Late-onset granuloma formation after poly-l-lactic acid injection

INTRODUCTION Poly-L-lactic acid (Sculptra, Sanofi Aventis, Bridgewater, NJ) is a gel polymer made of poly-Llactic acid microspheres and water suspended in a mannitol and carboxymethyl cellulose suspension. This injectable tissue filler has been used for correction of lipoatrophy in HIV patients as well as for cosmetic purposes since its US Food and Drug Administration approval in 2004. The mechanism of action involves induction of a subclinical inflammatory response that stimulates fibroblast proliferation and collagen formation, ultimately leading to a progressive increase in volume of the dermis and subcutaneous tissues. Late-onset immune-mediated adverse effects associated with the use of poly-L-lactic acid can appear years after the initial injection with reported range of 6 to 60 months. These effects include inflammatory nodules, papules, and edema. Previous reports of adverse effects associated with poly-L-lactic acid identify a maximum of 60 months before development of a subcutaneous nodule. These adverse effects can cause significant distress for patients, as the erythema, edema or nodules that can result may cause cosmetic disfigurement and mimic an infectious process, necessitating, at times, extensive workup including biopsy. Here, we present a case of granuloma formation that appeared more than 70 months after treatment, surpassing the previously reported maximum latency of 60 months for poly-Llactic acid and long surpassing the 2-year duration that the product is purported to last in the tissues. To our knowledge, this is the longest reported latency