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Analysis of US Food and Drug Administration Data on Radiofrequency Microneedling Device Complications
Margaret Chou1, Bridget Myers, Mathew Avram
1All authors are affiliated with the Dermatology Cosmetic and Laser Center, Harvard Medical School, Massachusetts General Hospital, Boston, Massachusetts.
Background:
Radiofrequency microneedling (RFMN) is increasingly used for rejuvenation, acne scars, and tightening. Although marketed as minimally invasive, lasting adverse effects have been reported. Postmarketing surveillance provides insight into real-world safety.
Objective:
To characterize adverse events associated with RFMN devices reported to the US FDA MAUDE database, emphasizing the frequency and spectrum of complications.
Materials And Methods:
A retrospective review of FDA MAUDE reports from January 2013 to October 2025 was conducted. Entries involving RFMN were analyzed for treatment location and adverse outcomes. Narrative descriptions were categorized into clinically relevant events, and descriptive statistics summarized complication frequencies and anatomic sites.
Results:
A total of 114 reports with 224 events were identified. The most frequent complications included textural changes ( n = 56, 25.0%), pigmentary alteration ( n = 41, 18.3%), and fat loss ( n = 26, 11.6%). Inflammatory reactions ( n = 18, 8.0%), burns ( n = 14, 6.3%), and pain ( n = 12, 5.4%) were also frequently reported. The face, neck, and abdomen were the most treated anatomic regions.
Conclusion:
Although RFMN is generally safe, significant complications may occur. Experience and proper training are crucial to minimizing risks. Clinicians should counsel patients, monitor outcomes, and support surveillance and standardized reporting to improve safety.
Insights
Radiofrequency microneedling (RFMN) can cause lasting adverse effects like textural changes and fat loss, despite its minimally invasive marketing. Proper training and patient counseling are essential for safe RFMN procedures.
Area of Science:
- Dermatology
- Medical Device Safety
- Aesthetic Medicine
Background:
- Radiofrequency microneedling (RFMN) is a popular cosmetic procedure for skin rejuvenation, acne scars, and tightening.
- Despite being marketed as minimally invasive, RFMN has been associated with reported lasting adverse effects.
- Postmarketing surveillance data is crucial for understanding the real-world safety profile of RFMN devices.
Purpose of the Study:
- To analyze adverse events linked to RFMN devices reported in the US FDA MAUDE database.
- To determine the frequency and types of complications associated with RFMN treatments.
Main Methods:
- A retrospective review of FDA MAUDE reports from January 2013 to October 2025.
- Analysis of RFMN-related reports, categorizing adverse outcomes and treatment locations.
- Descriptive statistics were used to summarize complication frequencies and affected anatomic sites.
Main Results:
- 114 reports detailing 224 adverse events were identified.
- The most common complications were textural changes (25.0%), pigmentary alteration (18.3%), and fat loss (11.6%).
- Other reported events included inflammatory reactions (8.0%), burns (6.3%), and pain (5.4%), primarily on the face, neck, and abdomen.
Conclusions:
- While generally safe, RFMN procedures carry risks of significant complications.
- Adequate clinician experience and training are vital for mitigating RFMN-related risks.
- Enhanced patient counseling, outcome monitoring, and standardized reporting are recommended to improve RFMN safety.
