to the mucocutaneous junction of the lip reaching with the tip a point placed laterally to the philtrum. Then, without being completely extracted, the cannula is moved back and forth in a fan-shaped technique

11.5.2 Our Material Choice In Europe • Glytone 2. • Belotero basic. • Belotero soft. • Surgiderm 18. • Surgiderm 24 xp. • Juvederm smile.

Fig. 11.33 Pre treatment (a), post treatment (b)

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• Juvederm volbella. In Asia • Juvederm refine. In America • Belotero basic. • Juvederm ultra XC.

Several factors such as stress, smoking, diet, lifestyle and exposure to natural or artificial UV light can increase the production of free radicals that cause ‘‘oxidative stress’’, a process that can trigger cell damage and decrease the duration of soft-lifting sponsored by the HA fillers. One tablet of antioxidant supplement is recommended 2 times a day for 15 days, then 1 times for 60 days (the composition is reported in Chap 21.18).

11.5.3 Operating Time The procedure usually takes 15 min.

11.5.4 Method Procedure is shown in Figs. 11.25–11.33

11.6

Complications and Management

Immediate complications (within 72 hours after injection) immediate hypersensitivity reaction, transient erythema, edema, induration, pruritus and ecchymosis. Early complications (days to weeks after injection) include overcorrection, local infection, skin necrosis, herpes reactivation, discoloration and persistent local symptoms (erythema, edema, induration, pruritus and hyperpigmentation). Late complications include infection, filler migration, delayed hypersensitivity reaction, foreign-body granuloma and scarring. See Chap. 21. Anti-inflammatory supplements can help reduce inflammation and pain without using drugs with potentially serious side effects. One tablet of anti-inflammatory supplements is recommended 2 times a day for 15 days (the composition is reported in Chap 21.6).

11.7

Summary: Treatment Options

indications

material

Needle or cannula

chapter

Redefining lip borders (vermillion).

Medium viscosity hyaluronic acid

Cannule 27 G, 37 mm length

11.3

Redefining lip borders (vermillion).

Medium viscosity hyaluronic acid

Needle 30 G, 13 mm length

11.4

Augmentation of lip volume

Medium viscosity hyaluronic acid

Needle 30 G, 13 mm lenght

11.4

Correction of ‘‘Bar Code’’ Wrinkles (Cutaneous Upper Lip)

Medium viscosity hyaluronic acid

Cannule 27 G, 37 mm length

11.5

12

Chin Magda Guareschi and Mario Goisis

The chin dimension and projection have a key role in facial aesthetic. Aesthetic medicine plays a role in chin correction through augmentation and camouflage of chin asymmetry.

12.1

Anatomy

The chin is the triangular extension of the anterior portion of the mandible below the lower lip. It is formed by the anterior projection of the lower jaw (mandible) (Fig. 12.1). Noble structures that are located in chin area and need to be preserved during the treatment are as follows: The inferior alveolar nerve (sometimes called the inferior dental nerve) is a branch of the mandibular nerve, which is itself the third branch (V3) of the trigeminal nerve (cranial nerve V) (Fig. 12.2a, b). Anteriorly, the nerve gives off the mental nerve at about the level of the mandibular 2nd premolars, which exits the mandible via the mental foramen (supplying sensory branches to the chin and lower lip).

12.2

Pitfalls

The noble structures can be preserved using the correct point of injection (safe point). Identification of the mental nerve prevents damages to the nerve itself which would lead to anaesthesia and paraesthesia of the inferior lip. The nerve can be easily identified by palpation of the mental foramen that is placed 1 cm superiorly to the inferior mandibular border between the first and second premolar.

Fig. 12.1 Bone anatomy of the chin

Injecting filler in the mental area, we recommend to use three points of injection: the centre of the mandibular symphysis and, for each side, a point placed medially to the mental foramen and around 1 cm laterally to the centre of the symphysis (Fig. 12.3).

12.3 M. Guareschi (&)  M. Goisis Doctor’s Equipe, via Carducci 19, 20123 Milan, Italy e-mail: [email protected] M. Goisis e-mail: [email protected]

M. Goisis (ed.), Injections in Aesthetic Medicine, DOI: 10.1007/978-88-470-5361-8_12,  Springer-Verlag Italia 2014

Augmentation of the Chin

Chin augmentation can lead to substantial improvement in the appearance of the face, giving a better look to the patient. It can correct the chin reduction due to age, and it can ameliorate the sagging of the neck. It is useful to create 137

138 Fig. 12.2 a, b Inferior alveolar nerve indicated with the arrow. a Reproduction of a lithograph plate from Gray’s anatomy (Henry Gray, Anatomy: Descriptive and Surgical)

M. Guareschi and M. Goisis

(a)

(b)

a camouflage of facial asymmetry, and it can augment the dimension of the lower third of the face in second-class patients.

Augmentation of the chin is a simple procedure, carried out in the office under local anaesthesia. Few noble structures need to be preserved, but this can be accomplished simply.

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Chin

139

Fig.12.3 Three safe points where to inject; the blue arrow indicates the 1 cm distance between the central and the lateral point

12.4

Fig. 12.4 Materials

Augmentation of the Chin with Calcium 12.4.3 Operating Time Hydroxylapatite The procedure usually takes from 10 to 15 min.

12.4.1 Indications Asymmetries, second-class patient, ageing.

12.4.2 Contraindications Anatomical alterations due to precedent trauma or surgical intervention (maxillofacial surgery). In fact, scarring and presence of internal fixation often induces a displacement of the structures that can lead to asymmetry and unequal filling of the part treated. Presence of surgical implants (previous chin augmentation with silicone implants, etc.) in fact, infection of the surgical implant after filler infection can result in surgical removal. – No injection should be done if the area has been previously treated with liquid silicone or other permanent fillers because new injection could lead to inflammation or infection of the implants. – Any hypersensitivity to any components of the filler obviously constitutes a contraindication for the treatment.

12.4.4 Materials • 1.5 cc of Calcium Hydroxylapatite. • Needle 28 g, 13 mm length. • 0.2 cc of Local anesthetic (2 % Lidocaine, 2 % mepivacaine) with epinephrine 1:100 000. • Bandages and antiseptic solution. (Fig. 12.4).

12.4.5 Material Choice In Europe, Asia, and America, Radiesse can be used.

12.4.6 Methods Procedure is described in Figs. 12.5a–c, 12.6, 12.7a, b.

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Fig. 12.6 Injection of Radiesse. As a bolus, 0.5 cc of Radiesse is then injected in every of the three points in the supra-periosteal layer. A total amount of 1.5 cc of Radiesse is injected.

Fig. 12.5 a–c The injection of local anaesthesia takes place in 3 different points. a The first safe point of injection is located at the centre of the mandibular symphysis; b the second point is located on the left, 1 cm medially to the mental foramen and around 1 cm laterally to the centre of the symphysis. The mental foramen is placed 1 cm superiorly to the inferior mandibular border between the first and second premolar and can be identified through palpation. c In each of the three injection points, 0.3 cc of the anaesthetic solution is injected 5 min before the treatment. The injection is performed in the supra-periosteal and subcutaneous layers, in order to reduce pain and bleeding

Fig. 12.7 a, b The product is spread over the chin with a vigorous massage

12

Chin

12.5

141

Augmentation of the Chin with Hyaluronic Acid

12.5.1 Indications Asymmetries, second-class occlusion, ageing.

12.5.2 Operating Time The procedure usually takes from 10 to 15 min.

12.5.3 Materials • 2 cc of high viscosity hyaluronic acid. • 22 G needle • 0.2 cc of local anesthetic (2 % Lidocaine, 2 % mepivacaine) with epinephrine 1:100 000. • Bandages and antiseptic solution (Fig. 12.8).

12.5.4 Material Choice In Europe • Glytone 4. • Belotero Intense. • Juvederm Voluma. • Juvederm Voluma lidocaine. • Restylane sub-q In Asia • Juvederm Voluma XC. • Restylane sub-q In America • Belotero Intense. • Juvederm Voluma XC. • Restylane sub-q

12.5.5 Methods Procedure is shown in Figs. 12.9, 12.10a–c, 12.11a–c, 12.12, 12.13a–b, 12.14, 12.15, 12.16. A further example of asymmetrical occlusion and subsequent correction is given in Figs. 12.17a–c and 12.18a–b.

Fig. 12.8 Materials

Fig. 12.9 A.C., clear asymmetry of the face and of the chin

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Fig. 12.10 a–cInjection takes place in three different points. In case of asymmetries, the points are drawn in order to create a camouflage of the part (Fig. 12.9). Safe points of injection are located at least 1 cm medially to the mental foramen. The mental foramen is placed 1 cm superiorly to the inferior mandibular border between the first and second pre-molar and can be identified through palpation. In case of

M. Guareschi and M. Goisis

asymmetric patient, a careful palpation is very important in order to avoid damage to the nerve. In each point, 0.3 cc of the anaesthetic solution is injected 5 min before the treatment. The injection is performed in the supra-periosteal and subcutaneous layers, in order to reduce pain and bleeding

Fig. 12.11 a–c Injection of hyaluronic acid. As a bolus, 0.7 cc of hyaluronic acid is then injected in every safe point in the supra-periosteal layer (Fig. 12.11 a–c). A total amount of 2 cc of hyaluronic acid is then injected.

Fig. 12.12 A tampon is applied to the area for 60 s

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Fig. 12.15 The patient’s occlusion, demonstrating asymmetry. The blue line shows the lateral deviation of the occlusal plane

Fig. 12.13 a, b The product is spread over the chin with a vigorous massage

Fig. 12.16 Posttreatment image; the asymmetry is corrected. The blue line shows the camouflage of the lateral deviation of the chin

Fig. 12.14 Pretreatment image; a marked asymmetry is evident. The blue line shows the lateral deviation of the chin

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(a)

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(b)

(c)

Fig. 12.17 a–c A.M., 34 years old, second class of occlusion

(a)

(b)

Fig. 12.18 a, b Camouflage of the mental ipolasia: final result. Chin augmentation with hyaluronic acid can lead to substantial improvement in the appearance of the face, giving a better look to the patient.

It is able to augment the dimension of the lower third of the face in second-class patients.

12.6

Several factors such as stress, smoking, diet, lifestyle and exposure to natural or artificial UV light can increase the production of free radicals that cause ‘‘oxidative stress’’, a process that can trigger cell damage and decrease the duration of soft-lifting sponsored by the HA fillers. One tablet of antioxidant supplement is recommended 2 times a day for 15 days, then 1 times for 60 days (the composition is reported in Chap. 21.18).

Complications and Management

Immediate complications (within 72 hours after injection) immediate hypersensitivity reaction, transient erythema, edema, induration, pruritus and ecchymosis. Early complications (days to weeks after injection) include overcorrection, local infection, skin necrosis, herpes reactivation, discoloration and persistent local symptoms (erythema, edema, induration, pruritus and hyperpigmentation). Late complications include infection, filler migration, delayed hypersensitivity reaction, foreign-body granuloma and scarring (See Chap. 21). Anti-inflammatory supplements can help reduce inflammation and pain without using drugs with potentially serious side effects. One tablet of anti-inflammatory supplements is recommended 2 times a day for 15 days (the composition is reported in Chap. 21.6).

12.7

Summary: Treatment Options

Indications

Material

Needle or cannula

Chapter

Chin augmentation

Calcium Hydroxylapatite

Cannule 28G, 13mm length

12.4

Chin augmentation

High density hyaluronic acid

Needle 22G

12.5

13

Neck and De´collete´ Enrica Stella and Mario Goisis

Treatment of the neck and décolleté is an integral part of the procedures aimed to improve patient’s beauty. The aging in this regions is associated to loss of skin elasticty and sagging. Good results can be achieved treating neck and décolleté with low or medium viscosity HA injections and even with the employment of autologous material as PRP.

13.1

Anatomy

The neck region is characterized by a great anatomical complexity. Between the structures present in the area attention should be paid in individuate superficial vassels. In particular, external jugular vein commences in the substance of the parotid gland, on a level with the angle of the mandible, and runs perpendicularly down the neck, in the direction of a line drawn from the angle of the mandible to the middle of the clavicle at the posterior border of the sternocleidomastoideus, crossing the muscle obliquely. The anterior jugular vein begins near the hyoid bone by the confluence of several superficial veins from the submaxillary region. It descends between the median line and the anterior border of the sternocleidomastoideus and, at the lower part of the neck, passes beneath that muscle to open into the termination of the external jugular or, in some instances, into the subclavian vein. It varies considerably in size, bearing usually an inverse proportion to the external jugular; most frequently there are two anterior jugulars, a right and left; but sometimes only one (Fig. 13.1).

E. Stella (&)  M. Goisis Doctor’s Equipe, via Carducci 19, 20123 Milan, Italy e-mail: [email protected]

13.2

Pitfalls

Neck examination and identification of the major superficial vessels of the neck, external and anterior jugular vein, is important to avoid neck hematomas. The existence of a great anatomic variety commands nevertheless to introduce the needle just some millimeters under the skin plane. Avoid too superficial injections, in particular in the epidermidis: In this case, small lumps might form that will disappear in a few days.

13.3

Bio-rejuvenation Technique for the Treatment of Neck and De´collete´

Bio-rejuvenation is a technique that uses generally lowviscosity hyaluronic acid to induce deep hydration of the skin and to stimulate the dermis to produce new matrix, improving skin structure and elasticity. The production of endogenous HA decreases drastically with age contributing to wrinkles formation. Injection of low-viscosity hyaluronic acid in the dermis enhances attraction of fibroblasts, macrophages, endothelial cells, and scavengers against radical-free damaged dermal proteins, thus inducing rejuvenation of the dermal layer.

13.3.1 Indications Bio-rejuvenation can be used to improve skin trophism, texture, and elasticity of dermis of every anatomic area, but is usually practiced on the skin of the face, neck, décolleté, and hands. Rejuvenation is particularly indicated in people who smoke and are exposed to sunlight for long periods of time.

M. Goisis e-mail: [email protected]

M. Goisis (ed.), Injections in Aesthetic Medicine, DOI: 10.1007/978-88-470-5361-8_13,  Springer-Verlag Italia 2014

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Fig. 13.1 External jugular vein in blue, sternocleidomastoideus muscle in red schematically drawn on the patient’s neck. Reproduction of a lithograph plate from Gray’s anatomy (Henry Gray, Anatomy: Descriptive and Surgical)

13.3.2 Contraindications In patients with coagulation defects or on current anticoagulant therapy the treatment is relatively controindicated. As with all injections in fact these subjects are at increasing risk of bleeding and Hematoma formation. • The filler should not be injected in areas that lack sufficient blood supply or have an infection or inflammation. • No injection should be done if the area has been previously treated with liquid silicone or other permanent fillers because a new injection could lead to inflammation or infection of the implants. • Any hypersensitivity to any components of the filler obviously constitutes a contraindication for the treatment. • Hypertiroidism for Grave’s Disease is a relative contraindication.

• See materials in (Figs. 13.2, 13.3). Examples of low viscosity HA are shown in the pictures.

13.3.5 Material Choice In Europe • Glytone 1. • Belotero Soft. • Hydrate. • Jalupro. • Restylane vital light lidocaine 1 ml.

13.3.3 Operating Time The procedure usually takes from 5 to 10 min.

13.3.4 Materials • • • •

0,8 cc of low density HA 29-30G needle Topical anesthetic Bandages and antiseptic solution

Fig. 13.2 Restylane vital light and glytone 2

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Neck and De´collete´

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Fig. 13.3 Jalupro

• Restylane • Newest • Ialest In Asia • Restylane • Restylane In America • Restylane • Restylane

vital light lidocaine injector 2 ml.

vital light lidocaine 1 ml. vital light lidocaine injector 2 ml. vital light lidocaine 1 ml. vital light lidocaine injector 2 ml.

13.3.6 Methods The procedure is described in Figs. 13.4, 13.5a, b, 13.6, 13.7, 13.8, 13.9a, b, 13.10a, b, and 13.11a, b.

Fig. 13.4 Some products (i.e., Jalupro) are sold as sterile powders and need to be diluted. Here is shown the method of dilution of Jalupro. The sterile powder is diluted with 2.5 ml of the included solvent

Fig. 13.5 a, b The patient neck and décolleté before the treatment

Fig. 13.6 The injection points on the patient’s skin are demonstrated. No local anesthesia is needed, except for a mild local anesthetic gel that could be applied 10–20 min before the treatment. Depending on the product, HA may or may not be mixed with an anesthetic solution. The presence of the anesthetic makes the treatment slightly more acceptable by the patient

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Fig. 13.7 The ideal distance between different points of injection is 1 cm

Fig. 13.8 The HA solution is injected in the neck according with the picottage technique; pinching the skin between thumb and index of the free hand allows injection in the correct plane, i.e., superficial dermis and reduces the sensation of pain. The needle is inserted for 2–3 mm; the quantity of product injected is really small, about 0.05 ml or less

E. Stella and M. Goisis

13

Neck and De´collete´

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(a)

(b)

Fig. 13.9 (a), Some products are sold with an injector incorporated, as some Restylane products. The injector contains a spring-loaded system that needs to be loaded before the treatment, and a trigger that activates that system. These injectors allow the ejection of a

predetermined quantity of material allowing very uniform treatment of a large area. (b), Some shots have to be ejected before starting the treatment in order to eliminate the air contained in the needle. After the first drop of HA has been ejected, the treatment can start

Fig. 13.10 Injections are made superficially in the dermal layer. The product may be injected using a picottage technique (many spotty injections of the same quantity of product in points equally distant one from the other). The needle used must be thin. Thinner needles make

the treatment much more acceptable. Some products are sold with needles composed by a special steel that makes the tip of the needle particularly resistant to multiple injections

Fig. 13.11 a, b Redness immediately after injection has to be expected

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Treatment of De´collete´ Using HA Injected with Blunt-tip Cannula

13.4.1 Indications The use of medium viscosity hyaluronic acid injected through a blunt tip cannula allows to obtain improvement of deeper wrinkles in the decollete area with few puncture sites and great comfort for the patient.

13.4.2 Contraindications In patients with coagulation defects or on current anticoagulant therapy the treatment is relatively controindicated. As with all injections in fact these subjects are at increasing risk of bleeding and ematoma formation. • The filler should not be injected in areas that lack sufficient blood supply or have an infection or inflammation. • No injection should be done if the hand has been previously treated with liquid silicone or other permanent fillers because a new injection could lead to inflammation or infection of the implants. • Any hypersensitivity to any components of the filler obviously constitutes a contraindication for the treatment.

Fig. 13.12 Materials

• • • •

Belotero Basic. Belotero Intense. Restylane. Juvederm Ultra XC.

13.4.5 Operating Time The procedure usually takes 15 min.

13.4.3 Materials • • • •

0,8 cc of HA Cannule 27G, 37mm length Needle 26G,13mm lenght 0,2 cc of Local anesthetic (2% lidocaine or 2% mepivacaine) with epinephrine 1:100 000 • Bandages and antiseptic solution (Fig. 13.12).

13.4.6 Method The procedure is described in Figs. 13.13, 13.14, 13.15, 13.16, 13.17, 13.18, 13.19, 13.20 and 13.21.

13.4.4 Material: Our Choice In Europe • Glytone 3. • Belotero Basic. • Belotero Intense. • Restylane. • Haequo. • Surgiderm 24 XP. • Juvederm Volbella. In Asia • Juvederm Refine. • Restylane. In America

Fig. 13.13 The pattern of the cannula is designed on the patient’s décolleté following the wrinkles

13

Neck and De´collete´

Fig. 13.14 Entrance point in red, pattern in green; right side of patient’s décolleté will be treated

151

Fig. 13.17 26-G needle is use to create the hole for the cannula

Fig. 13.15 The technique is previously shown

Fig. 13.18 The 27-G blunt cannula is fully inserted under the skin in the deep dermis

Fig. 13.16 0.1 cc of anesthesia is injected in each entrance point: local anesthetic (lidocaine, mepivacaine) with adrenaline 1:100 000

Fig. 13.19 It is useful to touch with a finger the tip of the cannula to assess the position reached

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13.5.2 Contraindications • • • • • • •

Platelet dysfunction syndrome Critical thrombocytopenia Local infection at the site of the procedure Consistent use of NSAIDs within 48 hours of procedure Corticosteroid injection at treatment site within 1 month Systemic use of coriticosteroids within 2 weeks Cancer (especially hematopoetic or of bone), HIV, HCV

13.5.3 Operating Time The procedure usually takes about 45 min. Fig. 13.20 1 cc HA is delivered while the cannula is withdrawn (retrograde injection technique)

13.5.4 Materials • PRP kit. • Disinfectant alcohol and bandages. • Centrifuge (Fig. 13.22).

Fig. 13.21 Final result (the side treated on the left and the side not treated on the right)

13.5

PRP in the Treatment of Neck and De´collete´

13.5.1 Indications PRP is not injected in dermis in order to anchieve a volume enhancement that goes filling the wrinkle but it’s used to obtain fibroblast stimulation. This will lead to production of new collagen and to skin renewing.

Fig. 13.22 Materials: PRP kit, Centrifuge, Bandages and antiseptic solution

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Neck and De´collete´

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13.5.5 Method The procedure is described in Figs. 13.23, 13.24, 13.25, 13.26, 13.27 and 13.28.

Fig. 13.25 The blood is fractionated; the red blood cells are trapped under the gel, and cellular elements settle on the surface of the gel. After homogenization, about 4 ml of PRP are obtained for each tube

Fig. 13.23 Patient’s whole blood is collected

Fig. 13.24 Centrifugation for 5–10 min at 1,500 g

Fig. 13.26 Collection of PRP with a 5 ml luer-lock

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13.6

Fig. 13.27 0.09 ml calcium gluconate are aspirated in 1-ml syringe and then 0.9 ml of PRP are aspired in the same syringe through a luer-connector

Immediate complications (within 72 hours after injection) immediate hypersensitivity reaction, transient erythema, edema, induration, pruritus and ecchymosis. Early complications (days to weeks after injection) include over correction, local infection, skin necrosis, herpes reactivation, discoloration and persistent local symptoms (erythema, edema, induration, pruritus and hyper pigmentation). Late complications include infection, filler migration, delayed hypersensitivity reaction, foreign-body granuloma and scarring. See Chap. 21. Anti-inflammatory supplements can help reduce inflammation and pain without using drugs with potentially serious side effects. One tablet of anti-inflammatory supplements is recommended 2 times a day for 15 days (the composition is reported in Chap. 21.6). Several factors such as stress, smoking, diet, lifestyle and exposure to natural or artificial UV light can increase the production of free radicals that cause ‘‘oxidative stress’’, a process that can trigger cell damage and decrease the duration of soft-lifting sponsored by the HA fillers. One tablet of antioxidant supplement is recommended 2 times a day for 15 days, then 1 times for 60 days (the composition is reported in Chap. 21.18).

13.7

Fig. 13.28 Multiple small injections of 0.1 cc of PRP is injected with 29-/30-G needle (picottage technique) into the neck and décolleté of the patient; the injection should be done into the superficial dermis in each point; the needle should penetrate the skin just 2–3 mm

Complications and Management

Summary: Treatment Options

Indications

Material

Needle or Cannule

Chapter

Neck and décolleté skin bio-rejuvination

low viscosity hyaluronic acid

Needle 29-30G, 13 mm length

13.3

Wrinkles correction in décolleté area

medium viscosity hyaluronic acid

Cannule 27G, 37 mm length

13.4

Neck and décolleté skin renewing

PRP

Needle 29-30G, 13 mm length

13.5

14

Arms Enrica Stella and Alessandro Di Petrillo

The aging process involves the face but does not spare arms that gradually lose their youthful look. Loss of skin elasticity is the principal factor that contributes to arms’ aging process.

14.1

Anatomy

The arm extends from the shoulder to the hand and consists of a complex mechanical and functional structure that makes it one of the most useful tools of the human body. A fascial layer separates the arm muscles in two compartements. The nerve supply is guaranteed by muscolocutaneus nerve and radial nerve. The main artery of the arm is the brachial artery with her important branch: the profunda branchii. The cephalic and the basilic veins are the main veins of the arm: the first is located on the medial side of the arm while the second travels on the lateral side of the arm and ends as the axillary vein. A connection between the two veins is guaranteed by the presence of the medial cubital vein. This vein that passes through the cubital fossa has a clinical importance for blood withdrawing (Fig. 14.1).

14.2

Pitfalls

Arm examination and identification of the major superficial vessels is useful to avoid hematomas. The needle is introduced just some millimeters under the skin plane. Avoid too superficial injections, in particular in the epidermidis: In this case, small lumps might form that will disappear in a few days.

14.3

Arm’s Treatment with Low-density HA

14.3.1 Indications Multiple injections of low-density HA provide skin hydration and improvement in skin’s structure and elasticity. It can be a preventative treatment for skin that is still in good condition like in younger patients and to reduce the fine lines. It’s useful to underline that if the problem is a very loose skin or abnormal fat deposal it would be unlikely to achieve a satisfactory result using only this approach. Hyaluronic acid injections will be supported by other means as radiofrequency, infrared or surgical approach with the excision of the loose skin to help smoothen and tighten the arms.

14.3.2 Contraindications In patients with coagulation defects or on current anticoagulant therapy the treatment is relatively controindicated. As with all injections in fact these subjects are at increasing risk of bleeding and ematoma formation. • The filler should not be injected in areas that lack sufficient blood supply or have an infection or inflammation. • No injection should be done if the hand has been previously treated with liquid silicone or other permanent fillers because a new injection could lead to inflammation or infection of the implants. • Any hypersensitivity to any components of the filler obviously constitutes a contraindication for the treatment.

14.3.3 Materials E. Stella (&)  A. Di Petrillo Doctor’s Equipe, via Carducci 19, 20123 Milan, Italy e-mail: [email protected]

M. Goisis (ed.), Injections in Aesthetic Medicine, DOI: 10.1007/978-88-470-5361-8_14,  Springer-Verlag Italia 2014

• 0,8 cc of low density HA (Fig. 14.2) • 29-30G needle • Topical anesthetic

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Fig. 14.2 Materials

• Bandages and antiseptic solution. Example of low viscosity HA is shown in the pictures (Restylane vital light injector preloaded with 2 ml Ha with 3 % Lidocaine).

14.3.4 Material Choice In Europe • Glytone 1. • Belotero Soft. • Hydrate. • Jalupro, newest, hyalest. In Asia • Restylane vital light lidocaine • Restylane vital light lidocaine In America • Restylane vital light lidocaine • Restylane vital light lidocaine

injector 1 ml. injector 2 ml. injector 1 ml. injector 2 ml.

14.3.5 Method Fig. 14.1 The Cefalic and the basilic vein of the arm. Reproduction of a lithograph plate from Gray’s anatomy (Henry Gray, Anatomy: Descriptive and Surgical)

The procedure is described in Figs. 14.3a, b, 14.4, 14.5, 14.6.

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Arms

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Fig. 14.5 P.A., 53 years old, before treatment

Fig. 14.3 a, b The low-density HA chosen is stored in an injector that allows a constant amount of product to be released at every injection (10 ll), meaning uniform injection; the disposable injector requires manual winding by the practitioner before using its trigger mechanism to release the hyaluronic acid

Fig. 14.6 Injections are performed keeping the needle in the superficial dermal plane

14.4

Fig. 14.4 The points of injection are designed on the patient’s arm: 2 cm of distance between each point

Complications

Immediate complications (within 72 hours after injection) immediate hypersensitivity reaction, transient erythema, edema, induration, pruritus and ecchymosis. Early complications (days to weeks after injection) include overcorrection, local infection, skin necrosis, herpes reactivation, discoloration and persistent local symptoms (erythema, edema, induration, pruritus and hyperpigmentation). Late complications include infection, filler migration, delayed hypersensitivity reaction, foreign-body granuloma and scarring. See Chap. 21. Anti-inflammatory supplements can help reduce inflammation and pain without using drugs with potentially serious side effects. One tablet of anti-inflammatory supplements is recommended 2 times a day for 15 days (the composition is reported in Chap. 21.6).

158

Several factors such as stress, smoking, diet, lifestyle and exposure to natural or artificial UV light can increase the production of free radicals that cause ‘‘oxidative stress’’, a process that can trigger cell damage and decrease the duration of soft-lifting sponsored by the HA fillers. One tablet of antioxidant supplement is recommended 2 times a day for 15 days, then 1 times for 60 days (the composition is reported in Chap. 21.18).

E. Stella and A. Di Petrillo

14.5

Summary: Treatment Options

Indications

Material

Needle or Cannule

Chapter

Arm’s skin biorejuvenation

Low viscosity hyaluronic acid

Needle 29-30 G, 13 mm length

14.3

15

Hands Mario Goisis and Alessandro Di Petrillo

Hands start showing aging signs, when they lose volume and anatomy under the skin is exposed. Adding volume to the hand through injectable fillers is a good way to restore the plump fullness and to lessen the joints and veins exposure.

15.1

Anatomy

The dorsal superficial fascia of the hand covers the tendons of the extensor muscles and the intrinsic muscles on the dorsal surface of the hand. Between the skin and the superficial dorsal fascia, a network of superficial veins is immersed in a thin layer of subcutaneous tissue (Fig. 15.1).

15.2

Pitfalls

While filling hand’s dorsum, it is important to insert the needle superficially into the dorsal fascia, in order to obtain a satisfying esthetical result. The use of a blunt needle is recommended to minimize the chances of damaging the superficial vein network. Safe and reliable points of injection can be obtained in the gap between each tendon distal to the wrist. Irregularities and overcorrection can be particularly evident in this area, involving significant discomfort to the patients as hands are needed for daily activities. For this reason, injection technique is critical to avoid noble structures’ injuries. It is mandatory not to inject too much product at once and to recommend the patient to massage the treated areas.

Fig. 15.1 Hand’s Vein plexus is shown. Reproduction of a lithograph plate from Gray’s anatomy (Henry Gray, Anatomy: Descriptive and Surgical)

15.3

Hand Filling with Calcium Hydroxylapatite and Blunt-tip Cannula

15.3.1 Indications Hands that have lost volume and roundness appearing bony and thin with prominent veins on the back. Calcium Hydroxylapatite is a filler that can successfully be employed in oldest hands. The product is long lasting, more than a year.

15.3.2 Contraindications

M. Goisis (&)  A. Di Petrillo Doctor’s Equipe, via Carducci 19, 20123 Milan, Italy e-mail: [email protected]

M. Goisis (ed.), Injections in Aesthetic Medicine, DOI: 10.1007/978-88-470-5361-8_15,  Springer-Verlag Italia 2014

The filler should not be injected in areas that lack sufficient blood supply or that have an infection or inflammation. No injection should be done if the hand has been previously treated with liquid silicone or other permanent fillers because new injection could lead to inflammation or infection of the implants. 159

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Fig. 15.2 Materials

Any hypersensitivity to any components of the filler obviously constitutes a contraindication for the treatment.

Fig. 15.3 Pictures of patient’s hands before (up) and after (down) the treatment

15.3.3 Materials • • • •

1,5 cc of Radiesse (Fig. 15.2). Cannule 27 G, 37 mm length. Needle 26 G, 13 mm length. 0,2 cc of Local anesthetic (2% lidocaine or 2% mepivacaine) with epinephrine 1:100 000. • Bandages and antiseptic solution.

15.3.4 Material Choice In Europe, Asia and America Radiesse can be used.

15.3.5 Operating Time The procedure takes about 20 min.

15.3.6 Method The procedure is described in Figs. 15.3, 15.4, 15.5, 15.6a, b, 15.7, 15.8, 15.9, 15.10a, b, 15.11a, b, c, 15.12a, b, c.

Fig. 15.4 Comparison of patient’s hands before the treatment with Merz scale (grade 3, severe loss of fatty tissue)

15

Hands

Fig. 15.5 The entrance points and pattern of the cannula are drawn on patient’s hand. Safe and reliable points of injection can be obtained in the gap between each tendon distal to the wrist

161

Fig. 15.7 An hole is done with a 26 G needle; the needle should penetrate only superficially into dorsal fascia

Fig. 15.8 A blunt-tip cannula 27 G is inserted through the hole; to make the procedure easier, it is better to stretch the skin with the free hand and to insert the cannula keeping it perpendicularly to the skin surface

Fig. 15.6 a, b 0.05 cc of anesthesia is injected in each of the entrance points 5 min before the treatment

Fig. 15.9 After entering the skin, the cannula is suddenly turned to slide parallel to the skin surface in a superficial plane. Touching the cannula’s tip is a good way to know exactly the position reached

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Fig. 15.10 a, b, c A fan-shaped technique is used to spread the filler, injecting the material as the cannula is withdrawn from the skin (retrograde injection). The procedure is performed again using all the four entrance points chosen allowing the product to be spread on the whole dorsum’s surface

Fig. 15.11 a, b, c After injection, the product should be molded to obtain a smooth-looking result. The massage is a compulsory step to avoid the formation of lumps

15

Hands

163

15.4

Hand Filling with Hyaluronic Acid and Blunt-tip Cannula

15.4.1 Indications Hands that have lost volume and roundness. HA is a filler that can successfully be employed in both young and old hands usually providing less volume than Calcium Hydroxylapatite.

15.4.2 Contraindications The filler should not be injected in areas that lack sufficient blood supply or have an infection or inflammation. No injection should be done if the hand has been previously treated with liquid silicone or other permanent fillers because new injection could lead to inflammation or infection of the implants.

Fig. 15.13 Materials

Fig. 15.12 a–c Pretreatment and post-treatment photos compared with Merz scale. A good amelioration is achieved, from grade 3 of Merz scale (severe loss of fatty tissue) to grade 1 (mild loss) Fig. 15.14 Pictures of patient’s hands before the treatment compared with Merz scale. Grade 3 with Severe loss of fat tissue is observed

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Fig. 15.15 a, b The fan-shaped technique is previously shown

Fig. 15.16 0.05 cc of anesthesia is injected in each of the entrance points 5 min before the treatment

Any hypersensitivity to any components of the filler obviously constitutes a contraindication for the treatment.

Fig. 15.17 A prehole is done with a 26 G needle; the needle should penetrate only superficially to dorsal fascia; safe and reliable points of injection can be obtained in the gap between each tendon distal to the wrist

15.4.3 Materials • 2 syringes of 0.8 cc of HA (one syringe for one hand) (Fig. 15.13). • Cannule 27 G, 37 mm length. • Needle 26 G, 13 mm length. • 0,2 cc of Local anesthetic (2% lidocaine, 2% mepivacaine) with epinephrine 1:100 000. • Bandages and antiseptic solution.

15.4.4 Material Choice In Europe • Glytone 3. • Surgiderm 24 xp. • Juvederm ultra 3.

Fig. 15.18 A blunt-tip cannula 27 G is inserted through the hole; to make the procedure easier, it is better to stretch the skin with the free hand to insert the cannula perpendicularly to the skin surface

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Fig. 15.19 a, b After entering the skin, the cannula is suddenly turned to slide parallel to the skin surface in a superficial plane. The filler is then spread with a fan shape technique injecting the HA while the cannula is withdrawn from the skin

Fig. 15.21 Final results (picture on the right) are compared with pretreatment conditions (picture on the left)

In Asia • Juvederm ultra plus XC. • Restylane. In America • Belotero intense. • Juvederm ultra plus XC. • Restylane.

15.4.5 Operating Time Fig. 15.20 a, b After injection, the product should be molded to obtain a smooth-looking result. The massage is a compulsory step to avoid the formation of lumps

The procedure usually takes 20 min.

15.4.6 Method • Juvederm volift. • Restylane.

The procedure is described in Figs. 15.14, 15.15a, b, 15.16, 15.17, 15.18, 15.19a, b, 15.20a, b, 15.21, 15.22a, b, c.

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Fig. 15.23 Materials

15.5

Hand Treatment with Low-density HA

15.5.1 Indications Injection of low-density HA provides skin hydration and improvement of skin’s structure and elasticity. It can be a preventive treatment for skin that is still in good conditions, like in younger patients, and to reduce fine lines.

15.5.2 Contraindications Injection should not be done in areas that have an infection or inflammation. No injection should be done if the hand has been previously treated with liquid silicone or other permanent fillers because new injection could lead to inflammation or infection of the implants. Any hypersensitivity to any components of the filler obviously constitutes a contraindication for the treatment. In particular, many products can be added with local anesthetic: sensibility to these drugs should be carefully investigated.

15.5.3 Materials Fig. 15.22 a–c Pretreatment and post-treatment pictures compared with Merz scale. A good amelioration is achieved

• 0,8 cc of low density HA (Fig. 15.23). • 29-30 G needle. • Topical anesthetic.

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Fig. 15.25 The injection points are drawn on the patient’s hand, keeping 1 cm of distance between each point

Fig. 15.24 a, b The low-density HA chosen is stored in an injector that allows a constant amount of product (10 ll) to be released into the skin at every injection, resulting in uniform injections; the disposable injector requires manual winding by the practitioner to activate the trigger mechanism that releases the HA

• Bandages and antiseptic solution. An example of low density HA is shown in Fig. 15.23. Restylane vital light injector preloaded with 2 ml HA with 3% lidocaine.

15.6

Material Choice

In Europe • Glytone 1. • Belotero soft. • Hydrate. • Restylane vital light lidocaine 1 ml. • Restylane vital light lidocaine injector 2 ml. In Asia • Restylane vital light lidocaine 1 ml.

Fig. 15.26 a, b Injections are performed in the superficial dermis; the operation is made easier by pinching the skin between thumb and index of the free hand

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• Restylane vital light lidocaine injector 2 ml. In America • Restylane vital light lidocaine 1 ml. • Restylane vital light lidocaine injector 2 ml.

15.6.1 Method The procedure is described in Figs. 15.24a, b, 15.25, 15.26a, b.

15.6.2 Complications and Management Immediate complications (within 72 hours after injection) immediate hypersensitivity reaction, transient erythema, edema, induration, pruritus and ecchymosis. Early complications (days to weeks after injection) include overcorrection, local infection, skin necrosis, herpes reactivation, discoloration and persistent local symptoms (erythema, edema, induration, pruritus and hyperpigmentation). Late complications include infection, filler migration, delayed hypersensitivity reaction, foreign-body granuloma and scarring (See chap. 21). Irregularities and overcorrection can be particularly evident in this area, It is mandatory not to inject too much product at once and to recommend the patient to massage the treated areas.

M. Goisis and A. Di Petrillo

Anti-inflammatory supplements can help reduce inflammation and pain without using drugs with potentially serious side effects. One tablet of anti-inflammatory supplements is recommended 2 times a day for 15 days (the composition is reported in chap. 21.6). Several factors such as stress, smoking, diet, lifestyle and exposure to natural or artificial UV light can increase the production of free radicals that cause ‘‘oxidative stress’’, a process that can trigger cell damage and decrease the duration of soft-lifting sponsored by the HA fillers. One tablet of antioxidant supplement is recommended 2 times a day for 15 days, then 1 times for 60 days (the composition is reported in chap. 21.18).

15.7

Summary: Treatment Options

Indications

Material

Needle or Cannule

Chapter

Hands’ filling (oldest and emptiest hands)

Calcium Hydroxylapatite

Cannule 27 G, 37 mm length

15.3

Hands’filling

Medium viscosity hyaluronic acid

Cannule 27 G, 37 mm length

15.4

Hands’ skin biorejuvination

Low viscosity hyaluronic acid

Needle 29-30 G, 13 mm length

15.5

Breast Augmentation

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16.1

Anatomy

The breast is a cone with the apex at the nipple and the base at the chest wall. The superficial subcutaneous envelope of the breast is the superficial fascia, which is found in the subcutis practically in all regions of the body. Superficial fascia is separated from the skin envelope by 0.5–3 cm of subcutaneous fat (adipose tissue). The adult glandular part of the breast contains lactiferous lobes that converge to the nipple, to the milk ducts. The base of the cone is attached to the deep fascia of the breast. This fascia is the dense fibrous connective tissue that sourronds the pectoralis muscles (Fig 16.1).

16.2

Has Hyaluronic Acid Still a Role in Breast Augmentation?

The main advantage of using hyaluronic acid in breast augmentation is that the treatment is minimally invasive. In contrast, breast augmentation with permanent implants, such as silicon prosthesis, entails a surgical procedure under general anaesthesia. Additionally, the fact that the NASAHbased gel can be used under local anaesthesia results in a shorter recovery time than traditional surgical methods. Hyaluronic acid is degraded naturally and gradually, and therefore, some of the problems associated with permanent fillers, such as the permanency of technical errors or migration of the filler or prosthesis, are not applicable. Despite this, recent Q-Med’s decisions about Macrolane ( Chap. 1.4) open a discussion about the role of this treatment in the future.

M. Goisis (&) Doctor’s Equipe, Via Carducci 19, Milan 20123, Italy e-mail: [email protected]

M. Goisis (ed.), Injections in Aesthetic Medicine, DOI: 10.1007/978-88-470-5361-8_16,  Springer-Verlag Italia 2014

16.3

Macrolane for Breast Augmentation: Clinical Experience and Future Perspectives

Our experience in breast augmentation from July 2008 to April 2012 is described (case series of Doctor’s Equipe). The management of complications arising from treatment and their relationship with injection technique will be analysed. A total of 390 patients underwent breast augmentation with NASHA-based gel (MacrolaneTM VRF 30) from July 2008 to April 2012 in our clinics in Italy. During this time, two groups of patients received NASHA-based gel injections using two different injection techniques. The first group (Group 1; n = 207) was treated from July 2008 to November 2009. In this group, multiple deposits of NASHA-based gel were injected through a single injection site at a level posterior to the mammary gland, without the use of ultrasonography guidance. Ultrasonography imaging was carried out on 46 patients, after an average time of 46 days post-injection to determine the location of NASHA-based gel in the breast. Active follow-up was not done on many patients of this group. In the second group (Group 2; n = 183) treated from December 2009 to March 2012, NASHA-based gel was injected under ultrasonography guidance to ensure deposition in the intended location. A single deposit of NASHAbased gel into the space between the deep fascia of the breast and the pectoralis muscle was preferred, using a cannula to create a cavity with a uniform symmetrical globular shape. In the case of very small breasts, NASHAbased gel was injected into the space posterior to the pectoralis muscle (submuscular plane). Injection of NASHAbased gel into the space between the gland tissue and the deep fascia of the breast was avoided. This group underwent active follow-up for medical and echo graphic examination 1, 3, 6 months and 1 year after treatment. These examinations were carried out free of charge, to avoid losing patients to follow-up and to treat complications earlier. 169

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Results

16.4.1 NASHA-Based Gel Injected Without Ultrasonography Guidance A total of 207 women were treated with NASHA-based gel without ultrasonography guidance. At the time of analysis, follow-up had been carried out on 100 of the 207 women up to 1 year after treatment, and 72 patients (35 %) had received a second treatment with NASHA-based gel. None of the women treated at our clinic experienced severe complications that required surgical removal of the product. After injection of NASHA-based gel without ultrasonography guidance, a total of 47 % of patients experienced multiple lumps in the breast; however, in 92 % of cases, these lumps disappeared completely within 30 days of treatment. In seven patients, the lumps were removed by direct aspiration or hyaluronidase injection (see chapter: Complications of Macrolane). Baker 2 and 3 capsule formations developed in 10 of the treated breasts (2.4 %); seven of these breasts were treated with external manipulation (closed capsulotomy) and the other three breasts were treated with capsulotomies using a blunt cannula. Ultrasonography analysis was performed on 46 patients (92 treated breasts) by our consultant radiologist after an average time of 46 days post-injection to determine the

location of NASHA-based gel in the breast. In 43 breasts, NASHA-based gel was located in a space posterior to the deep fascia of the breast; in 35 of these breasts, NASHAbased gel was located between the deep fascia of the breast and pectoralis muscle; in three breasts, it was located in the pectoralis muscle; and in five breasts, it was located in the submuscular plane. There were no lumps or aesthetic problems in this group of patients and no one complained of pain or discomfort related to the NASHA-based gel injections. In the other 49 breasts, ultrasonography analysis revealed that the NASHA-based gel was located in a space superficial to the deep fascia of breast. These breasts showed a high rate of dislocation of NASHA-based gel into the breast parenchyma and into the subcutaneous tissue (12 breasts, 24 %) (Figs. 16.2, 16.3, 16.4, 16.5, 16.6,16.7).

Fig. 16.2 MacrolaneTM located superficially to the deep fascia

Fig. 16.1 Anatomy of the breast: 1 Chest wall, 2 Pectoralis muscles, 3 Lobules, 4 Nipple, 5 Areola, 6 Milk duct, 7 Fatty tissue, 8 Skin

Fig. 16.3 Dislocation of MacrolaneTM into the gland tissue two months after injection. This dislocation was usually associated with palpable areas of NASHA-based gel and patient discomfort. (Figures 16.4, 16.5, 16.6, 16.7 Images published in 2011 on Aesth. Plast. Surg)

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Fig. 16.4 Patient before treatment

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Fig. 16.7 After one month, the lumps are resolved

16.4.2 NASHA-Based Gel Injected Under Ultrasonography Guidance A total of 183 women were treated with NASHA-based gel under ultrasonography guidance (Figs. 16.8, 16.1, 16.9, 16.10, 16.11, 16.12a, b, 16.13a, b, 16.14, 16.15, 16.16, 16.17, 16.18, 16.19, 16.20a, b, 16.21a, b, 16.22a, b, 16.23, 16.24, 16.25, 16.26, 16.27a, b, 16.28, 16.29a, b, 16.30a, b, 16.31a, b, 16.32, 16.33a, b, 16.34, 16.35, 16.36, 16.37, 16.38, 16.39a, b, 16.40, 16.41, 16.42, 16.43a, b, 16.44, 16.45, 16.46, 16.47, 16.48, 16.49, 16.50a, b, 16.51a, b, 16.52a, b, 16.53a, b, 16.54). At the time of analysis, 100, 94, 87 and 78 % of women had completed the 1-, 3-, 6-months and 1-year follow-up visits, respectively (average: 290 Fig. 16.5 Patient 1 week after the treatment

Fig. 16.6 Patient 3 weeks after the treatment: big lumps can be observed

Fig. 16.8 Injection of Macrolane with cannula

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(a)

Fig. 16.9 Submuscular location of Macrolane

(b)

Fig. 16.10 Pre-treatment image of A.C., 27 years old

Fig. 16.12 a, b A pocket of Macrolane is created under the pectoralis muscle (submuscular location)

Fig. 16.11 The treatment is performed under ultrasound guidance

[range: 47–565] days). Only 16 % of these patients experienced lumps after the treatment, and these were usually located subcutaneously in the injection/incision site. Using ultrasonography, NASHA-based gel was located in 34

breasts the submuscular plane (Figs. 16.8, 16.1, 16.9, 16.10, 16.11, 16.12a, b, 16.13a, b, 16.14, 16.15, 16.16, 16.17), and in 50 breasts, it was observed into the pectoralis muscle (Figs. 16.18, 16.19, 16.20a, b, 16.21a, b, 16.22a, b, 16.23, 16.24, 16.25), and in 279 breasts, between the deep fascia of the breast and the pectoralis muscle (Figs. 16.26, 16.27a, b, 16.28, 16.29a, b, 16.30a, b, 16.31a, b, 16.32, 16.33a, b, 16.34, 16.35, 16.36). In 3 breasts, a small volume of NASHA-based gel was dislocated into the breast parenchyma (Fig. 16.37) This was not associated with a palpable lump. Ultrasonography analysis in this set of patients revealed a 60 % resorption rate one year after treatment, which has been reported previously.

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(a)

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(b)

Fig. 16.13 a,b Macrolane is injected in close proximity of the chest wall. The ultrasound guidance is very important in order to avoid damages as pneumothorax

Fig. 16.14 A.C. 6 months after the treatment

Fig. 16.16 A.C. 14 months after the first the treatment, and 2 months after the first touch-up

Fig. 16.15 Ultrasound image 6 months after the treatment. Macrolane is still located in the submuscular plane

Fig. 16.17 A.C. 27 months after the first treatment, and 1 month after the second touch-up

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Fig. 16.18 Intramuscular location of Macrolane (blue arrow)

Fig. 16.19 N.F., 48 years old. Pre-treatment image

(a)

(b)

Fig. 16.20 a,b Ultrasound image of the insertion of the cannula into the pectoralis muscle

(a)

(b)

Fig. 16.21 a,b Ultrasound image of the bolus of Macrolane inside the muscle

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(a)

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(b)

Fig. 16.22 a,b sMacrolane is spread off from the cannula

Fig. 16.25 L.P., 43 years old: comparison between pre (on the left)and post (on the right)-treatment images Fig. 16.23 N.F., photo taken during the treatment. The right breast is filled with Macrolane, the left breast has not yet been treated

Fig. 16.26 Subfascial and retroglandular location of Macrolane (blue area)

Fig. 16.24 N.F.: comparison between pre (on the left)- and post (on the right)-treatment images

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Fig. 16.30 a,b C.N. 6 months after the treatment

Fig. 16.27 a,b C.N., 22 years old. Pre-treatment image

Fig. 16.31 a,b 15 months after the first the treatment, and 4 months after the first touch-up

Fig. 16.28 C.N. the Macrolane is injected in the subfascial plane under ultrasonography guidance

(a)

(b)

Fig. 16.29 a,b Ultrasound image of the insertion of the cannula behind the deep fascia of the gland (blue line)

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Fig. 16.32 A.C., ultrasound image 15 months after the first the treatment, and 4 months after the first touch-up

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Fig. 16.35 N.N., 57 years old. Pre-treatment photos

Fig. 16.33 a,b A.C:, 27 months after the first the treatment, and 3 months after the second touch-up

Fig. 16.36 N.N. 10 months after breast enhancement with Macrolane in subglandular location

Fig. 16.34 A.C., ultrasound image 27 months after the first treatment, and 3 month after the second touch-up

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Fig. 16.37 A.C. and C.C., 53 years old, homozygote twin sisters. Image before treatment, performed without ultrasonography guidance

Fig. 16.38 A.C. and C.C. one week after the first treatment

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(a)

(b) Fig. 16.40 A.C. follow-up image at 6 months

Fig. 16.39 a,b A.C. ultrasonography image acquired one week after the treatment. The Macrolane is located superficially to the deep fascia of the breast (blue line), posteriorly but in close proximity with breast parenchyma

Fig. 16.41 A.C. follow-up ultrasound image at 6 months

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Fig. 16.42 A.C. follow-up image at 12 months

Fig. 16.44 A.C., mammography image one year after the treatment: the Macrolane is located into the breast, and it disturbs the visualization (blue arrow)

(a)

(b)

Fig. 16.43 a,b A.C. follow-up ultrasound image, performed 12 months after treatment, demonstrating a small amount of Macrolane dislocated into the breast parenchyma (blue arrow: deep fascia of the breast)

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Fig. 16.45 In order to inject material in the correct plane, first touch-up is performed under ultrasound guidance

Fig. 16.46 A.C. immediately after the first touch-up, 13 months after the first treatment

Fig. 16.47 A.C. ultrasound image demonstrating the submuscular location of Macrolane. The thickness of Macrolane is 1.87 cm

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(a)

(b)

Fig. 16.48 A.C. 24 months after the first treatment, and 11 months after the first touch-up Fig. 16.50 A.C. mammography image 24 months after the first treatment, and 11 months after the first touch-up the Macrolane (blue arrows) is located behind the muscle, and it does not disturbs breasts cancer diagnosis

(a)

(b)

Fig. 16.49 A.C. ultrasound image 24 months after the first treatment, and 11 months after the first touch-up. The thickness of Macrolane is 1.22 cm

Fig. 16.51 a,b C.C. mammography image 24 months after the first treatment, and 14 months after the first touch-up. The first touch-up was performed under ultrasound guidance, as in the case of the twin sister. Macrolane (blue arrow) is located behind the muscle, and it does not disturb breast cancer diagnosis

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Breast Augmentation

Fig. 16.52 a,b D.F., 47 years old. Pretreatment photos

Fig. 16.53 a,b D.F. 2 month after treatment

Fig. 16.54 D.F. follow-up ultrasound image, demonstrating Macrolane located into subcutaneous and intramuscular plane

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Gluteal Augmentation and Remodeling

17

Mario Goisis and Magda Guareschi

Gluteal augmentation and remodeling are generally sought by patients who desire their buttock to be rounder and full. Gluteal contour defects are common and may be related to a deficiency in gluteal mass, loss of fat in the buttock area, or in the shape of the lower spine.

17.1

Anatomy

The sciatic nerve begins in the lower back and runs through the buttock and down the lower limb (Fig. 17.1). Going from the top of the leg to the foot, it is the longest and widest single nerve in the human body. The sciatic innervates the muscles of the posterior compartment of the thigh and all the muscles of the leg and foot and nearly the whole of the skin of the leg. The superior gluteal nerve originates in the pelvis and innervates the tensor fasciae latae muscles and the gluteus medius and minimus. The inferior gluteal nerve is mainly responsible for motor innervation of the gluteus maximus muscle. It extends the thigh to execute activities such as climbing stairs. All the cited nerves are placed deeply into the gluteus maximus. The superficial branch of the superior gluteal artery enters the deep surface of the gluteus maximus and supplies the muscle anastomosing with the inferior gluteal artery. Numerous terminal branches perforate its tendinous origin to supply the superficial tissues covering the posterior surface of the sacrum.

Fig. 17.1 Sciatic nerve anatomy. Reproduction of a lithograph plate from Gray’s anatomy (Henry Gray, Anatomy: Descriptive and Surgical)

The inferior branch of the gluteal artery descends in the gap between the greater trochanter of the femur and tuberosity of the ischium and is continued down the back of the thigh, supplying the skin. It anastomoses with branches of the perforating arteries.

17.2 M. Goisis (&)  M. Guareschi Doctor’s Equipe, Milan, Italy e-mail: [email protected]

Pitfalls

Accidental injuries to nerve and vessel of gluteal region can be avoided by introducing the injecting cannula in the subcutaneous layer, keeping the hedge superficial to the muscularis fascia of the gluteus (Fig. 17.2).

M. Guareschi e-mail: [email protected]

M. Goisis (ed.), Injections in Aesthetic Medicine, DOI: 10.1007/978-88-470-5361-8_17,  Springer-Verlag Italia 2014

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Fig. 17.3 Materials

Fig. 17.2 The sciatic nerve is located in a deep plane. Reproduction of a lithograph plate from Gray’s anatomy (Henry Gray, Anatomy: Descriptive and Surgical)

17.3

Buttock Augmentation by Hyaluronic Acid

Buttock augmentation by hyaluronic acid is a simple procedure, performed in the office operating room under local anesthesia.

17.3.4 Materials Usually, the procedure is performed using 80 to 200 cc of hyaluronic acid and Macrolane VRF20 or Hyacorp 500 (40 to 100 cc injected in every buttock) (Fig. 17.3) • Blade number 15 • Sharp scissors • Hudson forceps • Small Kleimer • 2.5 9 150 mm, 12G, filling cannula • 3 9 10 cc syringes • 1 9 100 cc bottle of physiologic solution.

17.3.1 Indications Improvement of gluteal contour.

17.3.2 Contraindications The filler should not be injected in areas that lack sufficient blood supply or that have an infection or inflammation. No injection should be done if the hand has been previously treated with liquid silicone or other permanent fillers because new injection could lead to inflammation or infection of the implants. Any hypersensitivity to any components of the filler obviously constitutes a contraindication for the treatment.

17.3.3 Operating Time The procedure usually takes 30 to 60 min.

Fig. 17.4 Preparation of anesthesia. Anesthetic solution is made up by mixing 6.4 ml of physiologic solution with 3.6 ml of mepivacaine (20 mg/ ml) with epinephrine (1/100000) in a 10 ml syringe. Three syringes are prepared

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Fig. 17.6 The area of interest is identified. Injection of local anesthesia is performed only in the area of the buttock that will be treated. For this reason, pre-treatment evaluation and marking of the area are the most important and difficult steps in buttock augmentation

Fig. 17.5 A.C., 39-year-old patient. Pre-treatment photograph in lateral view

Fig. 17.7 Pre-treatment ultrasonography is performed

Anesthetic solution is made up by mixing 6.4 ml of physiologic solution with 3.6 ml of mepivacaine (20 mg/ ml) with epinephrine (1/100000).

17.3.6 Methods

17.3.5 Material choice • • • •

Macrolane VRF20 Macrolane VRF30 Hyacorp 1000 Hyacorp 500

The procedure is described in (Figs. 17.4, 17.5, 17.6, 17.7, 17.8, 17.9, 17.10, 17.11, 17.12, 17.13, 17.14, 17.15, 17.16, 17.17, 17.18, 17.19, 17.20, 17.21, 17.22, 17.23, 17.24, 17.25, 17.26, 17.27, 17.28, 17.29, 17.30).

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Fig. 17.8 The anesthesia of the area is performed by injections of 2.5 cc of anesthetic solution. The distance between points of injection is 2 cm

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Fig. 17.11 The cannula entrance is facilitated by creating a tunnel with sharp scissors

Fig. 17.12 The 150-mm-long cannula is inserted Fig. 17.9 7.5 cc of local anesthesia is injected into the subcutaneous area in every buttock

Fig. 17.10 2-mm skin incision is performed by a number 15 blade

Fig. 17.13 The cannula is moved in order to dissect the subcutaneous area from the border of the marked area

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Fig. 17.17 10 cc of hyaluronic acid has been injected Fig. 17.14 The cannula is connected to the hyaluronic acid syringe

Fig. 17.15 A space filled with hyaluronic acid is created in the subcutaneous area

Fig. 17.16 The correct injection area is checked by ultrasonography. Red arrow muscle. Yellow arrow Macrolane

Fig. 17.18 The cannula is moved in order to dissect the subcutaneous area from the border of the designed area, and a second tunnel is created 2 cm laterally to the first one

Fig. 17.19 The same procedure is performed 4 times, in order to create a uniform area filled by hyaluronic acid

190

Fig. 17.20 An unique incision is used, and the angle of entrance of the cannula will vary in order to inject the whole buttock

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Fig. 17.23 The difference between augmented left buttock and natural not yet augmented right buttock is evident in lateral view (green line)

Fig. 17.21 60 cc of hyaluronic acid was injected in the right buttock

Fig. 17.24 Same as Fig. 17.23 but in  view

Fig. 17.22 The patient can observe the amelioration of the left in the mirror. Can discuss with the surgeon the result, and can decide to adjust the volume

Fig. 17.25 Immediately after the treatment, lumps can be observed

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Gluteal Augmentation and Remodeling

Fig. 17.26 Lumps are corrected by a vigorous massage

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Fig. 17.29 The same patient before (on the left) and 2 weeks after the treatment (on the right)

Fig. 17.27 The skin incision is closed with 5–0 Vicryl

Fig. 17.30 Another patient: C.M., 27 years old, before (on the left) and 10 weeks after the treatment (on the right)

17.4

Complications and Management

Immediate complications (within 72 hours after injection) immediate hypersensitivity reaction, transient erythema, edema, induration, pruritus and ecchymosis. Early complications (days to weeks after injection) include overcorrection, local infection, skin necrosis, herpes reactivation, discoloration and persistent local symptoms (erythema, edema, induration, pruritus and hyperpigmentation). Late complications include infection, filler migration, delayed hypersensitivity reaction, foreign-body granuloma and scarring. See Chap. 21. Fig. 17.28 12 syringes of 10 cc of hyaluronic acid were used to treat both buttocks

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Anti-inflammatory supplements can help reduce inflammation and pain without using drugs with potentially serious side effects. One tablet of anti-inflammatory supplements is recommended 2 times a day for 15 days (the composition is reported in Chap 21.6). Several factors such as stress, smoking, diet, lifestyle and exposure to natural or artificial UV light can increase the production of free radicals that cause ‘‘oxidative stress’’, a process that can trigger cell damage and decrease the duration of soft-lifting sponsored by the HA fillers. One

M. Goisis and M. Guareschi

tablet of antioxidant supplement is recommended 2 times a day for 15 days, then 1 times for 60 days (the composition is reported in Chap 21.18).

17.5

Summary: Treatment Options

Indications

Material

Needle or Cannule

Chapter

Gluteal remodeling and volume augmentation

High viscosity Hyaluronic Acid

2.5 9150 mm, 12G, cannula

17.3

Calf Augmentation and Remodeling

18

Mario Goisis and Enrica Stella

Calf enlargement (calf augmentation) is often considered by patients whose calves are excessively narrow (in extreme cases, they may be described as ‘‘stork legs’’) due to insufficient muscular mass, fat atrophy, or illness such as clubfoot, spastic paralysis, spina bifida, and poliomyelitis.

18.1

Anatomy

The great saphenous vein, also long saphenous vein, is the large, subcutaneous, superficial vein of the leg and thigh (Fig. 18.1).

Fig. 18.1 Anatomy of the great saphenous vein Reproduction of a lithograph plate from Gray’s anatomy (Henry Gray, Anatomy: Descriptive and Surgical)

It originates from where the dorsal vein of the first digit (the large toe) merges with the dorsal venous arch of the foot. After passing anterior to the medial malleolus (where it often can be visualized and palpated), it runs up the medial side of the leg. At the knee, it runs over the posterior border of the medial epicondyle of the femur bone. The small saphenous vein is a relatively large vein of the superficial posterior leg. Its origin is where the dorsal vein of the fifth digit (smallest toe) merges with the dorsal venous arch of the foot, which attaches to the great saphenous vein. It is considered a superficial vein and is subcutaneous (just under the skin). From its origin, it courses around the lateral aspect of the foot (inferior and posterior to the lateral malleolus), runs along the posterior aspect of the leg, passes between the heads of the gastrocnemius muscle, and usually drains into the popliteal vein approximately at or above the level of the knee joint. Accidental injury to saphenous veins leads to noticeable hematomas and blood infarction of the implant with possible infection.

18.2

Pitfalls

Identification of the saphenous veins must be accomplished prior to injecting the filler by means of visual, tactile, and echographic examination (Figs. 18.2, 18.3, 18.4). The injecting cannula must be directed into the subcutaneous layer, keeping the hedge superficial to the muscularis fascia of the gastrocnemius.

M. Goisis (&)  E. Stella Doctor’s Equipe, via Carducci 19, 20123 Milan, Italy e-mail: [email protected]

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Fig. 18.2 Ultrasound examination is performed in order to design the course of saphenous vein Fig. 18.4 Design of saphenous vein course

The point and area of injection must be decided according to the defect to be corrected.

18.3

Calves Augmentation with Hyaluronic Acid

Augmentation of the calves by hyaluronic acid is a simple procedure, performed in the office operating room under local anesthesia.

18.3.1 Indications Fig. 18.3 Ultrasound Doppler image of saphenous vein

Augmentation of the calves to improve harmony of the legs.

18

Calf Augmentation and Remodeling

195

18.3.2 Contraindications

18.3.4 Materials

The filler should not be injected in areas that lack sufficient blood supply or that have an infection or inflammation. No injection should be done if the hand has been previously treated with liquid silicone or other permanent fillers because new injection could lead to inflammation or infection of the implants. Any hypersensitivity to any components of the filler obviously constitutes a contraindication for the treatment. Vascular problems as arterial or venous occlusion are relative contra-indications that must be evaluated by a specialist before treatment.

Usually, the procedure is performed using from 20 to 120 cc of hyaluronic acid and Macrolane VRF20 or Hyacorp 500 (from 10 to 60 cc injected in one calf) (Figs. 18.5, 18.6a, b, c). • Blade number 15 • Sharp scissors • Hudson forceps • Small Kleimer • 2.5 9 150 mm, 12 G, filling cannula • 3 9 10 cc syringes • 1 9 100 cc bottle of physiologic solution.

18.3.3 Operating Time

18.3.5 Material Choice

The procedure usually takes 30–60 min.

• • • •

Macrolane VRF 20 Macrolane VRF 30 Hyacorp 500 Hyacorp 1000

18.3.6 Methods Important skill: Injection of local anesthesia is performed only in the area of the calf that will be treated. For this reason, the pre-treatment evaluation and design are the most important and difficult steps in calf augmentation (Figs. 18.7, 18.8, 18.9, 18.10, 18.11a, b, 18.12, 18.13, 18.14, 18.15, 18.16, 18.17, 18.18, 18.19a, b, 18.20, 18.21, 18.22, 18.23, 18.24a, b, c, d, 18.25, 18.26a, b, 18.27, 18.28a, b, c, 18.29, 18.30).

Fig. 18.5 Calves augmentation by hyaluronic acid: Materials

Fig. 18.6 a, b, c Preparation of anesthesia. Anesthetic solution is made up by mixing 6.4 ml of physiologic solution with 3.6 ml of mepivacaine (20 mg/ml) with epinephrine (1/100000)

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Fig. 18.9 The anesthesia of the area is performed by injections of 2.5 cc of anesthetic solution. The distance between points of injection is 2 cm

Fig. 18.7 Y.A., 27-year-old patient. Pre-treatment picture in frontal view

Fig. 18.10 10 cc of local anesthetic solution is injected into the subcutaneous space in both calves

Fig. 18.8 The area of interest is designed. Injection of local anesthesia performed only in the area of the calf that will be treated. For this reason, the pre-treatment evaluation and design are the most important and difficult steps in calf augmentation

Fig. 18.11 a, b The treatment is shown: The 15-cm-long cannula can distribute hyaluronic acid along all of the calf

18

Calf Augmentation and Remodeling

Fig. 18.12 2-mm skin incision is performed by number 11 blade

197

Fig. 18.15 The cannula is moved in order to dissect the subcutaneous space from the border of the designed area

Fig. 18.13 The entrance of cannula is facilitated by creating a tunnel with sharp scissors

Fig. 18.16 The cannula is moved in order to dissect the subcutaneous space from the border of the designed area, and a second tunnel is created near the first one

Fig. 18.14 The 150-mm-long cannula is inserted

Fig. 18.17 The angle of entrance of the cannula is changed, and the same procedure is performed for 3 or 4 times, in order to create a uniform space filled by hyaluronic acid. In this way, a place filled by hyaluronic acid will be created in the subcutaneous space

198

Fig. 18.18 30 cc of hyaluronic acid is injected in every calf with a retrograde technique

M. Goisis and E. Stella

Fig. 18.21 The skin incision is closed by the use of Vicryl 5–0

Fig. 18.19 a, b A strong massage is performed

Fig. 18.22 A.B., 31 years old, before the treatment

Fig. 18.20 The patient can observe the amelioration of left calf in the mirror. The patient can discuss with the surgeon the result and can decide to adjunct more volume or to change the shape of the calf. The difference between augmented left calf and the natural right calf is evident in posterior view (arrow)

Fig. 18.23 The treatment is performed under ultrasound guidance

18

(a)

Calf Augmentation and Remodeling

199

(b)

macrolane cannula muscle

(c)

(d)

cannula macrolane

Fig. 18.24 a, b, c, d The macrolane is injected in the subcutaneous plane

200 Fig. 18.25 The same patient 11 months after the treatment

Fig. 18.26 a, b Ultrasound image of the calf 11 months after the treatment

M. Goisis and E. Stella

After 11 months

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Calf Augmentation and Remodeling

201

pre

After 11 months

After second treatment

Fig. 18.27 Result after the second treatment

(a)

(b)

(c) subcutis macrolane muscle

Fig. 18.28 a, b, c Ultrasound images one week after the second treatment

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Fig. 18.30 P.F. before the treatment (on the left) and after the treatment (on the right). Posterior view Fig. 18.29 P.F. before the treatment with Hyacorp 500 (on the left) and after the treatment (on the right). Anterior view

18.3.7 Complications and Management Immediate complications (within 72 hours after injection) immediate hypersensitivity reaction, transient erythema, edema, induration, pruritus and ecchymosis. Early complications (days to weeks after injection) include overcorrection, local infection, skin necrosis, herpes reactivation, discoloration and persistent local symptoms (erythema, edema, induration, pruritus and hyperpigmentation). Late complications include infection, filler migration, delayed hypersensitivity reaction, foreign-body granuloma and scarring. See chap. 21. Anti-inflammatory supplements can help reduce inflammation and pain without using drugs with potentially serious side effects. One tablet of anti-inflammatory supplements is recommended 2 times a day for 15 days (the composition is reported in chap. 21.6).

Several factors such as stress, smoking, diet, lifestyle and exposure to natural or artificial UV light can increase the production of free radicals that cause ‘‘oxidative stress’’, a process that can trigger cell damage and decrease the duration of soft-lifting sponsored by the HA fillers. One tablet of antioxidant supplement is recommended 2 times a day for 15 days, then 1 times for 60 days (the composition is reported in chap. 21.8).

18.4

Summary: Treatment Options

Indications calf remodelling and volume augmentation

Material

Needle or Cannule

High viscosity Hyaluronic Acid

2.5 X 150 mm, 12 G, cannula

Chapter 18.3

19

Scar Revision Mario Goisis and Magda Guareschi

19.1

Correction of Scars with Hyaluronic Acid 19.1.4 Materials

Correction of scars by means of hyaluronic acid is usually a very simple procedure, performed in the office under local anesthesia.

19.1.1 Indications Small surgical scars, complications of liposuction, complications of steroid injections and vaccinations.

19.1.2 Contraindications The filler should not be injected in areas that lack sufficient blood supply or that have an infection or inflammation. No injection should be administered if the area has been previously treated with liquid silicone or other permanent fillers because new injection could lead to inflammation or infection of the implants. Any hypersensitivity to any components of the filler obviously constitutes a contraindication for the treatment.

19.1.3 Operating Time The procedure usually takes from 15 to 30 min.

Fig. 19.1 Materials: 18 G blunt tip cannule, 9 cm length is used to easly approach smaller areas

• From 10 to 20 cc of hyaluronic acid. Usually, the procedure is performed using Macrolane VRF20 or Hyacorp 500 (Fig. 19.1) • Number 11 blade • Sharp scissors • 1.2 9 70 mm—18G filling cannula • Anesthetic solution is prepared by mixing 6.4 cc of physiologic solution with 3.6 cc of Mepivacaine (20 mg/ml) with adrenaline (1/100,000) • 6 9 75 mm sterile adhesive cutaneous suture (Steri-Strip 3 M).

M. Goisis (&)  M. Guareschi Doctor’s Equipe, via Carducci 19, 20123 Milan, Italy e-mail: [email protected] M. Guareschi e-mail: [email protected]

M. Goisis (ed.), Injections in Aesthetic Medicine, DOI: 10.1007/978-88-470-5361-8_19,  Springer-Verlag Italia 2014

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19.1.5 Methods The treatment is described in Figs. 19.2, 19.3, 19.4, 19.5, 19.6, 19.7, 19.8, 19.9, 19.10, 19.11, 19.12, 19.13, 19.14.

2

Fig. 19.2 47-year-old female with surgical scar 24 months after liposuction. The arrow shows the loss of volume

Fig. 19.3 The area of interest is designed and 5 cc of local anesthesia is injected into the subcutaneous space. After injection of local anesthesia, is very difficult to understand where is the scar and where ends the area of treatment. For this reason, the pre-treatment evaluation and design are the most important and difficult step of the scar correction

Fig. 19.4 a–c The procedure is demonstrated

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Scar Revision

205

Fig. 19.7 The cannula will be moved in order to dissect the scar Fig. 19.5 2-mm skin incision is performed by number 11 blade

Fig. 19.8 Space will be created in the subcutaneous plane

Fig. 19.6 a, b The entrance of cannula is encouraged by creating a tunnel with sharp scissors

Fig. 19.9 10 cc of hyaluronic acid is injected

206

Fig. 19.10 Immediately after injection, a bulky appearance with lumps will be observed

M. Goisis and M. Guareschi

Fig. 19.12 The skin incision is closed by use of Steri-Strip 3 M

12

Fig. 19.13 Correction of the deformity immediately after treatment

(a)

Fig. 19.11 a,b The lumps are corrected by strong massage

(b)

Fig. 19.14 a 22-year-old patient with scar after vaccination performed 20 years ago (blue arrow), b result after injection of 10 cc of Hyacorp 500

19

Scar Revision

19.2

Complications and Management

Immediate complications (within 72 hours after injection) immediate hypersensitivity reaction, transient erythema, edema, induration, pruritus and ecchymosis. Early complications (days to weeks after injection) include overcorrection, local infection, skin necrosis, herpes reactivation, discoloration and persistent local symptoms (erythema, edema, induration, pruritus and hyperpigmentation). Late complications include infection, filler migration, delayed hypersensitivity reaction, foreign-body granuloma and scarring. See Chap. 21. Anti-inflammatory supplements can help reduce inflammation and pain without using drugs with potentially serious side effects. One tablet of anti-inflammatory supplements is recommended 2 times a day for 15 days (the composition is reported in Chap. 21.6).

207

Several factors such as stress, smoking, diet, lifestyle and exposure to natural or artificial UV light can increase the production of free radicals that cause ‘‘oxidative stress’’, a process that can trigger cell damage and decrease the duration of soft-lifting sponsored by the HA fillers. One tablet of antioxidant supplement is recommended 2 times a day for 15 days, then 1 times for 60 days (the composition is reported in Chap. 21.18).

19.3

Summary: Treatment Options

Indications

Material

Needle or Cannule

Chapter

Hypotrophic scars or correction

High viscosity Hyaluronic Acid

90 mm, 18G, blunt tip cannula

19.1

Full-body and Full-face Treatment

20

Mario Goisis

20.1

From the Full Body to the Full Face: The Sense of Multiple Treatments in the Same Day in Aesthetic Medicine

In this book, many different techniques of aesthetic medicine are described. These techniques are very easy to perform, so it is possible to combine multiple treatments in the same day on the same patient. This approach, which is called full-face or full-body treatment, has many advantages. In fact, the patient can obtain a complete and harmonious amelioration of the face and the body. He or she has to come to the office only one time. Complications such as bruising or redness are limited to one application. Despite of these advantages, the doctor in full-face or full-body approach has to remember the key concept of aesthetic medicine. The aim of aesthetic medicine is to change a part of the face of the body through medical techniques in order to increase beauty. Because beauty is harmony of form and proportions, it is important to not consider full-face approach as injecting an enormous amount of fillers and botulin toxin in the face of the patient. This in fact results in an innatural and, at the end, in a not improved aspect. Avoiding excess is the key of success in full-face and fullbody approach (Figs. 20.1, 20.2, 20.3a–c, 20.4, 20.5, 20.6, 20.7, 20.8, 20.9, 20.10, 20.11, 20.12a, b, 20.13, 20.14, 20.15, 20.16, 20.17a–d, 20.18, 20.19, 20.20, 20.21, 20.22a, b).

Fig. 20.1 These pictures show the patient before full-face approach

Fig. 20.2 Particular attention is given to nasofrontal and nasolabial angles M. Goisis (&) Doctor’s Equipe, via Carducci 19, 20123 Milan, Italy e-mail: [email protected]

M. Goisis (ed.), Injections in Aesthetic Medicine, DOI: 10.1007/978-88-470-5361-8_20,  Springer-Verlag Italia 2014

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Fig. 20.4 The nasal tip elevation is obtained with the injection of 0.2 cc of botulinum toxin (bocouture 50 unites diluted with 1.25 cc saline) is injected into the depressor nasi muscle in two sites of injection located bilaterally to the columella

Fig. 20.5 Combining botulinum toxin and filler injections the nasofrontal and nasolabial angles are improved

Fig. 20.3 a–c The pictures shows the patient before and after (pictures on the right) a full-face treatment approach

20

Full-body and Full-face Treatment

Fig. 20.6 Patient face before the treatment

211

Fig. 20.8 An accurate planning is done; the forehead, crow feet and glabella will be treated with botulinum toxin; the tear trough, the nasolabial folds and marionette lines are corrected using medium density HA; Calcium Hydroxylapatite is used in temple, zygomatic, cheek and chin areas

Fig. 20.7 Patient’s hands before the treatment

Fig. 20.9 Treatment of neck, decolleté and arms is done performing several injections of low-density HA

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Fig. 20.10 Calcium hydroxylapatite is used to address hands loss of volume Fig. 20.12 a Before treatment, b after treatment c closer comparison before (left) and after (right) treatment

Fig. 20.11 Pre-treatment and post-treatment pictures of the patient’s face

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Full-body and Full-face Treatment

213

Fig. 20.15 Evident asymmetry of the eyebrows

Fig. 20.13 A.C., 34-year-old; pre-treatment image; a marked asymmetry is evident. The blue line evidences face scoliosis

Fig. 20.16 The cheek augmentation performed only on one side is useful to help correcting the evident asymmetry of the patient; 0.8 cc HA is used

Fig. 20.14 The patient’s occlusion, demonstrating asymmetry. The blue line shows the lateral deviation of the occlusal plane

214

Fig. 20.17 a–d Pre- and post-treatment images; the asymmetry is corrected

M. Goisis

20

Full-body and Full-face Treatment

215

Fig. 20.18 Picture after a full-face treatment (on the right) is compared with the previous situation; the whole aspect of the face is improved

Fig. 20.19 Examples of augmentation of pectoralis and of buttock obtained with Macrolane injection

216

Fig. 20.20 A.V., 41-year-old. Breast and buttock before treatment

M. Goisis

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Full-body and Full-face Treatment

217

Fig. 20.21 Breast volume and buttock shape are both ameliorated in the same day using Macrolane

(a)

(b)

Fig. 20.22 a, b M.B., 47-year-old. Before and 7 days after treatment with Macrolane that was injected in breast, buttock and arms

218

20.2

M. Goisis

Surgery or Not Surgery?

Aesthetic surgery is not in contrast with aesthetic medicine. In some patients, surgery is the best option in order to enhance beauty in a better and more complete way (Figs. 20.23, 20.24, 20.25, 20.26, 20.27a, b, 20.28, 20.29, 20.30, 20.31, 20.32, 20.33a, b, 20.34, 20.35). In other cases,

aesthetic medicine can support and complete surgery (Figs. 20.36, 20.37, 20.38). The choice between aesthetic surgery alone, aesthetic medicine alone or medicine and surgery together have to be an open-mind choice, based on patient’s examination and evaluation of risks and advantages.

Fig. 20.23 Example of surgery approach (upper- and lower-lid blepharoplasty with cheeklift). Pictures of the patient before and after two years from the surgical treatment

Fig. 20.24 Goisis Elevator is an excellent tool in lower-lid blepharoplasty with primary cheeklift. In fact, it is very useful in periosteal cutting and dissection

Fig. 20.25 Pictures of the patient before and after two years from the surgical treatment: later view

20

Full-body and Full-face Treatment

Fig. 20.26 Lower-lid blepharoplasty with primary cheeklift is shown; after local anaesthesia infraciliary incision is performed

219

Fig. 20.28 The orbicularis muscle is dissected from the orbital septum

Fig. 20.29 The orbicularis muscle is elevated since the inferior orbital rim

Fig. 20.27 Undermining of the skin flap: the skin is dissected from the orbicularis muscle Fig. 20.30 The orbital septum is exposed

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Fig. 20.31 The orbital septum is opened, and the lower-lid fat pad is opened and removed

Fig. 20.33 a, b The muscle flap is anchored at the lateral cantus

Fig. 20.32 The orbital rim is exposed and the periosteum is cut with the Goisis Elevator. The subperiosteal elevation is then carried out with the elevator over the zigomatic area. In this way, the cheek tissue is elevated from the cheekbone

Fig. 20.34 Resection of excess of skin

Fig. 20.35 Skin suture

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Full-body and Full-face Treatment

221

Fig. 20.36 Example of a patient suitable for a surgery procedure combined with aesthetic medicine treatment

Fig. 20.37 Upper- and lower-lid blepharoplasty with primary cheeklift combined with botulinum injection and malar area enhancement with hyaluronic acid

Fig. 20.38 Aesthetic improvement is evident two months after the treatments (picture on the right)

Complications in Aesthetic Medicine

21

Enrica Stella, Mario Goisis, and Mariangela Giarda

In recent years, many products have been developed and approved for use as dermal and subdermal injectable fillers for facial rejuvenation and body amelioration.

21.1

Hyaluronic Acid

Hyaluronic acid (HA) fillers are biocompatible, biodegradable, and nonpermanent fillers. HA has no organ or species specificity, and therefore, in theory, there is no risk of an allergic reaction if exogenous HA is injected into the skin. HA fillers offer an excellent balance of efficacy, safety, and duration of cosmetic benefit and have a lower incidence of complications than semipermanent and permanent agents. Furthermore, HA fillers can be rapidly reversed by injection of hyaluronidase. The complications are described in Table 21.1.

21.2

As already said HA has no organ or species specificity, and therefore, in theory, there is no risk of an allergic reaction if exogenous HA is injected into the skin. Macrofillers offer an excellent balance of efficacy and safety compared with the cosmetic benefit of major surgery as the insertion of silicon prosthesis. This is particularly true in case of remodeling and/or small augmentation of the treated area. In case of major augmentation, the use of macrofillers is very expensive, and the degree of complication increases. The complications are described in Table 21.2.

21.3

Calcium Hydroxylapatite (Radiesse)

The duration and severity of adverse effects associated with calcium hydroxylapatite gel are comparable to those seen with other filler agents (collagen and HAs) and chiefly associated with the delivery of the material rather than the material itself. The complications are described in Table 21.3.

Macrofiller

The Macrofiller is a hyaluronic acid specifically designed for body remodelling. In 2006, Macrolane was approved for body and breast remodeling. In 2009, Hyacorp 1000 was introduced for body enhancement, except breasts. Macrolane and Hyacorp are macrofillers composed of HA. For this reason, they are biocompatible, biodegradable, and nonpermanent fillers.

E. Stella (&)  M. Goisis  M. Giarda Doctor’s Equipe, via Carducci 19, 20123 Milan, Italy e-mail: [email protected] M. Goisis e-mail: [email protected] M. Giarda e-mail: [email protected]

M. Goisis (ed.), Injections in Aesthetic Medicine, DOI: 10.1007/978-88-470-5361-8_21,  Springer-Verlag Italia 2014

21.4

Classification of Complications

All the fillers we have just described can cause immediate, early and late complications. The complications are described in Table 21.3. • Immediate complications (within 72 h after injection) include immediate hypersensitivity reaction, transient erythema, edema, induration, pruritus and ecchymosis. • Early complications (days to weeks after injection) include overcorrection, local infection, skin necrosis, herpes reactivation, discoloration, and persistent local symptoms (erythema, edema, induration, pruritus, and hyperpigmentation). • Late complications include infection, filler migration, delayed hypersensitivity reaction, foreign-body granuloma and scarring, rapid resorption, [1–4], problems in case of radiological imaging (in particularly for Macrofillers).

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Table 21.1 Complications related to hyaluronic acid fillers: personal data based on 11.047 treatments Complications

Incidence

Events

Diagnosis

Treatment

Chapter

Immediate hypersensitivity reaction

Rare

3

Edema, severe and disfiguring swelling

Systemic steroids

21.4

Edema

Common

2764

Moderate swelling

Ice, Arnica gel, pineapple stem extract 200 mg

21.5

Eritema and pruritus

Rare

12

Moderate redness

Arnica gel, pineapple stem extract 200 mg

21.5

Indurations

Rare

75

Hardness

2 days massage

21.6

Ecchymosis and Hematoma

Common

1028

Extravasation of blood under the skin, bruising

Ice, topical arnica

21.7

Bacterial Infections

Rare

9

Heat, redness, swelling, and pain

Amoxicillin associated with clavulanic acid 1 mg x 2 for 5 days

21.8

Biofilm

Very rare

3

Low-grade chronic infection

Clarithromycin (500 mg x 2 die) for 6 weeks, hyaluronidase incision and drainage

21.9

Herpes simplex

Rare

33

Typical lip rash

Topical Aciclovir, Valaciclovir 500 mg twice per day or oral Aciclovir: 200 mg x 5 die (every 4 hours except night)

21.12

Herpes Zoster

Rare

4

Pain in the affected dermatome. followed by skin rash

Topical Acyclovir and oral Valacyclovir: 1000 mg x 3 die or oral Aciclovir: 800 mg x 5 die (every 4 hours except night)

21.12

Overcorrection

Common

147

Excess of filler injected

Hyaluronidase

21.12

Migration

Uncommon

19

Spontaneous displacement of the material away from the site of injection

Hyaluronidase

21.12

Chronic inflammation

Uncommon

31

Chronic inflammatory reaction with erythema and swelling

Clarithromycin, Hyaluronidase incision and drainage

21.13

Foreign body granulomas

Rare

2

Chronic inflammatory nodules

Clarithromycin, Hyaluronidase incision and drainage

21.14

Discoloration (Tindall effect)

Rare

1

Bluish discoloration

Hyaluronidase

21.15

Skin Necrosis

Very rare

0

Interruption of the vascular supply: pain, discoloration

Kept warm 2% nitroglycerine paste hyaluronidase

21.16

Rapid resoption

Common

1197

Rapid loss of volume

Ascorbic acid 350 mg Polygonum Cuspidatum 150 mg Gingko Biloba 150 mg

21.17

21.5

Immediate Complications

True allergic reaction is rare; in fact, both HA and hydroxylapatite fillers do not require allergy testing. Although patient can be allergic to some product component, especially sodium hyaluronate, anaphylaxis could occur secondary to preservatives. Some reactions are simply edema or sometimes angioneurotic edema, which can lead to severe and disfiguring swelling [5–7]. Treatment: These reactions are treated with systemic steroids (Betamethasone disodium posphate 1 mg: 4 mg 9 2 die for 3 days then 1 mg die for 2 days).

21.6

Transient Erythema, Edema, and Pruritus

These side effects are nonallergic local side effects at the sites of injections; they are frequent but resolve spontaneously in 48 h [8, 9]. In particular, redness is very frequent after injection with Radiesse. Icing and cold: Icing the areas before and immediately after injection is helpful. The use of ice masks before treatment can be useful to reduce edema. Also the application of oxygen and cold solution immediately after injection should be useful (Figs. 21.3, 21.4, 21.5).

21

Complications in Aesthetic Medicine

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Table 21.2 Complications related to macrofillers: personal data based on 892 treatments Complications

Incidence

Events

Diagnosis

Treatment

Chapter

Immediate hypersensitivity reaction

Rare

1

Edema, severe and disfiguring swelling

Systemic steroids

21.4

Edema

Common

94

Moderate swelling

Arnica gel, pineapple stem extract 200 mg, systemic steroids

21.5

Eritema and pruritus

Rare

11

Moderate redness

Arnica gel, pineapple stem extract 200 mg

21.5

Indurations

Common

45

Hardness

2 weeks massage

21.6

Ecchymosis and hematoma

Common

194

Extravasation of blood under the skin, hard masses within the muscle

For severe hematoma: surgical drainage

21.7

Bacterial infections

Rare

6

Heat, redness, swelling, pain and fever

Amoxicillin associated with clavulanic acid 1 mg x 2 for 10 days, removal of macrofiller

21.8

Biofilm

Very rare

2

Low-grade chronic infection

Clarithromycin (500 mg x 2 die) for 6 weeks, hyaluronidase incision and drainage

21.9

Herpes Zoster

Rare

1

Pain in the affected dermatome. followed by skin rash

Topical Acyclovir, oral Valacyclovir: 1000 mg x 3 die or oral Acyclovir: 800 mg x 5 die

21.10

Overcorrection

Common

22

Excess of filler injected

Hyaluronidase

Migration

Common

98

Spontaneous displacement of the material away from the site of injection

Hyaluronidase direct aspiration

21.12

Chronic inflammation

Uncommon

7

Chronic inflammatory reaction with erythema and swelling

Clarithromycin, hyaluronidase incision and drainage

21.13

Foreign body granulomas

Rare

1

Chronic inflammatory nodules

Clarithromycin, hyaluronidase incision and drainage

21.14

Discoloration (Tindall effect)

Rare

2

Bluish discoloration

Hyaluronidase

21.15

Skin necrosis

Very rare

0

Interruption of the vascular supply: pain, discoloration

Kept warm removal

21.16

Rapid resoption

Common

102

Rapid loss of volume

Ascorbic acid 350 mg, Polygonum Cuspidatum 150 mg, Gingko Biloba 150 mg. Follow-up by ultrasound and free of charge treatment

21.17

Radiological problems

Common

28

Problems for visualization of mammary glandular tissue

Correct injection with ultrasound guidance. In case of displacement: hylaluronidase and removal

21.18

Anti-inflammatory supplements can help reduce inflammation and pain without using drugs with potentially serious side effects. One tablet of anti-inflammatory supplements is recommended 2 times a day for 15 days [8] and should be composed by: • Pineapple stem extract 200 mg: It contains bromelain, a proteolytic enzyme (proteinase). In laboratory studies, bromelain has been shown to be able of inactivating the protein responsible for inflammatory processes and to favor the absorption of edema. • Quercetin 150 mg: The anti-inflammatory effects of Quercetin seem to come from its ability to dampen the production and activity of pro-inflammatory biochemicals

such as leukotrienes and prostaglandins, and to block the release of histamine, the biochemical that causes allergic symptoms like runny nose and itchy eyes. • Ascorbic acid 200 mg is believed to repair damaged tissue and to help keep skin healthy. Natural medications: Natural and homeopathic medications have been reported to reduce these effect. Arnica gel: It is made from Arnica Montana as its main active ingredient. Other ingredients that are added to make the gel are pure water, carbomer, alcohol, sodium hydroxide, and silicone oil. The use of topical arnica can prevent and speed up the resolution of local inflammation. Recommended application is two to three times a day.

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Table 21.3 Complications related to Radiesse: personal data based on 547 treatments Complications

Incidence

Events

Diagnosis

Treatment

Chapter

Immediate hypersensitivity reaction

Rare

3

Edema, severe and disfiguring swelling

Systemic steroids

21.4

Edema

Common

114

Moderate swelling

Ice, Arnica gel, pineapple stem extract 200 mg

21.5

Eritema and pruritus

Common

118

Redness

Arnica gel, pineapple stem extract 200 mg

21.5

Indurations

Common

28

Hardness

2 days massage

21.6

Ecchymosis and hematoma

Common

39

Extravasation of blood under the skin, bruising

Ice, topical arnica

21.7

Bacterial infections

Rare

1

Heat, redness, swelling, and pain

Amoxicillin associated with clavulanic acid 1 mg x 2 for 5 days,

21.8

Biofilm

Very rare

0

Low-grade chronic infection

Clarithromycin (500 mg x 2 die) for 6 weeks, hyaluronidase incision and drainage

21.9

Herpes simplex

Rare

2

Typical lip rash

Topical Acyclovir, oral Valacyclovir: 500 mg x 2 die or oral Acyclovir: 200 mg x 5 die

21.10

Herpes Zoster

Rare

1

Pain in the affected dermatome. followed by skin rash

Topical Acyclovir, oral Valacyclovir: 1000 mg x 3 die or oral Acyclovir: 800 mg x 5 die

21.10

Overcorrection

Common

18

Excess of filler injected

Wait for Radiesse resorption

Migration

Uncommon

5

Spontaneous displacement of the material away from the site of injection

Wait for Radiesse resorption, surgical removal

21.12

Chronic inflammation

Uncommon

1

Chronic inflammatory reaction with erythema and swelling

Clarithromycin, incision and drainage

21.13

Foreign body granulomas

Rare

4

Chronic inflammatory nodules

Triamcinolone 1 mg local injection, incision and drainage

21.14

White discoloration (‘‘xantelasmic’’ effect)

Rare

1

White or yellow lumps or worms

Triamcinolone 1 mg local injection, surgical removal

21.15

Skin necrosis

Very rare

0

Interruption of the vascular supply: pain, discoloration

Kept warm 2% nitroglycerine paste

21.16

Fig. 21.1 C.N., 22-year-old. Pretreatment image

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Fig. 21.2 C.N., edema immediately after breast injection of macrofiller

Fig. 21.3 a, b Icing the treated parts before and after the treatment helps to reduce edema

Betamethason: Usually, no treatment with steroids is needed. Only when big edema appears after filler injection (for example, after full facial treatment or calf enhancement), it is recommended the somministration of Betamethason 2 mg one tablet 2 times a day for 3 days.

21.7

Induration

Induration at injection site is a frequent but transient adverse effect of filler.

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Fig. 21.4 Application of oxygen with solution is useful

Fig. 21.6 Hyaluronic acid is distributed along the lips

Fig. 21.5 C.C., 10 min after the treatment with radiesse. An evident redness of the face can be observed

Fig. 21.7 A strong massage of the cheek is performed immediately after injection of calcium hydroxylapatite

Treatment massage: Early treatment consists in a local massage. If induration interests the naso-labial area, it is usually a massage from top to bottom along the wrinkle pressing on the maxillary bone. If induration interests lips area, it is possible to practice a bimanual massage by squeezing the product between the fingers. In this way, the HA is distributed along the lips (Fig. 21.6). If induration interests the zygomatic area, the massage is not recommended, because there is the risk of moving the high density HA down in the cheek [10]. If the patient complains about an induration at the injection site after injection of macrofiller, early treatment consists in a local massage that has to be continued for 2 weeks after treatment.

21.8

Ecchymosis and Hematoma

Ecchymosis is an almost invariably minor side effect and is generally limited to around the injection site. If a patient is on some form of blood thinning medication or some vitamin supplements (including vitamin E, ginseng, garlic, ginger, gingko, etc.), bruising can be quite deep. In some instances, ecchymosis covers the majority of the facial anatomy below the injection site and may require several weeks to fully resolve. One should be cautious, if there is a history of bleeding disorders or ingestion of aspirin, warfarin, ginseng, vitamin E, or herbal supplements with anticoagulant effects. A history of bleeding disorders or ingestion of aspirin, warfarin, ginseng, vitamin E, or herbal supplements with

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Fig. 21.8 a–g Ecchymosis. A cosmetic cream application can guarantee a good camouflage of ecchymosis

anticoagulant effects is an absolute contraindications for treatment with macrofillers. Hematoma is an uncommon occurrence, but it can result from the inadvertent laceration of small facial blood vessels. Because of the supratrochlear artery and anastomosing blood vessels in the glabellar region, there may be a higher risk of hematoma when injecting frown lines. Treatment: To prevent ecchymosis icing the areas before and immediately after injection is helpful. A cosmetic cream application can guarantee a good camouflage of ecchymosis (Fig. 21.8a–g). The use of topical Arnica can prevent and speed the resolution of local ecchymosis. In the case of important hematomas, drainage is necessary. With a n11 blade, make a small incision in the hematoma area which can be drained with compression. In case of hematoma in breast enhancement, it is mandatory to evaluate the surgical drainage of the hematoma and the placement of a drainage tube.

21.9

Bacterial Infections

During filler injections, micro-organisms can be introduced into the dermal tissues. The incidence of infections appears to be low if the procedure is performed in an appropriate setting with proper sterile techniques. It’s essential to disinfect the injection area with an alcoholic solution. Do not re-use the syringe, because sterility of the device cannot be guaranteed in this case. Local infection is characterized by local rubor, tumor, calor, and dolor (heat, redness, swelling, and pain) and sometimes can be accompanied by fever [11–17]. Staphylococcus aureus is the most common organism responsible for facial filler and macrofiller infections (Fig. 21.9a, b). Treatment: Acute infections are treated with oral antibiotics. The antibiotic most commonly used for skin infections is amoxicillin associated with clavulanic acid (1 g 9 3 die for 6 days).

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Fig. 21.11 Injection of a small amount of local anesthesia

Fig. 21.9 a, b Staphylococcus aureus is often responsible of infections

Fig. 21.10 In case of infection a culture test of the infected material is useful

In case of infection (Fig. 21.10), it is useful to do a culture test of the infected material. The procedure for aspiration is to inject a small amount of local anesthesia (Fig. 21.11), to insert a 23-gauge needle (Fig. 21.12) and to aspire the content of the infected area (Fig. 21.13a, b).

Fig. 21.12 23-gauge needle insertion

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If infection occurs in an area injected with macrofiller, the surgical scar is opened, and a small amount of previously injected macrofiller is extracted and sent to the laboratory (Figs. 21.14–21.17). Prevention: Because injection of macrofiller is quite similar to a surgical intervention, we suggest to all patients to take amoxicillin 875 mg plus clavulanic acid 125 mg twice daily from the day before to 5 days after the treatment (Figs. 21.11–21.17).

Fig. 21.14 V.N., 31-year-old female. Ultrasound image of left breast performed immediately after treatment shows a single cavity of NASHA-based injected between the deep fascia of the breast and the pectoralis muscle Fig. 21.13 a, b Aspiration of the content of the infected area

Fig. 21.15 Two days after injection the patient developed a painful swelling in the left breast with pyrexia of 38.4 C

Fig. 21.16 Ultrasonography examination showed a enlargement of the macrolane deposit in the left breast

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Treatment: Inflammatory nodules caused by biofilms should be treated with antibiotics for several weeks, and often more than one antibiotic is needed. Clarithromycin (500 mg x 2 die) for 6 weeks has been suggested on early infections that are presumed to have been caused by biofilm activation. After the patient has begun antimicrobial therapy, evacuation of the filler by incision and drainage or surgery or the injection of hyaluronidase will often be required to clear and prevent recurrence of the infection and biofilm.

21.11

Herpes Reactivation

Fig. 21.17 Microbiological culture of the gel was negative, and the infection resolved following antibiotic treatment with amoxicillin 875 mg plus clavulanic acid 125 mg twice daily for 10 days. It was not necessary to remove the implanted material

Acid, macrofillers and hyaluronic and calcium hydroxylapatite injections can cause herpes reactivation (Fig. 21.18a, b) [19]. Prophylactic antiviral should be prescribed if there is a history of herpes virus infections [2, 4]. Macrofiller injection should be avoided, if there is a history of herpes zoster virus infections in the area to treat.

21.10

21.11.1 Herpes Zoster

Biofilm

If the infection is not treated with relevant antibiotics (but instead steroids or large doses of NSAIDs), the bacteria form a biofilm, which gives rise to a low-grade chronic infection that is resistant to antibiotics. These biofilms are self-sustaining colonies that have reduced metabolism allowing antibiotic resistance and genetic alterations that protect them from the immune system. In the early stage of biofilm development, the culture is negative. Bacteria from dental work, trauma, steroid injection, or the reinjection of filler over a previously treated site may activate biofilms, creating an acute purulent infection or a subacute granulomatous reaction [18]. Fig. 21.18 a, b Both hyaluronic acid and calcium hydroxylapatite injections can cause herpes reactivation

Diagnosis: The earliest symptom of herpes zoster is pain in the affected dermatome, associated with sensations that are often described as tingling, aching, stinging or throbbing. After one to three days (but sometimes as long as three weeks) the characteristic skin rash appears. Usually, hives can be observed in the affected dermatome. Later the skin forms small blisters filled with serum exudate (vesicular rash). The painful vesicles then become gray or darkened, and crusts can be observed within seven to ten days; when the crusts fall off, the skin heals. Despite that, scarring and discolored skin usually remain for many weeks.

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Pitfall: Be careful if a patient come back in office the day after treatment complaining pain in a specific dermatome. If this dermatome was treated with injection, it is useful to prescribe oral Valacyclovir or Aciclovir. In fact, the characteristic skin rash appears only after one to three days (but sometimes as long as three weeks). Treatment: The treatment includes topical or systemic medications. Topical acyclovir 5%: One application every 2 hours. Oral Valacyclovir: 1000 mg x 3 die or Oral Aciclovir: 800 mg x 5 die (every 4 hours except night). For recurrent episodes, treatment should be seven days. For initial episodes, which can be more severe, treatment may have to be extended to ten days. Therapy should begin as soon as possible. Therapy should begin at the first sign of herpes labialis (such as tingling, itching or burning). Profilaxis: Prophylactic antiviral should be prescribed if there is a history of herpes virus infections. Oral Valacyclovir: 1000 mg x 3 die or Oral Aciclovir: 800 mg x 5 die (every 4 hours except night) the day before treatment and 4 days after the treatment Complementary medicines such as echinacea, eleutherococcus and uncaria, which have precisely the ability to stimulate or modulate the immune system, and because of these peculiar properties, can be used prophylactically.

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Profilaxis: prophylactic antiviral should be prescribed if there is a history of herpes virus infections. Valaciclovir 500 mg twice daily or Oral Aciclovir: 200 mg x 5 die (every 4 hours except night) the day before treatment and 4 days after the treatment. Complementary medicines such as echinacea, eleutherococcus and uncaria can be used prophylactically, because they specifically stimulate and modulate the immune system.

21.12

Overcorrection

Overcorrection consists of injecting excess filler agent. This can create facial asymmetry and patient dissatisfaction (Fig. 21.19) [20]. Treatment: An energetic massage is generally sufficient to flatten and disperse excessive, superficial, or unaesthetic HA derivative placement, although overfilling can be treated by hyaluronidase injection. Hyaluronidase is effective for treating bumps and over injection of HA (Fig. 21.20a– c). Hyaluronidase dissolves the peptide bonds in long-chain proteins within HA, increasing the mobility of the injected viscoelastic material and allowing it to disperse more freely as oligoproteins through the tissue.

21.11.2 Herpes Labialis Diagnosis: Herpes simplex labialis can be easily diagnosed by the typical lip rash, with hives and, later, small blisters filled with serum exudate (vesicular rash). Treatment: Topical acyclovir 5%: one application every 2 hours.Valaciclovir 500 mg: twice daily, or Oral Aciclovir: 200 mg x 5 die (every 4 hours except night). For recurrent episodes, treatment should last seven days. For initial episodes, which can be more severe, treatment might be extended to ten days. Therapy should begin as soon as possible. Therapy should start at the first sign of herpes labialis (such as tingling, itching or burning).

Fig. 21.19 Injecting an excess of filler agent can cause overcorrection and asymmetry

Fig. 21.20 a2c A injection of hyluranidase is generally sufficient to flatten and disperse excessive, superficial, or unaesthetic hyaluronic acid

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Fig. 21.21 a–e Hyaluronidase is effective for treating bumps and displacement of hyaluronic acid

Calcium Hydroxilapatite cannot be dissolved: it takes at least one year for the product to dissolve spontaneously.

21.13

Migration

Filler migration consists of spontaneous displacement of the material away from the site of injection. This complication can create imperfections and asymmetry or can be debilitating if the filler migrates to sensitive areas. Treatment: Hyaluronidase is effective for treating bumps and displacement of HA (Fig. 21.21a–e). When dealing with macrofillers both hyaluronidase and direct aspiration are effective for treating bumps and displacement of macrofiller (Figs. 21.22, 21.23, 21.24, 21.25a, b, 21.26).

Fig. 21.22 M.N., 32-year-old, showing a bump 3 weeks after treatment with Macrolane

Fig. 21.23 Ultrasonography image showing the large dislocation of Macrolane in subcutaneous tissue (1 cm to 2 cm)

Fig. 21.24 Direct aspiration of Macrolane with a 15 cm 12 g spatula tip cannula

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Fig. 21.25 a, b Ultrasonography image of the aspiration

(a)

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(b)

Fig. 21.27 Inflammatory malar area 13 months after injection of hyaluronic acid Fig. 21.26 M.N. immediately after the treatment. The bump has disappeared

Buchanan [21] reports anterior filler displacement Fig 21.26 following injection of calcium hydroxylapatite gel (Radiesse) for anophthalmic enophthalmos correction. Four cases of anterior filler displacement and expansion following injection of calcium hydroxylapatite were identified. Two patients required transconjunctival excision of the filler and infiltrated orbital fat. Anecdotic reports of lid displacement during zygomatic augmentation are present on the web, with one patient claiming that surgical removal was needed.

21.14

Inflammation

Inflammatory reaction, such as swelling, tenderness or redness, are usually transient and are easily managed with the application of ice (Fig. 21.1a, b). However, filler agents can occasionally elicit a chronic inflammation of subcutaneous tissues. Chronic inflammation and perhaps lymphatic obstruction caused by the filler materials can lead to scar

Fig. 21.28 An ultrasound analysis is performed

formation. Particularly, severe fibrotic reactions have been reported with liquid silicone. When erythema and swelling or induration occurs weeks after filler injection, one should consider atypical mycobacterial and biofilm development.

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Malar bone

Fig. 21.29 Ultrasound analysis: hyaluronic acid is collected at the level of the bump (hy)

Fig. 21.30 The bump is dissolved by injection of hyaluronidase

Fig. 21.31 Post-treatment ultrasound: the hyaluronic acid and the bump are dissolved

Fig. 21.32 A.L., 44-year-old. An inflammatory nodule is observed in the right breast

Fig. 21.33 A.L., ultrasound image demonstrating the presence of the nodule in the subcutaneous tissue

A biofilm occurs when bacteria adhere to a matrix made of extracellular polysaccharides. The biofilm is a three-dimensional structure containing one or more species of bacteria. Bacteria that live in the biofilm environment have been shown to be more resistant to antimicrobial therapy [22–24]. Treatment: Inflammatory nodules caused by biofilms should be treated with antibiotics for several weeks, and often more than one antibiotic is needed. Clarithromycin or Minocycline for 6 weeks have been suggested on early infections that are presumed to have been caused by biofilm activation. After the patient has begun antimicrobial therapy, removal of the filler by hyaluronidase injection, incision and drainage or surgery or the injection of hyaluronidase will often be required to clear and prevent recurrence of the infection and biofilm (Figs. 21.27, 21.28, 21.29, 21.30, 21.31, 21.32, 21.33, 21.34, 21.35, 21.36).

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Fig. 21.34 Injection of hyaluronidase

Fig. 21.36 Ultrasound performed 2 weeks after the injection of hyaluronidase. The nodule has disappeared

Fig. 21.35 Clinical resolution of the nodule

21.15

Foreign-Body Granulomas

Foreign-body granulomas are considered rare complications of HA and Macrofillers injections that tend to develop several months to years after injection. Histopathologically, a granulomatous foreign-body reaction involves the dermis, with abundant multinucleated giant cells surrounding an extracellular basophilic amorphous material. Some authors have proposed a grading system classification of foreign-body reactions induced by injected fillers into four categories: grade I, slight reaction with a few inflammatory cells; grade II, clear inflammatory reaction with one or two giant cells; grade III, fibrous tissue with inflammatory cells, lymphocytes, and giant cells; and grade IV, granuloma with encapsulated implants and clear foreign-body reaction [25, 26]. Concerning the injection of calcium hydroxylapatite nodules and granulomas has been described as complications of Radiesse. Lip nodules are relatively frequent because of product crowding and are associated with this

specific area of injection. For this reason, Radiesse is not suggested for lip augmentation. Nodules and granulomas in other areas are due to excessive immunological reaction and are not frequent. Both nodules and granulomas can be treated with triamcinolone local injection on the first occurrence or through a small incision in persistent cases [27–29] (Figs. 21.37, 21.38, 21.39, 21.40a, b, 21.41, 21.42, 21.43, 21.44, 21.45a, b, 21.46).

Fig. 21.37 M.N., 57-year-old, photo taken 1 month after the treatment with radiesse

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Fig. 21.38 A small lump of radiesse is observed in the subcutis

Fig. 21.40 a, b Strong massage of the area

Fig. 21.39 Injection of 0.3 cc of solution of Desametasone (10 mg/ mL)

Daley [27] studied 8 patients with foreign-body granulomas containing the characteristic microscopic appearance of hydroxylapatite microspheres. Analysis of the microspheres of 1 case was carried out by energy dispersive X-ray microanalysis to confirm the calcium and phosphorus content. This study concludes that oral Radiesse-induced nodules occur more often in older women, most commonly in the lips and the mandibular labial vestibule. Sadick [28] reported complications occurred on 113 patients undergoing Radiesse fillers for aesthetic enhancement. There were only 7 reported minor adverse events. Two patients experienced submucosal nodules of the lip, which were successfully treated with triamcinolone injection (1 mg injected into each lesion).

Fig. 21.41 C.S., 63-year-old, small lump in the left cheek 5 weeks after injection of Radiesse

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Fig. 21.42 The lump is clearly palpable

idoxyapatite

Fig. 21.45 a, b Strong massage

Fig. 21.43 Ultrasound image of the lump of radiesse

Fig. 21.44 Injection of 1 cc of solution of desametasone (10 mg/mL)

Fig. 21.46 Ultrasound image 1 week after the treatment. The complication is resolved

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Treatment: Intralesional steroid injections have been widely used for foreign-body granulomas caused by implants. Although this treatment is effective, it should be used judiciously and in weak concentrations (Desametasone no greater than 10 mg/mL) because it can result in adjacent skin atrophy and erythema. It may require multiple injections over time which can not only increase patient anxiety, but also the risk of an adverse effect.

21.16

Discoloration

In rare cases, a bluish discoloration (Tindall effect) might occur after HA filler injection. This complication is thought to be caused by injections made too superficially. The patient should be reassured because this adverse effect disappears with time. Tyndall effects (blue lumps or worms associated with superficial placement of HA) may be seen more frequently with the novice injector (Fig. 21.47). Lumps occur more often in tear troughs, lips, and lids. In rare cases, a white discoloration (‘‘xantelasmic’’ effect) might occur when injecting calcium hydroxylapatite, most probably due to too superficial injections. Also in this case, patients can be reassured about a spontaneous disappearance of this adverse event. Xantelasmic effect (white or yellow lumps or worms associated with superficial placement of radiesse) may be seen more frequent in tear troughs and lids (Fig. 21.48a, b). Treatment: A puncture with a No. 11 blade with expression of gel, the injection of hyaluronidase to dissolve the filler, and massage will help reverse some of the undesired injected HA filler placement. With calcium hydroxylapatite, the spontaneous dissolution of the product should be waited.

Fig. 21.47 Tyndall effects in naso-labial fold after hyaluronic acid injection

Fig. 21.48 a, b R.B., 47-year-old, 9 months after injection of Radiesse in the tear troughs. A white discolaration is still evident

21.17

Skin Necrosis

Skin necrosis is one of the most serious complications of fillers. The pathogenesis is unknown; possibly due to interruption of the vascular supply to the area by direct injury to the vasculature, compression of vasculature or direct obstruction of the vessel by the filler. There are two ‘‘danger zones’’ that are particularly vulnerable to tissue necrosis following filler injection: the glabella and the nasal ala. The glabella is the most common site of necrosis reported after filler injection. Inadvertent injection of fillers into the supratrochlear artery may cause pain, skin discoloration and skin necrosis. The nasal ala is another reported site of necrosis following filler injection. The nasal ala is supplied by the alar branch of angular artery. Inadvertent injection of fillers into the angular artery in the nasolabial folds area can cause necrosis of the nasal ala, which has a limited collateral circulation [30–38]. Treatment: Several treatments have been suggested: massage to disrupt the filler embolus, warm compression, nitroglycerin paste, prostaglandin E1 and injection of hyaluronidase into the area. Arterial occlusion typically becomes apparent immediately. Injection should be stopped and aspiration attempted to reduce the blanching. The area should be kept warm and compression applied to increase vasodilatation. Additionally, 2 % nitroglycerine paste can be considered to cause further vasodilatation. In this situation, injection of hyaluronidase may offer some benefit.

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Venous obstruction and occlusion may occur when larger volumes are injected into a small area and will present with prolonged pain and swelling and a dark discoloration. Nitroglycerin paste and warm compresses should also be used in this situation. Again, hyaluronidase can be injected locally.

21.18

Rapid Resorption

The organic shelf life of natural HA in the skin is 1–2 days. In the preparation, most of the HA dermal fillers are chemically modified with cross-linkers to improve the stabilization and the permanence in the implant site. The principal cross-linker molecule is the ButaneDiol Diglicidil Etere (BDDE). During the cross-linking, the BDDE binds mainly through strong covalent bonds in an irreversible reaction. When HA is totally absorbed, it turns into water and carbon dioxide and disappears without a trace. The resorption times are variable and depend on the type of HA used, on the individual ability to degrade and on the lifestyle of the patient. The molecular weight of the preparation of HA affects the timing of resorption, and in fact, the higher the molecular weight the slower the process of resorption. Several factors such as stress, smoking, diet, lifestyle and exposure to natural or artificial UV light can increase the production of free radicals that cause ‘‘oxidative stress’’, a process that can trigger cell damage and decrease the duration of soft-lifting sponsored by the HA fillers. One tablet of antioxidant supplement is recommended 2 times a day for 15 days, then 1 times for 60 days, and should be composed by:

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• Ascorbic acid 350 mg: The properties of ascorbic acid are due to its ability to reduce reactions. Ascorbic acid is a cofactor of several enzymes that catalyze metabolic reactions. It also intervenes in the processes of cellular defense, promoting the elimination of oxygen free radicals by donating an electron. Finally, vitamin C promotes the reduction of folic acid in its coenzyme forms and the intestinal absorption of iron. • Polygonum Cuspidatum 150 mg contains Resveratrol, a potent antioxidant polyphenolic compound that is found naturally in many foods of plant origin, such as red grapes and peanuts. It is found also in some plants, like polygonum cuspidatum, or Japanese knotweed. Resveratrol inhibits oxidation of LDL cholesterol, platelet aggregation, reduces the level of cholesterol and triglycerides and induces a vasodilator effect of the arterial system. • Astaxanthin 15 mg comes from the microalgae haematococcus pluvialis, found in abundance in arctic marine environments. It’s a natural carotenoid (any of a class of yellow to red pigments, including the carotenes and the xanthophylls). It is the most potent of all of the carotenoids—in fact it is 10 times stronger than beta-carotene and 100 times stronger than Vitamin E. Provides wrinkle reduction by internal supplementation and reduces hyperpigmentation (better known as ‘‘age spots’’). • Coenzyme Q10 10 mg: it is a natural antioxidant in the body that helps the cells grow and protects them from the ravages of cancer. A drop in natural levels of coenzyme Q10 that occurs in our later years is thought to contribute to aging skin.

Post 1 week

Fig. 21.49 A.C., 53-year-old, clinical photo before treatment that will be performed without ultrasonography guidance

Fig. 21.50 A.C. ultrasonography image acquired one week after the treatment. The thickness of Macrolane is 2.11 cm

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Post 6 months

Post second treatment

Fig. 21.51 A.C. ultrasonography image acquired 6 months after the treatment. The thickness of Macrolane is 0.98 cm

Fig. 21.53 In order to inject material in the correct plane, first touch up is performed under ultrasound guidance. Ultrasound image demonstrates the submuscular location of Macrolane. The thickness of Macrolane is 1.87 cm

Post 1 year

muscle

submuscolar macrolane one year after injection

Fig. 21.52 A.C. follow-up ultrasound image 12 months after treatment. It demonstrates a great resorption, with a small amount (thickness 0.48) of Macrolane dislocated into the breast parenchyma

•

Ginko Biloba 150 mg: Contains flavonoids that neutralize free radicals. It also has a positive effect on the capillaries, decreasing permeability and increasing the tone of the vessel wall. For these tasks, the ginkgo leaves and their extracts are used in disorders of peripheral circulation (spider veins or varicose veins, cellulite, water retention problems, intermittent claudication). It is recommended to take one tablet 2 times a day for 30 days. Talking about treatment with macrofiller, as it is quite expansive, it is mandatory to organize to schedule a follow-

Fig. 21.54 A.C. ultrasound image 24 months after the first treatment, and 11 months after the first touch up. The thickness of Macrolane is 1.22 cm the breast. Two advantages are otained by this new location of macrofiller: a lesser resorption and a better visualization of mammary gland

up protocol. In this protocol, it is necessary to evaluate the thickness of macrofiller by ultrasound measurements. In case of rapid resorption (Figs. 21.49, 21.50, 21.51, 21.52, 21.53, 21.54), a free of charge treatment should be offered to the patient.

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21.19

243

(a)

Radiological Problems

(b)

The injection of Macrolane into the breast can determine many problems in terms of evaluation of the gland by ultrasonography and mammography. In particular, the injection of macrofiller superficially to the deep fascia increased the risk of displacement into the gland tissue. Such displacement can create problems related to the radiological evaluation of patients. The appearance of NASHA-based gel in the gland tissue may mimic a cyst on mammography and sonography and, like in breast implants, it may reduce the visualization of the glandular tissue and the diagnosis of cancer. Our experience suggested that it is important to avoid the multiple-injection/tunneling technique and superficial placement to the deep fascia of the breast (Figs. 21.55, 21.56a, b,).

Fig. 21.56 A.C. mammographic image 24 months after the first treatment, and 11 months after the first touch up. The Macrolane is located behind the muscle, and does not disturb breast cancer diagnosis

21.19.1 Radiographic Problems Due to Radiesse A study conducted by Carruthers et al. [39] in 2008 assessed the radiographic appearance produced by radiesse following augmentation to correct the nasolabial folds or facial wasting associated with human immunodeficiency virus lipoatrophy. A total of 58 patients, with either lipoatrophy or pronounced nasolabial folds, were treated with CaHA. Radiographic (X-ray) and computed tomographic (CT) imaging studies were conducted pre and post treatment in most patients. This study shows no overt radiographic safety concerns. CaHA is unlikely to be confused with conventional abnormal and adverse radiographic findings. The product is not always visible on X-ray. Although usually visible on CT scans, its appearance is distinct from surrounding bony structures and does not interfere with normal analysis. In addition, the product does not obscure underlying structures on CT scans.

21.20

Fig. 21.55 A.C., mammography image one year after the treatment: the Macrolane is located into breast gland

Incorrect Placement of Macrofillers

The use of ultrasonography guidance is very useful to place the macrofiller in the correct place. Despite of that, many surgeons did not use this valid auxilium, and the macrofiller was placed superficially.

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(b)

Fig. 21.57 a, b L.N., 39-year-old. Photo taken 3 weeks after injection of Macrolane performed in another office without ultrasound guidance. Macrolane in located in the subcutaneous plane in the right breast

Fig. 21.58 a–c A big lump of Macrolane is observed by ultrasound. The diameter is 2.71 cm

(a)

(b)

Fig. 21.59 a, b L.N. in the left breast Macrolane is located in the subcutaneous and the mammary tissue

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Fig. 21.60 a–c The ultrasound shows a mass of 2.49 cm of diameter in the left breast

Fig. 21.61 The Macrolane is treated by injection of hyaluronidase

Fig. 21.62 Ultrasound one week after the first injection of hyaluronidase in the right breast

Fig. 21.63 Ultrasound one week after the second injection of hyaluronidase, two weeks after the first injection in the right breast. The Macrolane is reabsorbed

Fig. 21.64 Ultrasound one week after the first injection of hyaluronidase in the left breast

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Fig. 21.65 Ultrasound one week after the second injection of hyaluronidase, two week after the first injection in the left breast. The Macrolane is reabsorbed

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Fig. 21.66 L.N. one month after the second injection of hyaluronidase. The lumps have disappeared

Correction: If macrofiller causes bumps or is palpable, it should be necessary to remove it by hyaluronidase injection or direct aspiration. (Figs. 21.57a, b, 21.58a–c, 21.59a, b, 21.60a–c, 21.61, 21.62, 21.63, 21.64, 21.65, 21.66, 21.67, 21.68a, b, 21.69, 21.70a, b, 21.71, 21.72a, b, 21.73a, b, 21.74a, b, 21.75)

21.21

Fig. 21.67 L.N immediately after the reinjection of Macrolane with ultrasound guidance in the submuscular plane

(a)

Defensive Aesthetic Medicine

Defensive medicine is the application of measures aimed primarily to protect the professional against possible malpractice liability [40]. These measures are applied in order to: a) reduce adverse events b) dissuade patients from filing medical malpractice claims

(b) left breast

muscle

macrolane

Fig. 21.68 a, b Ultrasound image showing the result of the second treatment

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(a)

(b)

Fig. 21.69 C.R., 42-year-old. She had a superficial placement of Macrolane in another office. She required Macrolane removal because of pain and hardness. Image before removal

Fig. 21.70 a, b Ultrasound image showing the location of Macrolane anteriorly the deep fascia of the breast

Fig. 21.71 The removal is performed under ultrasound guidance

c) register every material injected and archive traceability labels in order to demonstrate what was injected d) provide documented evidence that the practitioner is practicing according to the standard of care In particular, the appliance of Standard for quality assurance (for example, AQ standard, Chap. 22) is very useful. AQ standard requires that the offices and the doctors

set out clear procedures for all medical processes – usually these are set out in manuals and reinforced through staff training. Regular audits are carried out to ensure that procedures are being carried out every time according to standards. In this way, if in the future legal action is initiated, legal responsibility can be pre-empted. However, to reduce adverse outcomes, it’s important to remember ten rules: 1) When you observe a lump of hyaluronic acid or macrofiller in one of your patient that you injected more than 2 weeks before, remove it immediately. In fact, a lump of hyaluronic acid is not a cancer, but it can spread as a metastasis from your clinic to the clinic of one of your competitors. 2) When you observe a lump of hyaluronic acid or macrofiller in a patient that was injected by one of your competitors, remove it immediately. Don’t charge any cost for this treatment and don’t criticize your

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(a)

(a)

(b)

(b)

Fig. 21.72 a, b Ultrasound image showing the cannula inserted in the wrong plane. In fact, the cannula is beneath the deep fascia of the breast, and it is not possible to aspire Macrolane

Fig. 21.74 a, b The Macrolane is totally removed

Fig. 21.73 a, b The cannula is removed and is reinserted in the area filled by Macrolane

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with warm compression, nitroglycerin paste application and hyaluronidase injection. 10) If you are doing a full-face approach, remember the aim of aesthetic medicine: to change a part of the face of the body through medical techniques in order to increase beauty. Because beauty is harmony of form and proportions, it is important to not consider full-face approach as injecting an enormous amount of fillers and botulin toxin in the face of the patient. This in fact results in an innatural and not improved aspect.

References

Fig. 21.75 Ultrasound image showing the removal of Macrolane

3)

4) 5)

6)

7)

8)

9)

competitor. Anyone of us can have complications, and criticism is not useful! Do not inject in areas with anatomical alterations due to previous trauma or surgical intervention. Scarring often induces a displacement of the noble structures and can lead to vessel perforation or nerve section. It can also induce retracting scars that can cause asymmetry and unequal filling of the part treated. Do not inject in areas that lack sufficient blood supply or that have an infection or inflammation. Do not inject in area which has been previously treated with liquid silicone or other permanent fillers because new injection could lead to inflammation or infection of the old implants. In case of history of herpes simplex or herpes zoster, give to the patient a prophylactic antiviral oral treatment. If a patient comes back to the clinic the day after treatment complaining pain in a specific dermatome treated with injection, it is useful to prescribe antiviral oral treatment. In fact, the characteristic skin rash of herpes zoster appears only after one to three days (but sometimes as long as three weeks). If a patient comes back to the clinic one day after treatment complaining increasing heat, redness, swelling and pain in the area treated with injection, in particular if associated with fever, it is necessary to prescribe antibiotic oral treatment. In fact, the bacterial infection appears one to two days after treatment. If you are injecting zones that are particularly vulnerable to tissue necrosis (gabella, nasal ala) and you suspect arterial occlusion, stop immediately injection, try a massage to disrupt the filler embolus, together

1. Tezel A, Fredrickson GH (2008) The science of hyaluronic acid dermal fillers. J Cosmet Laser Ther 10:35–42 2. Lupo MP (2006) Hyaluronic acid fillers in facial rejuvenation. Semin Cutan Med Surg 25:122–126 3. Andre P (2004) Hyaluronic acid and its use as a ‘‘rejuvenation’’ agent in cosmetic dermatology. Semin Cutan Med Surg 23:218–222 4. Winslow C (2009) The management of dermal filler complications. Facial Plast Surg 25:324–328 5. Niatmu J (2009) Complications in Fillers and Botox. Oral Maxfac Surg Clin 21(1):13–21 6. Larsen N, Pollack CT, Reiner K, Leshchiner E, Balazs EA (1993) Hylan gel biomaterial: dermal and immunologic compatibility. J Biomed Mater Res 27:1129–1134 7. Kajimoto Y, Rosenberg ME, Kytta J et al (1995) Anaphylactoid skin reactions after intravenous regional anesthesia using 0.5 % prilocaine with or without preservative—double-blind study. Acta Anesthesiol Scand 39:782–784 8. Pollack SV (1999) Some new injectable dermal filler materials: hylaform, restylane and artecoll. J Cutan Med Surg 4:527–532 9. Graivier MH et al (2007) Calcium hydroxylapatite (radiesse) for correction of the mid- and lower face: consensus recommendations. Plastic Reconst Surg 33:55–66S 10. Gladstone HB, Cohen JL (2007) Adverse effects when injecting facial fillers. Semin Cutan Med Surg 26:34–39 11. Chaput B, Eburdery H, Crouzet C, Grolleau JL, Chavoin JP, Garrido I (2012) Macrolane: a severe case of calf cellulitis after modeling injection. Ann Chir Plast Esthet 57(1):83–86. 12. McCleave MJ (2010) Is breast augmentation using hyaluronic acid safe? Aesthetic Plast Surg 34(1):65–68. 13. Goisis M, Savoldi A, Guareschi M (2011) Is hyaluronic acid gel a good option for breast augmentation? Aesthetic Plast Surg 35(1):134–136 14. McCleave MJ, Grover R, Jones BM (2010) Breast enhancement using Macrolane: a report of complications in three patients and a review of this new product. J Plast Reconstr Aesthet Surg. doi: 10.1016/j.bjps.2010.02.021 15. Goisis M, Yoshimura K, Heden P (2011) Breast augmentation after macrolane filler injection. Aesthetic Plast Surg 35(4):684–686 16. Goisis M, Casale A, Guareschi M (2011) Hyaluronic acid breast injections: difficulties for mammographic monitoring. Cir Esp 89(2):125 17. Goisis M (2011) Macrolane complications after breast augmentantion: treatment and prevention. Eur J Plastic Surg 35(1):65–71

250 18. Narins RS, Coleman WP, Glogau RG (2009) Recommendations and treatment options for nodules and other filler complications. Dermatol Surg 35(suppl 2):1667–1671 19. Sires B, Laukaitis S, Whitehouse P (2008) Radiesse-induced herpes zoster. Ophthal Plast Reconstr Surg 24(3):218–219 20. Sclafani AP, Fagien S (2009) Treatment of injectable soft tissue filler complications. Dermatol Surg 35(suppl 2):1672–1678 21. Buchanan AG, Holds JB, Vagefi MR, Bidar M, McCann JD, Anderson RL (2012) Anterior filler displacement following injection of calcium hydroxylapatite gel (radiesse) for anophthalmic orbital volume augmentation. Ophthal Plast Reconstr Surg 28(5):335–337 22. Judodihardjo H, Dykes P (2008) Objective and subjective measurements of cutaneous inflammation after a novel hyaluronic acid injection. Dermatol Surg 34(suppl 1):S110–S114 23. Rapaport MJ, Vinnik C, Zarem H (1996) Injectable silicone: cause of facial nodules, cellulitis, ulceration, and migration. Aesthetic Plast Surg 20:267–276 24. Mertz PM (2003) Cutaneous biofilms: friend or foe? Wounds 15:129–132 25. Lupton JR, Alster TS (2000) Cutaneous hypersensitivity reaction to injectable hyaluronic acid gel. Dermatol Surg 26:135–137 26. Lowe NJ, Maxwell CA, Patnaik R (2005) Adverse reactions to dermal fillers: review. Dermatol Surg 31:1616–1625 27. Daley T, Damm DD, Haden JA, Kolodychak MT (2012) Oral lesions associated with injected hydroxylapatite cosmetic filler. Oral Surg Oral Med Oral Pathol Oral Radiol 114(1):107–111 28. Sadick N et al (2007) A Multicenter, 47-month study of safety and efficacy of calcium hydroxylapatite for soft tissue augmentation of nasolabial folds and other areas of the face. Dermatol Surg 33:S122–S127 29. Jacovella PF (2006) Calcium hydroxylapatite (radiesse): indications, technique and results. Clin Plast Surg 33:511

E. Stella et al. 30. Cohen JL (2008) Understanding, avoiding, and managing dermal filler complications. Dermatol Surg 34(Suppl. 1):S92e9 31. Weinberg MJ, Solish N (2009) Complications of hyaluronic acid fillers. Facial Plast Sur 25:324e8 32. Park TH, Seo SW, Kim JK, Chang CH (2011) Clinical experience with hyaluronic acid-filler complications. J Plast Reconstr Aesthet Surg 64(7):892–896 33. Cox SE (2009) Clinical experience with filler complications. Dermatol Surg 35(Suppl. 2):16616 34. Alam M, Dover JS (2007) Management of complications and sequelae with temporary injectable fillers. Plast Reconstr Surg 120:98Se105S 35. Glaich AS, Cohen JL, Goldberg LH (2006) Injection necrosis of the glabella: protocol for prevention and treatment after use of dermal fillers. Dermatol Surg 32:276e81 36. Bachmann F, Erdmann R, Hartmann V, Wiest L, Rzany B (2009) The spectrum of adverse reactions after treatment with injectable fillers in the glabellar region: results from the injectable filler safety study. Dermatol Surg 35(Suppl. 2):1629e34 37. Inoue K, Sato K, Matsumoto D, Gonda K, Yoshimura K (2008) Arterial embolization and skin necrosis of the nasal ala following injection of dermal fillers. Plast Reconstr Surg 121:127ee8e 38. Burt B, Nakra T, Isaacs DK, Goldberg RA (2010) Alar necrosis after facial injection of hyaluronic acid. Plast Reconstr Surg 125:199ee200e 39. Carruthers A, Liebeskind M, Carruthers J, Forster BB (2008) Radiographic and computed tomographic studies of calcium hydroxylapatite for treatment of HIV-associated facial lipoatrophy and correction of nasolabial folds. Dermatol Surg 34(Suppl 1):S78–S84 40. Anderson RE (1999) Billions for defense: the pervasive nature of defensive medicine. Arch Intern Med 159(20):2399–2402

Part III

Miscellany

Quality Standards in Aesthetic Medicine

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Mario Goisis

In many aspects standards in aesthetic medicine are set by Health and Safety legislation, that is different in every country. The quality standards, enforce legislation in order to offer the best service to patients. This is especially important in areas such as injection of fillers and Botulinum toxin and for any product that might pose risks to patients in case of poor quality of treatments.

22.1

The AQ Standard for Aesthetic Medicine

AQ Standard (www.aesthetic-quality.com) is a Standard for quality assurance in aesthetic medicine and surgery. This approach requires that the offices and the doctors set out clear procedures for all medical processes—usually, these are set out in manuals and reinforced through staff training. Regular audits are carried out to ensure that procedures are being carried out every time according to standards. AQ Standard was introduced in 2011 and now a large number of well-informed patients would only buy products and services from offices that possess AQ Accreditation. In general, accreditation is achieved by hiring consultants to help with the documentation processes and with setting and monitoring results targets. Many medical offices obtained substantial benefits from this process, by reducing medical and organisation problems and by improving their quality reputation. A Quality Standard does not have to be a rigid, inflexible, process-driven approach to patients treatment. Every doctor has the complete choice in terms of treatment options. Also employees are encouraged to take ownership for improvement.

M. Goisis (&) Doctor’s equipe, via Carducci 19, 20123 Milan, Italy e-mail: [email protected]

M. Goisis (ed.), Injections in Aesthetic Medicine, DOI: 10.1007/978-88-470-5361-8_22,  Springer-Verlag Italia 2014

A Quality Standard, such as AQ, is a process by which entities review the quality of all factors involved in treatment. This approach places an emphasis on five aspects: 1. Standards for patient management (call centre, office, etc). 2. Standards for registrations of products that are injected. 3. Standards for registrations of patients by a costumer relationship management (CRM) or, better, by a patient relationship manager (PRM). 4. Standards for marketing. 5. Competence, such as knowledge, skills, experience and qualifications of medical doctors and staff.

22.2

The Quality Protocol for Patient Management and for Registration of Products

Francesco Goisis The described protocol is based on the AQ standard for office procedures. This standard is applied in many medical offices and was elaborated on the experience of more than 40,000 medical aesthetic treatments every year. • Standards for call centers: the patient can reserve by calling the office from 9:00 to 21:00, Monday through Sunday. The call centre answers in 3 min. After 3 min, the phone number is saved, and the call centre recalls the patient within 24 h. • Standards for patients registration: the patients name, phone number and the e-mail are saved by call centre on the tuOtempO system. The treatment type and time are selected on the system. For example, a first visit takes 30 min. A follow-up visit takes 10 min. A treatment with Macrolane takes 1 h, etc. A good time organisation helps to reduce patients waiting time. • Standards for acceptance: the patient is accepted by a smiling staff. He/she is referred to an assistant, who brings him/her to the doctor’s office (Fig. 22.1). The assistant’s role is very important: she assists the patient step by step. 253

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Fig. 22.1 Standards for acceptance: the patient is accepted by a smiling staff. He/she is referred to an assistant, who brings him/her to the doctor’s office

• Medical visit: the assistant brings the patient to the visiting room. The doctor introduces himself/herself. After that, the first step is to discuss the three different aspects of the organisation, which are summarised in three consent forms. The first consent form is about Privacy. The patient accepts that his/her personal data are collected by the office (Fig. 22.2), and the doctor can explain the high level of security and confidence of the database. The second consent form is the Quality consent form (AQ Standard Form). By this form, the quality standards are presented and explained to the patient. If the patient has a coupon, he/she has to sign a third consent form. In this consent form, he/she is informed that he/she can have his money back. This option must be clearly explained when selling the coupon, but it must be also summarised at the time of the first visit.

Fig. 22.2 The doctor introduces himself/herself. After this, the first step is to discuss the three different consent forms

M. Goisis

Fig. 22.3 The patient’s exam is based on facial observations and palpation in order to evaluate the presence of filler, lumps, etc

• The doctor starts the anamnesis, asking the patient about allergies, drugs, diseases, previous admission in hospital, previous aesthetic treatments, etc. All the information is registered on PRM. • The patient’s makeup is removed. • The patient’s exam is based on facial observations and palpation in order to evaluate the presence of filler, lumps, etc. (Fig. 22.3). • A photographic analysis is performed with Canfield Camera System, and pictures are taken at 180, 45 and 90 with standard light (Fig. 22.4). • In some cases (lumps, etc.) it should be useful to perform an ultrasound analysis (Fig. 22.5). • In order to discuss treatment options, it is very useful to ask the patient to bring some old pictures. This will make it easier to study the age-related changes.

Fig. 22.4 A photographic analysis is performed with canfield camera system, and pictures are taken at 180, 45 and 90 with standard light

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Fig. 22.5 In some cases (lumps, etc), it should be useful to perform an ultrasound analysis

Fig. 22.7 The informed consent is discussed. Treatments, potential results, adverse effects are evaluated

• The old pictures are compared with Canfield analysis (Fig. 22.6). • The treatment program is decided with the patient. • The informed consent is discussed. Treatments, potential results, adverse effects are evaluated (Fig. 22.7). • The blister container of the product is opened in front of the patient. Syringes, package insert, traceability labels and needles are enclosed in the box. • The traceability labels are shown and explained to the patient (Fig. 22.8). • Two copies of traceability labels are glued to two consent forms. • The patient signs both consent forms. One consent form is archived, and the other is given to the patient. The traceability labels allow the patient to know the product name, the production and expiration dates (Fig. 22.9). • The treatment is performed.

Fig. 22.8 The traceability labels are shown and explained to the patient

Fig. 22.6 In order to discuss treatment options, it is very useful to ask the patient to bring some old pictures

Fig. 22.9 Two copies of traceability labels are glued to two consent forms. One consent form is archived, and the other is given to the patient

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• After the treatment, the patient is accompanied to the administration room. The payment does not occur in front of other patients. • The assistant accompanies the patient to the reception to schedule a follow-up appointment with the PRM system. The PRM system allows to choose the date and the hour of the appointment and to confirm it by mail or sms.

22.3

Customer Relationship Management or PRM

Mario Goisis, Andrea Goisis Patient management can be simplified by using a Customer Relationship Management software (CRM). A wellbuilt CRM makes it possible to raise the level of services provided to patients, maintain an easily searchable historical patient archive and reduce administrative costs. The move from a traditional organisational system to the use of a CRM may initially be laborious and complicated: creating the entry for each customer, learning to use the system and, above all, managing to change one’s habits, requires commitment and a degree of constancy that should not be underestimated. The benefits are, however, many, and we will try to illustrate them clearly in the following sections. The Doctor’s Equipe medical centres use an evolved CRM (internally renamed PRM, or Patient Relationship Management Software) that make possible to keep track of patients’ purchases over time, of the services purchased, the purchase dates, and notes regarding the patients’ personal history, as well as information on how they heard about the centre. Using the PRM, it is also possible to obtain precise figures on the various aspects that may be of interest to the centre, in order to optimise management and improve treatments.

22.3.1 Key Points of PRM For the sake of clarity of PRM and efficiency, we decided to analyse each point of strength individually: 1. Organisational benefits There are two main tools we can exploit for organisational purposes: (a) A single patient file that is easy to analyse and update: a file containing the personal details of each patient is created on the first visit and updated from time to time with the treatment or examinations carried out. In this way, patient information is always easily available, which saves considerable time (Fig. 22.10). (b) On-line calendar linked directly to the PRM: the use of a calendar makes it possible to reduce the number of telephone calls between the centre and the patient thanks to online availability of information and especially thanks to the sending of reminders (text messages and e-mails or voice mails) to all the parties involved (doctors, assistants and patients). In addition, the diaries can also be accessed by smart phone, making it possible to work on the move and also here to optimise the use of time (Fig. 22.11). 2. Optimising staff performance ThePRMcanbeusedtomeasuretheperformanceofdoctors and assistants with regard to the various products offered, monitoring the degree of customer satisfaction and the quantityandtypeoftreatmentsperformedbyeachindividual member of staff: in this way, it is possible to improve staff training in a targeted manner and use the best resources for each situation (Fig. 22.12).

Fig. 22.10 Using PRM, patient information is always easily available, which saves considerable time

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Fig. 22.11 In addition, the diaries can also be accessed by smart phone, making it possible to work on the move and also here to optimise the use of time

3. Maintaining personal relations With an increase in the number of customers treated, it is difficult to remember important events for each patient dealt with. Remembering their birthday or the age of the children may at first sight seem trivial, but such details make the person we are relating to feel at ease. Also in this case, the PRM can come to aid. Assistants and doctors have an immediate overview of patient history and know personal details regarding them, creating a climate of harmony and trust. 4. Increased turnover through statistical analysis The analysis and comparison of data becomes quick and simple also thanks to charts, self-generated using data in the PRM. For example, specific promotions may be introduced for the least sold treatments, or aimed at customers who have not made any purchases for some time. Conversely, the most popular services may be kept at full price. Data analysis also makes it possible to

perform differentiated offers on the basis of age group, gender, or in function of products that need to be cleared out of the warehouse. 5. Optimising advertising investments The use of an advanced PRM makes it possible to immediately view the origin of each patient. As a result, it is possible to identify the most profitable sources and to invest or divest in promotional activities. Moreover, the average cost of acquiring a patient can also be calculated. 6. Purchasing optimisation The PRM makes it possible to keep tabs on stock, to make precise estimates, and to use statistical data to produce average consumption figures broken down by individual product or drug. This means that repeat orders can be precise and, moreover, that from year to year, once the amount of orders has been estimated, supply strategies can be planned and supply costs optimised, for example by making larger orders.

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22.4.1 Marketing Campaigns In our experience, marketing is based on three fundamental points: • The PRM • The e-commerce platform • The communication on newspapers and other medias These three elements are interconnected and inter-communicating: a patient can book and buy treatments online, based on the availability of doctors updated in real time in the calendar. All transactions are recorded and become part of the patient’s history, whose data on file are automatically updated, thus allowing further time savings. The use of the online calendar makes it possible to automate the majority of direct customer management activities and to save work and time.

22.4.2 Coupon or not Coupon: The Profitability of Large Discounts in Aesthetic Medicine

Fig. 22.12 By PRM, it is possible to use the best resources for each situation

22.4

Quality Standards of Marketing in Aesthetic Medicine

In collaboration with Alessandro Farad Marketing is the activity, set of tools, and processes for creating, communicating, delivering, and exchanging offers that have value for customers. (Definition Approved by the American Marketing Association Board of Directors October 2007). Also in the field of cosmetic medicine and surgery, it is necessary to create value for patients and make sure that they perceive this value as unique. This takes place using a rigid quality protocol, thanks to the knowledge of the patient’s tastes and by choosing the most appropriate services based on the continuous monitoring of his/her (changing) needs.

Nowadays, there are many companies and websites that feature coupons and discounted gift certificates, offering the ‘deal of the day’ for a wide range of goods and services, and of course, aesthetic medicine is no exception. Discount vouchers can benefit doctors through advertising, by informing patients of their existence. Some wellknown deal-of-the-day websites charge 50 % of voucher price: if a doctor offers an $80 voucher for a $400 Botox treatment, the company retains $40, a large fee compared to marginal costs of voucher provision [1]. Other companies have recently reduced this fee to 30 or 20 %. Despite these considerations, it is not possible to ignore this medium. Hiding one’s head in the sand and ignoring the obviously changing moods of the market can be positively harmful. The high number of offers published in fact leads patients to have a distorted perception of the value of the services offered, to wait for an offer and to betray their usual centre with fewer feelings of guilt. However, every cloud has a silver lining, and this promotional method makes it possible to achieve direct contact with many potential customers in a very short time, thus increasing turnover with immediate effect.

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Quality Standards in Aesthetic Medicine

The second, less obvious, but no less important advantage is the fact that medical centres also have access to the medium: the investment required to advertise is simply the direct work of doctors and their assistants, without any economic outlay as such. This lowers the entrance threshold into the world of advertising, an advantage for many, but, as we shall see, a headache for everyone. New markets, new rules: we need to change the way we approach this type of market and be prepared to deal with it. As we mentioned, such an extensive offer at a low cost dramatically limits the possibility of loyalty from those customers we encounter, increases the risk of losing loyal patients, and creates serial deal hunters more interested in the purchasing experience than in the service purchased. If we approach this market with the same methodology used for traditional markets, we will come up against the following critical issues: 1. The number of loyal patients in relation to those encountered will be dramatically lower than expected. 2. The centre will very probably be clogged in a very short space of time with patients who do nothing to increase its short-term profitability. 3. Patients will be distrustful and suspicious. 4. The costs and the amount of work to deal with will be higher than expected. Like all promotional tools, it should be used with intelligence and moderation in order to avoid its problematic aspects and take full advantage of the opportunities it offers. Let’s see how to overcome the critical aspect of this kind of promotion tools and how to take advantage from the opportunities. 1. Patients purchase offers not so much for their content as for their price: we should thus not consider them to be acquired. 2. Staff need to be prepared to manage this influx and effectively calculate the capacity of the centre before preparing the promotion. 3. The main error of buying groups is that they are not interested in offering high quality for this reason, to their users, but only in maximising their sales. The patient has thus often been previous treated as a second-rate customer. In order to overcome the mistrust deriving from this, we must follow a rigid protocol. 4. We should not underestimate the amount of work and as a result should control the frequency of these offers in relation to the centre’s working capacity. In relation to point 3, it is important to observe a rigid protocol, for example opening the product in front of the patient, asking them to look at the box of the filler, explaining the procedure step by step. It is also vital for doctors to introduce themselves to patients, talking about their experience and specialisation. At the end, patients must be informed that they can receive their money back

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from the company that sold them the discounted voucher, in the event of contraindications for the treatment or the failure to provide informed consent. In relation to point 1, an excellent strategy may be that of accompanying promotion of the voucher with a second promotion to be bought immediately. This would create an opportunity to channel patients and keep them linked to the structure. We thank Alessandro Farhad for his cooperation in this Paragraph.

22.5

Standard for Qualification of Medical Doctors

Not all Medical doctors who practice aesthetic medicine are specialist in plastic surgery or dermatology or maxillofacial surgery. For this reason the board certifications are very important. In fact, board certifications are voluntary process that demonstrates a doctor’s training specifically in the area of Aesthetic Medicine. Board certification is different from possessing a medical license, which is the minimum required by law to practice aesthetic medicine in many countries. For example, all Aesthetic Doctors who work in AQ clinics must be AQ board certified. Board certification by the AQ is a process that demonstrates a doctor’s commitment to permanent learning and excellent patient care. AQ certification recognizes individuals who have met the highest standards of education and knowledge specifically in Aesthetic Medicine. How Does a Doctor Become Board Certified? AQ board certification in aesthetic medicine involves the following steps: 1. Education and Training Doctors looking for board certification by AQ must have graduated from a medical school. Following medical school, doctors must complete at least one year of training in a residency program accredited by AQ standard. During their training, they must acquire extensive practical experience and an extensive knowledge of patient management. 2. Application for Certification Upon conclusion of their residency training, doctors can apply for board certification by the AQ. The director of their residency program must declare to the doctor’s treatment skills, ethics and professionalism. In addition, they must provide a record of their treatment experience for review, which must be acceptable in size and scope. For example, to complete an davanced level of AQ certification the doctor must provide a record of at least 400 treatments with filler, 200 treatments with botox and 100 treatments with laser.

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If the application is approved, the doctor is admitted to the necessary examinations for certification. 3. Examinations for Certification Doctors must first pass an extended oral examination known as the First Examination, which assesses their knowledge in aesthetic medicine. Doctors must then pass an extended practical examination called the Certifying Examination, which tests their judgment and decision making. Candidates are interviewed and observed by experienced aesthetic doctors who evaluate their ability to diagnose and treat. If successful on both examinations, the doctor is deemed board certified and becomes a ‘‘diplomate’’ of the AQ certification.

M. Goisis

4. Maintenance of Certification To maintain their certification, diplomates must demonstrate a commitment to professionalism, continuing education and practice improvement, every 5 years.

References 1. Edelman B, Jaffe S, Kominers SD (2011) To groupon or not to Groupon: the profitability of deep discounts. Harvard Business School Working paper 11–063

Complementary Treatments

23

Mario Goisis

The gold standard treatment for many aesthetic aspects of aging has been described in this book as injections in their many forms. However, there is a growing interest in a wide range of nonablative interventions that, predictably, are claimed to rejuvenate skin ‘‘safely and effectively.’’ Several of these nonablative systems have been approved by the U.S. Food and Drug Administration (FDA) for the purpose of skin rejuvenation, and there are many significant reported improvements in the appearance of signs and symptoms of aging by relatively noninvasive means. In our experience, clinical results have been generally less than impressive, with most subjects showing only mild improvement. Despite that, nonablative treatments as radiofrequency, tissue stimulation, and shock waves can be an excellent complement to injections and a treatment option for patients.

23.1

Radiofrequency for Nonablative Skin Rejuvenation

Redundant facial, neck, or body laxity is a major feature of aging. Monopolar and bipolar radiofrequency have been introduced for nonablative tissue tightening by volumetric heating of the deep dermis without ablating the skin [1, 2] (Fig. 23.1). The net result of this is a noninvasive brow lift, face-lift, or neck lift. This modality does not replace current medical procedures as injection, but is an excellent complement to these and a treatment option for patients to consider. However, there are many possible risks and side effects, as severe facial burns and scarring as a result of radiofrequency treatments [3, 4]. Due to the risk of permanent damage of tissues, the indications for radiofrequency

M. Goisis (&) Doctor’s Equipe, via Carducci 19, 20123, Milan, Italy e-mail: [email protected]

M. Goisis (ed.), Injections in Aesthetic Medicine, DOI: 10.1007/978-88-470-5361-8_23,  Springer-Verlag Italia 2014

Fig. 23.1 Application of radiofrequency on the face (courtesy of Doctor’s Equipe Medical, Italy)

interventions should be made carefully. Potential contraindications should be analyzed, and written informed consent about all possible side effects and risk factors should be signed. According to current experience, the familiarity of the physician using radiofrequency devices is most important in determining the outcome of this procedure. Therefore, the use of radiofrequency therapy requires extensive teaching.

23.2

Mechanical Stimulation of the Skin

Mechanical stimulation of the skin is a technique that employs micropulsations (LPG Systems) and performed with different devices (rolls and flaps). Its efficacy has been confirmed by various studies [5]. In particular, LPG delivers micropulsations onto the surface and to the deep layers of the skin to stimulate the natural production of collagen and elastin. The treatment is painless, noninvasive, and nonaggressive.

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Fig. 23.2 Application of acoustic waves on arm (a), leg (b), and face (c), (courtesy of EMS Medical and Storz Medical, Switzerland)

23.3

Acoustic Waves

Acoustic waves (AW) have been used in medicine since 1980 for the disintegration of kidney stones and since 1993 for the treatment of orthopedic diseases such as tendon and muscle disorders. In aesthetic medicine application, AW increase the firmness of the epidermis. Also, blood circulation in the tissue is significantly enhanced. The density and the natural elasticity of the skin and connective tissue are improved along with a visible and long-lasting amelioration in skin texture (Fig. 23.2a, b, and c). For this reason, AW represent an easy-to-handle, noninvasive, side effect-free complementary treatment of filler injections [6, 7].

References 1. Koch RJ (2004) Radiofrequency nonablative tissue tightening. Facial Plast Surg Clin North Am 12(3):339–346 2. Dierickx CCJ (2006) The role of deep heating for noninvasive skin rejuvenation. Lasers Surg Med 38(9):799–807 3. Mayoral FA, Vega JM (2011) Multiple facial burns with the new Thermage CPT system. Drugs Dermatol 10(11):1320–1321 4. Paasch U, Bodendorf MO, Grunewald S, Simon JC (2008) Skin rejuvenation by radiofrequency therapy: methods, effects and risks. J Dtsch Dermatol Ges 7(3):196–203. 5. Revuz J (2002) Clinical and histological effects of the LIFT 6 device used on facial skin ageing. Nouv Dermatol 21:335–342 6. Siems W, Grune T, Voss P, Brenke R (2005) Anti-fibrosclerotic effects of shock wave therapy in lipedema and cellulite. Biofactors 24(1–4): 275–282 7. Adatto MA, Adatto-Neilson R, Novak P, Krotz A, Haller G (2011) Body shaping with acoustic wave therapy AWT()/EPAT(): randomized, controlled study on 14 subjects. J Cosmet Laser Ther 13(6):291–296

24

Products Magda Guareschi

This chapter presents the most common products employed by aesthetic surgeons for injections. Data were provided by the respective pharmaceutical producers, and the following

list of products is by no means exhaustive but based on the authors’ own personal experience.

24.1

24.1

Azzalure

Azzalure

Trade name

Azzalure, 10 Speywood units/0.05 ml, powder for solution for injection

Company

Q-Med, a Galderma Division

Description

Botulinum toxin type Aa 10 Speywood units b/0.05 ml of reconstituted solution Vial of 125 units The Speywood units of Azzalure are specific to the preparation and are not interchangeable with other preparations of botulinum toxin Pharmaceutical Form: Powder for solution for injection The powder is white Posology: The recommended dose is 50 Speywood units (0.25 ml of reconstituted solution) of Azzalure to be divided into 5 injection sites, 10 Speywood units (0.05 ml of reconstituted solution) are to be administered intramuscularly into each of the 5 sites: 2 injections into each corrugator muscle and one into the procerus muscle During the clinical development of Azzalure, more than 2,600 patients were included in the different clinical trials In clinical studies, 1,907 patients with moderate to severe glabellar lines have been treated at the recommended dose of 50 Speywood units. Of these, 305 were treated with 50U in two pivotal phase III double-blind placebo-controlled studies and 1,200 treated with 50U in a long-term open-label repeated-dose phase III study. The remaining patients were treated in supportive and dose-ranging studies [1–6]

a b

Intended use

Azzalure is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines (vertical lines between the eyebrows) seen at frown, in adult patients under 65 years, when the severity of these lines has an important psychological impact on the patient

Onset of response and duration

The median time to onset of response was 2–3 days following treatment, with the maximum effect observed at day 30. In two pivotal placebo-controlled phase III studies, Azzalure injections significantly reduced the severity of glabellar lines for up to 4 months. The effect was still significant after 5 months in one of the two pivotal studies. Treatment interval should not be more frequent than every three months

Clostridium botulinum toxin A haemagglutinin complex One Speywood unit (U) is defined as the median lethal peritoneal dose in mice (LD50)

M. Guareschi (&) Doctor’s Equipe, via Carducci 19, Milano 20123, Italy e-mail: [email protected]

M. Goisis (ed.), Injections in Aesthetic Medicine, DOI: 10.1007/978-88-470-5361-8_24,  Springer-Verlag Italia 2014

263

264

M. Guareschi

Azzalure: Reference 1. Ascher B, Zakine B, Kestemont P et al. (2004) A multicentre, randomized, double-blind, placebo-controlled study of efficacy and safety of three doses of botulinum toxin A in the treatment of glabellar lines. J Am Acad of Dermatol 51(2):223–33 2. Ascher B, Zakine B, Kestemont P et al. (2005) Botulinum tox A in the treatment of glabellar lines: scheduling the next injection. Aesth Surg J 25:365–375 3. Monheit G, Carruthers A, Brandt F, Rand R (2007) A randomized, double-blind, placebo-controlled study of botulinum toxin type A for the treatment of glabellar

24.2

Belotero Range

lines: determination of optimal dose. Dermatol Surg 33(1):S51–S59 4. Moy R, Maas C, Monheit G, Huber B (2009) Long-term safety and efficacy of a new botulinum toxin type A in treatment glabellar lines. Arch Facial Plast Surg 11(2):77–83 5. Rzany B, Dill-Mueller D, Grablowitz D et al. (2007) Repeated botulinum toxin A injections for the treatment lines in the upper face: a retrospective study of 103 treatments in 945 patients. Dermatol Surg 33:S18–S25 6. Rzany B, Asher B, Monheit GD (2010) Treatment of glabellar lines with botulinum toxin type A (Speywood Unit): a Clinical overview. JEADV 24(1):1–14

24.2

Belotero Range

24.2.1

Belotero Basic Filler

24.2.1 Belotero Basic Filler

Trade name

Belotero basic

Volume/package

Cross-linked sodium hyaluronate: 22.5 mg/ml in 1-ml glass syringe

Company

Merz Pharma

Certifications

CE, FDA

Commercialization

2006 Austria, Germany, Italy, Russia, Switzerland, Uk and USA

Description

Belotero Basic is a sterile, pyrogenic, viscoelastic clear colourless transparent, isotonic gel. Belotero Basic consists of cross-linked sodium hyaluronate of non-animal origin Belotero has a CPM technology based on a dynamic, double cross-linking process of the cohesive monophasic hyaluronic acid gel with the stabilizer BDDE1 The unique Cohesive Polydensified Matrix (CPM) provides a stable, cohesive gel and provides outstanding product qualities as low-viscosity properties that make it able to fill in even the tightest intradermal spaces, homogenous distribution into the dermis, smooth transitions between treated and untreated areas and low injection pressure making treatment nearly pain-free

Intended use

Belotero Basic is an injectable implant indicated for use to increase the volume of skin tissue which enables: the correction of facial depressions, either due to injury or age-related (scarring, moderate or deep wrinkles, furrows), remodelling of the contours of the face by injection into facial areas such as the cheeks, chin, etc., increase in lip volume (the border of the red part of the lip, increasing roundness)

Duration

No published data

Needle TWN

2 27 G (0.4 9 1.3 mm) (supplied)

Suggested cannulas

30 G 1 inch; 27 G 1 inch; 25 G 1 inch; 25 G 2 inch (not supplied)

24

Products

24.2.2

265

Belotero Soft Filler

Trade name

Belotero soft

Company

Merz Pharma

Volume/Package

Cross-linked sodium hyaluronate: 20 mg/ml in 1-ml glass syringe

Certifications

CE, FDA

First commercialization

2006 Austria, Germany, Italy, Russia, Switzerland and Uk

Description

Belotero soft is a sterile, pyrogenic, viscoelastic clear colourless transparent, isotonic gel. Belotero Basic consists of cross-linked sodium hyaluronate of non-animal origin Belotero has a CPM technology based on a dynamic, double cross-linking process of the cohesive monophasic hyaluronic acid gel with the stabilizer BDDE1 The unique Cohesive Polydensified Matrix (CPM) provides a stable, cohesive gel and provides outstanding product qualities as low-viscosity properties that make it able to fill in even the tightest intradermal spaces, homogenous distribution into the dermis, smooth transitions between treated and untreated areas and low injection pressure making treatment nearly pain-free

Intended use

Belotero Soft is an injectable implant indicated for use to increase the volume of skin tissue which enables: to correct shallow facial depressions, either due to injury or age-related (scars, fine lines, crow’s feet wrinkles), to retouch a correction undertaken with Belotero Basic, immediately or a few weeks after the first injection

Duration

No published data

Needle TWN

2 30 G100 /2 (0.3 9 13 mm) (supplied)

Suggested cannulas

30 G 1 inch; 27 G 1 inch (not supplied)

24.2.3

Belotero Intense Filler

Trade name

Belotero intense

Company

Merz Pharma

Volume/Package

Cross-linked sodium hyaluronate: 25.5 mg/ml in 1-ml glass syringe

Certifications

CE, FDA

First commercialization

2009 Austria, Germany, Italy, Russia, Switzerland, Uk and USA

Description

Belotero soft is a sterile, pyrogenic, viscoelastic clear colourless transparent, isotonic gel. Belotero Basic consists of cross-linked sodium hyaluronate of non-animal origin Belotero has a CPM technology based on a dynamic, double cross-linking process of the cohesive monophasic hyaluronic acid gel with the stabilizer BDDE1 The unique Cohesive Polydensified Matrix (CPM) provides a stable, cohesive gel and provides outstanding product qualities as low-viscosity properties that make it able to fill in even the tightest intradermal spaces, homogenous distribution into the dermis, smooth transitions between treated and untreated areas and low injection pressure making treatment nearly pain-free

Intended use

Belotero Intense is an injectable implant indicated to restore or significantly improve deep folds and augment face skin volume defects which enables: the correction of facial depressions, either due to injury or age-related (scarring, deep wrinkles, furrows), remodelling of the contours of the face by injection into facial areas such as the cheeks, chin, etc., lip enhancement especially the border of the red part of the lip

Duration

No published data

Needle TWN

2 21 Gy 2 (0.4 9 13 mm) needles (supplied)

Suggested cannulas

27 G 1 inch; 25 G 2 inch (not supplied)

266

M. Guareschi

Belotero: Reference 1. Huber J. Efficacy of combined treatment using hyaluronic acid (belotero soft) and botulinium toxin type A (xeomin) to optimize aesthetic outcome in radial upperlid lines. Kosmetische Medizin 3(10):4–10 2. Pavicic T, Ruzicka T, Korting H–K, Gauglitz G. Monophasic (2010) Cohesive-polydensified-matrix crosslinking-technology-based hyaluronic acid filler for the treatment of facial lipoatrophy in HIV-infected patients. J Drugs Dermatol 9(6): 690–695 3. Prager W, Steinkraus V (2010) A prospective, raterblind, randomized comparison of the effectiveness and

24.3

tolerability of belotero basic versus restylane for correction of nasolabial folds. Eur J Dermatol 4. Reinmüller J, Wolters M, Lampe H, Steinkraus V, Dirting K, Sommer B, Leva S, Flatau-Baque B (2007)Poster presented at the 21st World Congress of Dermatology, Buenos Aires, Argentina, Sept 30–Oct 5 2007. (This was then published as a supplement to Dermatology News: Kammerer S (2007) Belotero: a CPM-technology based HA-filler. easy handling, smooth spreading in the tissues. Dermatol News 2007(11):2–3) 5. Taufig AZ, Szöke A, Kühnel W (2009) A new strategy to detect intradermal reactions after injection of resorbable dermal fillers. J Ästhetische Chirurgie 2:29–36

24.3

Bocouture

24.3.1

Botulinum Toxin Merz-A Drug

Bocouture

24.3.1 Botulinum Toxin Merz-A Drug

Trade name

Bocouture, Xeomin, Xeomin cosmetic and Xeomeen

Company

Merz Pharma

Volume/Package

1 vial containing 50 LD50 units of Botulinum toxin type A 0.1 ml solution contains 4 LD50 units of Botulinum toxin type A (150 kD) reconstituted in 1.25 ml

Certifications

FDA

First commercialization

2011 Argentina (Xeomin), Austria (Bocouture), Belgium (Bocouture), France (Bocouture), Germany (Bocouture), Italy (Bocouture), Mexico (Xeomeen), Netherlands (Bocouture), Portugal (Bocouture), Russia (Xeomin), Spain (Bocouture), Sweden (Bocouture), UK (Bocouture) and USA (Xeomin)

Description

Bocouture Botulinum Toxin Type A is a highly pure neuromodulator formulation that contains only active neurotoxin and that is free from complexing proteins; thanks to a precision engineering process, Bocouture contains pure (150 kD) neurotoxin. Due to its purity, Bocouture could be beneficial in reducing the risk of non-response or a decrease in response, especially in long-term treatment Bocouture is highly stable and the only botulinum toxin type A that does not have to be refrigerated during transportation or storage Complete recovery of endplate function/impulse transmission after injection normally occurs within 3–4 months as nerve terminals sprout and reconnect with the endplate

Intended use

Bocouture is indicated for the temporary improvement in the appearance of moderate to severe vertical lines between the eyebrows seen at frown (glabellar frown lines) in adults below 65 years when the severity of these lines has an important psychological impact for the patient

Duration

An improvement in the glabellar frown lines generally takes place within 2–3 days with the maximum effect observed on day 30. The effect lasts up to 4 months after the injection. The intervals between treatments should not be shorter than 3 months

Needle TWN

Reconstituted Bocouture is injected using a thin sterile needle (e.g. 30-gauge needle) (not supplied)

Suggested cannulas

24

Products

267

Bocouture Botulinum Toxin-A Drug: Reference 1. Bocouture SmPC June 2010 2. Frevert J (2010) Drugs in R&D 10(2):1–7

3. Grein S et al. Mov Discord 23; Supplement 1, S24 (2008) Xeomin is stable without refrigeration. Complexing proteins are not required for stability of Botulinum neurotoxin type A preparations

24.4

24.4

Emervel Range

Emervel Range

Trade name

Emervel touch

Company

Q-Med, a Galderma Division

Volume/Package

1 ml

Certifications

CE-2010

First commercialization

2011

Description

Emervel Touch is a viscoelastic, monophasic, isotonic, sterile, pyrogen-free, bioresorbable transparent gel consisting of non-animal cross-linked hyaluronic acid (20 mg/ml) in a physiological buffer system is cross-linked with BDDE which regulates resorption of the product, providing lasting volume correction

Intended use

Emervel Touch is an injectable dermal filler used to augment the volume of facial tissues. Emervel Touch is indicated for injection into the superficial dermis for the correction of superficial wrinkles

Duration

Emervel Touch increases the volume of the dermis for a period of 6–9 months

Needle UTW

30G (supplied)

Trade name

Emervel classic

Company

Q-Med, a Galderma Division

Volume/Package

1 ml

Certifications

CE-2010

First commercialization Description

Emervel Classic is a particulate, monophasic, isotonic, sterile, pyrogen-free, bioresorbable transparent gel consisting of non-animal cross-linked hyaluronic acid (20 mg/ml) in a physiological buffer system is cross-linked with BDDE which regulates resorption of the product, providing lasting volume correction

Intended use

Emervel Classic is an injectable dermal filler used to augment the volume of facial tissues. It is indicated for injection into the mid-dermis for the treatment of moderate to deep wrinkles, or to redefine the shape of the face (cheekbones, tear trough, or lips)

Duration

Emervel Classic increases the volume of the dermis for a period of 6–9 months

Needle

30G (supplied)

268

M. Guareschi

Trade name

Emervel classic lidocaine

Company

Q-Med, a Galderma Division

Volume/Package

1 ml

Certifications

CE-2010

First commercialization Description

Emervel Classic lidocaine is a particulate, monophasic, isotonic, sterile, pyrogen-free, bioresorbable transparent gel consisting of non-animal cross-linked hyaluronic acid (20 mg/ml) in a physiological buffer system. 0.3 % lidocaine is added to the formulation to diminish the pain resulting from the injection during the treatment Emervel Classic lidocaine is cross-linked with BDDE which regulates resorption of the product, providing lasting volume correction

Intended use

Emervel Classic lidocaine is an injectable dermal filler used to augment the volume of facial tissues. It is indicated for injection into the mid-dermis for the treatment of moderate to deep wrinkles, or to redefine the shape of the face (cheekbones, tear trough, or lips)

Duration

Emervel Classic lidocaine increases the volume of the dermis for a period of 6–9 months

Needle UTW

30G (supplied)

Trade name

Emervel deep

Company

Q-Med, a Galderma Division

Volume/Package

1 ml

Certifications

CE-2010

First commercialization

2011

Description

Emervel Deep is a particulate, monophasic, isotonic, sterile, pyrogen-free, bioresorbable transparent gel consisting of non-animal cross-linked hyaluronic acid (20 mg/ml) in a physiological buffer system Emervel Deep is cross-linked with BDDE which regulates resorption of the product, providing lasting volume correction

Intended use

Emervel Deep is an injectable dermal filler used to augment the volume of facial tissues. EmervelDeep is indicated for injection into the deep dermis for the correction of moderate to deep wrinkles, or to redefine the shape of the face (cheekbones, tear trough, or lips)

Duration

Emervel Deep increases the volume of the dermis in a durable manner, for a period of 6–9 months

Needle UTW

27 G (supplied)

Cost

Trade name

Emervel deep lidocaine

Company

Q-Med, a Galderma Division

Volume/Package

1 ml

Certifications

CE-2010

First commercialization

2011

Description

Emervel Deep lidocaine is a particulate, monophasic, isotonic, sterile, pyrogen-free, bioresorbable transparent gel consisting of non-animal cross-linked hyaluronic acid (20 mg/ml) in a physiological buffer system. 0.3 % lidocaine is added to the formulation to diminish the pain resulting from the injection during the treatment Emervel Deep lidocaine is cross-linked with BDDE which regulates resorption of the product, providing lasting volume correction

Intended use

Emervel Deep lidocaine is an injectable dermal filler used to augment the volume of facial tissues. Emervel Deep lidocaine is indicated for injection into the deep dermis for the correction of moderate to deep wrinkles, or to redefine the shape of the face (cheekbones, tear trough, or lips)

Duration

Emervel Deep lidocaine increases the volume of the dermis in a durable manner, for a period of 6–9 months

Needle UTW

27 G (supplied)

24

Products

269

Trade name

Emervel volume

Company

Q-Med, a Galderma Division

Volume/Package

2 ml

Certifications

CE-2010

First commercialization

2011

Description

Emervel Volume is a particulate, monophasic, isotonic, sterile, pyrogen-free, bioresorbable transparent gel consisting of non-animal cross-linked hyaluronic acid (20 mg/ml) in a physiological buffer system Emervel Volume increases the volume of the tissues. Emervel Volume is cross-linked with BDDE which regulates resorption of the product, providing lasting volume correction

Intended use

Emervel Volume is an injectable dermal filler used to augment the volume of facial tissues. Emervel Volume is indicated for injection into the supraperiostic zone or subcutaneous fat tissue for the correction of facial volume (cheeks and chin)

Duration

Not provided in IFU

Needle UTW

23 1 UTW (supplied)

Cost

Trade name

Emervel volume lidocaine

Company

Q-Med, a Galderma Division

Volume/Package

2 ml

Certifications

CE-2010

First commercialization

2011

Description

Emervel Volume is a particulate, monophasic, isotonic, sterile, pyrogen-free, bioresorbable transparent gel consisting of non-animal cross-linked hyaluronic acid (20 mg/ml) in a physiological buffer system. 0.3 % lidocaine is added to the formulation to diminish the pain resulting from the injection during the treatment Emervel Volume increases the volume of the tissues. Emervel Volume is cross-linked with BDDE which regulates resorption of the product, providing lasting volume correction

Intended use

Emervel Volume is an injectable dermal filler used to augment the volume of facial tissues. Emervel Volume is indicated for injection into the supraperiostic zone or subcutaneous fat tissue for the correction of facial volume (cheeks, chin)

Duration

Not provided in IFU

Needle UTW

23 1 UTW (supplied)

Trade name

Emervel lips

Company

Q-Med, a Galderma Division

Volume/Package

1 ml

Certifications

CE-2010

First commercialization

2011

Description

Emervel Lips is a particulate, monophasic, isotonic, sterile, pyrogen-free, bioresorbable transparent gel consisting of non-animal cross-linked hyaluronic acid (20 mg/ml) in a physiological buffer system Emervel Lips is cross-linked with BDDE which regulates resorption of the product, providing lasting volume correction

Intended use

Emervel Lips is an injectable dermal filler used to restore and/or augment the volume of the lips

Duration

Emervel Lips increases the volume of the dermis for a period of 6–9 months

Needle

27 G (supplied)

270

M. Guareschi

Trade name

Emervel lips lidocaine

Company

Q-Med, a Galderma Division

Volume/Package

1 ml

Certifications

CE-2010

First commercialization

2011

Description

Emervel Lips lidocaine is a particulate, monophasic, isotonic, sterile, pyrogen-free, bioresorbable transparent gel consisting of non-animal cross-linked hyaluronic acid (20 mg/ml) in a physiological buffer system. 0.3 % lidocaine is added to the formulation to diminish the pain resulting from the injection during the treatment Emervel Lips lidocaine is cross-linked with BDDE which regulates resorption of the product, providing lasting volume correction

Intended use

Emervel Lips lidocaine is an injectable dermal filler used to restore and/or augment the volume of the lips

Duration

Emervel Lips lidocaine increases the volume of the dermis for a period of 6–9 months

Needle UTW

27 G (supplied)

Emervel: Reference 1. Ascher B, Bayerl C, Brun P, Kestemont P, Rzany B, Poncet M, Guennoun M, Podda M (2011) Efficacy and safety of a new hyaluronic acid dermal filler in the treatment of severe nasolabial lines—6 month interim results of a randomized, evaluator-blinded, intra-individual comparison study. J Cosmet Dermatol 10(2):94–98

24.5

Glytone Range

2. Rzany B (2012) Emervel: full-face rejuvenation with a range of customized hyaluronic acid fillers. J Drugs Dermatol 11(1 Suppl):S4 3. Rzany B, Bayerl C, Bodokh I, Boineau D, Dirschka T, Queille-Roussel C, Sebastian M, Sommer B, Poncet M, Guennoun M, Podda M (2011) Efficacy and safety of a new hyaluronic acid dermal filler in the treatment of moderate nasolabial folds: 6 month interim results of a randomized, evaluator-blinded, intra-individual comparison study. J Cosmet Laser Ther 13(3):107–112

24.5

Glytone Range

24.5.1

Glytone 1 Filler

24.5.1 Glytone 1 Filler

Trade name

Glytone 1

Company

Merz Pharma

Volume/Package

HA concentration: 14 mg/ml in 2 2 9 1 ml syringes

Certifications

CE, FDA technology

First commercialization

2009 (P. Fabre) 2012 (Europe, Merz Pharma)

Aree di vendita

France, Italy, Netherlands, Belgium, Luxembourg, Spain and Portugal

Description

Glytone Professional 1 is a sterile non-pyrogenic physiological gel made of non-reticulated high molecular weight hyaluronic acid of non-animal origin. This gel comes in a pre-filled graduated single-use syringe In combination with HA, there are mannitol known as free radical scavenger for a longer duration and stability and glycerol known for its ability to hydrate in a patented-specific product composition

Intended use

Glytone Professional 1 is an injectable implant for the mesotherapy to rehydrate deep layers of the skin through repeated injections into dermo-epidermal junction and superficial dermis Glytone Professional 1 can be injected on face, neck, cleavage and hands

Duration

No published data

Needle TWN

4 9 30 G (supplied)

Suggested cannulas

30 G; 27 G (not supplied)

Cost

24

Products

24.5.2

271

Glytone 2 Filler

Trade name

Glytone 2

Company

Merz Pharma

Volume/Package

HA concentration: 20 mg/ml in 2 1-ml syringe

Certifications

CE, FDA technology

First commercialization in Italy

2009 (P. Fabre)

Aree di vendita

France, Italy, Netherlands, Belgium, Luxembourg, Spain and Portugal

Description

Glytone Professional 2 is a sterile non-pyrogenic physiological gel made of reticulated hyaluronic acid (crosslinking agent: BDDE) of non-animal origin. This gel Glytone 2 is a monophasic filler, and in combination with the cross-linked HA, it contains mannitol known as free radical scavenger for a longer duration and stability and non-cross-linked HA known for its inhibition of matrix-metallo-proteinase which degrades collagen in a patented-specific product composition

Intended use

Glytone Professional 2 filling superficial wrinkles by injection into the superficial and/or mid-dermis injected on face, neck, cleavage and hands

Duration

No published data

Needle TWN

1 9 27 G; 1 9 30 G  (supplied)

Suggested cannulas

30 G; 27 G (not supplied)

2012 (Merz Pharma)

Cost

24.5.3

Glytone 3 Filler

Trade name

Glytone 3

Company

Merz Pharma

Volume/Package

HA concentration: 23 mg/ml in 2 1-ml syringe

Certifications

CE, FDA technology

First commercialization

2009 (P. Fabre) 2012 (Merz Pharma, Europe)

Aree di vendita

France, Italy, Netherlands, Belgium, Luxembourg, Spain and Portugal

Description

Glytone Professional 3 is a sterile non-pyrogenic physiological gel made of reticulated hyaluronic acid (cross-linking agent: BDDE) of non-animal origin. This gel Glytone 3 is a monophasic filler, and in combination with the crosslinked HA, it contains mannitol known as free radical scavenger for a longer duration and stability and non-crosslinked HA known for its inhibition of matrix-metalloproteinase which degrades collagen in a patented-specific product composition

Intended use

Glytone Professional 3 is an injectable implant for filling deep wrinkles by injection into the mid- and/or deep dermis and to increase lip volume

Duration

No published data

Needle TWN

2 9 27 G ; (supplied)

Suggested cannulas

27 G (not supplied)

Cost

272

M. Guareschi

24.5.4

Glytone 4 Filler

Trade name

Glytone 4

Company

Merz Pharma

Volume/Package

HA concentration: 24 mg/ml in 2 2x 1 ml syringe

Certifications

CE, FDA technology

First commercialization in Italy

2009 (P. Fabre) 2012 (Merz Pharma)

Aree di vendita

France, Italy, Netherlands, Belgium, Luxembourg, Spain and Portugal

Description

Glytone Professional 4 is a sterile non-pyrogenic physiological gel made of reticulated hyaluronic acid (cross-linking agent: BDDE) of non-animal origin. This gel Glytone 4 is a monophasic filler, and in combination with the cross-linked HA, it contains mannitol known as free radical scavenger for a longer duration and stability and non-cross-linked HA known for its inhibition of matrix-metalloproteinase which degrades collagen in a patented-specific product composition

Intended use

Glytone Professional 4 is an injectable implant for filling deep skin folds, cutaneous depressions, facial localized volume loss by mid-dermal and/or deep dermis injection and for increasing the lips volume

Duration

No published data

Needle TWN

2 9 23 G ; 2 9 25 G

Suggested cannulas

25 G (not supplied)

5/8

(supplied)

Cost

Glytone Range: Reference 1. Virginie T et al. (2010) Assessment of the clinical efficacy of a hyaluronic acid-based deep wrinkle filler using

24.6

Hyacorp Range

new instrumental 12:195–202

methods.

24.6

Hyacorp Range

24.6.1

Hyacorp Filler

J

Cosmetic

Therapy

24.6.1 Hyacorp Filler Trade name

Hyacorp H 1000

Company

Bioscience GmbH

Volume/Package

10, 2 ml

Certifications

CE

First commercialization

2009

Aree di vendita

All European countries, Japan and Middle East

Description

Hyacorp is a clear and viscous gel supplied in a special syringe of 10 ml/2 ml. The product is for single use only. The gel consists in a form of a cross-linked hyaluronic acid non-animal source. The particle size is approx. 1,000 l

Intended use

Restoration and contouring of body surfaces The depth of the injection may vary from subcutaneous to supraperiostal administration depending on the treatment site • Buttocks • Calves • Correction of concave deformities • Regio zygomatica

Duration

The degree and duration of the correction depend on the character of the defect treated, the tissue stress at the implant site, the depth of the implant into the tissue and the injection technique

Needle TWN

Not supplied

Suggested cannulas

Not supplied

24

Products

273

Trade name

HYACORP H/S 500

Company

Bioscience GmbH

Volume/Package

10, 2 ml

Certifications

CE

First commercialization in Italy

2010

Aree di vendita

All European countries, Japan and Middle East

Description

Hyacorp is a clear and viscous gel supplied in a special syringe of 10 ml/2 ml. The product is for single use only. The gel consists in a form of a cross-linked hyaluronic acid non-animal source. The particle size is approx. 500 l

Intended use

Restoration and contouring of body surfaces The depth of the injection may vary from subcutaneous to supraperiostal administration depending on the treatment site • Buttocks • Calves • Correction of concave deformities • Regio zygomatica

Duration

The degree and duration of the correction depend on the character of the defect treated, the tissue stress at the implant site, the depth of the implant into the tissue and the injection technique

Needle TWN

Not supplied

Suggested cannulas

Not supplied

Trade name

Hyacorp L

Company

Bioscience GmbH

Volume/Package

2 ml

Certifications

CE

First commercialization in Italy

2009

Aree di vendita

Italy, all European countries, Japan and Middle East

Description

Hyacorp is a clear and viscous gel supplied in a special syringe of 2 ml. The product is for single use only. The gel consists of cross-linked hyaluronic acid non-animal source. The particle size is approx. 350 l

Intended use

Restoration of the volume and contour of the body surfaces and the face. The depth of the injection may vary from subcutaneous to supraperiostal administration depending on the treatment site

Duration

The duration of the filling effect can vary and is depending of the depth and area of injection

Needle TWN

22G 9 1 1/4

Suggested cannulas

Not supplied

Trade name

Hyacorp face

Company

Bioscience GmbH

Volume/Package

1 ml

Certifications

CE

First commercialization in Italy

2009

Aree di vendita

All European countries, Japan and Middle East

Description

Hyacorp Face is a clear and viscous gel supplied in a syringe of 1 ml. The product is for single use only. The gel consists of cross-linked hyaluronic acid non-animal source. Particle size approx. 150 l

Intended use

Hyacorp Face is designed to be used for the restoration of the facial volume and contour. The gel is injected intradermal and lifts the tissue in a natural way. Warning: Hyacorp Face is only intended for intradermal administration. Do not inject intravascularly

Duration

The duration of the filling effect can vary and is depending of the depth and area of injection

Needle TWN

27G 9 12 mm

Suggested cannulas

Not supplied

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M. Guareschi

Trade name

Hyacorp lips

Company

Bioscience GmbH

Volume/Package

1 ml

Certifications

CE

First commercialization in Italy

2009

Aree di vendita

All European countries, Japan and Middle East

Description

Hyacorp Lips is a clear and viscous gel supplied in a syringe of 1 ml. The product is for single use only. The gel consists of cross-linked hyaluronic acid non-animal source. Particle size approx. 150 l

Intended use

Hyacorp Lips is designed to be used for the restoration of volume and contouring of the Lips. The gel is injected intradermal and lifts the tissue in a natural way. Warning: Hyacorp Lips is only intended for intradermal administration. Do not inject intravascularly

Duration

The duration of the filling effect can vary and is depending of the depth and area of injection

Suggested Needle

30 G Nano needle

Suggested cannulas

Not supplied

Trade name

Hyacorp fine

Company

Bioscience GmbH

Volume/Package

1 ml

Certifications

CE

First commercialization in Italy

2012

Aree di vendita

All European countries, Japan and Middle East

Description

Hyacorp Fine is a sterile, apyrogenic, visco-elastic, biologically compatible (non-immunizing, non-inflammatory, non-toxic) gel implant that is insoluble in water and produced from a hyaluronic acid gained through fermentation

Intended use

Hyacorp Fine is implanted into the medium dermal tissue to supplement the intercellular matrix and the intradermal tissue and to restore lost anatomical structures of the skin. Its mechanism of action is based on the latest biotechnology in the production of highly purified hyaluronic acid

Duration

The duration of the filling effect can vary and is depending of the depth and area of injection

Suggested Needle

34 G Nano needle

Suggested cannulas

Not supplied

Trade name

Ephyal

Company

Bioscience GmbH

Volume/Package

50 ml

Certifications

CE

First commercialization in Italy

2012

Aree di vendita

Italy, Russia and Ukraine

Description

Ephyal Solution is a sterile medical device, certified by the notified body DQS in Frankfurt/Germany with the CE mark 0297. It contains hyaluronic acid non-animal source with a special designed molecular weight

Intended use

Ephyal is indicated for areas with thin and dry skin. Regions to treat are neck, face, décolleté and hands

Duration

No published data. Supposed to be up to 6 months

Suggested Needle

Not supplied

24

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275

Juve´derm HydrateTM

Trade name

Juvéderm HydrateTM

Company

ALLERGAN

Certification

CE Mark

Year CE mark receipt

2008 [1]

Volume/Package

One syringe contains 1 ml of Juvéderm HYDRATETM Each box contains 1 syringe of Juvéderm HYDRATETM, 2 sterile 30 G1/600 for single use reserved for injection of Juvéderm HYDRATETM, an instruction leaflet and a set of labels in order to ensure traceability [1]

Intended Use

Juvéderm HYDRATETM is a solution indicated for use in improving skin hydration and elasticity by multi-injection into the dermo-epidermal junction and into the superficial dermis [1]

Description

Juvéderm HYDRATETM is sterile, physiological solution of hyaluronic acid of non-animal origin containing 0.9 % mannitol. The gel is presented in a graduated pre-filled syringe for single use [1]

Composition

Hyaluronic Acid 13.5 mg Mannitol 9 mg Phosphate buffer pH 7.2 q.s.p. 1 mL

Sterilization

The Juvéderm HYDRATETM filled syringes are sterilized by moist heat The 30 G1/600 needles are sterilized by ethylene oxide [1]

Method of use

This product is designed to be injected by an authorized medical practitioner in accordance with local applicable regulation. The technicality of the latter is essential to the success of the treatment The device must be used by medical practitioners having undertaken specific training in injection techniques [1]

Duration

Not reported in DFU Duration, safety, efficacy and patient’s satisfaction have been reported in a post-marketing surveillance study [2]

Juve´derm HYDRATETM: Reference 1. DFU Juvéderm HYDRATETM 2. Taieb et al. (2012) Hyaluronic acid plus mannitol treatment for improved skin hydration and elasticity. J Cosmet Dermatol 11:87–92

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M. Guareschi

Juvederm ULTRATM RANGE

Trade name

Juvéderm ULTRATM 2

Company

ALLERGAN

Certification

CE Mark

Year CE mark receipt

2007 [1]

Volume/Package

One syringe contains 0.55 ml of Juvederm ULTRA 2 Each box contains two 0.55 mL Juvéderm ULTRA 2 syringes, 2 single-use 30 G1/200 sterile needles to be used only for injecting Juvéderm ULTRA 2, an instruction leaflet and a set of labels in order to ensure traceability [1]

Intended use

Juvéderm ULTRA 2 is an injectable implant used for filling any medium-sized depressions of the skin via mid-dermis injection, as well as for lip definition The presence of lidocaine is meant to reduce the patient’s pain during treatment [1]

Description

Juvéderm ULTRA 2 is a sterile, pyrogen-free, physiological solution of cross-linked hyaluronic acid which is not of animal origin. The gel is presented in a graduated, pre-filled, disposable syringe [1]

Composition

Hyaluronic acid gel 24 mg Lidocaine hydrochloride 3 mg Phosphate buffer pH 7.2 q.s. 1 ml [1]

Sterilization

The contents of the Juvéderm ULTRA 2 syringes are sterilized by moist heat The 30 g1/200 needles are sterilized by radiation [1]

Method of use

This product is designed to be injected into the dermis or the mucous membrane of the lips by an authorized medical practitioner in accordance with local applicable regulation. As precision is essential to a successful treatment, the product must be used by medical practitioners who have undertaken specific training in injection techniques for filling [1]

Not reported in DFU Duration, safety, efficacy and patient’s satisfaction of the Juvederm ULTRA range have been demonstrated in several studies reported in literature [2–8] [1] DFU Juvederm ULTRA 2 Duration

Trade name

Juvéderm ULTRATM 3

Company

ALLERGAN

Certification

CE Mark

Year CE mark receipt

2007 [1]

Volume/Package

Juvéderm ULTRA 3 is available in two volumes: 1.0 mL and 0.8 mL Each box contains two 1.0 (or 0.8) mL Juvéderm ULTRA 3 syringes, 2 single-use 27 G1/200 sterile needles to be used only for injecting Juvéderm ULTRA 3, an instruction leaflet and a set of labels in order to ensure traceability [1]

Intended use

Juvéderm ULTRA 3 is an injectable implant used for filling mid- and/or deep depressions of the skin via mid- and/or deep dermis injection, as well as for lip definition and enhancement The presence of lidocaine is meant to reduce the patient’s pain during treatment [1]

Description

Juvéderm ULTRA 3 is a sterile, pyrogen-free, physiological solution of cross-linked hyaluronic acid which is not of animal origin. The gel is presented in a graduated, pre-filled, disposable syringe [1]

Composition

Hyaluronic acid gel 24 mg Lidocaine hydrochloride 3 mg Phosphate buffer pH 7.2 q.s. 1 mL [1]

Sterilization

The contents of the Juvéderm ULTRA 3 syringes are sterilized by moist heat The 27 G1/200 needles are sterilized by radiation [1]

Method of use

This product is designed to be injected into the dermis or the mucous membrane of the lips by an authorized medical practitioner in accordance with local applicable regulation. As precision is essential to a successful treatment, the product must be used by medical practitioners who have undertaken specific training in injection techniques for filling [1]

Duration

Not reported in DFU

Duration, safety, efficacy and patient’s satisfaction of the Juvéderm ULTRA range have been demonstrated in several studies reported in literature [2–8] [1] DFU Juvederm Ultra 3

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277

Trade name

Juvéderm ULTRATM 4

Company

ALLERGAN

Certification

CE Mark

Year CE mark receipt

2007 [1]

Volume/Package

Juvéderm ULTRA 4 is available in two volumes: 1.0 and 0.8 mL Each box contains two 1.0 (or 0.8) mL Juvéderm ULTRA 4 syringes, 2 single-use 27G1/200 sterile needles to be used only for injecting Juvéderm ULTRA 4, an instruction leaflet and a set of labels in order to ensure traceability [1]

Intended use

Juvéderm ULTRA 4 is an injectable implant used for filling any deep depressions of the skin via deep dermis injection, as well as for lip enhancement and cheekbone augmentation The presence of lidocaine is meant to reduce the patient’s pain during treatment [1]

Description

Juvéderm ULTRA 4 is a sterile, pyrogen-free, physiological solution of cross-linked hyaluronic acid which is not of animal origin. The gel is presented in a graduated, pre-filled, disposable syringe [1]

Composition

Hyaluronic acid gel 24 mg Lidocaine hydrochloride 3 mg Phosphate buffer pH 7.2 q.s. 1 mL [1]

Sterilization

The contents of the Juvéderm ULTRA 4 syringes are sterilized by moist heat The 27 G1/200 needles are sterilized by radiation [1]

Method of use

This product is designed to be injected into the dermis or the mucous membrane of the lips by an authorized medical practitioner in accordance with local applicable regulation. As precision is essential to a successful treatment, the product must be used by medical practitioners who have undertaken specific training in injection techniques for filling [1]

Duration

Not reported in DFU Duration, safety, efficacy and patient’s satisfaction of the Juvéderm ULTRA range have been demonstrated in several studies reported in literature [2–8]

[1] DFU Juvederm ULTRA 4 Trade name

Juvéderm ULTRATM SMILE

Company

ALLERGAN

Certification

CE Mark

Year CE mark receipt

2009 [1]

Volume/package

One syringe contains 0.55 mL of Juvéderm ULTRA SMILE. Each box contains two 0.55 mL Juvéderm ULTRA SMILE syringes, 2 single-use 30G1/200 sterile needles to be used only for injecting Juvéderm ULTRA SMILE, an instruction leaflet and a set of labels in order to ensure traceability [1]

Intended use

Juvéderm ULTRA SMILE is an injectable implant used for filling mid- and/or deep depressions of the skin via midand/or deep dermis injection, as well as for lip definition and enhancement The presence of lidocaine is meant to reduce the patient’s pain during treatment [1]

Description

Juvéderm ULTRA SMILE is a sterile, pyrogen-free, physiological solution of cross-linked hyaluronic acid which is not of animal origin. The gel is presented in a graduated, pre-filled, disposable syringe [1]

Composition

Hyaluronic acid gel 24 mg Lidocaine hydrochloride 3 mg Phosphate buffer pH 7.2 q.s. 1 mL [1]

Sterilization

The contents of the Juvéderm ULTRA SMILE syringes are sterilized by moist heat. The 30G1/200 needles are sterilized by radiation [1]

Method of use

This product is designed to be injected into the dermis or the mucous membrane of the lips by an authorized medical practitioner in accordance with local applicable regulation. As precision is essential to a successful treatment, the product must be used by medical practitioners who have undertaken specific training in injection techniques for filling [1]

Duration

Not reported in DFU Duration, safety, efficacy and patient’s satisfaction of the Juvederm ULTRA range have been demonstrated in several studies reported in literature [2–8]

278

M. Guareschi

Juvederm ULTRATM: Reference 1. Juvéderm ULTRATM SMILE 2. Baumann L et al., Juvéderm vs Zyplast, Nasolabial Fold Study Group (2007) Comparison of smooth-gel hyaluronic acid dermal fillers with cross-linked bovine collagen: a multicenter, double-masked, randomized, within-subject study. Dermatol Surg 33(Suppl 2): S128–S135 3. Pinsky et al. Juvedérm injectable gel: A multicenter, double-blind, randomized study of safety and effectiveness [poster]. American Society for Aesthetic Plastic Surgery Annual Meeting, New York, NY, April 19–24

24.9

Juvederm VolbellaTM with Lidocaine

4. Lupo M, et al. (2008) Effectiveness of juvéderm ultra plus dermal filler in the treatment of severe nasolabial folds. Plast Reconstr Surg 121:289–297 5. Smith KC (2007) Practical use of juvederm: early experience. Plast Reconstr Surg 120(6S):67S–73S 6. Smith SR et al. (2010) Duration of wrinkle correction following repeat treatment with juvederm hyaluronic acid fillers. Arch Dermatol Res 302:757–776 7. Wahl G (2008) European evaluation of a new hyaluronic acid filler incorporating lidocaine. J Cosmet Dermatol 7:298 8. Weinkle SH et al. (2009) A multi-center, double-blind, randomized controlled study of the safety and effectiveness of Juvederm injectable gel with and without lidocaine. J Cosmet Dermatol 8(3):205–210

24.9

Juvederm VolbellaTM with Lidocaine

Trade name

Juvederm VolbellaTM with Lidocaine

Company

ALLERGAN

Certification

CE mark

Year CE mark receipt

2011 [1]

Volume/package

The gel is presented in a graduated pre-filled disposable syringe. Each box contains 1 Juvéderm VOLBELLATM with lidocaine syringe, 2 single-use 30G1/200 sterile needles specifically intended for injecting Juvéderm VOLBELLATM with lidocaine, an instruction leaflet and a set of labels in order to ensure traceability [1]

Intended use

• Juvéderm VOLBELLATM with lidocaine is an injectable gel implant intended for the treatment of any fine lines and medium-sized skin depressions due to conditions such as premature [1] • Juvéderm VOLBELLATM with lidocaine can also be used for enhancement and pouting of the lips to correct structural defects such as asymmetry, contour deformities, volume loss [1] • Juvéderm VOLBELLATM with lidocaine is intended to be used via superficial or mid-dermis injection or lips mucosa injection by an authorized medical practitioner [1]

Description

Juvéderm VOLBELLATM with lidocaine is a sterile pyrogen-free physiological solution of cross-linked hyaluronic acid gel which is not of animal origin [1] Its patented VycrossTM technology incorporates short chain HA together with long chain HA to provide more efficient cross-linking and a longer product duration than other HA products [2]

Composition

Hyaluronic acid gel. 15 mg Lidocaine hydrochloride 3 mg Phosphate buffer pH 7.2 q.s.p. 1 mL

Sterilization

The contents of the Juvéderm VOLBELLA is sterilized by moist heat The 30G1/200 needles are sterilized by radiation [1]

Method of use

This product is designed to be injected into the dermis or the mucous membrane of the lips by an authorized medical practitioner in accordance with local applicable regulation Use of the supplied 30G1/200 needle is recommended. However, depending on the medical practitioner’s preferred injection technique, it is possible to use a 30-G sterile cannula (please refer to the DFU for more details). Choice of cannula length is determined by the user according to his/her injection technique The technicality of the latter being essential to the success of the treatment, the device must be used by medical practitioners having undertaken specific training in injection techniques for filling skin depressions and for enhancement and pouting of the lips [1]

Duration

Not reported in the DFU. Duration, safety, efficacy and patient’s satisfaction have been demonstrated in a study reported in literature [2]

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279

Juvederm VolbellaTM with Lidocaine: Reference 1. DFU Juvederm Volbella with Lidocaine

2. Eccleston D et al. (2012) Juvéderm VolbellaTM in the perioral area: a 12 month prospective, multicenter, openlabel study. Clin Cosmetic Invest Dermatol 5:167–172

24.10 24.10

Juve´derm VolumaTM

Juve´derm VolumaTM

Trade name

Juvéderm VolumaTM

Company

ALLERGAN

Certification

CE Mark

Year CE mark receipt

2008 [1]

Volume/package

One syringe contains 2 mL of Juvéderm VolumaTM Each box contains 1 syringe of Juvéderm VolumaTM, 2 single-use 23G100 U.T.W (Ultra Thin Wall) needles and 2 single-use 18G, 70-mm cannulae intended only for injecting Juvéderm VolumaTM, an instruction leaflet and a set of labels to ensure traceability [1]

Intended use

Juvéderm VolumaTM is an injectable implant intended to restore volume to the face [1]

Description

Juvéderm VolumaTM is a sterile, non-pyrogenic, physiological gel of cross-linked hyaluronic acid that is not of animal origin. The gel is presented in a pre-filled, single-use syringe [1]

Composition

Hyaluronic acid gel 20 mg Phosphate buffer pH 7.2 q.s. 1 mL [1]

Sterilization

The contents of the Juvéderm VolumaTM syringes are sterilized by moist heat The 23 G100 U.T.W (Ultra Thin Wall) needles are sterilized by ethylene oxide. The 18G, 70-mm cannulae are sterilized by ethylene oxide [1]

Method of use

This product is intended to be injected slowly into the deep dermis, subcutaneously, or in the upper periostea by an authorized medical practitioner in accordance with local applicable regulation [1]

Duration

Not reported in DFU Duration, safety, efficacy and patient’s satisfaction have been demonstrated in studies reported in literature [2–4]

[1] DFU Juvederm VOLUMA

24.11

Juve´derm Voluma (1 ml)

TM

with Lidocaine

24.11

Juve´derm VolumaTM with Lidocaine (1 ml)

Trade name

Juvéderm VolumaTM with Lidocaine

Company

ALLERGAN

Certification

CE Mark

Year CE mark receipt

2009 [1]

Volume/package

One syringe contains 1 mL of Juvéderm Voluma with lidocaine. Each box contains 2 syringes of Juvéderm Voluma with lidocaine, 4 single-use 27 G1/200 sterile needles intended only for injecting Juvéderm with Lidocaine Voluma with lidocaine, an instruction leaflet and a set of labels to ensure traceability [1]

Intended use

Juvéderm VolumaTM with lidocaine is an injectable implant intended to restore volume of the face The presence of lidocaine is meant to reduce the patient’s pain during treatment [1] (continued)

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M. Guareschi

(continued) Trade name

Juvéderm VolumaTM with Lidocaine

Description

Juvéderm VolumaTM with lidocaine is a sterile, non-pyrogenic, physiological gel of cross-linked hyaluronic acid that is not of animal origin. The gel is presented in a pre-filled, single-use syringe [1]

Composition

Hyaluronic acid gel 20 mg Lidocaine hydrochloride 3 mg Phosphate buffer pH 7.2 q.s. 1 mL [1]

Sterilization

The contents of the Juvéderm VolumaTM with lidocaine syringes are sterilized by moist heat The 27 G1/200 needles are sterilized by radiation [1]

Method of use

This product is intended to be injected slowly into the deep dermis, subcutaneously, or in the upper periostea by an authorized medical practitioner in accordance with local regulation [1]

Duration

Not reported in DFU There are no clinical data specific on the formulation with lidocaine but you can refer on the published articles on Juvéderm VolumaTM [2–4]

[1] DFU Juvederm with Lidocaine (1mL)

24.12

Juve´derm VolumaTM with Lidocaine (2 ml)

Trade name

Juvéderm VolumaTM with Lidocaine

Company

ALLERGAN

Certification

CE Mark

Year CE mark receipt

2009 [1]

Volume/package

One syringe contains 2 mL of Juvederm Voluma with lidocaine. Each box contains 1 syringe of Juvederm Voluma with lidocaine, 2 single-use 23 G/100 U.T.W (Ultra Thin Wall) needles and 2 single-use 18G, 70-mm cannulae intended only for injecting Juvederm Voluma with lidocaine, an instruction leaflet and a set of labels to ensure traceability [1]

Intended use

Juvéderm VolumaTM with lidocaine is an injectable implant intended to restore volume of the face The presence of lidocaine is meant to reduce the patient’s pain during treatment [1]

Description

Juvéderm VolumaTM with lidocaine is a sterile, non-pyrogenic, physiological gel of cross-linked hyaluronic acid that is not of animal origin. The gel is presented in a pre-filled, single-use syringe [1]

Composition

Hyaluronic acid gel 20 mg Lidocaine hydrochloride 3 mg Phosphate buffer pH 7.2 q.s. 1 mL [1]

Sterilization

The contents of the Juvederm Voluma with lidocaine syringes are sterilized by moist heat The 23 G/100 U.T.W (Ultra Thin Wall) needles are sterilized by ethylene oxide The 18G, 70-mm cannulae are sterilized by ethylene oxide [1]

Method of use

This product is intended to be injected slowly into the deep dermis, subcutaneously, or in the upper periostea by an authorized medical practitioner in accordance with local regulation [1]

Duration

Not reported in DFU There are no clinical data specific on the formulation with lidocaine but you can refer on the published articles on Juvederm VolumaTM [2–4]

Juvederm Voluma: Reference 1. DFU Juvéderm VOLUMATM with Lidocaine 2. Hoffmann K (2009) Volumizing effects of a smooth, highly cohesive, viscous 20 mg/ml hyaluronic acid volumizing filler: prospective European study. BMC Dermatol 9:9

3. Carruthers J et al. (2009) Volumizing with a 20 mg/ml smooth, highly cohesive, viscous hyaluronic acid filler and its role in facial rejuvenation therapy. Dermatol Surg 36:1886–1892 4. Raspaldo H (2008) Volumizing effect of a new hyaluronic acid sub-dermal facial filler: a retrospective analysis based on 102 cases. J Cosmetic Laser Therapy 10:134–142

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Products

24.13

281

Juvederm VoliftTM with Lidocaine

Trade name

Juvéderm VOLIFTTM with Lidocaine

Company

ALLERGAN

Certification

CE Mark

Year CE mark receipt

2011 [1]

Volume/package

The gel is presented in a graduated, pre-filled, disposable syringe. Each box contains two 1mL Juvéderm VOLIFTTM with Lidocaine syringes, 4 single-use 30G1/200 sterile needles to be used only for injecting Juvéderm VOLIFTTM with Lidocaine, an instruction leaflet and a set of labels in order to ensure traceability [1]

Intended use

• Juvéderm VOLIFTTM with Lidocaine is an injectable gel implant intended for the treatment of any deep skin depressions due to conditions such as premature aging [1] • Juvéderm VOLIFTTM with Lidocaine can also be used for face contouring and volume restoration to correct facial structural defects such as asymmetry, contour deformities, volume loss in the lips, cheeks, chin, lower face [1] • Juvéderm VOLIFTTM with Lidocaine is intended to be used via deep dermis or lips mucosa injection by an authorized medical practitioner [1] • The presence of lidocaine is meant to reduce the patient’s pain during treatment [1]

Description

Juvéderm VOLIFTTM with Lidocaine is a sterile pyrogen-free physiological solution of cross-linked hyaluronic acid which is not of animal origin [1]. Its patented VycrossTM technology incorporates short chain HA together with long chain HA to provide more efficient crosslinking and a longer product duration than other HA products [2]

Composition

Hyaluronic Acid gel 17.5 mg Lidocaine hydrochloride 3 mg Phosphate buffer pH 7.2 q.s. 1 mL

Sterilization

The contents of the Juvéderm VOLIFTTM with Lidocaine syringes are sterilised by moist heat. The 30G1/200 needles are sterilised by radiation

Method of use

This product is designed to be injected into the dermis or the mucous membrane of the lips by an authorized medical practitioner in accordance with local applicable regulation. Use of the supplied 30 G 1/200 needle is recommended. However, depending on the medical practitioner’s preferred injection technique, it is possible to use a 25 G, 27 G or 30 G sterile cannula (please refer to the DFU for more details). Choice of cannula length is determined by the user according to his/her injection technique. For lip indication, the use of 25G00 cannula (please refer to the DFU for more details) is not recommended. As precision is essential to a successful treatment, the product must be used by medical practitioners who have undertaken specific training in injection techniques for filling skin depression and volume restoration.

Duration

Not reported in DFU

Reference 1. DFU Juvederm Volift with Lidocaine 2. Eccleston et al. Juvéderm VolbellaTM in the perioral area: a 12-month prospective, multicenter, open-label study Clinical, Cosmetic and Investigational Dermatology 2012:5 167–172

282

24.14

M. Guareschi

Haequeo Range

Trade name

Haequeo

Company

GENETHIA

Volume/Package

1 ml

Certifications

CE-2008

First commercialization

2009

Description

Haequeo is a viscoelastic, monophasic, isotonic, sterile, pyrogen-free, bioresorbable transparent gel consisting of nonanimal cross-linked hyaluronic acid (23 mg/ml) in a physiological buffer system It is cross-linked with BDDE which regulates resorption of the product, providing lasting volume correction

Intended use

Haequeo is an injectable dermal filler used to augment the volume of facial tissues. Haequeo is indicated for injection into the superficial dermis for the correction of superficial wrinkles

Duration

It increases the volume of the dermis for a period of 6–9 months

Needle UTW

27 G (supplied)

Trade name

Haequeo plus

Company

GENETHIA

Volume/Package

1 ml

Certifications

CE-2008

First commercialization

2009

Description

Haequeo is a viscoelastic, monophasic, isotonic, sterile, pyrogen-free, bioresorbable transparent gel consisting of nonanimal cross-linked hyaluronic acid (23 mg/ml) in a physiological buffer system It is cross-linked with BDDE which regulates resorption of the product, providing lasting volume correction

Intended use

Haequeo is an injectable dermal filler used to augment the volume of facial tissues. Haequeo is indicated for injection into the superficial dermis for the correction of deep tissues

Duration

It increases the volume of the dermis for a period of 9–12 months

Needle UTW

27 G (supplied)

24

Products

24.15

283

Macrolane VRF 20 and Macrolane VRF 30

Trade name

Macrolane

Company

Q-Med, a Galderma Division

Volume/Package

10- and 20-ml syringes

Certifications

CE

First commercialization

2008

Description

Macrolane Volume Restoration Factor (VRF) gels, Macrolane VRF20 and Macrolane VRF30 are sterile, transparent gels of stabilized hyaluronic acid of non-animal origin. The products have a pH of 6.0–7.5. Macrolane VRF20 and VRF30 are designed for deep tissue implantation and differ with respect to the physical structure of the gel. Macrolane VRF20 and VRF30 are supplied in plastic syringes with Luer lock

Intended use

Macrolane VRF20 and Macrolane VRF30 are intended to be used for volume restoration and contouring of body surfaces. The products are not intended for facial tissue augmentation. In general, deep subcutaneous administration is recommended. For both products sufficient tissue cover and support are important parameters to achieve a good aesthetic treatment outcome. A minimum of 1 cm skin thickness, including subcutaneous fat, is usually required to attain good results. The choice between Macrolane VRF20 and Macrolane VRF30 is based on an assessment of tissue cover as determined by skin fold measures. Macrolane VRF30 is intended in areas where skin fold thickness is greater. The injection should be made by physicians who have thorough knowledge of the anatomy of the treatment site and are experienced with injection techniques in the relevant area. The treatment facility must be suitable for performance of aseptic procedures

Duration

Macrolane gels act by adding volume to the tissue, thereby restoring and enhancing body contours. The product will be degraded over time

Cannulas

16-G, or wider, blunt cannula. In clinical studies where 20-ml syringes were used, 12-G blunt cannulas were preferred

24.16

NEWEST: Skin Biorevitalization

Trade name

NEWEST

Company

MASTELLI SRL

Volume/Package

Polynucleotides and hyaluronic Acid: 20 mg/ml in 2-ml syringe

Certifications

CE0373—class III MD

First commercialization in Italy

2011

Areas of sales

European registration and Russia

Description

NEWEST is a visco-elastic, non-pyrogenic sterile gel for single use for intradermal implants NEWEST is a medical device containing the original association of polynucleotides (10 mg/ml) and hyaluronic acid (10 mg/ml) Polynucleotides are substances of natural origin, highly purified and re-absorbable that are ubiquitous in our body. Besides their moisturizing properties, they play a trophic action on fibroblasts improving both elasticity and tonicity of the skin. The hyaluronic acid is also one of the major components of the dermal extra-cellular matrix strengthening both mechanical and elastic properties of the tissues. The reduction with age of the hyaluronic acid of endogenous origin alters the epidermal and dermal structures accelerating skin ageing and the onset of wrinkles The two substances mixed together trigger a synergic action consisting in a strong moisturizing effect, induced by both components (hyaluronic acid in particular), combined with the trophic action polynucleotides play on the fibroblasts, these latter recovering and/or improving trophism and tonicity of the skin under these Conditions www.mastelli.com

Intended use

NEWEST moisturizes the tissues, enhances the trophism of the skin and improves the turgidity, elasticity and tonicity of the skin. These effects also foster the re-modelling of striae distensae and depressed scars, in therapeutical protocols customized by the practitioner

Duration

No published data

Needle TWN

2 9 30 G (supplied)

Suggested cannulas

30 G, 27 G (not supplied)

284

24.17

M. Guareschi

PLINEST: Skin Biorevitalization

Trade name

PLINEST

Company

MASTELLI SRL

Volume/Package

Polynucleotides: 20 mg/ml in syringes

Certifications

CE0373—class III MD

First commercialization

2005

Areas of sales

European registration, Russia and other country ongoing

Description

PLINEST is a polynucleotide gel for intradermal implants, visco-elastic, non-pyrogenic, sterile for single use only PLINEST is a medical device containing polynucleotides (20 mg/ml) Polynucleotides are substances of natural origin, highly purified and re-absorbable that are ubiquitous in our body. Besides their moisturizing properties, they play a trophic action on fibroblasts improving both elasticity and tonicity of the skin

Intended use

Thanks to its biochemical, visco-elastic and moisturizing properties, PLINEST improves the turgidity, elasticity and tonicity of the skin. It is also effective on highly fibrous areas, such as striae and scars PLINEST is the ultimate for mature skin, photo ageing, intensive treatments

Duration Needle TWN

2 9 30 G (supplied)

Suggested cannulas

30 G, 27 G (not supplied)

24.18

PLINEST fast: Skin Biorevitalization

Trade name

PLINEST fast

Company

MASTELLI SRL

Volume/Package

Polynucleotides: 7, 5 mg/ml syringes

Certifications

CE0373—class III MD

First commercialization

2008

Areas of sales

European registration, Russia and other country ongoing

Description

PLINEST fast is a polynucleotide gel for intradermal implants, visco-elastic, non-pyrogenic, sterile for single use only PLINEST fast is a medical device containing polynucleotides (7, 5 mg/ml) Polynucleotides are substances of natural origin, highly purified and re-absorbable that are ubiquitous in our body. Besides their moisturizing properties, they play a trophic action on fibroblasts improving both elasticity and tonicity of the skin

Intended use

PLINEST fast thanks to its biochemical, moisturizing and trophic properties and improves the turgidity, elasticity and tonicity of the skin. It also helps remodelling striae and depressed scars and is included in integrated biorestructuring protocols PLINEST fast is the ultimate for fine and delicate skin areas, particular areas like scalp, eye contour, young skin and as maintenance

Duration

No published data

Needle TWN

2 9 30 G (supplied)

Suggested cannulas

30 G, 27 G (not supplied)

24

Products

24.19

285

IALEST: Skin Biorevitalization

Trade name

IALEST

Company

MASTELLI SRL

Volume/Package

Hyaluronic Acid: 20 mg/ml in 2 ml syringe

Certifications

CE0373—class III MD

First commercialization

2008

Areas of sales

European registration, Russia and other country ongoing

Description

IALEST is a medical device based on sodium hyaluronate. It is a sterile, non-pyrogenic, viscoelastic and transparent solution packaged in 2-ml syringes for single use only. Hyaluronic acid is one of the main components of the extracellular matrix. Besides giving tissue mechanical and elastic properties, it takes part in the attraction of fibroblasts, macrophages and endothelial cells and has a scavenger effect against certain free radical. Endogenous hyaluronic acid dramatically decreases with age and this lower concentration contributes to altering epidermal and dermal structures thereby accelerating skin ageing and the onset of wrinkles

Intended use

Thanks to its natural moisturizing function, IALEST remarkably improves skin trophism and texture, considerably increasing skin turgidity and elasticity

Duration Needle TWN

2 9 30 G (supplied)

Suggested cannulas

30 G; 27 G (not supplied)

Reference

1. Cavallini M, Papagni M (2007) Long chain polynucleotides gel and skin biorevitalization. Int J Plastic Dermatol ISPLAD 3(3):27–32

286

24.20

M. Guareschi

Radiesse

24.20.1 Radiesse Filler

Trade name

RADIESSE

Company

Merz Pharma

Certifications

CE, FDA

First commercialization

2008

Market

Europe (Austria, Belgium, Bulgaria, Czech. Republic, Denmark, Estonia, Finland, France, Georgia, Germany, Greece, Hungary, Ireland, Italy, latvia, Lithuania, Luxemburg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Russia, Slovakia, Spain, Sweden, Switzerland, Turkey, Uk and Ukraine), Asia/South Pacific (Australia, Hong Kong, Korea, Malaysia and Taiwan), Africa (Egypt, South Africa and Tunisia), Latin America (Argentina, Brazil, Colombia, Panama and Chile), Middle Est (Iran, Israel, Jordan, KSA, Kuwait, Lebanon, Oman, Qatar and UAE) and North America (Canada, Dominician Rep., Mexico and US)

Description

Radiesse injectable implant is a steam-sterilized, latex-free, non-pyrogenic, semi-solid, cohesive completely biodegradable deep- and sub-dermal implant. The principle components are synthetic calcium hydroxylapatite, a biomaterial with over twenty years of use in orthopedics, neurosurgery, dentistry, otolaryngology and ophthalmology. Calcium hydroxylapatite is the primary mineral constituent of bone and teeth. The semi-solid nature of the implant is created by suspending calcium hydroxylapatite in a gel carrier that consists primarily of water and glycerine. The gel structure is formed by the addition of a small amount of sodium carboxymethylcellulose. The gel is dissipated in vivo and replaced with soft tissue growth, while the calcium hydroxylapatite remains at the site of injection

Intended use

RadiesseTM is approved in the United States (FDA) for the correction of moderate to severe facial folds and wrinkles, including nasolabial folds and for restoration of the signs of facial fat loss (lipoatrophy) in HIV patients. In Europe, RadiesseTM is approved for plastic and reconstructive surgery, including deep-dermal and sub-dermal soft tissue augmentation of the facial area

Duration

The result is long-term yet non-permanent restoration and augmentation. Reported cosmetic improvement until 9–12 months

Needle TWN

27 G 1 or 28 G (supplied)

Suggested cannulas

27 G 1 inch; 27 G 1 inch; 25 G 1 inch; 25 G 2 inch (not supplied)

Radiesse Filler: Reference

1. (2007) Minimizing discomfort during the injection of radiesse with the use of either local anesthetic or ice. Dermatol Online J 13(3):5 2. (2007) Hand augmentation with radiesse (calcium hydroxylapatite). Dermatol Ther (20):385–387 3. (2007) Calcium hydroxylapatite (Radiesse) for correction of the mid- and lower face: consensus recommendations. Plast Reconstruct Surg 120(6 Suppl):55–66 4. (2007) Injectable calcium hydroxylapatite for orbital volume augmentation. Arch Facial Plast Surg 9(6): 439–442 5. (2007) A multicenter, randomized trial comparing calcium hydroxylapatite to two hyaluronic acids for treatment of nasolabial folds. Dermatol Surg 33:S144–S151 6. (2008) Calcium hydroxylapatite versus nonanimal stabilized hyaluronic acid for the correction of nasolabial

folds: a 12-month, multicenter, prospective, randomized, controlled, split-face trial. Dermatol Surg 34:210–215 7. (2008) Use of calcium hydroxylapatite (Radiesse) for facial augmentation. Clin intervent Aging 3(1): 161–174 8 (2008) Aesthetic 338e–339e 9. (2008) Neocollagenesis after injection of calcium hydroxylapatite composition in a canine model. Derm Surg 34:S53–S55 10. (2008) A 52-month summary of results using calcium hydroxylapatite for facial soft tissue augmentation. Derm Surg 34:S9–S15 11. (2008) Adverse cutaneous reactions to soft tissue fillers—a review of the histological features.J Cutan Pathol. 35(6):536–548 12. (2008) Evaluation of injectable calcium hydroxylapatite for the treatment of facial lipoatrophy associated with human immunodeficiency virus. Derm Surg 34(11):1486–1499

24

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287

13. (2009) Hand recontouring with calcium hydroxylapatite (Radiesse). J Cosmet Dermatol, 8(1):44–51 14. (2009) Injectable calcium hydroxylapatite microspheres (radiesse). Facial Plast Surg 25(2):100–5 15. (2010) Controlled, randomized study of pain levels in subjects treated with calcium hydroxylapatite premixed with lidocaine for correction of nasolabial folds. Dermatol Surg 36(3):309–315 16. (2010) Calcium hydroxylapatite (Radiesse) for treatment of nasolabial folds: long-term safety and efficacy results. Aesthetic Surg J 30(2):235–238 17. (2010) Multinational, multipatient study of calcium hydroxylapatite for treatment of the aging hand: European cosmetic physician group on hand augmentation. Dermatol Surg 36 (S1):782–789

24.21

18. (2010) Multicenter, randomized trial assessing the effectiveness and safety of calcium hydroxylapatite for hand rejuvenation. Dermatol Surg 36(S1):790–797 19. (2010) Hand rejuvenation using radiesse. Plast Reconstr Surg 125(6):259e–260e 20. (2010) Ocular ischemia and ischemic oculomotor nerve palsy after vascular emobilation of injectable calcium hydroxylapatite filler. Opthal Plast Reconstr Surg 26(4):289–291 21. (2010) Facial shaping: beyond lines and folds with fillers. J Drugs Dermatol,9(8S):s129–s137 22. (2010) A review of dermal fillers in facial plastic surgery. Curr Opin Otolaryngol Head Neck Surg 18(4):295–302

Restylane Range: Q-Med, A Galderma Division

24.21.1 Restylane Filler

Trade name

Restylane

Company

Q-Med, a Galderma Division

Volume/Package

1, 0.5 ml

Certifications

CE, FDA

First commercialization

1997

Description

Restylane is a sterile, transparent gel of stabilized hyaluronic acid of non-animal origin (20 mg/ml) supplied in a glass syringe with a Luer lock fitting. Disposable sterile needles are provided with each syringe. Restylane is a filler that acts by adding volume to the tissue, thereby supporting the overlying (dermal) tissue to restore the skin contours or enhancing the lips to the desired level of correction. The manufacturing process is based on the patented NASHATM technology, that allows to obtain an gel through a very low degree of synthetic cross-linking (BDDE) while keeping the natural three-dimensional structure of the native HA molecule by preserving its natural entanglements. Higher strength of the HA gel (i.e. a higher resistance to deformation) and superior capacity to lift the tissue are the most important features of the NASHA manufacturing process. Restylane will in time undergo isovolemic degradation, which means that the product maintains its volume even during degradation [1–6]

Intended use

Facial tissue augmentation. It is recommended to be used for the correction of wrinkles and lip enhancement [7]. It should be injected into the middle part of the dermis layer

Duration

The degree and duration of the correction depend on the character of the defect treated, the tissue stress at the implant site, the depth of the implant into the tissue and the injection technique. Documented to last from 6 to 12 months after one treatment according to different clinical studies [1–3]. Documented persistence of the aesthetic results until 18 months after one re-treatment session and until 36 months after two re-treatment sessions [8, 9]. In vivo stimulation of de-novo production of collagen has been shown after injection of Restylane [10]

Needle TWN

29 G  (supplied)

Suggested cannulas

Pix’L 27 G or pix’L 28G reinforced (not supplied)

288

M. Guareschi

Trade name

Restylane Lidocaine

Company

Q-Med, a Galderma Division

Volume/Package

1, 0.5 ml

Certifications

CE, FDA

First commercialization

2009

Description

The same chemical composition such as Restylane with the addition of lidocaine hydrochloride 3 mg/ml. The Restylane formulation with lidocaine has the same chemical and physical characteristics (gel content, particle size, pH and degree of modification) as NASHA-based gel without lidocaine. The addition of lidocaine provides a painrelieving effect during treatment. In a controlled study, Restylane lidocaine was shown to have comparable efficacy and safety profile as Restylane without lidocaine [11]

Intended use

See Restylane

Duration

See Restylane

Needle TWN

29G  (supplied)

Suggested cannulas

Pix’L 27 G or pix’L 28G reinforced (not supplied)

Trade name

Restylane Perlane

Company

Q-Med, a Galderma Division

Volume/Package

1, 0.5 ml

Certifications

CE, FDA

First commercialization in Italy

2000

Description

Stabilized hyaluronic acid of non-animal origin (20 mg/ml) supplied in a glass syringe with a Luer lock fitting. The volume and the lifting capacity originate from the ability of hyaluronic acid to attract high amount of water, which is further increased by the stabilization process. Restylane Perlane will in time undergo isovolumic degradation, which means that the product maintains its volume even during degradation

Intended use

Restylane Perlane is intended to be used for facial tissue augmentation. It is recommended to be used for shaping the contours of the face, the correction of folds and for lip enhancement. It should be injected into the deep layer of the dermis and/or the surface layer of the subcutis. For facial areas with limited soft tissue support and soft tissue cover, e.g., the periorbital region, injection into the subcutaneous fatty tissue or supraperiostal administration is recommended

Duration

Restylane Perlane for the correction of nasolabial folds, 75 % of the subjects maintained a clinically significant improvement 6 months after treatment [11]

Needle TWN

29G  (supplied)

Suggested cannulas

Pix’L 23 G or 25G or pix’L 28 G reinforced (not supplied)

Trade name

Restylane Perlane Lidocaine

Company

Q-Med, a Galderma Division

Volume/Package

1, 0.5 ml

Certifications

CE, FDA

First commercialization in Italy

2009

Description

The same chemical and physical composition such as Restylane Perlane with the addition of lidocaine hydrochloride 3 mg/ml. The addition of lidocaine provides a pain-relieving effect during the treatment

Intended use

See Restylane Perlane

Duration

In a randomized controlled 12 months follow-up study, Restylane Perlane with lidocaine was comparable to Restylane Perlane alone in terms of aesthetic efficacy [13]

Needle TWN

29G  (supplied)

Suggested cannulas

Pix’L 23 G or 25G or pix’L 28 G reinforced (not supplied)

24

Products

289

Trade name

Restylane SubQ

Company

Q-Med, a Galderma Division

Volume/Package

2 ml

Certifications

CE

First commercialization in Italy

2004

Description

Restylane SubQ is a sterile, transparent gel of 20 mg/ml stabilized hyaluronic acid of non-animal origin. It is supplied in a glass syringe with a Luer lock fitting. The mode of action into the tissue is comparable to the other NASHA formulations

Intended use

Intended to be used for facial tissue augmentation. It is recommended to be used for shaping the contours of the face, e.g., more pronounced cheeks or chin [14–16]. The depth of injection may vary from injection into the subcutaneous fatty tissue to supraperiostal administration depending on the treatment site. Restylane SubQ shall only be injected by practitioners with expertise in the correction of volume defects in the facial area

Duration

Reported cosmetic improvement until 9–12 months in the studies [14, 15]

Suggested Needle

21G (not supplied)

Suggested cannulas

16–21 G (pix’L 21 G)(not supplied)

Trade name

Restylane SubQ Lidocaine

Company

Q-Med, a Galderma Division

Volume/Package

2 ml

Certifications

CE

First commercialization in Italy

2012

Description

Restylane SubQ is a sterile, transparent gel of 20 mg/ml stabilized hyaluronic acid of non-animal origin with the addition of 0.3 % lidocaine hydrochloride. It is supplied in a glass syringe with a Luer lock fitting. The mode of action into the tissue is comparable to the other NASHA formulations

Intended use

See Restylane SubQ

Duration

No published data on the formulation with lidocaine. Supposed to be as long-lasting as Restylane SubQ without lidocaine

Suggested Needle

21G (not supplied)

Suggested cannulas

16–21 G (pix’L 21 G) (not supplied)

Trade name

Restylane Lip Volume

Company

Q-Med, a Galderma Division

Volume/Package

1 ml

Certifications

CE

First commercialization in Italy

2012

Description

Restylane Lip Volume is a sterile, transparent, biodegradable gel of 20 mg/ml stabilized hyaluronic acid of nonanimal origin with the addition of 0.3 % lidocaine hydrochloride

Intended use

Intended for lip enhancement. It should be administered by submucosal injection

Duration

No published data. Supposed to be up to 6 months

Needle TWN

29G  (supplied)

Suggested cannulas

Pix’L 25 G or 27G (not supplied)

290

M. Guareschi

Trade name

Restylane Lip Refresh

Company

Q-Med, a Galderma Division

Volume/Package

1 ml

Certifications

CE

First commercialization in Italy

2012

Description

Restylane Lip Refresh is a sterile, transparent, biodegradable gel of stabilized hyaluronic acid of non-animal origin with the addition of 0.3 % lidocaine hydrochloride It is supplied in a glass syringe. It is naturally integrated into the tissue where it helps to restore hydro balance and improve skin structure of the lips. This is accomplished by the water associated with the stabilized hyaluronic acid in the gel

Intended use

Restylane Lip Refresh is intended to restore hydro balance and improve skin structure of the lips. It should be administered by submucosal injection

Duration

No published data. Supposed to be up to 6 months

Needle TWN

30G  (supplied)

Suggested cannulas

Pix’L 27 G (not supplied)

Restylane Filler: Reference

1. Olenius M (1998) The first clinical study using a new biodegradable implant for the treatment of lips, wrinkles and folds. Aesth Plast Surg 22:97–101 2. Duranti F, Salti G, Bovani B, Calandra M, Rosati ML (1998) Injectable hyaluronic acid gel for soft tissue augmentation. A clinical and histological study. Dermatol Surg 24(12):1317–1325 3. Narins RS, Brandt F, Leyden J, et al. (2003) A randomized, double-blind,multicenter comparison of the efficacy and tolerability of Restylane versus Zyplasts for the correction of nasolabial folds. Dermatol Surg 29 (6):588–595 4. Edsman K,Lars I, Nord LI, Öhrlund A et al. (2012) Gel properties of hyaluronic acid dermal fillers. Dermatol Surg 38:1170–1179 5. Friedman PM, Mafong EA, Kauvar ANB, et al. (2002) Safety data of injectable nonanimal stabilized hyaluronic acid gel for soft tissue augmentation. Dermatol Surg 28:491–494 6. Hamilton RGH, ABMLI D, Strobos J, Adkinson F (2007) Immunogenicity studies of cosmetically administered nonanimal-stabilized hyaluronic acid particles. Dermatol Surg 33:S176–S185 7. Matarasso SL, Carruthers JD, Jewell ML (2006) Consensus recommendations for soft tissue augmentation with nonanimal stabilized hyaluronic acid (Restylane).Plast Reconstr Surg 117:3S-34S; discussion 5S–43S 8. Narins RS, Dayan SH, Brandt FS e Baldwin EK (2008) Persistence and improvement of nasolabial fold correction with nonanimal-stabilized hyaluronic acid 100,000 gel particles/ml filler on two retreatment schedules: results up to 18 months on two retreatment schedules. Dermatol Surg 34:S2–S8

9. Narins RS, Brandt FS, Dayan SH, Hornfeldt CS (2011) Persistence of naso-labial fold correction with a hyaluronic acid dermal filler with retreatment: results of an 18-month extension study. Dermatol Surg 37:1–7 10. Wang F, Garza LA, Kang S et al. (2007) In vivo stimulation of de novo collagen production caused by crosslinked hyaluronic acid dermal filler injections in photodamaged human skin. Arch Dermatol 143:155–163 11. Weiss R, Bank D, Brandt F. (2010) Randomized, double-blind, split-face study of small gel particle hyaluronic acid with and without lidocaine during correction of nasolabial folds. Dermatol Surg 36:750–759 12. Lindqvist C, Tveten S, Bondevik BE, Fagrell D (2005) A randomized, evaluator-blind, multicenter comparison of the efficacy and tolerability of Perlane versus Zyplast in the correction of nasolabial folds. Plast Reconstr Surg 115(1):282–289 13. Heden P, Fagrell D, Jernbeck J et al. (2010) Injection of stabilized hyaluronic acid-based gel of non-animal origin for the correction of naso-labial folds: comparison with and without lidocaine. Dermatol Surg 36:775–781 14. Wu W, Carlisle I, Huang P, Ribé N, Russo R, Schaar C, Verpaele A, Strand A. 2009 Novel Administration Technique for Large-Particle Stabilized Hyaluronic Acid-Based Gel of Nonanimal Origin in Facial Tissue Augmentation. Aesthetic Plast Surg. Nov 19 (Epub ahead of print) 15. De Lorenzi C, Weinberg M, Solish N, Sweift A. (2009) The long-term efficacy and safety of a subcutaneously injected large-particle stabilized hyaluronic acid-based gel of nonanimal origin in esthetic facial contouring. Dermatol Surg 2009 35:313–321 16. Lowe NJ, Grover R. (2006) Injectable hyaluronic acid implant for malar and mental enhancement. Dermatol Surg 32:881–885

24

Products

24.22

291

Range Restylane Vital

Trade names

Restylane Vital/Restylane Vital Injector/ Restylane Vital Lidocaine/Restylane Vital Injector Lidocaine

Company

Q-med a galderma division

Volume/Package

Syringe: 1 ml; Injector: 2 ml

Certifications

CE

First commercialization

2004 (Restylane Vital); 2009 (Restylane Vital Injector)

Description

Sterile, transparent gel of stabilized hyaluronic acid of non-animal origin 20 mg/ml supplied in a 1-ml glass syringe or a 2-ml pre-filled injector, both with a Luer lock fitting. Restylane Vital is naturally integrated into the skin where it helps to restore skin hydro balance and improve skin structure and the elasticity of the skin. This is accomplished by the water associated with the stabilized hyaluronic acid in the gel. The unique characteristics of the gel help maintain the effect for a long period of time. The addition of 0.3 % lidocaine hydrochloride in Restylane Vital lidocaine and Restylane Vital lidocaine Injector provides increased overall treatment comfort

Intended use

Restylane Vital is intended to restore skin hydro balance and improve skin structure and the elasticity of the skin. It should be injected in the dermal layer of the skin, preferably in the deeper part of dermis. A treatment plan for Restylane Vital is recommended with three treatments 4 weeks apart. Generally, it is recommended to repeat the treatment plan every 6 months, but results and patient preferences may vary

Duration

In clinical studies with Restylane Vital, patients experienced significant improvement in dermal elasticity and skin morphology up to 6 months after initial treatment [1–4]

Needle

Syringe: 30G 1/2; Injector: TWN 29G  (supplied)

Suggested cannula

Pix’L 27 G or 30G (with syringe)

2011 (Restylane Vital lidocaine); 2011 (Restylane Vital lidocaine Injector)

Cost

Trade names

Restylane Vital Light/Restylane Vital Light Injector/ Restylane Vital Light Lidocaine/Restylane Vital Light Injector Lidocaine

Volume/Package

Syringe: 1 ml; Injector : 2 ml

Certifications

CE

First commercialization

2008 (Restylane Vital Light); 2008 (Restylane Vital Light Injector)

Description

Sterile, transparent gel of stabilized hyaluronic acid of non-animal origin 12 mg/ml, supplied in a 1-ml glass syringe or a 2-ml pre-filled injector, both with a Luer lock fitting. Restylane Vital is naturally integrated into the skin where it helps to restore skin hydro balance and improve skin structure and the elasticity of the skin. This is accomplished by the water associated with the stabilized hyaluronic acid in the gel. The unique characteristics of the gel help maintain the effect for a long period of time. The addition of 0.3 % lidocaine hydrochloride in Restylane Vital lidocaine and Restylane Vital lidocaine Injector provides increased overall treatment comfort

Intended use

Restylane Vital is intended to restore skin hydro balance and improve skin structure and the elasticity of the skin. It should be injected in the dermal layer of the skin. A treatment plan for Restylane Vital is recommended with three treatments 4 weeks apart. Generally, it is recommended to repeat the treatment plan every 6 months, but results and patient preferences may vary

Duration

In clinical studies with Restylane Vital, patients experienced significant improvement in dermal elasticity and skin morphology up to 6 months after initial treatment [1–5]

Needle

Syringe: 30G  Injector: TWN 29G  (supplied)

2011 (Restylane Vital Light lidocaine); 2011 (Restylane Vital Light Injector lidocaine)

292

M. Guareschi

Range Restylane Vital: Reference 1. Kerscher M, Bayrhammer J, Reuther T (2008) Rejuvenating influence of a stabilised hyaluronic acid-based gel of nonanimal origin on facial skin aging. Dermatol Surg 34:1–7 2. Williams S, Tamburic S, Stensvik H, Weber M (2009) Changes in skin physiology and clinical appearance after microdroplet placement of hyaluronic acid in aging hands. J. Cosm Dermatol 8:216–225 3. Distante F, Pagani V, Bonfigli A (2009) Stabilized Hyaluronic Acid of Non-animal origin for

rejuvenating the skin of the upper arm. Dermatol Surg 35:389–394 4. Reuther T, Bayrhammer J, Kerscher M (2010). Effects of a three-session skin rejuvenation treatment using stabilized hyaluronic acid-based gel of non-animal origin on skin elasticity: a pilot study. Arch Dermatol Res 302(1):37–45 5. Ribé NA & Ribé N (2011) Neck skin rejuvenation: Histological and clinical changes after combined therapy with a fractional non-ablative laser and stabilized hyaluronic acid-based gel of non-animal origin. J Cosmet Laser Ther 13(4):154–61

24.23

Surgiderm Range

24.22.1 Surgiderm18

24.22.2 Surgiderm 24XP

24.22.3 Surgiderm 30XP

24.23

Surgiderm Range 24.22.4 Surgiderm 30

24.23.1 Surgiderm18

Trade name

Surgiderm18

Company

ALLERGAN

Certification

CE Mark

Year CE mark receipt

2005 1

Volume/package

One syringe contains 0.8 ml of Surgiderm 18. Each box contains two 0.8-ml syringes, four single-use 30G1/200 sterile needles, an instruction leaflet and a set of labels to ensure traceability [1]

Intended use

Surgiderm 18 is an Injectable implant indicated for filling superficial skin depressions by injection in the superficial dermis. It can be also used in Mesolift applications [1]

Description

Surgiderm18 is a sterile pyrogenic-free, physiological solution of cross-linked hyaluronic acid which is not of animal origin. The gel is presented in a graduated pre-filled disposable syringe [1]

Composition

Hyaluronic acid gel 18 mg and phosphate buffer pH 7.2 q.s. 1 ml [1]

Sterilization

The contents of the Surgiderm 18 syringes are sterilized by moist heat. The 30G1/2needles are sterilized by radiation [1]

Method of use

This product is designed to be injected into the dermis by an authorized medical practitioner in accordance with local applicable regulation. As precision is essential to a successful treatment, the product must be used by medical practitioners who have undertaken specific training in injection techniques for filling [1]

Duration

Not reported in DFU

24

Products

293

24.23.2 Surgiderm 24XP

Trade name

Surgiderm 24XP

Company

ALLERGAN

Certification

CE Mark

Year CE mark receipt

2005 1

Volume/package

One syringe contains 0.8 ml of Surgiderm 24XP Each box contains two 0.8-ml syringes, four single-use 30G1/200 sterile needles, an instruction leaflet and a set of labels to ensure traceability [1]

Intended use

Surgiderm 24XP is an Injectable implant used for filling any medium depression of the skin via mid-dermis injection, as well as for definition and pouting of the lips [1]

Description

Surgiderm 24XP is a sterile pyrogenic-free, physiological solutions of cross-linked hyaluronic acid which is not of animal origin. The gel is presented in a graduated pre-filled disposable syringe [1]

Composition

Hyaluronic acid gel 24 mg and phosphate buffer pH 7.2 q.s. 1 ml [1]

Sterilization

The contents of the Surgiderm 24XP syringes are sterilized by moist heat. The 30G1/2needles are sterilized by radiation [1]

Method of use

This product is designed to be injected into the dermis by an authorized medical practitioner in accordance with local applicable regulation. As precision is essential to a successful treatment, the product must be used by medical practitioners who have undertaken specific training in injection techniques for filling [1]

Duration

Not reported in DFU

24.23.3 Surgiderm 30XP

Trade name

Surgiderm 30XP

Company

ALLERGAN

Certification

CE Mark

Year ce mark receipt

2005 1

Volume/package

One syringe contains 0.8 ml of Surgiderm 30XP. Each box contains two 0.8-ml syringes, four single-use 27G1/200 sterile needles, an instruction leaflet and a set of labels to ensure traceability [1]

Intended use

Surgiderm 30XP is an Injectable implant used for filling mid- and/or deep depression of the skin via mid- and/or deep dermis injection, as well as for volume increase, definition and pouting of the lips [1]

Description

Surgiderm 30XP is a sterile pyrogenic-free, physiological solution of cross-linked hyaluronic acid which is not of animal origin. The gel is presented in a graduated pre-filled disposable syringe [1]

Composition

Hyaluronic acid gel 24 mg and phosphate buffer pH 7.2 q.s. 1 ml [1]

Sterilization

The contents of the Surgiderm 30XP syringes are sterilized by moist heat. The 27G1/2needles are sterilized by radiation [1]

Method of use

This product is designed to be injected into the dermis by an authorized medical practitioner in accordance with local applicable regulation. As precision is essential to a successful treatment, the product must be used by medical practitioners who have undertaken specific training in injection techniques for filling [1]

Duration

Not reported in DFU

294

M. Guareschi

24.23.4 Surgiderm 30

Trade name

Surgiderm 30

Company

ALLERGAN

Certification

CE Mark

Year ce mark receipt

2005 1

Volume/package

One syringe contains 0.8 ml of Surgiderm 30. Each box contains two 0.8-ml syringes, four single-use 27G1/200 sterile needles, an instruction leaflet and a set of labels to ensure traceability [1]

Intended use

Surgiderm 30 is an injectable implant used for filling any deep depression of the skin via deep dermis injection, as well as for lip enhancement and cheekbone augmentation [1]

Description

Surgiderm 30 is a sterile pyrogenic-free, physiological solution of cross-linked hyaluronic acid which is not of animal origin. The gel is presented in a graduated pre-filled disposable syringe [1]

Composition

Hyaluronic acid gel 24 mg and phosphate buffer pH 7.2 q.s. 1 ml [1]

Sterilization

The contents of the Surgiderm 30 syringes are sterilized by moist heat. The 27G1/2needles are sterilized by radiation [1]

Method of use

This product is designed to be injected into the dermis by an authorized medical practitioner in accordance with local applicable regulation. As precision is essential to a successful treatment, the product must be used by medical practitioners who have undertaken specific training in injection techniques for filling [1]

Duration

Not reported in DFU

24.24

Vistabex

VISTABEX



Company

ALLERGAN

Trade Name

Vistabex, 4 allergan units/0.1 ml, powder for solution for injection

Intended Use

Vistabex is indicated for the temporary improvement in the appearance of moderate to severe vertical lines between the eyebrows seen at frown, in adults\65 years old, when the severity of these lines has an important psychological impact for the patient (1)

Description Qualitative and quantitative composition (1)

Botulinum toxin type A1—4 allergan units per 0.1 ml of reconstituted solution 1 of Clostridium botulinum Allergan units are not interchangeable with other preparations of botulinum toxin Vial of 50 units

Pharmaceutical Form

Powder for solution for injection White Powder

Posology

Reconstituted Vistabex (50 U/1.25 ml) is injected using a sterile 30-gauge needle. 0.1 ml (4 U) is administered in each of the 5 injection sites: 2 injections in each corrugator muscle and 1 injection in the procerus muscle for a total dose of 20 U (continued)

24

Products

295

(continued) VISTABEX



Clinical Data

As stated in the SPC, 537 patients with moderate to severe vertical lines between the eyebrows (glabellar lines) at maximum frown have been included in clinical studies Vistabex injections significantly reduced the severity of glabellar lines for up to 4 months, as measured by the investigator assessment of glabellar line severity at maximum frown and by subject’s global assessment of change in appearance of his/her vertical lines between the eyebrows (glabellar lines). None of the clinical endpoints included an objective evaluation of the psychological impact. Thirty days after injection, 80 % (325/405) of Vistabex-treated patients were considered by investigators as treatment responders (none or mild severity at maximum frown), compared to 3 % (4/132) of placebo-treated patients. At this same time point, 89 % (362/405) of Vistabel-treated patients felt that they had a moderate or better improvement, compared to 7 % (9/132) of placebo-treated patients Vistabex injections also significantly reduced the severity of glabellar lines at rest. Of the 537 patients enrolled, 39 % (210/537) had moderate to severe glabellar lines at rest (15 % had no lines at rest). Of these, 74 % (119/161) of Vistabex-treated patients were considered treatment responders (none or mild severity) thirty days after injection, compared with 20 % (10/49) of placebo-treated patients Safety and efficacy of Vistabex have been demonstrated in several studies reported in literature [2–9]

Onset of Response and Duration

Improvement of severity of vertical lines between the eyebrows (glabellar lines) generally occurs within one week after treatment. The effect was demonstrated for up to 4 months after injection Treatment intervals should not be more frequent than every three months (1)

Package

Powder in a vial (type I glass) fitted with a stopper (chlorobutyl rubber) and a seal (aluminium); Vial of 50 allergan Units of Botulinum toxin type A—pack of one of two It is possible that not all registered pack sizes are marketed (1)

Shelf Life

3 years (1)

Vistabex: Reference 1. Carruthers et al. (2002) Vistabex summary of product characteristics 2. A multicenter, double-blind, randomized, placebo-controlled study of the efficacy and safety of botulinum toxin type A in the treatment of glabellar lines. J Am Acad Dermatol 46:840–649 3. Carruthers et al. (2003) Double-blind, placebo-controlled study of the safety and efficacy of botulinum toxin type A for patients with glabellar lines. Plast Reconstr Surg 112:1089 4. Fagien et al. (2007) Patient-reported outcomes with botulinum toxin type A treatment of glabellar rhytids: a double-blind, randomized, placebo-controlled study. Dermatol Surg 33:S2–S9 5. Harii et al. (2008) A double-blind, randomized, placebocontrolled, two-dose comparative study of botulinum toxin type A for treating glabellar lines in Japanese subjects. Aesth Plast Surg 32:724–730 6. Wu et al. (2010) Botulinum toxin type A for the treatment of glabellar lines in Chinese: a double-

blind, randomized, placebo-controlled study. Dermatol Surg 7. Dailey et al. (2011) Long-term treatment of glabellar rhytides using onabotulinumtoxinA. Dermatol Surg 37:918–928 8. Stotland et al. (2007) Patient-reported benefit and satisfaction with botulinum toxin type A treatment of moderate to severe glabellar rhytides: results from a prospective open-label study. Plast Reconstr Surg 120:1386 9. Carruthers et al. (2004) One-year, randomised, multicenter, two-period study of the safety and efficacy of repeated treatments with botulinum toxin type A in patients with glabellar lines. J Clin Res 7:1–20

24.25

Summary

An overview of the products described in the previous paragraphs is given in Table 24.1, with information about class, association with lidocaine, company, and areas where they are commercialized.

296

M. Guareschi

Table 24.1 Overview of the most common materials used in aesthetic medicine Commercial name

Class

Lidocaine

Company

Commercialization

Chapter

Azzalure (dysport)

Botulinum toxin

No

Galderma

Europe

24.1

Belotero basic

Medium viscosity HA

No

Merz Pharma

Austria, Germany, Italy, Russia, Switzerland, UK and USA

24.2

Belotero soft

Low viscosity HA

No

Merz

Austria, Germany, Italy, Russia, Switzerland, UK and USA

24.2

Belotero intense

Medium viscosity HA

No

Merz

Austria, Germany, Italy, Russia, Switzerland, UK and USA

24.2

Bocouture (Xeomin, Xeemin)

Botulinum toxin

No

Merz

Argentina, Austria, Belgium, France Germany, Italy, Mexico, Netherlands, Portugal, Russia, Spain, Sweden, UK and USA

24.3

Botox (Vistabex Vistabel)

Botulinum toxin

No

Allergan

Europe, USA, Asia

24.23

Emervel touch

Low viscosity HA

No

Galderma

Europe

24.4

Emervel classic

Medium viscosity HA

With and without

Galderma

Europe

24.4

Emervel deep

Medium viscosity HA

With and without

Galderma

Europe

24.4

Emervel volume

High viscosity HA

With and without

Galderma

Europe

24.4

Emervel lips

Medium viscosity HA

With and without

Galderma

Europe

24.4

Dysport

Botulinum toxin

No

Medicis

USA

24.1

Glytone 1 filler

Low viscosity HA

No

Merz Pharma

France, Italy, Netherlands, Belgium, Luxembourg, Spain and Portugal

24.5

Glytone 2 filler

Low viscosity HA

No

Merz Pharma

France, Italy, Netherlands, Belgium, Luxembourg , Spain and Portugal

24.5

Glytone 3 filler

Medium viscosity HA

No

Merz Pharma

France, Italy, Netherlands, Belgium, Luxembourg, Spain and Portugal

24.5

Glytone 4 filler

Medium viscosity HA

No

Merz Pharma

France, Italy, Netherlands, Belgium, Luxembourg, Spain and Portugal

24.5

Hyacorp H 1000

Macrofiller

No

Bioscience GmbH

Europe, Japan and Middle East

24.6

Hyacorp H/S 500

High viscosity HA

No

Bioscience GmbH

Europe, Japan and Middle East

24.6

Hyacorp L

Hight viscosity HA

No

Bioscience GmbH

Europe, Japan and Middle East

24.6

Hyacorp face

Medium viscosity HA

No

Bioscience GmbH

Europe, Japan and Middle East

24.6

Hyacorp lips

Medium viscosity HA

No

Bioscience GmbH

Europe, Japan and Middle East

24.6

Hyacorp fine

Low viscosity HA

No

Bioscience GmbH

Europe, Japan and Middle East

24.6

Ephyal

Low viscosity HA

No

Bioscience GmbH

Italy, Russia, Ukraine

24.6

Juvederm Hydrate

Low viscosity HA

No

ALLERGAN

Europe

24.7

Juvederm ULTRA 2

Medium viscosity HA

Yes

ALLERGAN

Europe

24.8

Juvederm ULTRA 3

Medium viscosity HA

Yes

ALLERGAN

Europe

24.8

Juvederm ULTRA 4

Medium viscosity HA

Yes

ALLERGAN

Europe

24.8

Juvederm ULTRA SMILE

Medium viscosity HA

Yes

ALLERGAN

Europe

24.8

Juvederm VOLBELLA

Medium viscosity HA

Yes

ALLERGAN

Europe

24.9

Juvederm VOLUMA

Hight viscosity HA

With and without

ALLERGAN

Europe

24.10– 24.12 (continued)

24

Products

297

Table 24.1 (continued) Commercial name

Class

Lidocaine

Company

Commercialization

Chapter

Juvederm VOLIFT

Medium viscosity HA

Yes

ALLERGAN

Europe

24.13

Haequo

Medium viscosity HA

No

Genethia

Europe

24.13

Haequo plus

Medium viscosity HA

No

Genethia

Europe

24.13

Macrolane VRF 20 and VRF30

Macrofiller

No

Q-med a Galderma division

Europe

24.14

NEWEST

Low viscosity HA

No

MASTELLI SRL

Europe and Russia

24.15

PLINEST

Polynucleotides

No

MASTELLI SRL

Europe and Russia

24.16

PLINEST fast

Polynucleotides

No

MASTELLI SRL

Europe and Russia

24.17

IALEST

Low viscosity HA

No

MASTELLI SRL

Europe and Russia

24.18

RADIESSE

Calcium Hydroxylapatite

No

Merz Pharma

Europe (Austria, Belgium, Bulgaria, Czech. Republic, Denmark, Estonia, Finland, France, Georgia, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxemburg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Russia, Slovakia, Spain, Sweden, Switzerland, Turkey, UK and Ukraine), Asia/South Pacific (Australia, Hong Kong, Korea, Malaysia and Taiwan), Africa (Egypt, South Africa and Tunisia), Latin America (Argentina, Brazil, Colombia, Panama and Chile), Middle Est (Iran, Israel, Jordan, KSA, Kuwait, Lebanon, Oman, Qatar and UAE) and North America (Canada, Dominician Rep., Mexico and US)

24.19

Restylane

Medium viscosity HA

With and without

Q-med a Galderma division

Europe and USA

24.20

Restylane Perlane

Medium viscosity HA

With and without

Q-med a Galderma division

Europe and USA

24.20

Restylane SubQ

Hight viscosity HA

With and without

Q-med a Galderma division

Europe and USA

24.20

Restylane lip Volume

Medium viscosity HA

Yes

Q-med a Galderma division

Europe and USA

24.20

Restylane Refresh

Medium viscosity HA

Yes

Q-med a Galderma division

Europe and USA

24.20

Restylane Vital and Vital Light

Low viscosity HA

Yes

Q-med a Galderma division

Europe

24.21

Surgiderm 18XP

Low viscosity HA

No

Allergan

Europe

24.22.1

Surgiderm 24XP

Medium viscosity HA

No

Allergan

Europe

24.22.2

Surgiderm 30XP

Medium viscosity HA

No

Allergan

Europe

24.22.3

Vistabex Vistabel (Botox)

Botulinum toxin

No

Allergan

Europe, USA, Asia

24.23

Xeomin, Xeemin (Bocouture)

Botulinum toxin

No

Merz

Argentina,Austria, Belgium, France Germany, Italy, Mexico, Netherlands, Portugal, Russia, Spain, Sweden, UK and USA

24.3