Consensus Recommendations on the Use of Injectable Poly-L-Lactic Acid for Facial and Nonfacial Volumization

April 2014 | Volume 13 | Issue 4 | Supplement Individual Articles | 44 | Copyright © April 2014


Danny Vleggaar MD,a Rebecca Fitzgerald MD,b Z. Paul Lorenc MD FACS,c J. Todd Andrews MD,d Kimberly Butterwick MD,e Jody Comstock MD,f C. William Hanke MD,g T. Gerald O’Daniel MD FACS,h Melanie D. Palm MD MBA,i Wendy E. Roberts MD,j Neil Sadick MD,k and Craig F. Teller MDl

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
dRiver Oaks, 3355 West Alabama, Houston, TX, USA
eDermatology/Cosmetic Laser Associates of La Jolla Inc., La Jolla, CA, USA
fSkin Spectrum, Tucson, AZ, USA
gDepartment of Dermatology, Saint Vincent Carmel Medical Center, Laser & Skin Surgery Center of Indiana, Carmel, IN, USA
h222 S. First Street, Louisville, KY, USA
iArt of Skin MD, Solana Beach, CA, USA
j35-280 Bob Hope Drive, Rancho Mirage, CA, USA
kSadick Dermatology, New York, NY, USA
lBellaire Dermatology Associates, 6565 W. Loop S, Bellaire, TX, USA

Abstract
Poly-L-lactic acid (PLLA) was approved for use in Europe in 1999. In the United States, it was approved by the Food and Drug Administration in 2004 for the treatment of facial lipoatrophy associated with human immunodeficiency virus, and in 2009 for cosmetic indications in immune-competent patients. The need for consistent, effective PLLA usage recommendations is heightened by an increased consumer demand for soft tissue augmentation and a shift toward a younger demographic. Over the past 14 years, considerable experience has been gained with this agent, and we have come to better understand the clinical, technical, and mechanistic aspects of PLLA use that need to be considered to optimize patient outcomes. These consensus recommendations regarding patient selection, proper preparation and storage, optimal injection techniques, and other practical considerations reflect the body of evidence in the medical literature, as well as the collective experience of this author group.

J Drugs Dermatol. 2014;13(suppl 4):s44-s51.

Introduction

Poly-L-lactic acid (PLLA) was approved for use in Europe in 1999. In the United States, it was approved by the Food and Drug Administration in 2004 for the treatment of facial lipoatrophy associated with human immunodeficiency virus (HIV),1 and in 2009 for cosmetic indications in immunecompetent patients.2 Over the past 14 years, considerable experience has been gained with PLLA; and its safe and effective use has been well documented.3-24
The need for consistent, effective usage recommendations is heightened by an increased consumer demand for soft tissue augmentation, and a shift toward a younger demographic that may have a lower tolerability for adverse events.25,26 The demonstrated preference of patients for gradual, long-lasting effects27,28 is well matched to the mechanism of action of PLLA,7,29-31 which provides distinct clinical advantages over other available options, including cosmetic benefits lasting 2 years or more.1,29
Our detailed review of the literature reveals that most of the early problems encountered with PLLA resulted from suboptimal methodology, including inadequate reconstitution volumes, short hydration times, injection of large volumes of highly concentrated product with short intervals between treatments, and injection into the dermis and in locations that were not optimally chosen vis-à-vis its mechanism of action.5,6,9,12,18,32 As clinical experience has grown, we have come to better understand the technical and mechanistic aspects of PLLA use that need to be considered to optimize patient outcomes (Table 1). With this enhanced understanding, PLLA utilization can now achieve predictable cosmetic benefits that are completely controlled by the treating clinician.
The consensus recommendations that follow reflect the body of evidence in the medical literature, as well as the collective experience of this author group, each of whom have more than a decade of experience in the clinical utilization of PLLA.