The FDA has warned of serious dangers associated with a popular cosmetic procedure.

U.S. Food and Drug Administration (FDA) warns consumers, patients, and healthcare professionals that some cosmetic procedures using radiofrequency (RF) microneedling devices may cause serious complications.

These devices use multiple tiny electrodes called microneedles to deliver radiofrequency energy into and under the skin, causing localized tissue heating. Serious side effects can occur when using these devices in dermatological and aesthetic procedures aimed at improving the appearance of skin (e.g., wrinkle reduction, firmness, or rejuvenation). The FDA has received reports of burns, scarring, loss of subcutaneous fat, deformity, and nerve damage. In some particularly severe cases, patients have required surgery or other treatment.

The FDA continues to evaluate these situations and encourages patients, their families, and healthcare providers to report any complications associated with the use of radiofrequency microneedling devices for cosmetic and dermatological procedures. Timely reporting of adverse events helps the FDA identify and better understand the risks associated with medical devices.

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Recommendations for patients and their relatives

• Please note that serious complications have been reported with the use of radiofrequency microneedling devices, including burns, scarring, fat loss, deformity and nerve damage.
• Discuss all your skin care treatment options, their benefits, and risks with your doctor.
• If you are considering a procedure using a radiofrequency microneedling device, only consult a licensed professional who is trained and experienced in using such devices. Check with the specific device that will be used.
• Radiofrequency microneedling is a medical procedure, not a cosmetic treatment, and these devices are not intended for home use.
• If you experience any discomfort or have any concerns about your skin after your procedure, please contact a licensed physician immediately.
• Report any problems or complications after radiofrequency microneedling treatments to the FDA.

Recommendations for healthcare professionals

• Inform patients and their families about the above recommendations.
• Be aware of reports of serious complications with radiofrequency microneedling devices, including burns, scarring, fat loss, deformities, and nerve damage, which may require medical intervention.
• Report to the FDA any complications that occur in patients following procedures using such devices.

Description of the devices

Radiofrequency (RF) energy is a form of electrical energy that causes tissue heating. Radiofrequency microneedling devices use a system of tiny electrodes (thin needle-like protrusions called microneedles) to deliver this energy. During the procedure, the microneedles penetrate the skin, delivering radiofrequency energy to a specific depth. Each microneedle creates a small area of ​​intense heating at its tip, causing tissue changes.

Radiofrequency microneedling devices are Category II medical devices and are cleared by the FDA through the 510(k) process. The 510(k) database provides information on approved devices by name or manufacturer. It also contains brief descriptions, including the date of approval, indications for use, and a summary of the data submitted to the FDA.

FDA actions

The FDA is informing patients, their families, and healthcare providers about the potential serious risks associated with the use of radiofrequency microneedling devices for dermatological and aesthetic procedures. The agency is working with manufacturers to assess the issue and identify risk mitigation measures.
The FDA will continue to monitor reports of adverse events and will inform the public when new significant information becomes available.

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Reporting problems

If you believe you have a problem with your device, the FDA recommends submitting a voluntary report using the MedWatch form.
Healthcare personnel working in institutions required to report such cases must follow their institutions' internal procedures.

If you have any questions, please contact the Industry and Consumer Affairs Department (DICE) FDA's Center for Devices and Radiological Health.

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