Practices in the Usage and Reconstitution of Poly-L-Lactic Acid

September 2019 | Volume 18 | Issue 9 | Original Article | 880 | Copyright © September 2019

Matthew J. Lin MD, Danielle P. Dubin BA, David J. Goldberg MD JD, Hooman Khorasani MD

Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY

Abstract

Background: Poly-L-lactic acid (PLLA) is increasingly used for a range of indications, from HIV lipodystrophy to gluteal augmentation; however, there is no clear consensus on appropriate product preparation and use. 

Objective: To establish current practices for PLLA reconstitution and usage in the USA.

Methods and Materials: A 19-question survey pertaining to the reconstitution and use of PLLA was distributed to members of the American Board of Cosmetic Surgery and American Board of Facial Cosmetic Surgery and at several cosmetic conferences. 410 questionnaires were returned anonymously over a 3-month period. The results were collated and analyzed. 

Results: The commonest indication for PLLA was HIV lipodystrophy (46.8%), followed by gluteal augmentation (42.4%). For the face, the majority used a dilution of 9-10 mL (60.4%). For the gluteal region, the majority used a dilution greater than 21 mL (51.3%). Most respondents reconstituted PLLA in sterile water (59.8%) more than 21 hours before use (51.0%) and added lidocaine to the solution (94.7%). Most physicians used topical anesthetic cream (83.2%), manual agitation (85.8%) and recommended self-massage post-treatment (99.6%).

Conclusion: There is considerable variation in PLLA reconstitution and use. Further well-designed studies are needed to establish the safest, most effective ways to use this product.

J Drugs Dermatol. 2019;18(9):880-886. 

BACKGROUND

Non-animal derived poly-L-lactic acid (PLLA) is biocompatible, biodegradable, and immunologically inert. It is a stimulatory filler that creates a foreign body tissue response, which upregulates fibroblast activity and neocollagenesis. This process ultimately results in volumization. An injectable form of PLLA (New-Fill®, Valeant US, Sinclair Pharma Paris, France) has been available in Europe since 1999 for soft tissue augmentation and the treatment of facial rhytides. In 2004, injectable PLLA received FDA approval under the trade name Sculptra® (Galderma, Lausanne, Switzerland) for the treatment of HIV-associated lipoatrophy. PLLA subsequently gained FDA approval for a range of cosmetic applications associated with volume depletion in the aging face.

The reconstitution and dilution of PLLA are important factors to consider when using this product; however, there is a scarcity of published information detailing appropriate preparation and use.

MATERIALS AND METHODS

To establish current practices with regards to the reconstitution and use of PLLA in the USA, a 19-question survey was developed pertaining to the reconstitution and use of PLLA. The survey was approved by the Icahn School of Medicine at Mount Sinai Institutional Review Board.

The survey was distributed online to all members of the American Board of Cosmetic Surgery and the American Board of Facial Cosmetic Surgery. Paper copies of the survey were distributed at several cosmetic conferences. The questionnaires were returned to the authors anonymously over a 3-month period. Results were collated and analyzed in a confidential, anonymous fashion. All answers were categorical with no free-text responses permitted. The survey instrument (Appendix 1) characterized the background training of respondents and cosmetic surgical experience. Respondents were asked if they used PLLA for HIV lipodystrophy, depressed scars, hand rejuvenation, décolleté rejuvenation, or gluteal augmentation. Reconstitution practices for PLLA were also solicited, including details regarding hydration time, dilution fluid, dilution volume, use of local anesthetic and mechanism of agitation. Participants were also questioned about other clinical practices related to PLLA, such as the routine use of topical anesthesia, cannula and post-procedure massage.

Descriptive statistics, including data distributions and cross-tabulation of the variables of interest, were calculated.