In last week’s safety communication, the US Food and Drug Administration (FDA) alerted healthcare providers, patients and caregivers to serious complications reported in association with radiofrequency (RF) microneedling devices used for aesthetic dermatology procedures. The agency is actively evaluating these risks and encourages clinicians to report adverse events through the MedWatch system to enhance post-market surveillance and patient safety.
“The main takeaway from this safety communication is that RF-microneedling devices are medical procedures, not cosmetic treatments,” Ardmore, PA dermatologist Kachiu Lee, MD told Dermatology Times.
RF microneedling devices are FDA-cleared Class II medical devices designed to deliver radiofrequency energy via insulated or non-insulated microneedles into the dermis and subdermal layers, often marketed as a minimally invasive alternative to ablative lasers and other energy-based devices. The resulting localized thermal injury is intended to induce collagen remodeling, with clinical applications including skin rejuvenation, wrinkle reduction, acne scarring, and skin tightening. Treatment parameters vary widely across devices, including needle length, energy output, pulse duration, and treatment density.
Reported Adverse Events
The FDA has received reports of significant complications following the use of RF microneedling for dermatologic or aesthetic indications. These include:
- Thermal burns – Superficial to deep dermal burns, sometimes necessitating wound care or surgical debridement
- Scarring – Hypertrophic or atrophic scars, occasionally requiring laser or surgical revision
- Subcutaneous fat loss (lipoatrophy) – Particularly concerning in the periorbital and malar regions, leading to contour irregularities
- Neurologic injury – Including numbness or dysesthesia, potentially due to excessive depth or energy delivery in high-risk facial zones
- Disfigurement – Resulting from the combined effects of scarring, atrophy, or pigmentary changes
In some instances, patients have required surgical repair or additional medical intervention to manage these complications. Providers should be aware of the potential for significant tissue injury with RF microneedling, especially in cosmetically sensitive or anatomically complex areas such as the periorbital, perioral and mandibular regions. While the majority of treatments are well-tolerated, device misuse, operator inexperience, or aggressive treatment parameters may increase the risk of adverse outcomes. These risks underscore the need for careful patient selection, provider training and awareness of device-specific parameters.
“RF microneedling requires the use of a well-tested safe device with the treatment delivered by a trained dermatologist, ” Zoe Diana Draelos, MD, consulting professor of dermatology at Duke University School of Medicine in Durham, NC and a Dermatology Times’ editor in chief emeritus, commented. Lee agreed and stressed that bulk heating underneath the skin can occur if these treatments are performed by untrained or poorly trained individuals.
“Similarly, if too many passes are done over the skin or without enough time for the skin to cool between passes, patients can experience serious adverse events,” she said.
Clinical Implications
Clinicians are advised to:
- Carefully assess treatment depth and energy settings, particularly when treating thin-skinned or bony areas where the risk of subdermal injury and fat loss is higher.
- Avoid overlapping passes or high-density stacking, which can contribute to excessive dermal heating and unintended tissue damage.
- Transparently educate patients about the procedure, including benefits and potential risks of burns, scarring and contour deformities.
- Exercise caution in patients with a history of keloid formation, connective tissue disorders, or prior facial filler treatments, where RF-induced heat may have unpredictable effects.
- Monitor patients post-procedure for delayed complications such as atrophy or neuropathy and report adverse events promptly to facilitate regulatory oversight.
- Ensure device selection is evidence-based, using FDA-cleared systems supported by safety data and proper clinical training and familiarize yourself with reported complications and emerging safety signals.
“If you’re considering this procedure, ask some important questions,” Lee advised. “When was your device last serviced? What is your training on this specific device? How many passes will you be doing? What depth are the microneedles penetrating to? Being an informed provider can prevent potential complications.”
The FDA has also issued specific guidance for patients and caregivers
- Understand that RF microneedling is a medical procedure, not a home-use cosmetic treatment.
- Be aware of the potential for serious complications, including disfigurement and nerve damage.
- Consult with a licensed healthcare provider experienced in RF microneedling prior to undergoing treatment, avoiding at-home use and non-medical settings.
- Inquire about the specific device being used and whether it is FDA-cleared.
- Seek immediate medical attention for any post-procedure concerns and report any adverse events to the FDA through the MedWatch Voluntary Reporting Form.
Ongoing Action
The FDA is actively working with manufacturers to investigate the root causes of reported complications and to identify potential mitigation strategies. These may include changes in device labeling, user training, or post-market surveillance requirements. The agency is also monitoring adverse event trends and will provide updates as more information becomes available.
Health care providers can verify FDA-cleared RF microneedling devices through the 510(k) database. It should be noted that the 510(k) process does not require new clinical trials if a device is substantially equivalent to a predicate device. As such, post-market data—including clinician reports—are critical in identifying unanticipated safety issues. As the FDA continues its evaluation, dermatologists are encouraged to contribute to the growing body of safety data and support efforts to ensure safe and effective use of RF microneedling.
Reference
1. Potential Risks with Certain Uses of Radiofrequency (RF) Microneedling – FDA Safety Communication. US Food and Drug Administration. Published October 15, 2025. Accessed October 16. 2025. https://www.fda.gov/medical-devices/safety-communications/potential-risks-certain-uses-radiofrequency-rf-microneedling-fda-safety-communication?utm_medium=email&utm_source=govdelivery
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