FDA Cracks Down on Energy-Based Vaginal Rejuvenation

Tuesday, July 31, 2018 | FDA Approval/Clearance , Lasers & Light Devices


The FDA is cracking down on the use energy-based devices to perform vaginal 'rejuvenation.'

The use of such 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 including vaginal burns, scarring, pain during sexual intercourse, and recurring/chronic pain, the FDA warns.  The safety and effectiveness of energy-based devices for treatment of these conditions has not been established.

To date, the FDA has 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.

“We are aware that certain device manufacturers may be inappropriately marketing their energy-based devices for the uses noted above that are outside of their cleared or approved intended uses,” they write in a safety alert. “We have contacted these manufacturers to share our concerns and will be monitoring their claims about uses of their products.”

In addition, the FDA will continue to monitor reports of adverse events associated with this issue and will keep the public informed if significant new information becomes available.

Doctors should discuss the benefits and risks of all available treatment options for vaginal symptoms with patients, and if any patients experience adverse effects from procedures that involved the use of energy-based devices to perform vaginal "rejuvenation", cosmetic procedures, or treat genitourinary symptoms of menopause, sexual dysfunction, or urinary incontinence, file a report through MedWatch, the FDA Safety Information and Adverse Event Reporting program.

Next Story

Comments

You must be logged in to leave a comment.