WASHINGTON -- The FDA on Monday warned against device manufacturers marketing 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 stated. "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 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 scarring and burns, pain during sex, and chronic pain. They advised healthcare providers to report any adverse effects of such unapproved procedures to the FDA Safety Information and Adverse Event Reporting program, MedWatch.
"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," FDA Commissioner Scott Gottlieb, MD, said in a . "The deceptive marketing of a dangerous procedure with no proven benefit, including to women who’ve been treated for cancer, is egregious."
Several manufacturers -- Alma Lasers, BTL Aesthetics, BTL Industries, Cynosure, InMode, Sciton, and Thermigen -- were put on notice, and their device claims will be monitoring.
"We requested that the manufacturers address our concerns within 30 days," said Gottlieb. "If our concerns are not addressed, then the FDA will consider what next actions, including potential enforcement actions, are appropriate."