The vaginal rejuvenation process is flawed, FDA says
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There's a procedure to fix every part of your body, including the parts of the body that need no "fixing" at all, like the vagina. However, that hasn't stopped some medical device companies and physicians from offering vaginal rejuvenation processes to do just that — and the U.S. Food and Drug Administration is not having it.

"We've recently become aware of a growing number of manufacturers marketing 'vaginal rejuvenation' devices to women and claiming these procedures will treat conditions and symptoms related to menopause, urinary incontinence or sexual function," FDA Commissioner Dr. Scott Gottlieb said in a statement.

"The procedures use lasers and other energy-based devices to destroy or reshape vaginal tissue. These products have serious risks and don't have adequate evidence to support their use for these purposes. We are deeply concerned women are being harmed."

Companies behind the vaginal rejuvenation process targeted

Seven companies have been issued warnings by the FDA: Alma Lasers, BTL Aesthetics, BTL Industries, Cynosure, InMode, Sciton and Thermigen.

 

These companies say the vaginal rejuvenation process — which uses lasers and ultrasound devices — will help women "take back" their sexual health by helping to tighten vaginal muscles, relieve intercourse pain or increase sexual pleasure.

Alma Lasers claims that their vaginal rejuvenation process known as FemiLift "is a virtually painless procedure without surgery, anesthesia or downtime. The lasting benefits of FemiLift can be an improved quality of life and deeply enhanced self-esteem."

vaginal rejuvenation process hurts women, FDA says

Cynosure says its vaginal rejuvenation process uses a laser to provide "a return to gynecologic health."

Many of these companies have hired outside advertising firms to help promote the products — and celebrities are often paid to endorse the procedures.

However, women are reporting vaginal burns and scarring from the laser-assisted vaginal rejuvenation process, according to the FDA. Some are even experiencing more pain during sex, which the lasers are often said to reduce.

Are the vaginal rejuvenation lasers approved for any medical use?

The devices used by the companies targeted are approved by the FDA, just not for the vaginal rejuvenation process. They're useful in removing growths, like genital warts, and can help with hysterectomies.

"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 in its public advisory. The treatment of these symptoms or conditions 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."

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

The FDA recommends that anyone affected by a service promising a vaginal rejuvenation process file a report through MedWatch, the FDA's Safety Information and Adverse Event Reporting program.

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