FDA Warns Against Use of Energy-Based Devices to Perform Vaginal Cosmetic Procedures
The FDA Safety Communication has put out a warning against using energy-bases devices to perform vaginal cosmetic procedures. Certain device manufacturers have been marketing their energy-based medical device for vaginal rejuvenation or cosmetic vaginal procedures. However, the safety and effectiveness of these medical devices to perform these types of procedures has not been established. These devices have only received FDA clearance as general gynecological tools to destroy abnormal or pre-cancerous cervical or vaginal tissue and genital warts.
The term “vaginal rejuvenation” is not clearly defined. However, it has been used to described non-surgical procedures intended to treat vaginal symptoms or conditions, including vaginal laxity, vaginal dryness or itching, pain during sexual intercourse, pain during urination, or decreased sexual sensation.
To date, the FDA has not cleared or approved marketing for any energy-based devices to treat these symptoms and conditions. The use of these energy-based devices to treat these symptoms of conditions may result in serious adverse reactions, including vaginal burns, scarring, pain during sexual intercourse, or recurring pain.
Tips for Identifying and Avoiding these Treatments
The FDA wants all patients to be aware of the dangers of these devices. Common examples devices that have been used in this manner include ThermiVa, and Vivieve Geneveve, however there are more. Be sure to educate yourself about these energy-based medical devices and be sure to discuss the benefits and risks of all treatments available for vaginal symptoms with your health care provider.
If you have received cosmetic treatments using these energy-based devices and have experienced a complication, you can file a report though MedWatch, the FDA Safety Information and Adverse Event Reporting program.