Poly-l-Lactic Acid Safety Over the Past 5-years: Analysis of US Food and Drug Administration Database Reports (2020-2025)

CONCLUSION: 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.