FDA warns about 'deceptive' vaginal rejuvenation claims, dangers

Enlarge  Food and Drug Administration Commissioner Scott Gottleib is not

The Food and Drug Administration (FDA) has issued an alert to healthcare providers concerning the use of energy-based devices for vaginal "rejuvenation", a term used to describe non-surgical procedures meant to treat vaginal laxity, atrophy, dryness, or itching; pain during sexual intercourse or urination; or for decreased sexual sensation.

The administration said some of the procedures use lasers or "energy-based devices" to "destroy or reshape vaginal tissue".

"Vaginal rejuvenation procedures claim to tighten the skin and the vaginal tissue beneath the skin by using various forms of energy devices", says Adeeti Gupta, M.D., a board-certified gynecologist and founder of Walk In GYN Care in NY.

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The US Food and Drug Administration (FDA) has warned against the use of devices that promise "vaginal rejuvenation", stating that it can cause serious effects. But the agency has not cleared the devices for symptoms related to menopause, urinary incontinence or sexual function.

According to CNBC, the American College of Obstetricians and Gynecologists recommends "doctors inform patients about the lack of data supporting the efficacy and potential complications of vaginal rejuvenation and other similar procedures".

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.

Gottlieb is concerned that these procedures are aimed at women who had cancer treatment that caused early menopause, a fact he considers to be egregious and, adding that the manufacturers use "deceptive marketing of a risky procedure with no proven benefit". "We are deeply concerned women are being harmed", said FDA commissioner Dr Scott Gottlieb in a statement. Their notifications express concerns over the "inappropriate marketing of their devices for "vaginal rejuvenation" procedures".

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"In reviewing adverse event reports and published literature, we have found numerous cases of vaginal burns, scarring, pain during sexual intercourse, and recurring or chronic pain", the agency said.

In addition to the deceptive health claims being made about the products, the devices are in some cases being marketed to women who have completed treatment for breast cancer and are experiencing symptoms caused by early menopause, Gottlieb said.

The FDA will closely monitor reports of problems associated with "vaginal rejuvenation" procedures, and will keep the public informed, Gottlieb said.

Hologic, Inc., which owns Cynosure, wrote in an email that they have "a strong track record of rooting our products in science and clinical evidence so, we take the contents of this letter seriously".

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

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