In a recent safety communication, the U.S. Food and Drug Administration (FDA) issued a warning to consumers, patients, and health care providers about serious complications reported in connection with certain uses of radiofrequency (RF) microneedling devices.
These devices deliver RF energy into or beneath the skin using small electrodes — microneedles — to improve the appearance of the skin. According to the FDA, adverse events have included burns, scarring, fat loss, disfigurement, and nerve damage. Some cases have required surgical repair or additional medical intervention.
Safe, High-Quality Care
The American Academy of Dermatology (AAD) responded to the agency’s announcement with a statement from its president, Susan C. Taylor, MD, FAAD.
“Patient safety is the top priority for the AAD and its member dermatologists, who have the most extensive medical training to help avoid complications and ensure the best possible outcomes with all skin, hair and nail procedures,” Dr. Taylor said.
She emphasized that while cosmetic treatments may appear simple, performing them safely requires an in-depth understanding of skin structure and function. “Board-certified dermatologists undergo rigorous medical education and specialized training in facial anatomy, including nerves and muscles. This advanced expertise allows them to minimize risks and effectively manage complications that may arise.”
Dr. Taylor added that the AAD remains committed to promoting safe, high-quality dermatologic care and encouraged individuals considering cosmetic treatments to consult a board-certified dermatologist to discuss their goals, treatment options, and expected outcomes.
Because RF microneedling is a medical procedure, and not a cosmetic treatment, these devices should not be used at home.
Recommendations for Health Care Providers
- Review and discuss RF microneedling risks and recommendations with patients and caregivers.
- Be aware of potential complications, including burns, scarring, fat loss, disfigurement, and nerve damage.
- Report any adverse events or complications associated with RF microneedling devices to the FDA through the appropriate reporting platform.
