FDA warns companies about 'deceptive' vaginal rejuvenation claim

FDA warns companies about 'deceptive' vaginal rejuvenation claim

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.

The laser devices used in vaginal rejuvenation are cleared for some medical uses.

"As a leader in women's health, Hologic has a strong track record of rooting our products in science and clinical evidence, so we take the contents of this letter seriously", Jane Mazur, a representative for Hologic, Inc., said in a statement.

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

But in a statement released Monday, the FDA said it's identified numerous cases of vaginal burns or scarring tied to vaginal rejuvenation, as well as post-procedural pain during sexual intercourse or recurring or chronic pain.

The seven device makers notified by FDA are: Alma Lasers, BTL Aesthetics, BTL Industries, Cynosure, InMode, Sciton and Thermigen.

The FDA clarifies that they have approved laser and energy-based devices for use to treat serious conditions such as genital warts.

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

The safety and effectiveness of energy-based devices to perform vaginal "rejuvenation" has not been established. The company is one of several that was issued a letter from the agency prompting device manufacturers to respond within 30 days or face potential enforcement actions.

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

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".

Gottlieb also said he was concerned that deceptive marketing of these devices might prevent some patients from getting appropriate therapies for severe medical conditions. 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. The agency has received 14 reports of adverse events related to the treatments, including burning sensations and significant pain. We will keep the public informed if significant new information becomes available.

The FDA is encouraging women to stop using these devices and report any issues to the FDA's adverse event reporting program, called MedWatch. 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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