The History Behind the Use of Injectable Poly-L-Lactic Acid for Facial and Nonfacial Volumization: The Positive Impact of Evolving Methodology openaccess articles

April 2014 | Volume 13 | Issue 4 | Supplement | s32 | Copyright © 2014

Danny Vleggaar MD,a Rebecca Fitzgerald MD,b and Z. Paul Lorenc MD FACSc

aHead of Cosmetic Dermatology in Private Practice, Geneva, Switzerland
bDepartment of Medicine, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, CA, USA
cLorenc Aesthetic Plastic Surgery Center, New York, NY, USA

Abstract

Poly-L-lactic acid (PLLA) was first approved for soft tissue augmentation in Europe in 1999 for the cosmetic correction of scars and wrinkles. Due, in part, to inadequate usage recommendations that included those related to product reconstitution and hydration, injection sites, techniques, and timing, and patient selection, PLLA use was initially associated with suboptimal cosmetic benefit and a high rate of specific adverse events, such as the formation of nodules. As clinical experience with PLLA has increased, the implementation of specific methodological changes has allowed greater, more consistent cosmetic effects to be achieved, with a low rate of adverse events. This enhanced PLLA methodology, coupled with an evolving understanding of the interplay between structures in the aging face, now allows predictably favorable results across a broad range of patient types.

J Drugs Dermatol. 2014;13(suppl 4):s32-s34.

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INTRODUCTION

Poly-L-lactic acid (PLLA) has been used in a variety of medical applications, such as absorbable sutures, fixation devices in orthopedic and plastic surgery, and vectors for sustained release of bioactive compounds for more than 30 years, during which time it has demonstrated excellent safety and biocompatibility.1-5

Poly-L-lactic acid was first approved for soft tissue augmentation in Europe in 1999, for the cosmetic correction of scars and wrinkles.3 The initial recommendations for its use, including those related to product reconstitution and hydration, injection sites, techniques, timing, and patient selection, were, in retrospect, inadequate or suboptimal.6,7 As a result, the full potential of PLLA was not immediately realized; instead, its clinical use was associated with a high rate of specific adverse events (AEs), such as nodules and papules.6-8 Although usually remaining nonbothersome, nonvisible, and small, nodules can sometimes necessitate additional interventions, such as surgical excision.9,10 The early experience with PLLA caused clinicians to become disenchanted regarding its clinical utility, with many specialists remaining wary and/or skeptical to this day.6

Over the past decade of clinical experience with the use of PLLA in soft tissue augmentation, much insight has been garnered regarding the specific shortcomings of those initial approaches. Evolution of specific aspects of PLLA methodology by clinicians and investigators has helped to decrease the frequency of AEs and improve the cosmetic benefits associated with its use.9,11-25

Taking a specific, historical look at the evolving methodology of PLLA injection can inform current practice with the use of this agent, as the accumulated experience provides a requisite dataset for the establishment of new recommendations. Upon the initial European approval of PLLA for soft tissue augmentation, a reconstitution in ≤3 mL of sterile water 3 minutes prior to injection was recommended.3,6 In clinical use, PLLA was often injected superficially (as with a dermal filler), at high concentrations, and with short intervals between treatments.6 In addition, injection sites were often chosen with less discrimination than was warranted, including facial areas where there was a risk of the material coalescing, such as the hypermobile perioral and periocular regions.6,7 Early studies with PLLA reflected the shortcomings of these practices, which were associated with a high incidence of PLLA injection-site subcutaneous papules (Table 1).3,11,18,26-32

In 2004, the European indication for PLLA was extended to include large volume corrections of lipoatrophy. Coincident with this labeling expansion, modifications to the methodology of PLLA reconstitution and injection were largely adopted. Reconstitution volume was increased to 5 mL, hydration times were increased from minutes to hours (and eventually to overnight), the interval between injections was increased to 4 to 6 weeks, postinjection massage was introduced into the regimen, and clinicians began to avoid the injection of PLLA into the dermis.9,14,16,19,22,23,30,31,33-36 Although it is impossible to determine which of these methodological changes had the greatest impact, a significant decrease

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