Washington DC, [USA] July 31 (ANI): The US Food and Drug Administration (FDA) has warned against the use of devices that promise ‘vaginal rejuvenation’, stating that it can cause serious effects.
As per CNN, FDA in a statement said, “We are aware that certain device manufacturers may be marketing their energy-based medical device for vaginal ‘rejuvenation’ and/or cosmetic vaginal procedures. The safety and effectiveness of energy-based medical devices to perform these procedures has not been established.”
The lasers or radiofrequency waves used by these devices, according to the FDA, can be only used by licensed gynecologists to treat pre-cancerous tissues and genital warts. These have not been approved by FDA to treat vaginal dryness, itching, laxity or sexual dysfunction like 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,” FDA said.
FDA has sent a 30-day-notice to Alma Lasers, BTL Aesthetics, BTL Industries, InMode, Cynosure, ThermiGen and Sciton, for the inappropriate marketing of their devices for ‘vaginal rejuvenation’ procedures. The administration says if the companies fail to address the issue within the notice period, it will take “potential enforcement actions.”
Hologic, Inc., owner of Cynosure, replied to this with an email saying 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.”
Opening up about this issue, a woman who used the “Thermiva” device from ThermiGen to treat her urinary incontinence said, “I was in so much pain… 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?”
In another such incident, a woman who used a device by Cynosure called ‘Mona Lisa Touch’ said, “Two days after the procedure, I developed severe and debilitating bladder/urethral pain.”
Meanwhile, FDA requested women to stop using these devices and encouraged them to discuss any of their sexual dysfunction problems and their treatments with their doctors. (ANI)