Jusleen Ahluwalia1, Mathew M Avram2, Arisa E Ortiz1. 1. Department of Dermatology, University of California, San Diego School of Medicine, 9500 Gillman Drive, La Jolla 92093, California. 2. Dermatology Cosmetic and Laser Center, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.
Abstract
INTRODUCTION: The FDA issued a statement on July 30, 2018, expressing concern over the marketing of lasers and energy-based devices to promote "vaginal rejuvenation." The FDA stated that there is insufficient data to recommend this modality for optimization of sexual function and alleviation of genitourinary syndrome of menopause (GSM)-related symptoms in postmenopausal or postpartum women. This analysis aims to characterize the mandatory and voluntary reports concerning laser and energy-based procedures marketed for vaginal rejuvenation. METHODS: Cross-sectional analysis of the FDA database, Manufacturer and User Facility Device Experience (MAUDE), for events related to laser and energy-based devices for vaginal rejuvenation. RESULTS: Between October 2015 and January 2019, 45 distinct events describing 46 patients were recorded and reviewed. The most commonly reported adverse event related to the procedure was pain (vulvar, bladder, urethral, or unspecified) (n = 19). The majority of patients sought medical care for their injuries, which included evaluation by urgent care, urology, gynecology, neurology, gastroenterology, pelvic floor therapy, primary care providers, and the device operator. Thirty-three patients indicated chronicity of their injury, which included long-term pain, numbness, burning, bladder disturbances, infections, scarring, dyspareunia, worsening symptoms, aggravation of lichen sclerosis, and disfigurement. CONCLUSIONS: A variety of adverse events associated with the use of laser and energy-based devices for "vaginal rejuvenation" was reported to the MAUDE database. Although the circumstances surrounding these events were unclear, these reports signify the importance of clinical trials that investigate the efficacy and safety profile of laser and energy-based devices for optimization of sexual function and treatment of GSM-related symptoms. Lasers Surg. Med.
INTRODUCTION: The FDA issued a statement on July 30, 2018, expressing concern over the marketing of lasers and energy-based devices to promote "vaginal rejuvenation." The FDA stated that there is insufficient data to recommend this modality for optimization of sexual function and alleviation of genitourinary syndrome of menopause (GSM)-related symptoms in postmenopausal or postpartum women. This analysis aims to characterize the mandatory and voluntary reports concerning laser and energy-based procedures marketed for vaginal rejuvenation. METHODS: Cross-sectional analysis of the FDA database, Manufacturer and User Facility Device Experience (MAUDE), for events related to laser and energy-based devices for vaginal rejuvenation. RESULTS: Between October 2015 and January 2019, 45 distinct events describing 46 patients were recorded and reviewed. The most commonly reported adverse event related to the procedure was pain (vulvar, bladder, urethral, or unspecified) (n = 19). The majority of patients sought medical care for their injuries, which included evaluation by urgent care, urology, gynecology, neurology, gastroenterology, pelvic floor therapy, primary care providers, and the device operator. Thirty-three patients indicated chronicity of their injury, which included long-term pain, numbness, burning, bladder disturbances, infections, scarring, dyspareunia, worsening symptoms, aggravation of lichen sclerosis, and disfigurement. CONCLUSIONS: A variety of adverse events associated with the use of laser and energy-based devices for "vaginal rejuvenation" was reported to the MAUDE database. Although the circumstances surrounding these events were unclear, these reports signify the importance of clinical trials that investigate the efficacy and safety profile of laser and energy-based devices for optimization of sexual function and treatment of GSM-related symptoms. Lasers Surg. Med.