Commentary on: What Is Being Reported About Vaginal "Lasers"?: An Examination of Adverse Events Reported to the Food and Drug Administration on Energy-Based Devices.

Abstract

Burkett et al provide an excellent review of adverse events (AEs) for energy-based devices, enhancing our understanding of the safety profile of these devices for vaginal rejuvenation.1 The authors employed the Manufacturer and User Facility Device Experience (MAUDE) database to evaluate voluntarily reported AEs in a 10-year period from 1999 to 2019 and compared AEs reported in genitourinary applications with those in dermatologic or general surgery applications. The reason these other specialties were chosen for comparison was because these specialties utilize these devices for their stated Food and Drug Administration (FDA) clearance and application, whereas many genitourinary and vaginal rejuvenation devices have 510k FDA clearance. The authors identified 39 AEs from 6 manufacturers with 11 products, with most AEs being injuries (82%) or local treatment reactions to the vaginal or vulva.1 No deaths were reported. In the spirit of patient safety, this review highlights several key messages for...