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Mauricio de Maio - Injectable Fillers in Aesthetic Medicine

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Book:
Injectable Fillers in Aesthetic Medicine
Author:
Mauricio de Maio / Berthold Rzany
Publisher:
Springer
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Books / Romance novel
Year:
2014
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This book offers an excellent and comprehensive overview on the clinical use of fillers in aesthetic medicine that will assist both novice and advanced practitioners. Based on an evidence-based perspective, the book opens by describing the most common fillers, with information on their characteristics, efficacy and safety. The main part of the book then explains how to use fillers for the most frequent facial indications, such as the glabella, nasolabial folds, infraorbital hollow, nose, cheeks, lips and marionette lines. This new edition also includes chapters on extrafacial indications and treatment planning. All specific aesthetic procedures for the facial and extrafacial areas are described step by step, with the emphasis on a hands-on approach that highlights important dos and donts. The book concludes with chapters on how to deal with adverse reactions and how to combine fillers with other aesthetic procedures, ranging from botulinum toxin A to plastic surgery.

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Mauricio de Maio and Berthold Rzany Injectable Fillers in Aesthetic Medicine 2nd ed. 2014 10.1007/978-3-642-45125-6_1

Springer-Verlag Berlin Heidelberg 2014

1. Overview on Injectable Fillers: Efficacy and Safety

Berthold Rzany 1

(1)

RZANY & HUND Privatpraxis fr Dermatologie und sthetische Medizin, Kurfstendamm, Berlin, Germany

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Abstract

In contrast to the USA, in most countries in Europe and South America, a great variety of injectable fillers are available. Therefore, not only for novices but also for experienced users it can sometimes be quite difficult to decide which filler to use. This chapter will give a brief overview on some of the most commonly used present and past injectable fillers. The selection of products reflects the interest of the authors and might appear arbitrary to someone familiar with other fillers.

1.1 Introduction

FAQs

Why should one show interest with fillers which are not on the market anymore?
Even when fillers are not present on the market anymore, they may be important for two reasons: (1) they may be marketed again, and (2) permanent fillers will be always present as they will stay with the patient until the end.

1.2 Classification of Fillers

Basically there is no uniformly accepted classification of fillers. Injectable fillers may be grouped according to (1) the degree of degradability and (2) the quality of the clinical data behind them.

1.2.1 Classification by Biodegradability

Fillers can be grouped as biodegradable and nonbiodegradable (permanent) products. There are also fillers where biodegradable as well as nonbiodegradable materials are combined.

1.2.2 Classification by the Quality of Clinical Data

As the rules for marketing of fillers are quite relaxed in Europe, e.g., a clinical trial is not required, fillers can be grouped in those with and without clinical data. Those with clinical data can be grouped in those with good and less good clinical data.

What means good clinical data? Basically a randomized controlled clinical trial with a sufficient number of patients included (e.g., for a two-arm trial you want at least 50 patients). Based on such a trial simple but important questions as grade of correction that can be achieved, durability of the correction (e.g., efficacy), impact on quality of life, and safety (proportion of patients with swelling, etc.) can be answered.

1.3 Biodegradable Fillers

Biodegradable fillers are defined as having a limited life span usually ranging from a couple to several months, or even to a couple of years. They consist of purified dermal components from human, animal, or bacterial sources and can be divided into the following categories: xenografts (donor and recipient are from different species), autografts (donor and recipient are from the same individual), homografts (donor and recipient are from the same species), and synthetic materials (Table ). Please note that in the last couple of years some of the most well-known biodegradable fillers were removed from the market.

Table 1.1

Overview on biodegradable fillers

Material	Origin	Productsa
Temporary injectable fillers
Alginate	Nonanimal, algae	Novabelb
Collagen	Bovine	Zydermb, Zyplastb
Porcine	Evolenceb
Human (cadaver derived)	Cymetrab
Human (self-derived)	Isolagenb
Human (cultivated)	Cosmodermb, Cosmoplastb
Hyaluronic acid	Avian	Hylaformb
Nonanimal	Beloteroc, Emervelc, Juvdermc, Restylanec, Teosyalc, Juvderm Volumac
Hyaluronic acid + dextran	Nonanimal	Reviderm
Poly-l-lactic acid (PLLA)	Nonanimal	Sculptra (former New Fill)
Calcium hydroxylapatite	Nonanimal	Radiesse

aPlease note that this list is not intended to be complete

bWere removed or will be removed from the market

cHA product families with at least one product with good clinical trial data (RCTs), e.g. for the Emervel family we have good RCTs on E. deep and E. classic

1.3.1 Collagen

Collagens from various sources and with specific characteristics exist or better used to exist as most of the fillers discussed are not on the market anymore.

1.3.1.1 Collagen of Bovine Origin

Prior to the introduction of the hyaluronic acids, collagen was the most widely used filler and was considered the gold standard with which other dermal fillers were compared. However, the role of bovine collagen is declining. In the USA and in Europe, they are not available on the markets anymore. Nevertheless, bovine collagen still might be available in other parts of the world, and therefore we will give a brief overview on that substance. The classical bovine enzyme-digested collagen (95 % type I, 5 % type III) was available in several preparations, which were distinguished by the collagen content and the addition of glutaraldehyde for stabilization (Homicz and Watson ).

Depending on the collagen content and the degree of cross-linking, different products were designed for different levels of the dermis. For example, Zyderm 1 and Zyderm 2, which were built on noncross-linked collagen, were supposed to be injected into the superficial dermis. Zyplast, a cross-linked form, was supposed to be injected more deeply into the dermis. All of these products were easy to inject. In contrast to other products, overcorrection was recommended for Zyderm 1 and Zyderm 2.

Zyderm was cleared for marketing in 1981 by the Food and Drug Administration (FDA) after reviewing clinical data based on a large case series of 9,427 tested and 5,109 treated patients (Cooperman et al. ).

As collagen may elicit quite often hypersensitivity reactions, pretesting was mandatory. Pretesting consisted of an intradermal injection of Zyderm 1 collagen into the volar aspect of the forearm. A minimum of one skin test which was valuated after 28 days was required. The incidence of adverse reactions to collagen pretesting (here Zyderm I) was approximately 3 %. Of all test site reactions, 50 % occurred within the first 24 h. An additional 1.3 % of patients experienced adverse reactions despite a negative pretest. The observed reactions ranged from localized swelling to induration, erythema, and pruritus (Cooperman et al. ).

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