FDA Warns Against Vaginal Rejuvenation Devices

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Products marketed for vaginal rejuvenation have not been approved as safe, and can lead to burns and chronic pain, the Food and Drug Administration said Monday.

The FDA sent out a warning letter to seven companies that produce vaginal rejuvenation devices, who they believe are “inappropriately marketing” their products as safe. The letter is also intended to caution doctors who use these devices.

The focus is on “energy-based devices” that use radiofrequency or lasers, and claim to heal or cure vaginal problems.

“To date, we have not cleared or approved for marketing any energy-based devices to treat these symptoms or conditions, or any symptoms related to menopause, urinary incontinence, or sexual function,” the letter states.

Rather, the FDA warns, these devices can cause more harm.

“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.”

“These products have serious risks and don’t have adequate evidence to support their use for these purposes,” FDA Commissioner Dr. Scott Gottlieb said in a statement. “We are deeply concerned women are being harmed.”

Gottlieb added that the “deceptive” claims these manufactures make about their products pose “serious risks.”

“In some cases, these devices are being marketed for this use to women who have completed treatment for breast cancer and are experiencing symptoms caused by early menopause,” he wrote. “The deceptive marketing of a dangerous procedure with no proven benefit, including to women who’ve been treated for cancer, is egregious.”

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Along with the FDA, the American College of Obstetricians and Gynecologists and the North American Menopause Society have not endorsed any vaginal rejuvenation products, and have said they are awaiting more comprehensive data before endorsing the procedure.

PEOPLE Health Squad member Dr. Mary Jane Minkin, MD, a board-certified OB/GYN at Yale University School of Medicine, warns against the procedure, which stars like Jada Pinkett Smith have recommended.

“I won’t say there’s no data on it but the problem is there’s really no prospective randomized double-blind trials on any of this so a lot of it is anecdotal,” Minkin told PEOPLE. “I’m always concerned about something like a laser burning somebody or hurting somebody.”

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