The term "vaginal rejuvenation" has been used to describe non-surgical procedures meant to treat symptoms and conditions including vaginal laxity, atrophy, dryness or itching, pain during sexual intercourse or urination, and decreased sexual sensation.
Hologic's (HOLX +1.7%) Cynosure unit is one of seven manufacturers warned by the FDA over their marketing of energy-based devices, including lasers, for "vaginal rejuvenation", an unapproved indication.
Although these devices have been approved to treat certain conditions, such as pre-cancerous lesions in the cervix, they have not been approved for vaginal rejuvenation, the FDA said.
"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", FDA Commissioner Dr. Scott Gottlieb said in a statement.
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.
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.
United States regulator the FDA says it will take action if deceptive marketing of the "dangerous procedure with no proven benefit" continues.
"We are deeply concerned women are being harmed", said Gottlieb, in a press release.
The FDA has notified Alma Lasers, BTL Aesthetics, BTL Industries, InMode, Cynosure, ThermiGen and Sciton over "concerns about inappropriate marketing of their devices for "vaginal rejuvenation" procedures", and expects them to address the issues raised by the agency within 30 days.
"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", according to Gottlieb's statement.
If you're dealing with painful sex or other sexual dysfunction issues-or if you're just into the idea of having a more enjoyable sex life-the recent trendiness of vaginal laser rejuvenation might have seemed like a magic wand.
Gottlieb also said he was concerned that deceptive marketing of these devices might prevent some patients from getting appropriate therapies for severe medical conditions. "If our concerns are not addressed, then the FDA will consider what next actions, including potential enforcement actions, are appropriate".
The new laser and ultrasound devices are being marketed as safer, but the FDA said they could be harmful.
"We are evaluating the letter in full and will collaborate with the agency to ensure all product communications adhere to regulatory requirements", Mazur said.
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