The United States Food and Drug Administration (FDA) has issued a medical device safety alert concerning energy-based devices.
The FDA is aware that certain device manufacturers may be marketing their energy-based medical device for the vaginal "rejuvenation" and/or cosmetic vaginal procedures. The safety and effectiveness of energy-based medical devices to perform these procedures has not been established. The 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:
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.
The FDA is alerting patients and health care providers with recommendations.
For details, please refer to the following FDA website:
https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm615013.htm
If you are in possession of the products, please contact your supplier for necessary actions.
Posted on 7 August 2018