Medicine

Vaginal 'Rejuvenation' Procedures Are Unproven, Pose Serious Risks, FDA Warns

Vaginal 'Rejuvenation' Procedures Are Unproven, Pose Serious Risks, FDA Warns

What's more, vaginal rejuvenation procedures have been tied to serious side effects, including vaginal burns, scarring, pain during sexual intercourse and recurring or chronic pain.

One such company that received a letter from FDA is Cynosure, which manufactures a device called MonaLisa Touch. "The deceptive marketing of a risky procedure with no proven benefit, including to women who've been treated for cancer, is egregious", he said. If the FDA's concerns aren't addressed, it will consider potential enforcement actions, Gottlieb said.

If you have undergone treatment for vaginal "rejuvenation" and experienced a complication, file a report through the FDA's MedWatch. Although these devices have been approved to treat certain conditions, such as pre-cancerous lesions in the cervix, they have not been approved for vaginal rejuvenation, the FDA said.

FDA has sent a 30-day-notice to Alma Lasers, BTL Aesthetics, BTL Industries, InMode, Cynosure, ThermiGen and Sciton, for the inappropriate marketing of their devices for "vaginal rejuvenation" procedures.

Some treatments use the devices to destroy or reshape vaginal tissue, which the manufacturers say can solve some problems related to dryness or other ailments.

CNN reached out to these companies for comment.

Over a dozen adverse reports after the use of these treatments have brought this issue to the forefront. "So how can they sell it?"

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"We are evaluating the letter in full and will collaborate with the agency to ensure all product communications adhere to regulatory requirements", Mazur continued. The manufacturers are asked to provide details on the product and on what basis they are assuming approval. In the announcement Monday, Gottlieb said the agency would strengthen its studies of devices after they have been approved for sale.

FDA Commissioner Scott Gottlieb issued the following statement about these vaginal rejuvenation procedures.

"Obstetrician-gynecologists should be cognizant of the evidence regarding innovative practices" and should be wary "of adopting new or innovative approaches on the basis of promotions or marketing", the college said.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.

"I think the FDA is trying to be conservative", she said.

But some doctors say the devices work well for their off-label use.


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