Medicine

Don't Believe the Hype on 'Vaginal Rejuvenation,' FDA Says

Don't Believe the Hype on 'Vaginal Rejuvenation,' FDA Says

The procedures, which use lasers and other energy-based devices to remove or reshape vaginal tissue, claim to treat conditions and symptoms related to menopause, urinary incontinence or sexual function.

Health care providers using lasers and similar devices for vaginal dryness, and pain during sex or urination are not using those medical devices for their intended use, the FDA says.

Opening up about this issue, a woman who used the "Thermiva" device from ThermiGen to treat her urinary incontinence said, "I was in so much pain. went to my OBGyn and she then informed me that I had bruising and she looked on the FDA website and told me that the product is not approved from FDA".

While these procedures are approved for as remedies for pre-cancerous cervical or vaginal tissue and genital warts, the FDA says they are not approved for use as vaginal rejuvenation treatments-even though some are being marketed as such.

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.

Experts say the "therapies", offered by some private clinics in the United Kingdom and the USA, pose a serious risk of burns, scarring and recurring pain.

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




However, these devices have not been approved for so-called vaginal rejuvenation. He said the agency doesn't know the extent of the risks because it hasn't reviewed the devices for such procedures.

The new laser and ultrasound devices are being marketed as safer, but the FDA said they could be harmful. Answers from the companies have been sought within the next 30 days.

"The deceptive marketing of unproven treatments may not only cause injuries but may also keep some patients from accessing appropriate, recognized therapies to treat severe medical conditions", said FDA commissioner Scott Gottlieb in a statement. The administration says if the companies fail to address the issue within the notice period, it will take "potential enforcement actions".

We've been focused on advancing new policies to improve our oversight of device safety.

These products are typically not covered by insurance, especially more serious treatment procedures, which are often referred to as "designer vaginoplasty", "revirgination", or "G-spot amplification".

As part of this critical work, we remain dedicated to closely monitoring reports of adverse events associated with "vaginal rejuvenation" procedures. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.


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