Monday, the FDA issued a statement warning that some of the “vaginal rejuvenation” treatments on the market can come with dangerous side effects, like vaginal burns, scarring, and pain.
“We’ve recently become aware of a growing number of manufacturers marketing ‘vaginal rejuvenation’ devices to women and claiming these procedures will treat conditions and symptoms related to menopause, urinary incontinence or sexual function,” reads the statement issued by FDA commissioner Scott Gottlieb, M.D. “The procedures use lasers and other energy-based devices to destroy or reshape vaginal tissue. These products have serious risks and don’t have adequate evidence to support their use for these purposes. We are deeply concerned women are being harmed.”
While these procedures are approved for as remedies for pre-cancerous cervical or vaginal tissue and genital warts, the FDA says they are not approved for use as vaginal rejuvenation treatments—even though some are being marketed as such.
“In reviewing adverse event reports and published literature, we have found numerous cases of vaginal burns, scarring, pain during sexual intercourse, and recurring or chronic pain,” according to Gottlieb’s statement.
The FDA has even sent warning letters to seven companies that make these devices—including Cynosure Inc’s MonaLisa Touch and Thermigen, Inc’s THERMIva—asking the companies to either remove statements linked to nonsurgical vaginal rejuvenation or provide them with backup for those claims.
But the FDA wants women to look out for their own safety, too.
“Today, we’re warning women and their healthcare providers that the FDA has serious concerns about the use of these devices to treat gynecological conditions beyond those for which the devices have been approved or cleared,” Gottlieb says. “Women considering treatment for vaginal symptoms should speak to their doctor about the potential and known benefits and risks of all available treatment options.”
The bottom line: Some nonsurgical “vaginal rejuvenation” treatments aren’t approved by the FDA to treat symptoms like vaginal dryness—and could even come with dangerous consequences like burns—so talk to your ob-gyn about alternative options if you’re considering one of them.
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