Devices that promise vaginal "rejuvenation" to women with urinary incontinence or sexual or menopausal symptoms might not be safe and can have serious side effects, the US Food and Drug Administration warned Monday.
"We are aware that certain device manufacturers may be marketing their energy-based medical device 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."
FDA warns women against using energy-based vaginal "rejuvenation" devices
Devices may cause vaginal burns, scarring and pain during sexual intercourse
The devices in question typically use laser or radiofrequency waves and have been cleared by the FDA for use by licensed gynecologists to treat abnormal and pre-cancerous vaginal and cervical tissue, as well as genital warts.
But their use to treat vaginal dryness, itching and laxity, the FDA said, has not been approved. The devices have also not been FDA approved for use in treating sexual dysfunction, such as decreased sexual sensation or pain during intercourse or urination.
"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 FDA stressed.
The FDA has notified Alma Lasers, BTL Aesthetics, BTL Industries, InMode, Cynosure, ThermiGen and Sciton over "concerns about inappropriate marketing of their devices for 'vaginal rejuvenation' procedures," and expects them to address the issues raised by the agency within 30 days. If the companies fail to respond, the FDA said, it will consider next steps, which might include "potential enforcement actions."
CNN reached out to these companies for comment.
"We are deeply concerned women are being harmed," FDA Commissioner Dr. Scott Gottlieb said in a statement. "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. "Two days after the procedure, i developed severe and debilitating bladder/urethral pain," the woman wrote, adding that visits to several doctors failed to resolve her symptoms.
"There is no viable research on the internet regarding this procedure and virtually no negative comments, feedback, or threads, which leads me and my physicians to wonder if the internet is being "scrubbed" 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 contents of this letter seriously. We are evaluating the letter in full and will collaborate with the agency to ensure all product communications adhere to regulatory requirements."
Another woman used the "Thermiva" device from ThermiGen to treat her urinary incontinence. "I was in so much pain," she wrote, adding "...went to my OBGyn and she then informed me that I had bruising and she looked on the FDA website and told me that the product is not approved from fda. So how can they sell it?"
The FDA is encouraging women to stop using these devices and report any issues to the FDA's adverse event reporting program, called MedWatch. The FDA also encourages women suffering from vaginal or sexual dysfunction problems to discuss their symptoms and potential treatments with their health care provider.
- Vaginal 'rejuvenation' devices have serious side effects, might be unsafe, FDA says
- FDA approves 1st birth control app, long-term vaginal contraception ring
- The health side effects of volcano eruptions
- FDA tightens restrictions on Essure birth control device
- FDA overhauls approval process as medical devices come under fire
- Side effects include ... a potential treatment for baldness
- Ambien maker Sanofi: 'Racism is not a known side effect'
- FDA isn't doing enough to prevent medical device hacking, HHS report says
- Lawmakers file bill to ban installation of unsafe, used tires
- FDA chief: Opioids are 'biggest crisis facing the FDA'