Laser devices licensed in Canada for the treatment of genitourinary menopausal syndrome (GSM) are often marketed for vaginal rejuvenation with claims that they will tighten the vagina and improve sexual function, despite a lack of evidence, a new review reveals.
Dr. Blayne Welk
Vaginal lasers heat the vaginal epithelium and cause thermal necrosis. This intervention induces collagen remodeling and synthesis, neovascularization, and elastin formation and may lead to improved vaginal elasticity and restoration of premenopausal epithelial function, according to co-authors Blayne Welk, MD, MSc, associate professor of urologic surgery at Western University in London. . , Ontario, and Erin Kelly, MD, lecturer in obstetrics and gynecology at the University of Alberta in Edmonton.
Their patients’ questions and experiences with the laser devices prompted the commentary, they said Medscape Medical News.
Dr. Erin Kelly
“A big part of my practice involves dealing with GSM and urinary incontinence,” Kelly said. “Many women who present to the clinic have heard of vaginal laser procedures, had vaginal laser procedures, or have been told they need vaginal laser procedures. My impression was that these procedures are being marketed to women…without rigorous study.”
“Many women are reluctant to have mesh straps for stress incontinence because of some of the potential risks” and are looking for less invasive options, Welk said. In recent years, he has had increasing inquiries from patients about using lasers to improve this condition.
The commentary had been issued online February 6 at Journal of the Canadian Medical Association.
Transparency is required
The first atrial energy device was licensed by Health Canada in 2015 for the treatment of GSM. This meant that the device was deemed to meet key safety, efficacy and quality criteria. However, controlled studies are not required for regulatory approval of such devices, and after licensure, some providers rebrand the device from GSM to vaginal resuscitation, Kelly and Welk said.
Vaginal laser treatments are offered across Canada, with at least one vaginal rejuvenation provider in the 10 most populous cities. Under the current system, the number of patients who pay for these procedures and the amount they pay cannot be traced. Nor can the number of vaginal laser systems active in Canada be identified. Patients can self-refer for the service, and publicly listed providers (for example on websites) cost thousands of dollars for treatment.
The rebrand for vaginal resuscitation “represents a difference between the licensing of a medical device by Health Canada and the way those devices are used and marketed,” according to the comment. “A procedure with limited high-quality evidence to support its effectiveness and a potential financial conflict of interest for providers may not serve the best interests of people in Canada, even if the risk of adverse events is low.”
Canada Medical Device Updates Action Plan, including mandatory reporting of serious events and the ability to compel manufacturers to provide safety and efficacy information, “represent significant progress,” according to Kelly and Welk. However, problems remain, including the lack of a requirement for peer-controlled studies.
In addition, women undergoing laser treatment for GSM, urinary incontinence, or vaginal resurfacing may not receive appropriate medical evaluation and standard treatments, the authors noted.
“I would like to see more transparency and public information available on approved medical devices,” Welk said. “Health Canada has an online database of approved devices, but no information is available on the evidence submitted during the approval process, nor are there any indications of the various devices.”
In addition, he said, many devices in the registry are listed by serial number rather than a name that would be known to the public, “making it difficult to match information.”
Kelly added the “encouraging” news that the Canadian Society for Pelvic Medicine is working with Health Canada to “improve knowledge translation around medical device transparency.”
Medicine Before Marketing
Dr. Jason Abbott
“The commentary provides an accurate and evidence-based assessment of the use of vaginal laser treatments,” Jason Abbott, B Med (Hons), PhD, professor of gynecology at the University of New South Wales in Sydney, Australia, told Medscape. “Marketing this device is a case of putting the cart before the horse. It is important that there are robust, scientific and reproducible studies of efficacy and safety before there is a direct-to-consumer marketing approach.”
Clinicians should counsel patients when the treatment effect is likely to be minimal or dangerous, especially when there is a financial incentive for the clinician, he said. “Governments, regulators and medical companies have a duty of care to the public to make sure that the drug goes to market. Otherwise, we are no better than snake oil salesmen.
“Given the size of the studies to date, the improvement in symptoms after treatment may be less than a few percent,” he noted. “That might be acceptable to some women. We don’t know.”
Abbott’s team is conducting research to determine what women would like as a minimum level of improvement, maximum cost and maximum risk from the laser procedure.
“In cancer … the benefit of a new treatment may be only a small percentage on survival,” he said. “This may be perfectly acceptable for some or even many patients. What we cannot do, however, is extrapolate these same expectations to a treatment for a benign condition where quality of life is compromised.”
Echoing Kelly and Welk, Abbott said, “It’s important to be transparent in clinical communication. Patients need to be told that the best quality scientific studies show that there is no benefit from laser treatment for the GSM or urinary incontinence.”
While the medical risks may be low, he added, “the financial risk also needs to be discussed. Patients should be encouraged to participate in clinical trials where there is no cost to get the information first, before wholesale use of the treatment . . . If patients still wish to undergo the procedure after being given the risks and an honest account of the evidence, that is of course their choice.”
Kelly, Welk, and Abbott had no commercial funding or relevant financial relationships to report.
CMAJ. Published online February 6, 2023. Comment
Follow Marilynn Larkin on Twitter: @MarilynnL.
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