PHOENIX – over a decade showed.
Dr. Hashemi
Dr. David A. Hashemi
To investigate, Dr. Hashemi, a third-year dermatology resident at Harvard University and Massachusetts General Hospital, Boston, and Mathew M. Avram, MD, JD, director of laser, cosmetics, and dermatologic surgery at MGH, drew from the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database, which compiles medical device reports for suspected injuries from device use or malfunction and represents the largest repository of device adverse effects. Medical device reports are submitted by manufacturers, clinicians, patients, and others.
The researchers limited their query to MDRs related to ablative and nonablative fractional resurfacing lasers over the 10-year period from 2013 to 2022. The query was performed in January 2023 using a comprehensive list of product names and manufacturers.
The initial search yielded 240 MDRs, which were individually reviewed for duplicate records or insufficient data, and the final analysis included 165 MDRs. The 10 most reported adverse events were burns (30%), followed by dyspigmentation (14%), scarring (12%), other (11%), postoperative infection (8%), blisters (6%), pain (5%), hypertrophic scar (4%), post-treatment inflammation (4%), and textural changes (3%). Within the 10-year period analyzed, 56% of MDRs occurred between 2016 and 2019, with a disproportionately low percentage of MDRs occurring in 2022 (5%).
“Adverse events due to ablative and nonablative fractional resurfacing lasers are rare but potentially serious,” Dr. Hashemi concluded. “Care must be taken with counseling, patient selection, and treatment settings to optimize safety, informed consent, and patient satisfaction. Given the relatively low number of adverse events seen with fractional resurfacing lasers, factors driving their safety should be further explored.”
He added that he was surprised by the relatively low number of reported issues, referring to the total of 165 cases over 10 years. By comparison, he said, body contouring had 660 cases reported over a 7-year period in one recent study.
According to the MAUDE website, submitting MDRs to MAUDE is mandatory for manufacturers, importers, and device user facilities, and are voluntary for other groups, such as health care professionals, patients, and consumers.
Dr. Hashemi disclosed that he is a consultant for Castle Biosciences. He is also an entrepreneur in residence for Gore Range Capital.