FDA warns about 'deceptive' vaginal rejuvenation claims, dangers

FDA warns about 'deceptive' vaginal rejuvenation claims, dangers

FDA warns about 'deceptive' vaginal rejuvenation claims, dangers

The term "vaginal rejuvenation" has been used to describe non-surgical procedures meant to treat symptoms and conditions including vaginal laxity, atrophy, dryness or itching, pain during sexual intercourse or urination, and decreased sexual sensation.

In a safety communication, the FDA told patients and doctors that laser and radiofrequency devices approved to treat abnormal tissue have been improperly promoted to address sexual discomfort and vaginal dryness.

As per CNN, FDA in a statement said, "We are aware that certain device manufacturers may be marketing their energy-based medical device for vaginal "rejuvenation" and/or cosmetic vaginal procedures".

To view the full article, register now. These are marketed to treat symptoms related to menopause, urinary incontinence, and sexual function.

"It is deceptive to give the impression that vaginal rejuvenation, designer vaginoplasty, revirgination, G-spot amplification, or any such procedures are accepted and routine surgical practices".

But the FDA says these companies have not gone through the correct approval process to show that the treatments work as advertised, or even that they are safe.

Unfortunately, manufacturers are making these deceptive health claims to women, particularly those who are experiencing early menopause or who just completed breast cancer treatment.

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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.

The agency originally permitted the lasers and related energy-based devices onto the market for treatment of serious conditions, like cancer, genital warts, or surgery including hysterectomies.

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.

This is why the agency has released the warning, adding that they have notified seven manufacturers about the "inappropriate marketing", asking for a response within 30 days. These products have serious risks and don't have adequate evidence to support their use for these purposes. Gottlieb explains that if the manufacturers don't rectify these concerns, "the FDA will consider what next actions, including potential enforcement actions, are appropriate".

If you suffered any adverse effects associated with these procedures, the FDA wants you to file a report through MedWatch.

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".

One of the companies that received a letter from FDA is Cynosure, which manufactures a device called MonaLisa Touch.

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