Health Care

FDA warns about vaginal 'rejuvenation' device claims

FDA warns about vaginal 'rejuvenation' device claims”

"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", said the agency in a statement. "The safety and effectiveness of energy-based medical devices to perform these procedures has not been established". These products have serious risks and don't have adequate evidence to support their use for these purposes.

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

The administration said some of the procedures use lasers or "energy-based devices" to "destroy or reshape vaginal tissue". 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. The companies are: Alma Lasers, BTL Aesthetics, BTL Industries, Cynosure, InMode, Sciton and Thermigen.

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

"During a treatment, a vaginal probe is inserted into the patient's vagina, and delivers gentle, virtually painless laser energy to the vaginal wall, stimulating a healing response". "The deceptive marketing of a unsafe procedure with no proven benefit, including to women who've been treated for cancer, is egregious", he said.

Meanwhile, FDA requested women to stop using these devices and encouraged them to discuss any of their sexual dysfunction problems and their treatments with their doctors. These products may be particularly appealing to women who may not be candidates for certain FDA-approved treatments to relieve vaginal dryness, and thus are seeking alternative, non-hormonal options. Gottlieb explains that if the manufacturers don't rectify these concerns, "the FDA will consider what next actions, including potential enforcement actions, are appropriate".

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

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

Hologic, Inc., owner of Cynosure, replied to this with an email saying they have "a strong track record of rooting our products in science and clinical evidence so, we take the contents of this letter seriously".

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

In an official statement issued by the agency, Scott Gottlieb, FDA commissioner, says they are recently aware of an increasing number of companies claiming that their products provide vaginal rejuvenation to women.

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