Poly-L-lactic acid gained U.S. Food and Drug Administration approval for use in human immunodeficiency virus–related facial lipoatrophy in August of 2004. Since that time, it has become available for use in the United States for human immunodeficiency virus facial lipoatrophy patients and for off-label uses in other areas for soft-tissue contouring. This article is intended to enumerate reconstitution, injection techniques, management, and avoidance of complications.
The authors have pooled their experiences to arrive at a consensus opinion for recommendations on treatment protocols for injectable poly-L-lactic acid use.
This article prescribes techniques to achieve safer, consistent results while minimizing risks of complications with injectable poly-L-lactic acid. Although the product has been used widely in Europe since 1999, physicians in the United States have only recently begun to explore the uses of Sculptra as a volumizing agent in the face and the body. U.S. physicians have benefited from the European experience with this product, including early problems secondary to overaggressive use, low-volume reconstitution, higher volume injection of product at one session, and inadequate time between injection sessions.
The authors therefore have opted for a more conservative approach in their treatment recommendations. Higher volume dilution (8 to 12 cc), fewer vials used at each session, injections placed in the subcutaneous plane without any product being placed in the dermis, adequate time between injection sessions (at least 6 weeks), and postinjection patient massage should decrease the risks and avoid the potential complications associated with poly-L-lactic acid soft-tissue augmentation.
Plano, Texas; Beverly Hills, Calif.; and Roswell, Ga.
From the Lam Facial Plastic Surgery Center and Hair Restoration Institute; Audrey-Skirball Kenis Center for Plastic and Reconstructive Surgery, Cedars-Sinai Medical Center; Division of Head and Neck Surgery, David Geffen School of Medicine at UCLA; and North Atlanta Plastic Surgery.
Received for publication March 21, 2006; accepted May 26, 2006.
Poly-L-lactic acid is approved by the FDA for restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus; other uses are “off-label.”
Miles H. Graivier, M.D., 1295 Hembree, Suite 100B, Roswell, Ga. 30076, email@example.com