Published: Fri, August 03, 2018
Medicine | By Brett Sutton

Vaginal Laser Treatments Can Cause Burns and Scarring, the FDA Says

Vaginal Laser Treatments Can Cause Burns and Scarring, the FDA Says

The FDA said "vaginal "rejuvenation" is an ill-defined term; however, it is sometimes used to describe non-surgical procedures meant 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 that it has approved such devices, which commonly use laser beams or radiofrequencies, for specific gynecologic uses, including the destruction of precancerous cervical or vaginal tissue and the removal of genital warts.

The FDA on Monday warned against device manufacturers marketing energy-based medical devices for cosmetic vaginal procedures, or so-called vaginal "rejuvenation".

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The Food and Drug Administration is cracking down on companies "deceptively" marketing unproven "vaginal rejuvenation" devices and treatments that have been reported to cause serious burns, scars, and chronic pain, the agency announced on Monday, July 30. But the agency has not cleared the devices for symptoms related to menopause, urinary incontinence or sexual function.

As part of this critical work, we remain dedicated to closely monitoring reports of adverse events associated with "vaginal rejuvenation" procedures.

In another such incident, a woman who used a device by Cynosure called "Mona Lisa Touch" said, "Two days after the procedure, I developed severe and debilitating bladder/urethral pain".

The FDA said it was "deeply concerned" people were being injured with these procedures.

Monday, the FDA issued a statement warning that some of the "vaginal rejuvenation" treatments on the market can come with risky side effects, like vaginal burns, scarring, and pain.

"The treatment of these symptoms or conditions 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", FDA said.

We haven't reviewed or approved these devices for use in such procedures.

In addition to the deceptive health claims being made about the products, the devices are in some cases being marketed to women who have completed treatment for breast cancer and are experiencing symptoms caused by early menopause, Gottlieb said. Since December of 2015, Deborah Kotz, a press officer with the FDA, said the agency has received a dozen reports of complications related to these procedures.

BTL and Cynosure, a division of Hologic, said they were reviewing the warning letters.

The FDA is warning consumers against serious risks of some "vaginal rejuvenation" devices, and a lack of evidence to support their uses for this goal.

"[We have] a strong track record of rooting our products in science and clinical evidence so, we take the contents of this letter seriously", Hologic, Inc.

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