Commissioner Scott Gottlieb, in a statement, said the products have serious risks, have not been reviewed or approved for use in such procedures and don't have adequate evidence to support the claims. "We are deeply concerned women are being harmed", said Gottlieb.
"The treatment of these symptoms or conditions by applying energy-based therapies to the vagina may lead to serious adverse events, including vaginal burns, scarring, pain during sexual intercourse, and recurring/chronic pain", FDA said.
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.
But the FDA wants women to look out for their own safety, too.
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. The procedures use lasers and other energy-based devices to destroy or reshape vaginal tissue.
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 unsafe procedure with no proven benefit".
So, for women who are experiencing incontinence or painful sex as a result of menopause, the best advice is to speak to your doctor about possible procedures which do work and to avoid vaginal rejuvenation procedures until more serious testing has been done. In these cases, the FDA had not reviewed or approved the used devices for the objective of 'vaginal rejuvenation'. 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.
If the FDA's concerns are not addressed, the agency said that they will consider potential enforcement actions.
Gottlieb also said he was concerned that deceptive marketing of these devices might prevent some patients from getting appropriate therapies for severe medical conditions. We will keep the public informed if significant new information becomes available.
Two reports have been received by the FDA from manufacturers as well as dozens of reports from patients in relation to adverse effects as a result of vaginal rejuvenation procedures. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
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