FDA warns 'vaginal rejuvenation' treatments may pose safety risks

Enlarge  Food and Drug Administration Commissioner Scott Gottleib is not

In a statement, FDA Commissioner Scott Gottlieb, MD, said the agency has recently become aware of a growing number of manufacturers marketing devices that claim to treat conditions and symptoms related to menopause, urinary incontinence and sexual function.

Dr Vanessa Mackay, from the UK's Royal College of Obstetricians and Gynaecologists (RCOG), said: "There is no evidence to suggest that non-surgical "vaginal rejuvenation" devices are effective in improving vaginal muscle tone or reshaping vaginal tissue". These products have serious risks and don't have adequate evidence to support their use for these purposes.

"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", the FDA stressed.

But the FDA wants women to look out for their own safety, too.

The benefits and risks of all available treatment options for vaginal symptoms should be discussed with patients.

The commissioner expressed particular concern over marketing of the procedures to women whose cancer treatments caused early menopause.

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.

"The deceptive marketing of a unsafe procedure with no proven benefit, including to women who've been treated for cancer, is egregious", Gottlieb added.

The agency noted in one letter that a manufacturer, BTL Industries, was marketing a radio-frequency device, Exilis Ultra 360, as a new approach to "women's intimate health" even though the product had been approved by the FDA only for uses in dermatology like wrinkle treatment, including the eyelids.

The FDA has requested that the manufacturers address the concerns within 30 days.

The laser and ultrasound equipment used in these unapproved procedures has FDA approval for removing genital warts, other growths and in operations such as hysterectomies.

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

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

The companies involved say they are reviewing the warning letters from the FDA, which advises them to stop promoting the treatments.

Women who may not be candidates for certain FDA-approved treatments to relieve vaginal dryness, and who are seeking alternative nonhormonal options, may be particularly drawn to "vaginal rejuvenation" devices, ' according to the agency.



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