A 20-Year Analysis of Adverse Events and Litigation With Light-Based Skin Resurfacing Procedures.

PURPOSE

The popularity and availability of facial rejuvenation procedures have increased exponentially during the previous decade. The present study aimed to provide an overview of photorejuvenation and evaluate the complications and litigation related to light-based skin resurfacing procedures.

MATERIALS AND METHODS

A retrospective study was performed using the US Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) registry and the Thomson Reuter Westlaw Edge database from May 1, 1999 to May 1, 2019. The MAUDE registry was queried using the manufacturer brands. Adverse events were individually reviewed, and data were gathered regarding the company, complication, body location, and device type. The litigation cases were individually reviewed, and information was gathered on plaintiff gender, defendant specialty, allegation, jury verdict, the appeals verdict, and the award amount, if applicable.

RESULTS

A total of 697 adverse events were included in the final sample. The most commonly reported complications were burns (61.1%), followed by scarring (16.2%), hyperpigmentation (7.8%), and hypopigmentation (7.0%). More rare, noncosmetic complications included infection (3.9%) and nerve (1.4%) and ocular (1.3%) damage. The rates of scarring with facial treatments were greater (24.3 vs 10.3%; P < .01) and the rates of burns with ablative lasers were lower (25.9 vs 66.0%; P < .01). With respect to litigation, of the 9 cases identified, all the plaintiffs were women. The most common allegation was procedural negligence (88.8%), followed by cosmetic deformity (77.7%) and the lack of informed consent (55.5%). The jury ruled in favor of the plaintiff in 4 cases (44.4%), and the mean award was $656,000.

CONCLUSIONS

The most common adverse events were burns, scars, and pigmentation changes. Patient expectations could play a role in the reporting of adverse events. Negligence was the most common basis for litigation, consistent with what has been reported for other procedures. Future studies should evaluate whether increasing exposure to cosmetic phototherapies during residency and fellowship training will reduce future complication rates and alleged malpractice.