“Vaginal Rejuvenation” Has Serious Risks, Limited Evidence to Support Procedures: FDA
Federal regulators warn that women considering “vaginal rejuvenation” procedures should be wary, as the procedures carry many serious risks, and there is limited evidence that the procedures are safe or effective for many of the marketed purposes.
Many different medical providers market procedures known as “vaginal rejuvenation” or cosmetic vaginal surgery, involving use of energy-based devices – commonly radiofrequency or laser – to treat symptoms related to menopause, urinary incontinence, or sexual function. However, the FDA warns that the safety and effectiveness of energy-based devices for treatment of these conditions has not been established, and they have been linked to reports of serious adverse events.
In a safety communication issued on Monday, the FDA warned about the serious risks with vaginal rejuvenation, indicating that the agency is concerned that women are being injured by the procedures.
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In reviewing adverse event reports and published literature involving vaginal rejuvenation problems, the FDA has identified numerous cases of vaginal burns, scarring, pain during sexual intercourse, and recurring or chronic pain.
Vaginal rejuvenation is advertised as a non-surgical way to treat vaginal laxity, vaginal atrophy, dryness, itching, pain during sex, pain during urination, and decreased sexual sensation. The procedure uses energy-based devices approved by the FDA for specific gynecological procedures, such as the destruction of abnormal or pre-cancerous cervical or vaginal tissue or condylomas (genital warts). However, the agency warns that the devices have not been approved for vaginal rejuvenation and may carry serious risks.
“These products have serious risks and don’t have adequate evidence to support their use for these purposes,” FDA Commission Scott Gottlieb said, in an accompanying press release. “We are deeply concerned women are being harmed.”
In one instance, a woman who underwent the “Mona Lisa Touch” laser marketed by Cynosure, reported severe bladder pain two days after the procedure. She visited multiple doctors in search of relief and was unable to resolve the problem.
Many manufacturers advertise that the devices and procedures will offer women a “better feminine life”. The procedures are described as “virtually painless” and a “no surgery” option that has “minimal risk” to the patient.
The energy-based devices have not been proven safe or effective for the conditions they are advertised for by manufacturers, the FDA warned. The agency sent seven device manufacturers warning notices indicating they plan to monitor their claims regarding the uses and outcomes of the devices.
“A large part of our work focuses on efforts to bring forth innovative, new products,” wrote FDA officials. “But we’re equally dedicated to monitoring the landscape to ensure products are delivering on their intended benefits and to ensure that if new health risks arise, we take appropriate action.”
The FDA sent warning letters to Alma Lasers, BTL Aesthetics, BTL Industries, Cynosure, InMode, Sciton, and Thermigen. The warning letters call for manufacturers to respond to the concerns within 30 days, otherwise enforcement actions may be taken.
Any woman who has experienced a complication or side effect after undergoing vaginal rejuvenation procedures of any kind should report the problem to the FDA using the MedWatch Adverse Event Reporting program.
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