Are Vaginal Lasers Safe for GSM Treatment in Menopause?

Currently, the safety and effectiveness of vaginal lasers (such as the MonaLisa Touch and others) have not been established for treating genitourinary syndrome of menopause (GSM)—the medical term for menopause-related changes in the vagina, vulva, and urinary tract ^[1][2]. While these devices are heavily marketed and some people report short-term relief from vaginal dryness and pain, major medical societies do not recommend them over established therapies ^[1][2]. In 2018, the FDA cautioned that energy-based devices were not approved for “vaginal rejuvenation” or menopause symptoms and highlighted reports of serious complications ^[3][4].

The FDA Communication and Known Risks

In July 2018, the FDA issued a public communication warning that the safety and effectiveness of energy-based devices (including lasers) for treating menopause-related vaginal symptoms, urinary incontinence, and sexual function had not been established ^[3][4]. The agency noted that some devices had been marketed for uses outside of their cleared approvals ^[4][5].

Through its adverse event reporting system, the FDA and subsequent analyses have received reports of complications associated with these procedures. Reported risks include:

• Vaginal burns and scarring ^[3][5]
• Chronic or persistent pain ^[3]
• Numbness and burning sensations ^[3]
• Dyspareunia (painful sex) that persists or worsens after treatment ^[3]
• Bladder disturbances ^[3]

Because these are spontaneous reports, it is impossible to determine exactly how often these complications occur or definitively prove that the laser caused all of them ^[3]. However, they highlight real risks that patients should carefully consider. Furthermore, anyone experiencing vaginal burning, unusual discharge, or postmenopausal bleeding should be evaluated by a doctor to rule out other causes like infections or cancer before considering any treatment.

What the Medical Societies Say

Leading organizations specializing in women’s health agree that evidence is insufficient to support lasers as a routine treatment for GSM:

• The American College of Obstetricians and Gynecologists (ACOG) stated that vaginal lasers should only be recommended after robust clinical trials demonstrate long-term safety, efficacy, and complication profiles ^[1].
• The North American Menopause Society (NAMS) concluded in its 2020 GSM Position Statement that placebo-controlled evidence is insufficient to determine the safety or efficacy of energy-based therapies for GSM, a stance that remains cautious ^[2].

Neither society endorses vaginal lasers over established, proven treatments ^[1][2].

What the Research Actually Shows

Early enthusiasm for vaginal lasers came from small, short-term, or observational studies where patients knew they were receiving the treatment ^[6][7]. However, higher-quality sham-controlled trials—studies where some participants receive a “fake” or inactive laser procedure to compare against the real one—have shown different results.

Recent systematic reviews reveal that the laser often provides little to no significant difference in symptom relief, quality of life, or vaginal health when compared to the sham procedure ^[8][9]. In some trials, patients in both the laser and sham groups experienced similar improvements, illustrating the uncertainty of the laser’s actual medical benefit ^[10][11]. Furthermore, durable benefit beyond approximately 12 months has not been established ^[11][12]. It is also important to note that “vaginal lasers” are not a single uniform treatment (e.g., fractional CO2 vs. erbium:YAG), and results can vary depending on the specific device used.

Established Treatment Alternatives

Because laser safety and effectiveness are unproven, experts recommend starting with standard, evidence-based therapies ^[2]. Treatment should be individualized based on your medical history, especially if you have a history of hormone-sensitive cancer, unexplained bleeding, or blood clots ^[13].

Before considering expensive, heavily marketed, out-of-pocket procedures, discuss these established and well-studied alternatives with your clinician.