Vaginal Laser Treatments Can Cause

Vaginal ‘Rejuvenation’ Treatments could also be Unsafe, the F.D.A. Says

WASHINGTON — The Food and Drug Administration on Monday announced that it had warned several companies to prevent 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 marketplace for the treatment of great conditions, like cancer, genital warts, or surgery including hysterectomies.

But in recent years, manufacturers are heavily promoting the lasers for symptoms associated with vaginal atrophy, menopause, enuresis, and sexual function. Cosmetic, spa treatments using laser and other products for vaginal health have also become popular among younger ladies.

Some treatments use the devices to destroy or reshape vaginal tissue, which the manufacturers say can solve some problems associated with dryness or other ailments. The F.D.A. disagrees. But albeit the agency originally approved the devices surely treatments, it's legal for doctors to use them for off-label conditions.

The agency noted in one letter that a manufacturer, BTL Industries were marketing a radiofrequency device, Exilis Ultra 360, as a replacement approach to “women’s intimate health” albeit the merchandise had only been approved by the F.D.A. for uses in dermatology like wrinkle treatment, including the eyelids.

The F.D.A. described the company’s “pelvic-suite” website, where the device was advertised as ready to build collagen and elasticity for “female intimate parts,” and requested that the corporate furnish documentation that it had been cleared to plug the merchandise for such uses.

The agency posted copies of letters it sent to manufacturers of the MonaLisa Touch, Femilift, Venus Fiore System, and other devices, telling them to not promote the devices 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 F.D.A. commissioner.

“We are deeply concerned women are being harmed.”

Dr. Gottlieb also said he was concerned that deceptive marketing of those devices might prevent some patients from getting appropriate therapies for severe medical conditions.

The F.D.A. said the complete extent of the risks is unknown, but that the agency has found cases of vaginal burns, scarring, and lasting pain following the treatments.

The agency has received 14 reports of adverse events associated with the treatments, including burning sensations and significant pain.

The companies targeted by the F.D.A. were In mode; Sciton; Alma Lasers; Thermigen; BTL Aesthetics, BTL Industries; Venus Concept and Cynosure.

Some companies didn't immediately answer requests for comment.

Jane G. Mazur, a spokeswoman for Hologic, Inc. whose subsidiary sells the MonaLisa Touch, said they were reviewing the F.D.A. notice.

“We are evaluating the letter fully and can collaborate with the agency to make sure all product communications adhere to regulatory requirements,” Ms. Mazur said.

Domenic DiSisto, general counsel for Venus Concept, said the Venus Fiore device isn't currently marketed or sold within the us, which the corporate had modified its website.

The F.D.A.’s letters are considered a step in need of a proper warning. The manufacturers are asked to supply details on the merchandise and on what basis they're assuming approval.

The agency has been struggling to hurry up the approval of medical devices.

Critics have said that the F.D.A. device approvals are already going too fast and happening with insufficient oversight.

within the announcement Monday, Dr. Gottlieb said the agency would strengthen its studies of devices after they need to be approved purchasable.

No agency or medical society has figures for the quantity of those procedures are done per annum, but an off-the-cuff search through gynecology practices show they're 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, don't have F.D.A. clearance or approval for treatment of menopausal symptoms, as advertised.

“Obstetrician-gynecologists should be cognizant of the evidence regarding innovative practices” and will be wary “of adopting new or innovative approaches on the idea of promotions or marketing,” the school said.

Dr. Cheryl B. Iglesia, director of the section of female pelvic medicine and plastic surgery at MedStar Washington Hospital Center said the laser technology held promise, but that more study was needed to know the security also as to which patients the devices might help.

“I think the F.D.A. is trying to be conservative,” she said. “They don't want the marketing to be before the science on this.”

But some doctors already say the devices work well for his or her off-label use.

During 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, also because of the company’s assistance with marketing.

“With Alma, I used to be ready to get the Femilift system that I wanted, alongside the marketing solution that included a replacement website fully optimized for Google and every one the opposite search engines,” Dr. Apgar said within the video.

“It has figured out extremely well on behalf of me, as I even have gotten new patients weekly directed to my practice.”