The Food and Drug Administration (FDA) in the United States recently said 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 FDA 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.
The agency noted in one letter that a manufacturer, BTL Industries, was marketing a radio-frequency device, Exilis Ultra 360, as a new approach to “women’s intimate health” even though the product had been approved by the FDA only for uses in dermatology like wrinkle treatment, including the eyelids. The FDA described the company’s “pelvic-suite” webpage, where the device was advertised as able to build collagen and elasticity for “female intimate parts,” and requested that the company furnish documentation that it had been cleared to market the product for such uses.
The agency posted copies of letters it sent to manufacturers of the MonaLisa Touch, Femilift, Venus Fiore RF Ablation System and other devices, telling them to stop promoting them for the rejuvenation procedure.
“These products have serious risks and don’t have adequate evidence to support their use for these purposes,” said Dr. Scott Gottlieb, the FDA commissioner. “We are deeply concerned women are being harmed.”
Gottlieb also said he was concerned that deceptive marketing of these devices might prevent some patients from getting appropriate therapies for severe medical conditions.
The FDA said the full extent of the risks is unknown, but that the agency has found cases of vaginal burns, scarring, and lasting pain after the treatments. The agency has received 14 reports of adverse events related to the treatments, including burning sensations and significant pain.
The companies targeted by the FDA were Inmode; Sciton; Alma Lasers; Thermigen; BTL Aesthetics, BTL Industries; and Cynosure. Some companies did not immediately respond to requests for comment.
Jane G. Mazur, a spokeswoman for Hologic Inc. whose subsidiary sells the MonaLisa Touch, said they were reviewing the FDA notice.
“We are evaluating the letter in full and will collaborate with the agency to ensure all product communications adhere to regulatory requirements,” Mazur said.
The FDA’s letters are considered a step short of a formal warning. The manufacturers are asked to provide details on the product and on what basis they are assuming approval.
The agency has been under pressure to speed up approval of medical devices. Critics have said that the FDA device approvals are already going too fast and happening with insufficient oversight. Gottlieb said the agency would strengthen its studies of devices after they have been approved for sale.
No federal agency or medical society has figures for the amount of these procedures done every year, but a casual search through gynecology practices shows they are becoming prevalent — despite opposition from the American College of Obstetricians and Gynecologists. The medical society has issued several statements noting that the devices, including the MonaLisa Touch, do not have FDA clearance or approval for treatment of menopausal symptoms, as advertised.
“Obstetrician-gynecologists should be cognizant of the evidence regarding innovative practices and should be waring of adopting new or innovative approaches on the basis of promotions or marketing,” the college said.
But some doctors say the devices work well for their off-label use. In a testimonial on its website, Alma Laser featured a video of Dr. Leslie Apgar, a Maryland gynecologist, who said she was pleased with the Femilift, as well as the company’s assistance with marketing.
“With Alma I was able to get the Femilift system that I wanted, along with the marketing solution that included a new website fully optimized for Google and all the other search engines,” Apgar said. “It has worked out extremely well for me, as I have gotten new patients weekly directed to my practice.”
The New York Times