Safety of Vaginal Laser Treatment of GSM

Abstract and Introduction

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.

Introduction

Genitourinary syndrome of menopause (GSM), previously known as vulvovaginal atrophy,^[1,2] is a chronic, progressive condition associated with menopausal hormonal changes of menopause.^[2–9] Manifesting as genital dryness, dyspareunia, vaginal bleeding, decreased sexual desire, dysuria, and urinary frequency/urgency, GSM is unlikely to resolve without treatment.^[10] GSM severely impairs sexual satisfaction and life in general in 59% and 23% of postmenopausal women, respectively.^[7] The vaginal symptoms of GSM have the greatest impact on a woman's enjoyment of sex, frequently damaging relationships.^[6,7,11]

Therapies for GSM include vaginal moisturizers, lubricants, barrier ointments, and medications targeting the underlying estrogen deficiency, which are frequently insufficient for symptomatic relief and can be expensive.^[12] Energy-based vaginal treatments, such as CO₂ laser therapies, have demonstrated efficacy as an effective, nonhormone alternative for the treatment of GSM,^[13] improving urinary function and sexual satisfaction.^[14–21] This nonhormone treatment for GSM provides an effective option for women with a history of estrogen receptor–positive breast cancer, an increased risk of thrombotic events, and other contradictions to hormone therapy.^[22]

Despite this favorable risk-benefit profile and the clinical need for nonhormone GSM treatment, in July 2018, the Food and Drug Administration (FDA) issued a safety communication cautioning against the use of vaginal lasers.^[23] To understand the source of concern cited in this warning, we applied a mixed-methods approach, with a review of the medical literature examining the safety of vaginal laser treatments, survey of adverse events (AEs) detailed in the Manufacturer and User Facility Device Experience (MAUDE) database, and comprehensive search of the Bloomberg Law database.

Table 1. Reported adverse events following vaginal laser treatments
Author	Case	Indication	Laser type	Sessions	Post-laser	Categories
Al-Badr et al (2019)⁴⁰	Case 1	Vaginal bulge, vaginal laxity, splint to defecate	Er:YAG	2	No benefit, underwent posterior vaginal repair 1 year later	Minimal change
Case 2	Vaginal laxity, vaginal wind	CO₂	2	No durable benefit, underwent posterior vaginal repair 1 year later	Minimal change
Case 3	Vaginal bulge, vaginal laxity, stress urinary incontinence	Er:YAG	4	No durable benefit, underwent posterior vaginal repair and sling	Minimal change
Gordon et al (2019)⁴¹	Case 4	Vaginal stenosis, dryness	CO₂	3	Postcoital vaginal bleeding, vaginal pain, dryness, tissue fibrosis, and shortened vaginal canal	More symptoms
Case 5	Mild painful intercourse	CO₂	3	Delayed worsening painful intercourse, vaginal dryness, pelvic floor hypertonus with spasm	More symptoms
Case 6	No info	CO₂	3	Persistent and worsening painful intercourse, vaginal dryness, burning, itchiness, crescent shaped fibrous band, decreased rugae, pale, frail, inelastic tissues	Not enough information
Case 7	Vaginal dryness, dyspareunia	CO₂	3	Worsening painful intercourse, pelvic floor hypertonus, levator ani spasms, vaginal scaring	More symptoms
Wallace (2019)⁴²	Case 8	Vaginal rejuvenation	CO₂	?	Bladder pain, urethral pain	Not enough information
Case 9	No info	CO₂	?	Unspecified pain	Not enough information
Case 10	Dyspareunia	CO₂	?	Dyspareunia	Minimal change
Case 11	Dyspareunia	CO₂	?	Dyspareunia, vaginal pain	Minimal change
Case 12	Vaginal pain	CO₂	?	Vaginal pain	Minimal change
Case 13	Vaginal dryness, urinary incontinence	CO₂	?	Vaginal dryness, urinary incontinence	Minimal change
Case 14	Vaginal rejuvenation	CO₂	?	Dyspareunia	Not enough information
Case 15	Vaginal rejuvenation	CO₂	?	Bartholin's cyst	Not enough information
Case 16	Dyspareunia	CO₂	?	Dyspareunia, urinary frequency, vaginal pain, lichen sclerosis, yeast infection	More symptoms
Case 17	Dyspareunia, urinary frequency	CO₂	?	Dyspareunia, urinary frequency	Minimal change
Case 18	No info	CO₂	?	Vaginal pain, bladder pain	Not enough information
Case 19	Vaginal pain	CO₂	?	Vaginal pain, vaginal burning	Minimal change
Case 20	Lichen sclerosis	CO₂	?	Lichen sclerosis, vaginal pain	Minimal change
Case 21	No info	Er:YAG	?	Bladder pain, dysuria, urinary tract infection, bacterial vaginosis	Not enough information
Case 22	No info	Er:YAG	?	Third-degree burns, vaginal pain	Not enough information
Case 23	No info	Er:YAG	?	Third-degree burns, vaginal pain	Not enough information
Case 24	Vaginal rejuvenation	Er:YAG	?	Dyspareunia, vaginal pain	Not enough information
Case 25	No info	CO₂	?	No info	Not enough information
Case 26	Vaginal atrophy	CO₂	?	Vaginal pain	Minimal change
Case 27	Urinary incontinence	CO₂	?	Vaginal pain, vaginal bleeding, dyspareunia, urinary incontinence, vaginal bleeding, yeast infection	More symptoms
Case 28	Vaginal rejuvenation	CO₂	?	Blurry vision, eye irritation, facial pain	Not enough information
Case 29	Vaginal atrophy	CO₂	?	Vaginal bleeding, vaginal pain	Minimal change

Table 1. Reported adverse events following vaginal laser treatments

Author

Case

Indication

Laser type

Sessions

Post-laser