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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. (Kaplan, 7/30)

The agency said that it has approved such devices, which commonly use laser beams or radiofrequencies, for specific gynecologic uses, including the destruction of precancerous cervical or vaginal tissue and the removal of genital warts. But the agency has not cleared the devices for symptoms related to menopause, urinary incontinence or sexual function. The FDA noted in a safety alert issued Monday that vaginal "rejuvenation" often is used to describe nonsurgical procedures intended to treat symptoms such as vaginal laxity, atrophy or dryness, and pain during intercourse or urination. During menopause, levels of estrogen decline, which may lead to symptoms such as pain during sexual intercourse. (McGinley, 7/30)

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. (Thielking, 7/30)