Women are being charged thousands of dollars a year for laser therapies to treat symptoms of menopause despite a crackdown by the medical device regulator and studies showing they are no more effective than a placebo.
When fractional carbon dioxide (CO₂) laser therapies, sold under names such as MonaLisa Touch and FemiLift, first emerged as a treatment for menopause symptoms a decade ago, initial studies reported improvement in up to 90 per cent of patients.
But Dr Fiona Li, an obstetrics and gynaecology researcher at the University of NSW, said numerous studies since had shown women who received laser therapy did not report a substantial improvement in symptoms compared to women who received a “sham” treatment mimicking the procedure.
The Therapeutic Goods Administration (TGA) this year reviewed all laser devices used for vaginal rejuvenation “in response to emerging safety signals”.Credit: Adobe
“What you’re paying for really is a marginal improvement compared to a placebo treatment,” Li said.
Fiona Li, conjoint associate lecturer at the University of NSW.
Li will present a follow-up study at the World Congress on Menopause in Melbourne on Monday, building on the growing body of evidence questioning the value of the treatment. Clinics charge up to $US2700 ($4000) per course and often recommend the procedure is repeated every six to 12 months, Li said.
In 2021, Li’s team conducted a double-blind trial where neither the patients nor the clinicians knew whether they were using the laser or sham treatment. They found no meaningful difference between the two.
When 25 women were given the laser treatment again for the latest study, this time aware they were receiving the real laser, they perceived a small but noticeable improvement in symptoms compared to when they didn’t know which treatment they’d received.
The therapies target symptoms including dryness, itching, urinary urgency and painful intercourse. Around 15 per cent of women will experience these symptoms in perimenopause, and up to 50 per cent report some form of physical discomfort within three years of menopause.
Li’s supervisor Professor Jason Abbott, who will also present at the conference, said doctors, patients and regulators needed to acknowledge laser therapies weren’t as effective as first promised.
“We can’t be charging people for a product that doesn’t work,” he said. “At the end of the day, if you’re making false claims, then regulating bodies may come down on you.”
A spokesperson for the Therapeutic Goods Administration (TGA) said the agency does not regulate clinical practice, but that it had recently undertaken a post-market review of all laser devices used for vaginal rejuvenation “in response to emerging safety signals”.
As a result, the TGA in March cancelled the registrations of a handful of devices involving hand pieces or accessories for vaginal rejuvenation.
“Cancellation of these devices means that they can no longer be supplied in Australia,” the spokesperson said. “The use of these devices for vaginal rejuvenation is outside of the approved indications and the intended use of the products.”
In 2018, the US Food and Drug Administration warned energy based “vaginal rejuvenation” devices may be unsafe. Some early patients reported scarring, severe chronic pain and burnings from the laser, but larger studies have not found significant side effects.
Dozens of clinics in Sydney alone continue to offer the procedure. The Herald contacted several, but none were willing or available to speak.
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