Tuesday, 18 December, 2018

"Vaginal rejuvenation" procedures and devices unsafe says FDA

The “safety and effectiveness” of procedures promising to treat vaginal conditions related to menopause is unclear the U.S. Food and Drug Administration warned Monday ‘Vaginal rejuvenation’ laser treatments can cause burns and pain, FDA warns
Gustavo Carr | 03 August, 2018, 02:24

"The use of energy-based devices to perform vaginal 'rejuvenation, ' cosmetic vaginal procedures, or non-surgical vaginal procedures to treat symptoms related to menopause, urinary incontinence, or sexual function may be associated with serious adverse events", the warning said.

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", Gottlieb said.

The agency said that it has approved such devices, which commonly use laser beams or radiofrequencies, for specific gynecologic uses, including the destruction of precancerous cervical or vaginal tissue and the removal of genital warts. He said the agency found numerous cases of injuries including vaginal burns, scarring and recurring pain in a review of adverse event reports.

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 FDA wants women to look out for their own safety, too. 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.

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The bottom line: Some nonsurgical "vaginal rejuvenation" treatments aren't approved by the FDA to treat symptoms like vaginal dryness-and could even come with unsafe consequences like burns-so talk to your ob-gyn about alternative options if you're considering one of them.

On 30 June, FDA Commissioner Scott Gottlieb, M.D. warned against laser treatment for "vaginal rejuvenation" or other procedure with a cosmetic goal.

"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 devices have also not been FDA approved for use in treating sexual dysfunction, such as decreased sexual sensation or pain during intercourse or urination.

The idea is that the vaginal rejuvenation process will help boost sexual desire and sexual function, but there's just one problem: These claims are probably all BS, says Dr. Gupta. FDA is committed to helping advance the development of safe, effective treatment options for these conditions. 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. We will keep the public informed if significant new information becomes available.

If you have undergone treatment for vaginal "rejuvenation" and experienced a complication, file a report through the FDA's MedWatch.