Sculptra Side Effects

Injectable poly-L-lactic acid (Sculptra, Dermik Laboratories, Bridgewater, NJ) available in Europe as New-fill since 1999 and in the US market since August 2004 has a significant history of side effects. The early usage of Sculptra was practiced with low volume (2 cc) reconstitution and higher volume of total product injected. This coupled with closely spaced treatment sessions led to frequent nodule formations (Sculptra lumps).
According to Vleggaar, many European injectors rejected this product as high risk for complications. The product is composed of particulate matter - microbeads of PLA and mannitol - which is prone to clump, extrude, and form small nodules even without an adverse host immune response. Lam et al recently published new guidelines for PLA injection: 8-12 cc dilutant (i.e. 5-10 cc sterile water and 2 cc 1% lidocaine with epinephrine) and a minimum of 12 hours for reconstitution. In addition they recommended no more than 2 vials for injection into the subcutaneous fat, and spacing sessions at least 6 weeks apart. These authors in Salyan report granulomatous nodules (Sculptra lumps) in 0.2-12% incidence, which occurs as a delayed hypersensitivity phenomenon.

Poly-L-lactic acid differs from the other fillers in that it is dependent on the host immune/reparative response to accomplish filling. Other similar products include silicone and polymethyl-metracrylate (neither is currently FDA approved for soft tissue augmentation). Unfortunately this mechanism of action for augmentation has two potentially negative effects inherent to the nature of the response: (1) the host immune system can respond less than optimally causing less augmentation then desired; or (2) the host immune system can respond overexuberantly creating granulomas or lumps. In the mouse model histologic evaluations at 1 month has shown: (1) polylactide surrounded by 100 (im thick capsule; (2) mononuclear cells, macrophages, fibroblasts with increased collagen; and (3) mature vascularized fibrous capsule. As reported by Gogoleski et al, at 3 months there are: (1) Decreased cell numbers and increased collagen fibers with a capsule thickness of 80 |J.m. At 6 months the cell numbers decreased and the capsule thickness is only 60 |im. Lemperle studied the histologic reaction in his own forearm to poly-L-lactic acid. At 1 month there was fine capsule around implant. At 3 months the Sculptra microspheres were intact, and surrounded by macrophages and lymphocytes. At 6 months the Sculptra microspheres were degraded and deformed, and surrounded by macrophages and giant cells. At 9 months the Sculptra microparticles completely degraded and there was no detectable scar tissue. Poly-L-lactic acid is a filler in which mechanism of augmentation has been proposed but not proven. Beljaards et al report the histology from side effects or complications has shown fibroblast giant cell granulomas but no new collagen. The immune system has an intergral role in fibroblast behavior so the response to this product in the immune-competent population might be quite different to that of the immunocompromised (HIV) population. The mechanism of augmentation for this product, particularly the short- and long-term tissue effects in immunocompetent patients, needs to be better characterized by further study.