The FDA warns patients, caregivers, and healthcare providers about the potential for serious, permanent injuries from radiofrequency (RF) microneedling. This procedure uses a device with an array of tiny needles to deliver RF energy and heat into the skin. The heat is intended to trigger tissue changes and boost collagen growth.
The agency has received numerous reports of severe harm linked to RF microneedling. Reported injuries include:
- Severe burns
- Permanent scarring
- Fat loss and diminished facial volume
- Physical disfigurement
- Nerve damage
Some cases required follow-up surgery or additional medical care.
Most RF microneedling devices are cleared by the FDA as Class II medical devices. The FDA emphasizes that RF microneedling is a medical procedure, not a cosmetic fad, and devices should never be used at home. Treatments should be performed only by an experienced, licensed provider.
The FDA is evaluating these devices and collaborating with manufacturers to reduce risks. It also offers guidance for those considering or performing the treatment.
Key recommendations for patients and caregivers:
Discuss benefits, risks, and alternatives with a licensed healthcare provider.
Receive treatment from a provider with specific training and experience in RF microneedling.
Seek medical care immediately if problems or unusual symptoms occur after a procedure.
Healthcare providers should review these risks with patients. Both patients and providers are encouraged to report problems with RF microneedling devices to MedWatch via the Voluntary Reporting Form.
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