FDA warns about vaginal 'rejuvenation' device claims

Vaginal'Rejuvenation Procedures Are Unproven Pose Serious Risks FDA Warns

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The Food and Drug Administration on Monday announced that it had warned several companies to stop marketing laser devices for procedures billed as "vaginal rejuvenation", saying they were unsafe and deceptive treatments. "The safety and effectiveness of energy-based medical devices to perform these procedures has not been established".

Commissioner Scott Gottlieb, in a statement, said the products have serious risks, have not been reviewed or approved for use in such procedures and don't have adequate evidence to support the claims.

The FDA said it was "deeply concerned" people were being injured with these procedures.

Some treatments use the devices to destroy or reshape vaginal tissue, which the manufacturers say can solve some problems related to dryness or other ailments. The statement adds, "The treatment of these symptoms or conditions by applying energy-based therapies to the vagina may lead to serious adverse events, including vaginal burns, scarring, pain during sexual intercourse, and recurring/chronic pain".

The FDA recently sent warning letters to seven companies, notifying them about the agency's concerns regarding inappropriate marketing of their devices for vaginal rejuvenation.

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"Vaginal rejuvenation procedures claim to tighten the skin and the vaginal tissue beneath the skin by using various forms of energy devices", says Adeeti Gupta, M.D., a board-certified gynecologist and founder of Walk In GYN Care in NY.

"Women considering treatment for vaginal symptoms should speak to their doctor about the potential and known benefits and risks of all available treatment options", he advised.

If you're dealing with painful sex or other sexual dysfunction issues-or if you're just into the idea of having a more enjoyable sex life-the recent trendiness of vaginal laser rejuvenation might have seemed like a magic wand.

Unfortunately, manufacturers are making these deceptive health claims to women, particularly those who are experiencing early menopause or who just completed breast cancer treatment. In these cases, the FDA had not reviewed or approved the used devices for the goal of 'vaginal rejuvenation'. We requested that the manufacturers address our concerns within 30 days. FDA is committed to helping advance the development of safe, effective treatment options for these conditions.

These products are typically not covered by insurance, especially more serious treatment procedures, which are often referred to as "designer vaginoplasty", "revirgination", or "G-spot amplification". The agency has received 14 reports of adverse events related to the treatments, including burning sensations and significant pain. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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