The Food and Drug Administration on Monday warned against the use of “energy-based” devices for vaginal “rejuvenation” or cosmetic procedures, saying such treatments could lead to vaginal burns, scarring and chronic pain.
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 it 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.
In a statement Monday, Scott Gottlieb, commissioner of the FDA, said that a growing number of manufacturers are marketing their devices for unapproved uses such a vaginal rejuvenation, in which tissue typically is destroyed or reshaped. In reviewing the FDA’s adverse-event reports and other information, he said, officials have found “numerous cases” of serious harm.
The agency recently notified seven device manufacturers expressing concern about “inappropriate marketing” and requested that they respond within 30 days. If the FDA’s concerns aren’t addressed, it will consider potential enforcement actions, Gottlieb said.
The commissioner expressed particular concern over marketing of the procedures to women whose cancer treatments caused early menopause. “The deceptive marketing of a dangerous procedure with no proven benefit, including to women who’ve been treated for cancer, is egregious,” he said.
One of the companies that received a letter from FDA is Cynosure, which manufactures a device called MonaLisa Touch. On its website, the company said, “During a treatment, a vaginal probe is inserted into the patient’s vagina, and delivers gentle, virtually painless laser energy to the vaginal wall, stimulating a healing response.” The website recommends three, five-minute treatments over 18 weeks and says there are “virtually no side effects.”
Cynosure referred calls about the FDA action to its parent company, Hologic, a medical technology firm based in Marlborough, Massachusetts. A spokeswoman for Hologic said company officials had not yet seen the FDA letter and so couldn’t comment on it.