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, FDA Commissioner Scott Gottlieb 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. He said the agency doesn't know the extent of the risks because it hasn't reviewed the devices for such procedures. But it has found "numerous cases" of harm in adverse-event reports and published literature, he said.
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, Inc., a medical technology firm based in Marlborough, Mass.
In a statement, Jane Mazur, Hologic's vice president of global divisional communications, said that "Hologic has a strong track record of rooting our products in science and clinical evidence" and that it is "evaluating the letter in full and will collaborate with the agency to ensure all product communications adhere to regulatory requirements."