The FDA issued a “safety communication” on the potential risks of radiofrequency (RF) microneedling but did not say what prompted the warning or give any sense of how many people may have experienced adverse effects from the procedure.

In the public alert, the FDA said it had become “aware of reports of serious complications (adverse events) including burns, scarring, fat loss, disfigurement, and nerve damage, and the need for surgical repair or medical intervention to treat injuries” with the use of these devices for “dermatologic or aesthetic procedures intended to improve the appearance of the skin.” It is not clear what prompted the alert, issued on October 16, during the ongoing federal government shutdown.

These types of adverse events are well known, said Mathew Avram, MD, director of the Laser and Cosmetic Center at Massachusetts General Hospital in Boston.

“I’m not sure what the urgency of this is, and without any data to indicate why they’re doing this at this time, I have no explanation for it,” Avram told Medscape Medical News. He said it would have been helpful if the alert had included more specific data.

RF microneedling devices employ an array of small electrodes (microneedles) to penetrate the skin, delivering RF energy to specific depths. Each microneedle produces intense heat, leading to changes in the tissue. The devices must go through the FDA’s 510(k) clearance process for medical devices before they can be marketed.

In the statement, the FDA recommended that patients considering a skin procedure that involves RF microneedling to “seek care from a licensed health care provider with training and experience on the use of RF microneedling devices,” and ask the provider “which devices they plan to use.” The statement also encourages health care professionals and consumers to report problems or complications associated with RF microneedling procedures to the FDA’s MedWatch program.

Avram said the agency did not suggest there was anything inherently unsafe about RF microneedling. He agreed with the FDA that training and skills were essential to a good outcome. “These treatments are overwhelmingly safe and effective in skilled hands,” he said, adding that anyone considering an energy-based device treatment should evaluate the qualifications of the person providing the treatment.

The FDA also advised consumers that RF microneedling “is a medical procedure, not a cosmetic treatment, and these devices should not be used at home.”

Multiple retailers sell RF devices for home use.

Avram was unequivocal that they should not be used at home. “If it’s used by someone who doesn’t understand the technology, doesn’t understand the skin, you can harm someone,” he said.

The risk of at home treatment with a microneedling device was illustrated in a report published this month in Cutis, which describes the case of a woman who developed a necrotic ulcer on her chin after treating herself with a microneedling device and vitamin E oil at home. TikTok and Instagram also contain dozens of photos and videos of injuries and adverse events related to RF microneedling procedures.

In the alert, the FDA did not name any specific devices but said that it “is working with manufacturers of these devices to evaluate the issue and identify mitigation strategies as appropriate” and that it will “continue to monitor reports of adverse events and keep the public informed if significant new information becomes available.”

Avram reported having no potential conflicts related to RF microneedling.

Alicia Ault is a Saint Petersburg, Florida-based freelance journalist whose work has appeared in many health and science publications, including Smithsonian.com. You can find her on X @aliciaault and on Bluesky @aliciaault.bsky.social.