Dive Brief:

• FDA is warning women and their healthcare providers of potential risks from the unapproved use of energy-based devices for “vaginal rejuvenation” or cosmetic procedures, and has notified seven device manufacturers of its concerns.
• 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. He said the agency found numerous cases of injuries including vaginal burns, scarring and recurring pain in a review of adverse event reports. “We are deeply concerned women are being harmed,” Gottlieb said.
• The seven device makers notified by FDA are: Alma Lasers, BTL Aesthetics, BTL Industries, Cynosure, InMode, Sciton and Thermigen. FDA did not take enforcement actions against the companies, but requested that they address the agency’s concerns within 30 days.

Dive Insight:

FDA has approved laser and energy-based devices for the treatment of serious conditions such as the destruction of abnormal or pre-cancerous cervical or vaginal tissue, as well as genital warts. But the agency said the safety and effectiveness of the devices haven’t been evaluated or confirmed for “vaginal rejuvenation.”

The term “vaginal rejuvenation” has been used to describe non-surgical procedures intended to treat symptoms and conditions including vaginal laxity, atrophy, dryness or itching, pain during sexual intercourse or urination, and decreased sexual sensation.

Gottlieb said the agency had recently become aware of a growing number of manufacturers marketing “vaginal rejuvenation” devices to women and claiming these procedures will treat conditions and symptoms related to menopause, urinary incontinence or sexual function. The procedures use lasers and other energy-based devices to destroy or reshape vaginal tissue.

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

— Scott Gottlieb, M.D. (@SGottliebFDA) July 30, 2018

In addition to the deceptive health claims being made about the products, the devices are in some cases being marketed to women who have completed treatment for breast cancer and are experiencing symptoms caused by early menopause, Gottlieb said. “The deceptive marketing of a dangerous procedure with no proven benefit, including to women who’ve been treated for cancer, is egregious,” he said.