FDA says unapproved 'designer vagina' treatments are unsafe

The FDA warned against

The FDA warned against"vaginal rejuventation treatments

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. If the FDA's concerns aren't addressed, it will consider potential enforcement actions, Gottlieb said.

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.

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". The medical society has issued several statements noting that the devices, including the MonaLisa Touch, do not have FDA clearance or approval for treatment of menopausal symptoms, as advertised. The statement adds, "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".

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.

But, the agency notes, there's no proof that these devices are effective for any of the "rejuvenating" procedures companies claim and some celebrities promote.

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. Since December of 2015, Deborah Kotz, a press officer with the FDA, said the agency has received a dozen reports of complications related to these procedures. Parent company Hologic, Inc. said it is aware of the FDA warning. 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.

However, these devices have not been approved for so-called vaginal rejuvenation.

Women who've experienced adverse side effects tied to vaginal rejuvenation devices are encouraged to report their problem to MedWatch, the FDA's adverse-event-reporting program, the agency said.

"We are evaluating the letter in full and will collaborate with the agency to ensure all product communications adhere to regulatory requirements", Mazur said.

Discuss the benefits and risks of all available treatment options for vaginal symptoms with your health care provider.

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