The Food and Drug Administration (FDA) has issued an alert to healthcare providers concerning the use of energy-based devices for vaginal “rejuvenation”, a term used to describe non-surgical procedures intended to treat vaginal laxity, atrophy, dryness, or itching; pain during sexual intercourse or urination; or for decreased sexual sensation.
While these energy-based devices (radiofrequency or laser) have been approved for general gynecologic tool indications (i.e., destruction of abnormal or pre-cancerous cervical or vaginal tissue, condylomas), the Agency has become aware of some manufacturers marketing these devices for vaginal “rejuvenation” or vaginal cosmetic procedures.
As part of their safety communication, the FDA is alerting healthcare providers of the following:
- Be aware that the safety and effectiveness of energy-based devices to perform vaginal “rejuvenation” or cosmetic vaginal procedures have not been established.
- 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.
- Treatment of these symptoms or conditions by applying energy-based therapies to the vagina may lead to burns, scarring, pain during sexual intercourse, and recurring/chronic pain.
- The benefits and risks of all available treatment options for vaginal symptoms should be discussed with patients.
In addition, clinicians should report any patient adverse effects from procedures that involved the use of energy-based devices to perform vaginal ‘rejuvenation’ to the FDA’s MedWatch program. In the meantime, the FDA will continue to investigate manufacturers who have been inappropriately marketing these energy-based devices.
For more information visit FDA.gov.