Poly-l-Lactic Acid Safety Over the Past 5-years: Analysis of US Food and Drug Administration Database Reports...

Poly-l-lactic acid (PLLA) is a widely used biostimulatory filler which promotes neocollagenesis and provides gradual, long-lasting volumization. While its safe and effective use is well documented, its adverse event profile may continue to evolve alongside expanding indications, increasing patient demand, broader treatment areas, heterogeneous dilution practices, and variability in injector experience and technique.

To characterize contemporary complication trends with PLLA using the US FDA Manufacturer and User Facility Device Experience database. Data were extracted on patient demographics, complication type, injection location, and dilution (when available). Data were summarized descriptively.

We identified a total of 146 unique reports, comprising 222 adverse events. The majority involved female patients (94%) with a median age of 50.5 years. Lumps/nodules were the most common complication (38.7%), followed by hypersensitivity reactions (12.2%), infection (11.3%), and swelling/induration (9.9%). Serious vascular events, including blindness and skin necrosis, were uncommon (5.4%) and most often involved high-risk vascular areas.

In this Manufacturer and User Facility Device Experience analysis, lumps/nodules remain the most frequently reported complication of PLLA injections, while vascular events, though rare, continue to occur especially in high-risk anatomical regions. Variability and underreporting of dilution and injection location and technique limit assessment of contributory risk factors.