Nonfacial Use of Injectable Poly-L-lactic Acid: Safety Data From a Multicenter Observational Study in the United States.

Background: Poly-L-lactic acid (PLLA-SCA) was approved for facial aesthetic use in the USA in 2009. Nonfacial aesthetic treatment using PLLA-SCA, a collagen-stimulating injectable implant, is a frequent clinical practice, and initial studies support its safety. Objectives: The objective of this study was to evaluate the safety of PLLA-SCA when used in nonfacial areas in real clinical practice in the USA. Methods: In this retrospective chart review, subjects treated in a nonfacial area with ≥2 vials of PLLA-SCA in ≥2 treatment sessions were eligible. Medical charts from 9 US sites were reviewed to collect demographics, treatment details, and treatment-related adverse events (AEs). The primary endpoint was treatment-related AEs. Results: Among the 498 subjects included, most subjects (72%) had 2 or 3 treatment sessions, with an average of 4.0 vials/treatment session. Reconstitution volumes were generally ≥10 mL/vial for all treatment areas, with 47% of treatments using volumes of 10-15 mL, and another 47% using ≥15 mL/vial. The most common treatment area was the gluteal region (buttocks or hip dip; 60.3% of sessions) and decolletage (8.2% of sessions). Most treatment-related AEs were injection related and mild or moderate in intensity. The most common AE was injection site bruising (5.0%), and AEs were mainly reported in the buttocks (4.0%) or posterior thigh (1.0%). Nodule occurrence was low (1 subject, 0.2%). Conclusions: Poly-L-lactic acid was well tolerated in real-world use for treatment of a range of nonfacial areas, with typically larger volumes than usually used for facial treatment. Level of Evidence 3 Therapeutic: