"We are deeply concerned women are being harmed", said FDA commissioner Dr Scott Gottlieb in a statement.
FDA has sent a 30-day-notice to Alma Lasers, BTL Aesthetics, BTL Industries, InMode, Cynosure, ThermiGen and Sciton, for the inappropriate marketing of their devices for "vaginal rejuvenation" procedures. But the safety and effectiveness of these devices hasn't been evaluated or confirmed by the FDA for "vaginal rejuvenation".
The FDA has not cleared or approved any energy-based medical device for vaginal "rejuvenation" or vaginal cosmetic procedures, or for the treatment of vaginal symptoms related to menopause, urinary incontinence, or sexual function.
In addition, clinicians should report any patient adverse effects from procedures that involved the use of energy-based devices to perform vaginal "rejuvenation" to the FDA's MedWatch program.
Gottlieb is concerned that these procedures are aimed at women who had cancer treatment that caused early menopause, a fact he considers to be egregious and, adding that the manufacturers use "deceptive marketing of a risky procedure with no proven benefit".
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"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", Gottlieb continues.
A company called BTL promised "a whole new approach to women's intimate health" using "a noninvasive, no downtime procedure with minimal risk".
The commissioner expressed particular concern over marketing of the procedures to women whose cancer treatments caused early menopause. He said the agency doesn't know the extent of the risks because it hasn't reviewed the devices for such procedures. He also said that officials have found "numerous cases" of serious harm.
Some women experiencing incontinence or post-menopausal painful sex have been turning to "vaginal rejuvenation" treatments in an effort to alleviate their symptoms. We've also established the Women's Health Technologies Strategically Coordinated Registry Network (CRN) to provide more complete evidence in clinical areas that are unique to women, such as uterine fibroids and pelvic floor disorders. The agency has received 14 reports of adverse events related to the treatments, including burning sensations and significant pain.
Meanwhile, FDA requested women to stop using these devices and encouraged them to discuss any of their sexual dysfunction problems and their treatments with their doctors. Dr. Cheryl B. Iglesia, director of the section of female pelvic medicine and reconstructive surgery at MedStar Washington Hospital Center, said the laser technology held promise but more study was needed to understand the safety as well as which patients the devices might help.