Vaginal laser treatment of genitourinary syndrome of menopause: does the evidence support the FDA safety communication?. Issue 10 (October 2020)

• Record Type: Journal Article
• Authors: Guo, Julia Z.; Souders, Colby; McClelland, Lynn; Anger, Jennifer T.; Scott, Victoria C.S.; Eilber, Karyn S.; Ackerman, A. Lenore
• Is Part Of: Menopause. Volume 27:Issue 10(2020)
• Publication Date: 2020-10
• Subjects: Adverse events -- Erbium:YAG laser -- FDA warning -- Genitourinary syndrome of menopause -- Specific fractionated CO2 laser -- Vaginal laser; Menopause -- Periodicals; 618.175005
• DOI: 10.1097/GME.0000000000001577
• Languages: English
• ISSNs: 1072-3714

Abstract

Abstract: Importance: Genitourinary syndrome of menopause (GSM) is a chronic, progressive condition frequently manifesting as vaginal dryness and pain with intercourse. Survey data indicate this is a highly prevalent, likely underreported, condition that profoundly affects quality of life for millions of women. Vaginal lasers demonstrate promise as an effective, nonhormone therapeutic alternative for GSM; however, the risks associated with them may have been overstated. Objective: Despite reports of improved sexual and vaginal comfort without serious safety concerns, the Food and Drug Administration (FDA) issued a 2018 safety communication warning against it. We conducted a systematic literature review and surveyed both the FDA Manufacturer and User Facility Device Experience (MAUDE) and Bloomberg Law Databases to evaluate risks associated with laser treatment for GSM. Evidence Review: A systematic literature review identified articles published before September 2019. The MAUDE database was searched by name from 2009 to 2019 for safety claims for 24 vaginal laser devices. The Bloomberg Law database was searched for product liability claims against any vaginal laser device manufacturer before July 2019. Findings: Literature review revealed 3 publications detailing 29 presumptive laser-associated complications, only 5 of which (17.2%) reported worsening symptoms after treatment. The MAUDE database contained 120 complaints; only 30 (25%) detailed potential adverse patient events, most frequently pain ( n = 12) and burning ( n = 10). The Bloomberg law database contained no claims asserting harm from device use. Conclusions and Relevance: Lacking strong evidence indicating significant patient risk for vaginal laser treatment of GSM, the FDA safety communication appears unsubstantiated and implies gender bias. Identified complications suggest most reported "adverse events" represent lack of treatment effect. The well-documented benefits and low risk of adverse event suggest laser therapy for GSM is reasonable with appropriate pretreatment counseling. Additional randomized, well-controlled clinical trials are needed to further elucidate both the safety and efficacy of this nonhormone therapy. Abstract : Supplemental Digital Content is available in the text