FDA warns against treatments to treat menopause side effects

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The use of lasers and other medical devices for vaginal “rejuvenation” treatments and similar cosmetic procedures have been warned against by the US Food and Drug Administration (FDA), after such treatments were found to be potentially harmful. The Independent reports that the warning was issued regarding “energy-based” devices that promise to treat vaginal conditions and symptoms through laser therapy.

Treatments such as vaginal rejuvenation claim to help with issues related to menopause, such as vaginal laxity or dryness, urinary incontinence, or pain during sex, however, the “safety and effectiveness” of these procedures has not been established, according to the FDA. Many vaginal rejuvenation treatments also claim to tighten the vaginal canal. Rather than help with vaginal issues, cosmetic procedures using energy-based devices may result in vaginal burns, scarring, pain during intercourse, or recurring, chronic pain, the FDA said.

The report says currently, energy-based devices have clearance for medicinal use only in the destruction of pre-cancerous cervical or vaginal tissue and genital warts.

To stop the falsely-marketed treatments, the FDA issued seven letters to companies offering vaginal rejuvenation procedures. “These products have serious risks and don’t have adequate evidence to support their use for these purposes,” said Dr Scott Gottlieb, the FDA commissioner. “We are deeply concerned women are being harmed.”

One company issued an “inappropriate marketing” warning, Cynosure, offers a procedure called the MonaLisa Touch, which claims to have “virtually no side effects,” according to its website.

The report says the American College of Obstetricians and Gynaecologists (ACOG) previously issued a statement on vaginal laser treatment, stating: “Obstetrician-gynaecologists should be cognisant of the evidence regarding innovative practices, and should be wary of adopting new or innovative approaches on the basis of promotions or marketing.”

In response to the FDA warning, ACOG vice president Dr Christopher Zahn, is quoted in the report as saying: “The ACOG has cautioned health care providers and patients about the risk of using laser technologies for so called ‘vaginal rejuvenation’ procedures or treatment of vaginal atrophy. ACOG is pleased that this week’s announcement from the FDA aligns with and affirms our position that the data to support the safety and efficacy of these procedures for these indications is markedly limited.

“Health care providers who receive requests for these procedures should discuss with the patient the reason for her request and the lack of data to support these procedures. ACOG continues to acknowledge that this technology has not been approved for vaginal rejuvenation, and providers must take this in consideration before using these devices for these indications.”

The report says despite the risks and lack of approval, some doctors continue to offer the treatments. On the American Society of Plastic Surgeons website, it states: “As women go through childbearing, hormonal changes and ageing, they can experience changes in their genitalia. Non-surgical vaginal rejuvenation treatments can help to reverse these changes.”

The Independent report

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