FDA Warns Vaginal 'Rejuvenation' Devices Unproven


FDA Warns Vaginal 'Rejuvenation' Devices Unproven

FDA Commissioner Scott Gottlieb said there are a growing number of manufacturers marketing these devices to women claiming the procedures will treat menopause, urinary incontinence or sexual function by destroying or reshaping tissue.

But, the agency notes, there's no proof that these devices are effective for any of the "rejuvenating" procedures companies claim and some celebrities promote.

"We requested that the manufacturers address our concerns within 30 days", said Gottlieb.

FDA also said that it has approved such devices which commonly use beams and radio frequencies for specific gynecologic uses including the destruction of precancerous cervical or vaginal tissue and also the removal of genital warts.

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.

It has sent warning letters to seven companies: Alma Lasers, BTL Aesthetics, BTL Industries, Cynosure, InMode, Sciton and Thermigen.

But the FDA wants women to look out for their own safety, too.

"To date, we have not cleared or approved for marketing any energy-based devices to treat these symptoms or conditions, or any symptoms related to menopause, urinary incontinence or sexual function", the FDA said.

The bottom line: Some nonsurgical "vaginal rejuvenation" treatments aren't approved by the FDA to treat symptoms like vaginal dryness-and could even come with risky consequences like burns-so talk to your ob-gyn about alternative options if you're considering one of them. 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 risky procedure with no proven benefit, including to women who've been treated for cancer, is egregious". The devices have not been approved for such use in sexual dysfunction.

The American College of Obstetricians and Gynecologists has been cautioning against surgical "rejuvenation" procedures for more than a decade.

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.

In one of a dozen adverse event reports, a woman describes her experience with the "Mona Lisa Touch" laser marketed by Cynosure. The FDA has urged women to stop using these devices and report the issues to the FDA's adverse event reporting programme called the 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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