Vaginal ‘rejuvenation’ devices have serious side effects, might be unsafe, FDA says
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.
“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.”
CNN’s Michael Nedelman contributed to this report.
News credit : Cnn