FDA Cracks Down on Cosmetic Gynecology Treatments

FDA Cracks Down on Cosmetic Gynecology Treatments

The FDA has issued a Safety Warning against the use of lasers for “vaginal rejuvenation” procedures due to severe safety risks and deceptive advertisements.

Lasers and similar energy-based tools are only approved for the treatment of cancer, genital warts, or hysterectomies.

The problem is that laser treatments are now being advertised for unapproved and possibly dangerous uses like pain-relief, boosting sexual pleasure, tightening vaginal tissues, dryness.

The treatments are advertised for women who are suffering from the symptoms of sexual dysfunction, menopause, urinary incontinence, or vaginal laxity.

The FDA has numerous reports of vaginal burns, scarring, burning sensations, and significant chronic pain after the laser treatments.

FDA commissioner Dr. Scott Gottlieb warned:

“These products have serious risks and don’t have adequate evidence to support their use for these purposes. We are deeply concerned women are being harmed.”

The FDA sent warning letters to 7 companies for promoting dangerous uses of laser treatments on women — Inmode, Sciton, Alma Lasers, Thermigen, BTL Aesthetics, BTL Industries and Cynosure.

The companies were asked to provide evidence that their devices were being advertised for treatments that were approved by the FDA.

Source: Vaginal ‘Rejuvenation’ Treatments May Be Unsafe, the F.D.A. Says