Summary
- The FDA issued a Safety Communication regarding radiofrequency microneedling (RFMN).
- Although there are risks of complications associated with any medical procedure, the Societies’ collective experience indicates RFMN in proper settings is a safe and effective treatment modality.
- ASLMS and ASDS encourage members to discuss reported safety issues with device manufacturers prior to purchasing any RFMN devices.
- Members are encouraged to include language in their consent forms for this procedure, which details that risks include burns, scarring, fat loss, disfigurement and nerve damage, in line with the FDA alert.
Dear Members,
On Oct. 15, 2025, the U.S. Food and Drug Administration (FDA) issued a Safety Communication alerting consumers, patients and health care providers that “serious complications have been reported with certain uses of radiofrequency (RF) microneedling devices.”
This Safety Communication by the FDA acknowledges that cosmetic skin procedures are indeed medical procedures that come with risks and require in-depth knowledge of skin biology and anatomy. The FDA detailed reports of Radiofrequency Microneedling (RFMN) complications such as burns, scarring, fat loss, disfigurement and nerve damage, which can have serious and permanent effects on patients. It also specifically recommends that patients considering a skin procedure using RFMN seek care from a licensed health care provider with training and experience on its use. RFMN is a technology developed and researched by dermatologists who are members of the American Society for Laser Medicine and Surgery (ASLMS) and the American Society for Dermatologic Surgery (ASDS). It is the position of both organizations that when used or supervised by an appropriately trained, board certified physician, RFMN can be performed safely and effectively for a variety of dermatologic applications in all skin types and races. Any patients seeking these treatments are urged to consult with members of the ASLMS and ASDS.
ASLMS and ASDS are leaders in patient safety and education. The
Societies will continue to update our members if any additional data or
recommendations become available.
Sincerely,
| Ashish Bhatia, MD
President, ASLMS | Kavita Mariwalla, MD
President, ASDS | Omar Ibrahimi, MD | Deirdre Hooper, MD
President-Elect, ASDS |
Girish Munavalli, MD, MHS | Eric Bernstein, MD, MSE | Jill Waibel, MD
Director of Government Communication and Education, ASLMS, Board Member, ASDS | |