Vaginal laser treatment of genitourinary syndrome of menopause: does the evidence support the FDA safety communication?

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.

Genitourinary Syndrome of Menopause

“…39 In conclusion, the authors found few reports of adverse events, and when they did it was unclear whether the adverse effects were due to a lack of efficacy, progression of the disease, incorrect use of the device, or harm caused by the procedure. 39 Many of the studies supported the effectiveness of the lasers for the treatment of GSM, but most also had small numbers of participants, short follow-up, lack of randomization, no placebo controls, and sponsorship support from laser manufacturers. 39 The VeLVET Trial, a randomized multicenter trial, enrolled 69 menopausal women with VVA to either fractionated CO 2 laser or vaginal conjugated estrogen cream.…”

“…39 Many of the studies supported the effectiveness of the lasers for the treatment of GSM, but most also had small numbers of participants, short follow-up, lack of randomization, no placebo controls, and sponsorship support from laser manufacturers. 39 The VeLVET Trial, a randomized multicenter trial, enrolled 69 menopausal women with VVA to either fractionated CO 2 laser or vaginal conjugated estrogen cream. 40 Of the 62 women who completed the 6-month protocol, the primary outcome of vaginal dryness, itching, irritation, and dysuria scores did not differ between the 2 groups.…”

Carbon Dioxide Laser Vulvovaginal Rejuvenation: A Systematic Review

“…Sexual activity can be resumed 1 to 3 days following the procedure, with no particular activity restriction [26,30] Adverse effects were generally mild and included irritation of the introitus [25], itching [27,41,53], mild burning sensation, pain during probe movement [30], scant bleeding [26,35,38], dysuria [41,48], vaginal discharge [53], and vaginal infection [41]. The presence of only mild complications in our review and relevant databases (MAUDE, Bloomberg Law) contradicts the FDA safety warning regarding vaginal laser therapy [74]. Some complications could have been reported only to the FDA.…”

“…Some complications could have been reported only to the FDA. As indicated by Guo et al, there are insufficient data to understand whether the adverse events represent a lack of efficacy, natural progression of disease, inappropriate device use, or true device-related harm, as the majority of post-treatment complaints are the symptoms of GSM for which the patients likely sought treatment [74]. The FDA warning may have been intended to prevent the marketing of vaginal laser treatments for cosmetic reasons or indications that are not well-defined.…”

“…The FDA warning may have been intended to prevent the marketing of vaginal laser treatments for cosmetic reasons or indications that are not well-defined. However, vaginal laser therapy for cosmetic purposes should not be equated with laser treatment of a highly impactful medical condition (GSM) for which there are only few therapeutic options [74]. Healthcare providers should engage affected women in the decision-making process when considering vaginal laser therapy for GSM [74].…”