FDA Safety Communication Warns Against Use of Energy-Based Devices to Perform Vaginal 'Rejuvenation' or Vaginal Cosmetic Procedures

PUBLISHED: Jul 31, 2018
Relevant to: Ambulatory Care, Critical Access Hospitals, Hospitals, Medical Office

The U.S. Food and Drug Administration (FDA) is alerting patients and health care providers that 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 safety and effectiveness of energy-based devices for treatment of these conditions has not been established.

According to the FDA, vaginal "rejuvenation" is an ill-defined term; however, it is sometimes used to describe non-surgical procedures intended to treat vaginal symptoms and/or conditions including, but not limited to:

  • Vaginal laxity
  • Vaginal atrophy, dryness, or itching
  • Pain during sexual intercourse
  • Pain during urination
  • Decreased sexual sensation

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. The treatment of these symptoms or conditions by applying energy-based therapies to the vagina may lead to serious adverse events, including vaginal burns, scarring, pain during sexual intercourse, and recurring/chronic pain.

Recommendations for Health Care Providers:

  • Be aware that the safety and effectiveness of energy-based devices to perform vaginal "rejuvenation" or cosmetic vaginal procedures has not been established.
  • Understand that the FDA has not cleared or approved any energy-based medical device for vaginal "rejuvenation" or vaginal cosmetic procedures, or for the treatment of vaginal symptoms related to menopause, urinary incontinence, or sexual function.
  • Discuss the benefits and risks of all available treatment options for vaginal symptoms with your patients.

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