 
The U.S. Food and Drug Administration (FDA) is making consumers, patients, and health care providers aware that serious complications have been reported with certain uses of radiofrequency (RF) microneedling devices. These devices use an array of small electrodes, also known as microneedles, to deliver RF energy into and under the skin to produce local heating.
With use of these devices for dermatologic or aesthetic procedures intended to improve the appearance of the skin (to treat wrinkles or to achieve skin effects, sometimes referred to as resurfacing, “tightening” or “rejuvenation”), the FDA is aware of reports of serious complications (adverse events) including burns, scarring, fat loss, disfigurement, nerve damage, and the need for surgical repair or medical intervention to treat injuries.
While the FDA’s evaluation is ongoing, we are asking patients, caregivers, and health care providers to report any complications related to the use of these devices to the FDA. The FDA is working with manufacturers of these devices to evaluate the issue and to identify mitigation strategies as appropriate.
This safety communication provides:
- Recommendations for patients, caregivers, and health care providers.
- Background information on the issue.
- The FDA’s actions to address the issue.
- Instructions to report problems with devices to the FDA.
Questions?
If you have questions, contact the Division of Industry and Consumer Education.
|
