FDI warns against vaginal rejuvenation devices

  • FDI warns against vaginal rejuvenation devices

FDI warns against vaginal rejuvenation devices

The Food and Drug Administration is cracking down on manufacturers promising "vaginal rejuvenation", saying it could have serious side effects.

Our most fundamental obligation to the American public is providing patients with access to safe and effective medical products to meet their health care needs as well as protecting them from harmful products and deceptive medical claims.

But, they highlighted the fact that it did not clear the devices for symptoms related to menopause, urinary incontinence or sexual function.

In the press release, the agency says that the devices were approved for other purposes: removal of genital warts or destruction of precancerous cervical or vaginal tissue.

The FDA is warning consumers against serious risks of some "vaginal rejuvenation" devices, and a lack of evidence to support their uses for this objective.

According to a statement from FDA Commissioner Dr. Scott Gottlieb, "We are deeply concerned women are being harmed".

"The FDA has serious concerns about the use of these devices to treat gynecological conditions beyond those for which the devices have been approved or". FDA has not yet approved them in dealing with vaginal dryness, itching, laxity, or for sexual dysfunction. "The deceptive marketing of a unsafe procedure with no proven benefit, including to women who've been treated for cancer, is egregious", he said.

Gottlieb went on to note that the agency has reviewed patient reports and medical literature and found "numerous cases of vaginal burns, scarring, pain during sexual intercourse, and recurring or chronic pain" from the treatments.

Gottlieb also said he was concerned that deceptive marketing of these devices might prevent some patients from getting appropriate therapies for severe medical conditions. In the meantime, the FDA will continue to investigate manufacturers who have been inappropriately marketing these energy-based devices.

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. Gottlieb explains that if the manufacturers don't rectify these concerns, "the FDA will consider what next actions, including potential enforcement actions, are appropriate".

We've been focused on advancing new policies to improve our oversight of device safety.

Hologic, Inc., who owns the company Cynosure that markets the Mona Lisa Touch laser, addressed a reviewer who says she developed debilitating bladder pain after using the device.

In a statement, Jane Mazur, Hologic's vice president of global divisional communications, said that "Hologic has a strong track record of rooting our products in science and clinical evidence" and that it is "evaluating the letter in full and will collaborate with the agency to ensure all product communications adhere to regulatory requirements".