Analysis of U.S. Food and Drug Administration Data on Soft-Tissue Filler Complications

Abstract

Background: With the rising popularity of dermal fillers, the number of complications associated with fillers has increased.

Objective: To identify and review reports of adverse events involving cosmetic injectable soft-tissue fillers from the FDA Manufacturer and User Facility Device Experience (MAUDE) database from June 1993 to August 2014.

Materials and methods: The authors conducted a search of adverse events within the U.S. Food and Drug Administration database that involved injectable dermal fillers for soft-tissue augmentation from June 1993 to August 2014. Search terms included generic and trade names of commercially available soft-tissue fillers.

Results: Three thousand seven hundred eighty-two complications involving dermal fillers were identified in the MAUDE database. Forty-four percent of complications implicated hyaluronic acid fillers, 40% involved poly-L-lactic acid fillers, 15% complications included calcium hydroxylapatite fillers, and <1% complications arose from polymethylmethacrylate fillers. Common adverse events included lumps, infection, allergic reaction, ischemia, and swelling. Rare events included trigger of autoimmune reactions, visual disturbances, and stroke.

Conclusion: Although complications with dermal fillers are infrequent in comparison with the growing number of filler procedures being performed in the United States every year, this study underscores the importance of appropriate skill and training when administering dermal fillers. Physicians using injectable dermal fillers should be trained to recognize potential complications and know how to appropriately manage them.