The Food and Drug Administration’s Commissioner, Scott Gottlieb, M.D., has released a statement warning consumers of serious risks associated with laser vaginal rejuvenation treatments.
“We’ve recently become aware of a growing number of manufacturers marketing ‘vaginal rejuvenation’ devices to women and claiming these procedures will treat conditions and symptoms related to menopause, urinary incontinence or sexual function,” says Gottlieb.
“The procedures use lasers and other energy-based devices to destroy or reshape vaginal tissue. These products have serious risks and don’t have adequate evidence to support their use for these purposes. We are deeply concerned women are being harmed.”
The FDA’s warning names seven device manufacturers who they say have been making deceptive marketing claims.
“In some cases, these devices are being marketed for this use to women who have completed treatment for breast cancer and are experiencing symptoms caused by early menopause,” says Gottlieb. “The deceptive marketing of a dangerous procedure with no proven benefit, including to women who’ve been treated for cancer, is egregious.”
The FDA is citing “numerous cases of vaginal burns, scarring, pain during sexual intercourse, and recurring or chronic pain.”
The New York Times spoke with Dr. Cheryl B. Iglesia, director of the section of female pelvic medicine and reconstructive surgery at MedStar Washington Hospital Center, who said the technology has promise but needs more study.
“I think the FDA is trying to be conservative,” she said. “They do not want the marketing to be ahead of the science on this.”
We’re investigating the facts and will update this article as the story unfolds.