FDA: Energy-Based Devices Should Not Be Used for Vaginal "Rejuvenation"

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The FDA also noted in a safety alert that vaginal rejuvenation is often used to describe nonsurgical procedures that are meant to treat symptoms such as vaginal laxity, atrophy or dryness, and pain during urination, among others.

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 Food and Drug Administration on Monday announced that it had warned several companies to stop marketing laser devices for procedures billed as "vaginal rejuvenation", saying they were risky and deceptive treatments. These are marketed to treat symptoms related to menopause, urinary incontinence, and sexual function.

According to CNBC, the American College of Obstetricians and Gynecologists recommends "doctors inform patients about the lack of data supporting the efficacy and potential complications of vaginal rejuvenation and other similar procedures".


The FDA says these companies have not undergone the correct approval process required to show that the treatments they offer work as advertised or even that they're safe to use.

"The deceptive marketing of a unsafe procedure with no proven benefit, including to women who've been treated for cancer, is egregious", Gottlieb said. "We are deeply concerned women are being harmed", stated the safety alert released on the agency's website.

"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. He said the agency doesn't know the extent of the risks because it hasn't reviewed the devices for such procedures.

Gottlieb also said he was concerned that deceptive marketing of these devices might prevent some patients from getting appropriate therapies for severe medical conditions.


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

"In addition to the deceptive health claims being made with respect to these uses, the "vaginal rejuvenation" procedures have serious risks", Gottlieb said.

If you suffered any adverse effects associated with these procedures, the FDA wants you to file a report through MedWatch. Some of the companies such as Cynosure that is owned by Hologic Inc. state that they have based their treatments on science.

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


"We are evaluating the letter in full and will collaborate with the agency to ensure all product communications adhere to regulatory requirements", Mazur continued.

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