Story snapshots
The FDA warns women against using energy-based vaginal “rejuvenation” devices
The devices can cause vaginal burns, scarring and pain during intercourse
CNN
—
Devices that promise vaginal “rejuvenation” for women with urinary incontinence or sexual or menopausal symptoms may not be safe and may have serious side effects, U.S. The Food and Drug Administration warned Monday.
“We are aware that some device manufacturers may market their medical device based on energy for vaginal ‘rejuvenation’ and/or cosmetic vaginal procedures.” the FDA said in a statement. “The safety and effectiveness of energy-based medical devices to perform these procedures has not been established.”
These devices typically use laser or radio frequency waves and are FDA-approved for use by licensed gynecologists to treat abnormal and precancerous vaginal and cervical tissue, as well as genital warts.
But their use to treat vaginal dryness, itching and looseness, the FDA said, is not approved. The devices are also not approved by the FDA for use in the treatment of sexual dysfunction, such as decreased sexual sensation or pain during intercourse or urination.
“Treatment of these symptoms or conditions by applying energy therapies to the vagina may result in serious adverse events, including vaginal burns, scarring, pain during intercourse, and recurrent/chronic pain,” the FDA pointed out.
The FDA notified Alma Lasers, BTL Aesthetics, BTL Industries, InMode, Cynosure, ThermiGen and Sciton of “concerns about the inappropriate marketing of their devices for ‘vaginal resurfacing’ procedures and expects them to address the issues raised by the agency within 30 days. If the companies don’t respond, the FDA said, it will consider next steps, which may include “potential enforcement actions.”
CNN has reached out to those companies for comment.
“We are deeply concerned that women are being harmed,” FDA Commissioner Dr. Scott Gottlieb said in a statement. “Misleading marketing of unproven treatments can not only cause injuries, but can also prevent some patients from accessing appropriate, recognized therapies to treat serious medical conditions.”
In a of twelve adverse event reports, one woman describes her experience with “Laser Mona Lisa Touch”. marketed by Cynosure. “Two days after the procedure, I developed severe and debilitating bladder/urethra pain,” the woman wrote, adding that visits to several doctors failed to resolve her symptoms.
“There is no viable internet research on this procedure and virtually no negative comments, feedback or threads, which leads me and my doctors to wonder if the internet is being ‘swept’ by the manufacturer,” the woman wrote.
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 content of this letter seriously. We are fully evaluating the letter and will work with the agency to ensure that all product communications comply with regulatory requirements.”
Another woman used it “Thermiva” device from ThermiGen to treat her urinary incontinence. “I was in so much pain” wrote, adding “…she went to my OBGyn and then informed me that I had bruising and looked on the FDA website and told me the product is not FDA approved. So how can they sell it?’
Follow CNN Health on Facebook and Twitter
The FDA encourages women to stop using these devices and report any problems to the FDA’s adverse event reporting program, called MedWatch. The FDA also encourages women who suffer from vaginal or sexual dysfunction problems to discuss their symptoms and possible treatments with their health care provider.
