Don't believe the hype on 'vaginal rejuvenation,' FDA says

Leslie Hanson
August 2, 2018

In a statement Monday, FDA Commissioner Scott Gottlieb said that a growing number of manufacturers are marketing their devices for unapproved uses such a vaginal "rejuvenation," in which tissue typically is destroyed or reshaped.

In some cases, women who've gone into early menopause after breast cancer treatments are opting for these interventions, but "the deceptive marketing of a risky procedure with no proven benefit, including to women who've been treated for cancer, is egregious", Gottlieb said. The notified manufacturers include: Alma Lasers, BTL Aesthetics, BTL Industries, Cynosure, InMode, Sciton, and Thermigen. We requested that the manufacturers address our concerns within 30 days. Some of the devices, which are commonly radiofrequency- or laser-based, have legit uses such as removing warts or pre-cancerous vaginal or cervical tissue.

The Food and Drug Administration is cracking down on manufacturers promising "vaginal rejuvenation", saying it could have serious side effects. More specifically, the companies collectively claim that the devices are able to treat vaginal "laxity", pain during urination or intercourse, decreased sexual sensation, and vaginal dryness, itching, or atrophy.

"To date, we have not cleared or approved for marketing any energy-based devices to treat these symptoms or conditions, or any symptoms related to menopause, urinary incontinence, or sexual function", the statement explained.

"Deceptive marketing of a risky procedure with no proven benefit, including to women who've been treated for cancer, is egregious", Gottlieb fumed in one tweet. For patients, the FDA suggests discussing any vaginal issues with your doctors.

The commissioner expressed particular concern over marketing of the procedures to women whose cancer treatments caused early menopause. "These products have serious risks and don't have adequate evidence to support their use for these purposes".

The FDA has warned seven companies that are promoting their devices for these procedures, and issued a general alert for patients and doctors. 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. 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 new laser and ultrasound devices are being marketed as safer, but the FDA said they could be harmful.

Other reports by Iphone Fresh

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