The seven companies targeted by the F.D.A. for promoting dangerous uses of laser treatments for women included Inmode, Sciton, Alma Lasers, Thermigen, BTL Aesthetics, BTL Industries and Cynosure, which makes the MonaLisa Touch.Cynosure
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.
Some treatments use the devices to destroy or reshape vaginal tissue, which the manufacturers say can solve some problems related to dryness or other ailments. The F.D.A. disagrees. But even though the agency originally approved the devices for certain treatments, it is legal for doctors to use them for off-label conditions.