FDA Safety Communication Warns Against Use of Energy-Based Devices to Perform Vaginal 'Rejuvenation' or Vaginal Cosmetic Procedures
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.
- 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, please file a report through MedWatch, the FDA Safety Information and Adverse Event Reporting program.
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