The Food and Drug Administration is cracking down on devices marketed for use in “vaginal rejuvenation.”
In a statement issued Monday, FDA Commissioner Scott Gottlieb said a growing number of manufacturers are marketing “vaginal rejuvenation” devices. Some manufacturers claim the devices can treat symptoms of menopause, problems with sexual function, and urinary incontinence. The FDA said those claims aren’t supported by scientific evidence — and warns the products could pose serious risks to women’s health.
“We are deeply concerned women are being harmed,” Gottlieb said.
The devices work by using lasers or other energy sources to destroy or reshape vaginal tissue. The FDA has cleared or approved such devices in the past, but to kill pre-cancerous tissue and genital warts. The agency hasn’t evaluated the safety or effectiveness of the devices for “vaginal rejuvenation.”
The FDA said it had reviewed adverse event reports and medical literature and catalogued “numerous cases” in which use of the devices resulted in vaginal burns, scarring, pain during intercourse, and chronic pain.
In some cases, the FDA said, the devices are being marketed specifically to women who have gone through treatment for breast cancer and are experiencing early menopause.
“The deceptive marketing of a dangerous procedure with no proven benefit, including to women who’ve been treated for cancer, is egregious,” Gottlieb said. And, he added, the misleading marketing of unproven treatments might keep some women from receiving appropriate, evidence-based care for their conditions.
The FDA recently issued warning letters to seven device manufacturers — Alma Lasers, BTL Aesthetics, BTL Industries, Cynosure, InMode, Sciton, and Thermigen — detailing its concerns about inappropriate marketing of “vaginal rejuvenation” procedures. The agency is encouraging patients to talk about the risks and benefits of any treatment for vaginal symptoms with their health care providers.
Gottlieb said the FDA will continue to closely monitor adverse event reports linked to “vaginal rejuvenation” procedures and is asking patients who have experienced adverse events to report them through Medwatch, the adverse event reporting system.