The US Food and Drug Administration (FDA) has issued warnings to patients and healthcare providers after serious complications were reported from radiofrequency (RF) microneedling devices.
According to the FDA, reported complications from RF microneedling for dermatologic or aesthetic skin procedures included burning, scarring, fat loss, disfigurement, nerve damage and, in some cases, the need for surgical repair or medical intervention.
The FDA has shared that it will continue to monitor reports of “adverse events” and is working with the manufacturers of these devices to evaluate the issue and identify mitigation strategies as appropriate.
In a written statement online, the FDA said, “While the FDA’s evaluation is ongoing, we are asking patients, caregivers and healthcare providers to report any complications related to the use of these devices for dermatologic or aesthetic skin procedures to the FDA. Prompt reporting of adverse events can help the FDA identify, and better understand, the risks associated with medical devices.”