PHOENIX – Burns, dyspigmentation, and scarring had been the three commonest issues from using ablative and nonablative fractional resurfacing lasers reported to the Meals and Drug Administration between 2013 and 2022, an evaluation of medical machine studies (MDRs) over a decade confirmed.
Dr David Hashemi
“In the present day, ablative and nonablative fractional resurfacing lasers are used for a broad vary of indications, together with scar resurfacing, laser-assisted drug supply, total enchancment in pores and skin texture and tone, dyspigmentation, and zits scarring,” David A. Hashemi, MD, MBA, stated on the annual convention of the American Society for Laser Medication and Surgical procedure, the place the outcomes of the evaluation had been offered throughout an summary session. These units symbolize a quickly rising section of laser drugs and surgical procedure, he added, but little is thought concerning the prevalence of issues associated to their use.
To research, Dr. Hashemi, a third-year dermatology resident at Harvard College and Massachusetts Common Hospital, Boston, and Mathew M. Avram, MD, JD, director of laser, cosmetics, and dermatologic surgical procedure at MGH, drew from the FDA’s Producer and Person Facility System Expertise (MAUDE) database, which compiles medical machine studies for suspected accidents from machine use or malfunction and represents the most important repository of machine antagonistic results. Medical machine studies are submitted by producers, clinicians, sufferers, and others.
The researchers restricted their question to MDRs associated to ablative and nonablative fractional resurfacing lasers over the 10-year interval from 2013 to 2022. The question was carried out in January 2023 utilizing a complete checklist of product names and producers.
The preliminary search yielded 240 MDRs, which had been individually reviewed for duplicate data or inadequate knowledge, and the ultimate evaluation included 165 MDRs. The ten most reported antagonistic occasions had been burns (30%), adopted by dyspigmentation (14%), scarring (12%), different (11%), postoperative an infection (8%), blisters (6%), ache (5%), hypertrophic scar (4%), post-treatment irritation (4%), and textural modifications (3%). Throughout the 10-year interval analyzed, 56% of MDRs occurred between 2016 and 2019, with a disproportionately low share of MDRs occurring in 2022 (5%).
“Hostile occasions on account of ablative and nonablative fractional resurfacing lasers are uncommon however doubtlessly severe,” Dr. Hashemi concluded. “Care have to be taken with counseling, affected person choice, and therapy settings to optimize security, knowledgeable consent, and affected person satisfaction. Given the comparatively low variety of antagonistic occasions seen with fractional resurfacing lasers, components driving their security must be additional explored.”
He added that he was stunned by the comparatively low variety of reported points, referring to the entire of 165 circumstances over 10 years. By comparability, he stated, physique contouring had 660 circumstances reported over a 7-year interval in a single latest research.
In accordance with the MAUDE web site, submitting MDRs to MAUDE is obligatory for producers, importers, and machine consumer amenities, and are voluntary for different teams, equivalent to well being care professionals, sufferers, and shoppers.
Dr. Hashemi disclosed that he’s a marketing consultant for Fort Biosciences. He’s additionally an entrepreneur in residence for Gore Vary Capital.
This text initially appeared on MDedge.com, a part of the Medscape Skilled Community.