SUMMARY
With the initial use of injectable PLLA in soft tissue augmentation,
inadequate usage guidelines coupled with a lack of clinical
experience resulted in a high incidence of nodules and papules,
compromising its image as a viable clinical option. Over
time, as experience grew, alterations in methodology revealed
several factors critical to effective PLLA utilization. Increased
reconstitution volume, hydration time, and duration of the interval
between treatments, along with a better appreciation
of the appropriate sites and depth for PLLA injection, have
greatly improved clinical outcomes. Our understanding and
techniques continue to evolve, allowing predictably favorable
results across a broad range of patient types.
DISCLOSURES
Danny Vleggaar MD has been a medical consultant for Sinclair
IS Pharma, France; PharmaSwiss SA, Switzerland; Valeant
Eastern Europe; and Cutanea Life Sciences, Inc. He has also
been a trainer for Valeant Pharmaceuticals International, Inc./
Medicis Corporation.
Rebecca Fitzgerald MD has been a consultant and speaker for
Valeant Pharmaceuticals North America LLC/Medicis Corporation;
Merz Aesthetic, Inc; and Allergan USA, Inc.
Z. Paul Lorenc MD has been a consultant for Johnson & Johnson;
La Lumiere LLC; Medicis Corporation; Merz Corporation;
and Mentor Corporation. In addition, he holds the following
patents: US Patent 5/611,814–Resorbable Surgical Appliance for
Use in Supporting Soft Tissue in a Superior Position; US Patent
60/950,423–Composition and Method of Use for Soft Tissue
Augmentation/Drug Delivery; US Patent 12/797,710–Method for
Measuring Change in Lip Size After Augmentation; and US Patent
13/604,012–Light Therapy Platform System.
REFERENCES
- Kulkarni RK, Pani KC, Neuman C, Leonard F. Polylactic acid for surgical implants. Arch Surg. 1966;93(5):839-843.
- Kulkarni RK, Moore EG, Hegyeli AF, Leonard F. Biodegradable poly(lactic acid) polymers. J Biomed Mater Res. 1971;5(3):169-181.
- Valantin MA, Aubron-Olivier C, Ghosn J, et al. Polylactic acid implants (New-Fill) to correct facial lipoatrophy in HIV-infected patients: results of the open-label study VEGA. AIDS. 2003;17(17):2471-2477.
- Simamora P, Chern W. Poly-L-lactic acid: an overview. J Drugs Dermatol. 2006;5(5):436-440.
- Matsusue Y, Yamamuro T, Oka M, Shikinami Y, Hyon SH, Ikada Y. In vitro and in vivo studies on bioabsorbable ultra-high-strength poly(L-lactide) rods. J Biomed Mater Res. 1992;26(12):1553-1567.
- Lowe NJ. Dispelling the myth: appropriate use of poly-L-lactic acid and clinical considerations. J Eur Acad Dermatol Venereol. 2006;20(suppl 1):s2-s6.
- Beljaards RC, de Roos KP, Bruins FG. NewFill for skin augmentation: a new filler or failure? Dermatol Surg. 2005;31(7 Pt 1):772-776.
- Vleggaar D, Fitzgerald R, Lorenc ZP. Understanding, avoiding, and treating potential adverse events following the use of injectable poly-L-lactic acid for facial and nonfacial volumization. J Drugs Dermatol. 2014;13(suppl 4):s35-s39.
- Vleggaar D. Soft-tissue augmentation and the role of poly-L-lactic acid. Plast Reconstr Surg. 2006;118(suppl 3):s46-s54.
- Lam SM, Azizzadeh B, Graivier M. Injectable poly-L-lactic acid (Sculptra): technical considerations in soft-tissue contouring. Plast Reconstr Surg. 2006;118(suppl 3):s55-s63.
- Mest DR, Humble G. Safety and efficacy of poly-L-lactic acid injections in persons with HIV-associated lipoatrophy: the US experience. Dermatol Surg. 2006;32(11):1336-1345.
- Woerle B, Hanke CW, Sattler G. Poly-L-lactic acid: a temporary filler for soft tissue augmentation. J Drugs Dermatol. 2004;3(4):385-389.
- Lowe NJ, Maxwell CA, Lowe P, Shah A, Patnaik R. Injectable poly-l-lactic acid: 3 years of aesthetic experience. Dermatol Surg. 2009;35(suppl 1):s344-s349.
- Levy RM, Redbord KP, Hanke CW. Treatment of HIV lipoatrophy and lipoatrophy of aging with poly-L-lactic acid: a prospective 3-year follow-up study. J Am Acad Dermatol. 2008;59(6):923-933.
- Burgess CM, Quiroga RM. Assessment of the safety and efficacy of poly-Llactic acid for the treatment of HIV-associated facial lipoatrophy. J Am Acad Dermatol. 2005;52(2):233-239.
- Borelli C, Kunte C, Weisenseel P, Thoma-Greber E, Korting HC, Konz B. Deep subcutaneous application of poly-L-lactic acid as a filler for facial lipoatrophy in HIV-infected patients. Skin Pharmacol Physiol. 2005;18(6):273-278.
- Hanke CW, Redbord KP. Safety and efficacy of poly-L-lactic acid in HIV lipoatrophy and lipoatrophy of aging. J Drugs Dermatol. 2007;6(2):123-128.
- Engelhard P, Humble G, Mest D. Safety of Sculptra: a review of clinical trial data. J Cosmet Laser Ther. 2005;7(3-4):201-205.
- Narins RS, Baumann L, Brandt FS, et al. A randomized study of the efficacy and safety of injectable poly-L-lactic acid versus human-based collagen implant in the treatment of nasolabial fold wrinkles. J Am Acad Dermatol. 2010;62(3):448-462.
- Carey D, Baker D, Petoumenos K, et al. Poly-l-lactic acid for HIV-1 facial lipoatrophy: 48-week follow-up. HIV Med. 2009;10(3):163-172.
- Carey DL, Baker D, Rogers GD, et al. A randomized, multicenter, open-label study of poly-L-lactic acid for HIV-1 facial lipoatrophy. J Acquir Immune Defic Syndr. 2007;46(5):581-589.
- Lee JY, Schulman MR, Skolnik RA. Modified poly-L-lactic acid injection technique: safety and efficacy of “cross-fanning” in non-HIV-related facial atrophy. Ann Plast Surg. 2010;64(4):435-441.
- Palm MD, Woodhall KE, Butterwick KJ, Goldman MP. Cosmetic use of poly-l-lactic acid: a retrospective study of 130 patients. Dermatol Surg. 2010;36(2):161-170.
- Rossner F, Rossner M, Hartmann V, Erdmann R, Wiest LG, Rzany B. Decrease of reported adverse events to injectable polylactic acid after recommending an increased dilution: 8-year results from the Injectable Filler Safety study. J Cosmet Dermatol. 2009;8(1):14-18.
- Hamilton DG, Gauthier N, Robertson BF. Late-onset, recurrent facial nodules associated with injection of poly-L-lactic acid. Dermatol Surg. 2008;34(1):123-126.
- Moyle GJ, Lysakova L, Brown S, et al. A randomized open-label study of immediate versus delayed polylactic acid injections for the cosmetic management of facial lipoatrophy in persons with HIV infection. HIV Med. 2004;5(2):82-87.
- Lafaurie M, Dolivo M, Porcher R, Rudant J, Madelaine I, Molina JM. Treatment of facial lipoatrophy with intradermal injections of polylactic acid in HIV-infected patients. J Acquir Immune Defic Syndr. 2005;38(4):393-398.
- Sculptra [package insert]. 2012.
- Sculptra [package insert]. 2004.
- Moyle GJ, Brown S, Lysakova L, Barton SE. Long-term safety and efficacy of poly-L-lactic acid in the treatment of HIV-related facial lipoatrophy. HIV Med. 2006;7(3):181-185.
- Engelhard P, Knies M. Safety and efficacy of New-Fill (polylactic acid) in the treatment of HIV-associated lipoatrophy of the face (HALF) [abstract]. Presented at: XIV International AIDS Conference; July 7-12, 2002; Barcelona, Spain.
- Mest DR, Humble G. Safety and efficacy of intradermal poly-L-lactic acid (Sculptra™) injections in patients with HIV-associated facial lipoatrophy [abstract 59]. Antiviral Therapy. 2004;9:L36-L37.
- Redaelli A, Forte R. Cosmetic use of polylactic acid: report of 568 patients. J Cosmet Dermatol. 2009;8(4):239-248.
- Mazzuco R, Hexsel D. Poly-L-lactic acid for neck and chest rejuvenation. Dermatol Surg. 2009;35(8):1228-1237.
- Schierle CF, Casas LA. Nonsurgical rejuvenation of the aging face with injectable poly-L-lactic acid for restoration of soft tissue volume. Aesthet Surg J. 2011;31(1):95-109.
- Rendon MI. Long-term aesthetic outcomes with injectable poly-l-lactic acid: observations and practical recommendations based on clinical experience over 5 years. J Cosmet Dermatol. 2012;11(2):93-100.
- Fitzgerald R, Vleggaar D. Facial volume restoration of the aging face with poly-l-lactic acid. Dermatol Ther. 2011;24(1):2-27.
- Vleggaar D, Fitzgerald R, Lorenc ZP, et al. Consensus recommendations on the use of injectable poly-L-lactic acid for facial and nonfacial volumization. J Drugs Dermatol. 2014;13(suppl 4):s44-s51.
AUTHOR CORRESPONDENCE
Rebecca Fitzgerald MDfitzmd@earthlink.net