WASHINGTON – The Food and Drug Administration announced on Monday that it had warned several companies not to sell laser devices for "vaginal rejuvenation" as they were dangerous and deceptive.
The agency originally allowed the laser and related energy-based devices to be marketed for the treatment of serious conditions, such as cancer, genital warts or surgery, including hysterectomies.
But in recent years, manufacturers have used lasers for symptoms related to vaginal atrophy, menopause, urinary incontinence, and sexual function. Cosmetics, laser-based spa treatments and other vaginal health products have also become popular with younger women.
The Authority noted in a letter that a manufacturer, BTL Industries, a radio marketed Exilis Ultra 360, a new approach to "intimate health for women," although the product was only approved by the FDA for uses in the Dermatology such as wrinkle treatment, including the eyelids. The F.D.A. described the company's "pelvic-suite" website on which the device was being advertised for the production of collagen and elasticity for "female intimate parts" and required the company to release it for marketing the product for such purposes.
The agency sent copies of letters sent to manufacturers of the MonaLisa Touch, Femilift, Venus Fiore RF ablation system and other devices, requesting that they no longer promote them for the rejuvenation process.
"These products have serious risks and do not have sufficient evidence to support their use for these purposes." Scott Gottlieb, the FDA commissioner. "We are deeply concerned that women are being harmed."
Dr. Gottlieb also said he was worried that fraudulent marketing of these devices might discourage some patients from getting suitable therapies for serious medical problems.
The F.D.A. The full extent of the risks was unknown, but the agency found cases of vaginal burns, scarring and persistent pain after the treatments. The agency has received 14 reports of adverse events related to the treatments, including burning sensations and significant pain.
Those of the F.D.A. On Monday were inmode; Sciton; Alma Laser; Thermigen; BTL aesthetics, BTL Industries; and Cynosure. Some companies did not respond immediately to requests for comment.
Jane G. Mazur, a spokeswoman for Hologic, Inc., whose subsidiary sells the MonaLisa Touch, said she was the F.D.A.
"We fully review the letter and will work with the agency to ensure that all product communications meet regulatory requirements," said Mazur.
The letters of the FDA are considered a step forward formal warning. Manufacturers are requested to provide details of the product and the basis for their approval
The Authority has been pressured to speed up the approval of medical devices. Critics have said that the F.D.A. Device approvals are already too fast and with insufficient monitoring. In the announcement Monday, dr. Gottlieb said the agency would step up its studies of equipment after it was approved for sale.
No federal agency or medical society has figures for the amount of these procedures every year, but a random search Through gynecological practices it shows that they prevail despite the opposition of the American College of Obstetricians and Gynecologists. The medical company has made several statements indicating that the devices, including the MonaLisa Touch, have no F.D.A. Clearance or approval for the treatment of menopausal symptoms, as announced.
"Obstetricians-gynecologists should be aware of the evidence relating to innovative practices" and should be cautious "adopting new or innovative approaches based on promotions or marketing," College said.
Dr. Cheryl B. Iglesia, Director of the Department of Pelvic Medicine and Reconstructive Surgery at the MedStar Washington Hospital Center, said the laser technology was promising, but that more studies were needed to understand the safety and which patients the devices could help. 19659002] "I think the FDA is trying to be conservative," she said. "They do not want marketing to be ahead of science."
But some doctors already say the devices work well for their off-label use. In a testimonial on her website, Alma Laser showed a video by Dr. med. Leslie Apgar, a Maryland gynecologist, said she was satisfied with the Femilift and the company's marketing support.
"With Alma, I Wanted The Femilift System I Wanted, along with the marketing solution that included a new website that was fully optimized for Google and all other search engines," Dr. Apgar in the video. "It worked very well for me as I brought new patients to my practice every week."