The FDA on Monday warned against device manufacturers marketing energy-based medical devices for cosmetic vaginal procedures, or so-called vaginal “rejuvenation.”
The term is used to describe non-surgical procedures intended to treat vaginal laxity, atrophy, dryness, or itching; reduced sexual sensation; and pain with sex or urination.
“The safety and effectiveness of energy-based medical devices to perform these procedures has not been established,” the agency said in the statement. “Understand that the FDA has not cleared or approved any energy-based medical device for vaginal ‘rejuvenation’ or vaginal cosmetic procedures, or for the treatment of vaginal symptoms related to menopause, urinary incontinence, or sexual function.”
The FDA said that these unapproved therapies — often radiofrequency or laser devices cleared for condylomas, abnormal or pre-cancerous tissue, and other conditions- – could lead to serious side effects, including “vaginal burns, scarring, pain during sexual intercourse, and recurring/chronic pain,” and advised healthcare providers to report any adverse effects of such procedures to the FDA Safety Information and Adverse Event Reporting program, MedWatch.
“We have contacted these manufacturers to share our concerns and will be monitoring their claims about uses of their products,” the agency said. “In addition, we will continue to monitor reports of adverse events associated with this issue and will keep the public informed if significant new information becomes available.”
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