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". But the agency has not cleared the devices for symptoms related to menopause, urinary incontinence or sexual function.
The U.S. Food & Drug Administration warned against "vaginal rejuvenation" treatments due to potential health and safety risks, including burns and scarring.
While these procedures are approved for as remedies for pre-cancerous cervical or vaginal tissue and genital warts, the FDA says they are not approved for use as vaginal rejuvenation treatments-even though some are being marketed as such.
Scott Gottlieb, a commissioner of the FDA, recently stated that a growing number of manufacturers are marketing their devices for unapproved uses such a vaginal rejuvenation. In these cases, the FDA had not reviewed or approved the used devices for the objective of 'vaginal rejuvenation'.
The idea is that the vaginal rejuvenation process will help boost sexual desire and sexual function, but there's just one problem: These claims are probably all BS, says Dr. Gupta.
"We are deeply concerned women are being harmed", said Gottlieb, in a press release.
The deceptive marketing of unproven treatments may not only cause injuries but may also keep some patients from accessing appropriate, recognized therapies to treat severe medical conditions.
In reviewing adverse event reports and published literature, we have found numerous cases of vaginal burns, scarring, pain during sexual intercourse, and recurring or chronic pain. The agency has received 14 reports of adverse events related to the treatments, including burning sensations and significant pain.
The seven companies called out by the FDA are: BTL Industries, Inc; Cynosure, Inc.; Alma Lasers; Sciton, Inc.; Thermigen, Inc.; BTL Aesthetics; and Inmode MD Ltd. The other companies contacted by NBC News had no immediate comment. "So how can they sell it?"
"We are evaluating the letter in full and will collaborate with the agency to ensure all product communications adhere to regulatory requirements", Mazur continued.
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.
Not only is vaginal rejuvenation likely ineffective when comes to its claims on sex drive, the FDA warns that the procedures come with other risky are downright unsafe. Speaking to the NY Times, Dr Cheryl B Iglesia, director of female pelvic medicine and reconstructive surgery at MedStar Washington Hospital Center, said, "I think the FDA is trying to be conservative". "They do not want the marketing to be ahead of the science on this".
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