FDA warns about 'deceptive' vaginal rejuvenation claims, dangers

Seven companies have received a letter from the FDA about marketing devices for 'vaginal rejuvenation' procedures

On its website, the company said, "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", Gottlieb said in a statement.

More specifically, the companies collectively claim that the devices are able to treat vaginal "laxity", pain during urination or intercourse, decreased sexual sensation, and vaginal dryness, itching, or atrophy.

Unfortunately, manufacturers are making these deceptive health claims to women, particularly those who are experiencing early menopause or who just completed breast cancer treatment. The devices have not been approved for such use in sexual dysfunction.

Such treatments, however, might lead to adverse effects, according to the Food and Drug Administration - including vaginal burns, scarring, and increased pain during sexual activity.

In the press release, the agency says that the devices were approved for other purposes: removal of genital warts or destruction of precancerous cervical or vaginal tissue.

Dr Vanessa Mackay, from the UK's Royal College of Obstetricians and Gynaecologists (RCOG), said: "There is no evidence to suggest that non-surgical "vaginal rejuvenation" devices are effective in improving vaginal muscle tone or reshaping vaginal tissue". Since December of 2015, Deborah Kotz, a press officer with the FDA, said the agency has received a dozen reports of complications related to these procedures.

"In addition to the deceptive health claims being made with respect to these uses, the "vaginal rejuvenation" procedures have serious risks", Gottlieb said.

As part of Monday's warning, the FDA announced it had notified seven companies about the "inappropriate marketing of their devices for "vaginal rejuvenation" procedures" including: Alama Lasers, BTL Aesthetics, BTL Industries, Cynosure, InMode, Sciton and Thermigen.

Scott Gottlieb, a commissioner of the FDA, recently stated that a growing number of manufacturers are marketing their devices for unapproved uses such a vaginal rejuvenation.

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".

They were given 30 days to address the FDA's concerns.

The FDA urges anyone who suffered a complication linked to a vaginal "rejuvenation" treatment to report it through MedWatch. "We are evaluating the letter in full and will collaborate with the agency to ensure all product communications adhere to regulatory requirements".

The benefits and risks of all available treatment options for vaginal symptoms should be discussed with patients.



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