Vaginal 'Rejuvenation' Devices Unproven, FDA Warns

Vaginal "rejuvenation" devices promising to solve symptoms related to menopause, sexual functions and other conditions are unproven, according to a medical device warning issued by the U.S. Food and Drug Administration on Monday.

The warning stated that the "safety and effectiveness" of such devices and procedures remain unclear.

"The use of energy-based devices to perform vaginal 'rejuvenation,' cosmetic vaginal procedures, or non-surgical vaginal procedures to treat symptoms related to menopause, urinary incontinence, or sexual function may be associated with serious adverse events,” the warning said.

"The safety and effectiveness of energy-based devices for treatment of these conditions has not been established."

One such device, MonoLisa Touch laser procedure by Cynosure, is advertised as a "long-lasting solution" for menopausal side effects, USA Today reported.

Hologic Inc., the parent company of Cynosure, told USA Today that it is aware of the FDA warning.

"As a leader in women's health, Hologic has a strong track record of rooting our products in science and clinical evidence, so we take the contents of this letter seriously," Jane Mazur, a representative for Hologic, Inc., said in a statement.

"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 FDA said "vaginal 'rejuvenation' is an ill-defined term; however, it is sometimes used to describe non-surgical procedures intended to treat vaginal symptoms and/or conditions including, but not limited to: vaginal laxity; vaginal atrophy, dryness, or itching; pain during sexual intercourse; pain during urination; and decreased sexual sensation."

The agency said treating such symptoms by applying energy-based therapies to the vagina may lead to serious adverse events, including vaginal burns, scarring, pain during sexual intercourse, and recurring/chronic pain.

The FDA suggested that patients:

• Be aware that the safety and effectiveness of energy-based devices to perform vaginal "rejuvenation" or cosmetic vaginal procedures has not been established.
• 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.
• Discuss the benefits and risks of all available treatment options for vaginal symptoms with your health care provider.
• If you have undergone treatment for vaginal "rejuvenation" and experienced a complication, file a report through the FDA's MedWatch.

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