Product News and Recalls

FDA Speaking Out on Vaginal “Rejuvenation” Treatments, Promises

“The FDA has not cleared or approved any energy-based medical device for vaginal ‘rejuvenation’ or vaginal cosmetic procedures, or for the treatment of vaginal symptoms related to menopause, urinary incontinence, or sexual function.” These are the words contained in a statement issued by the Food and Drug Administration as reports of injuries and complications related to such treatments continue to come in.

This means that regardless of names like MonoLisa and Ultra Femme 360, the device your doctor is using to conduct your treatment hasn’t actually been approved by the FDA for such uses – none have. However, this hasn’t stopped manufacturers from doing everything they can to get the devices into your doctor’s office. And, in many cases, they are doing so far outside of the rules of federal regulation.

While doctors are permitted to use any device or drug for any purpose they deem to be in the patient’s best interest – a practice known as off-label use – the manufacturers of those drugs and devices are only allowed to market products based on their approved use. Evidence might show that a diabetes drug can also be an effective treatment for some other condition and a doctor may use it that way. However, that drug can only be marketed for the treatment of diabetes.

Therein lies the problem when it comes to devices being marketed as effective treatment options for symptoms like vaginal dryness or pain during sex or urination. While no device currently holds FDA approval for the treatment of these kinds of symptoms, the agency has sent letters to several device manufacturers warning them against the continued marketing of devices claiming to do exactly that.

In fact, those marketing efforts have proven to be quite extensive. In the case of Femilift, a device manufactured and marketed by Alma Laser, a doctor uses a since-removed testimonial to describe the website Alma gave her as part of her overall purchase. Maryland gynecologist Dr. Leslie Apgar says that her Femilift system also came with a “marketing solution that included a new website fully optimized for Google and all the other search engines.”

A new website. And all this doctor had to do was buy a device from a company that was knowingly breaking federal regulations.