WASHINGTON — The Food and Drug Administration on Monday announced that it had warned several companies to stop marketing laser devices for procedures billed as “vaginal rejuvenation,” saying they were dangerous and deceptive treatments.
The agency originally permitted the lasers and related energy-based devices onto the market for treatment of serious conditions, like cancer, genital warts, or surgery including hysterectomies.
But in recent years, manufacturers have been heavily promoting the lasers for symptoms related to vaginal atrophy, menopause, urinary incontinence and sexual function. Cosmetic, spa treatments using laser and other products for vaginal health have also become popular among younger women.
“These products have serious risks and don’t have adequate evidence to support their use for these purposes,” said Dr. Scott Gottlieb, the F.D.A. commissioner. “We are deeply concerned women are being harmed.”
The F.D.A. said the full extent of the risks is unknown, but that the agency has found cases of vaginal burns, scarring, and lasting pain following the treatments. The agency has received 14 reports of adverse events related to the treatments, including burning sensations and significant pain.