SAVANNAH, Ga. — Fat loss was among the most commonly reported complications associated with radiofrequency microneedling (RFMN) over the past 6-13 years, according to two new studies using data from the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database.

However, several experts have questioned these findings, which were presented at The American Society for Laser Medicine and Surgery (ASLMS) 2026 Annual Meeting.

The first study, which included 86 reports and a total of 145 adverse events (AEs) from 2020 to 2025, found that the most reported AE following RFMN was fat loss, defined as indentations or contour irregularities. This was followed by scarring and erythema. 

“This has become a hot topic because people really want to know about potential device-related complications,” presenting investigator Isabella Camacho-Hubbard, MD, a dermatologist who practices in Charlotte, North Carolina, told Medscape Medical News.

The second study, presented by Margaret Chou, MD, of the Dermatology Laser and Cosmetic Center at Massachusetts General Hospital in Boston, included 114 reports and 224 AEs between 2013 and 2025. It showed that the most frequent postprocedural complications were textural changes, pigmentary alteration, and fat loss.

However, during the discussion period that followed the presentations, several meeting attendees pushed back about the number of fat-loss reports — despite the FDA issuing a warning last year about potential RFMN risks, including fat loss. E. Victor Ross, MD, director of the Scripps Clinic Laser and Cosmetic Dermatology Center in San Diego, and others noted that they had never seen any cases of fat loss associated with RFMN in their own patients.

Ross, who was not involved with the studies, later told Medscape Medical News there probably have been cases where patients have been overtreated, but regarding the reports of AEs from the presentations, more data would be needed to determine whether they were due to technique, settings, or operator error.

“There are a lot of ways that you can use these devices poorly,” but if they are “used properly,” Ross said, they are “pretty darn safe.”

The minimally invasive procedure, which combines traditional microneedling with radiofrequency-generated thermal energy, is often used for conditions such as acne and surgical scars, axillary hyperhidrosis, and skin rejuvenation. In October 2025, the FDA issued a safety communication describing serious complications that had been reported with RFMN devices, including burns, scarring, fat loss, disfigurement, and nerve damage.

The MAUDE database collects reports from clinicians, patients, and manufacturers for suspected injuries from medical devices. In the first study, investigators entered search terms such as mechanism of action and brand names into MAUDE to assess AEs associated with RFMN devices reported from 2020 to 2025.

They found 86 medical device reports and 145 reports of AEs linked to RFMN during this period. “The majority of device reports were associated with a bipolar radiofrequency device with insulated needles that can go to a treatment depth of 8 mm,” Camacho-Hubbard said during her presentation.

The Morpheus8 (InMode) was associated with 64 device reports. Additionally, the Sylfirm X (BENEV/VIOL) and Potenza (Jeisys Medical) had four reports each; the Genius (Cynosure Lutronic) had three reports; the Pixel 8 (Rohrer Aesthetics), Secret RF (Cutera), and Vivace (Aesthetics Biomedical) had two reports each; and Exion (BTL Aesthetics), Agnes RF (Agnes Medical), and Venus Viva (Venus Concept) had one report each. There were also two reports from unknown devices. Of these, only the Potenza and Genius have continuous impedance monitoring.

“From our analysis, devices with continuous impedance monitoring demonstrated significantly less adverse events and, therefore, may provide improved safety,” the investigators noted in their abstract.

However, Camacho-Hubbard added that although the MAUDE database has been shown previously to be helpful in determining safety patterns, its reports “are narrative and lack standardization.” Because it also lacks information on the number of treatments performed, device settings, operator technique, and patient-specific factors, the database is “a passive surveillance system best for hypothesis generation,” she said.

“Additionally, a high complication rate with one device may indicate higher procedural volumes,” Camacho-Hubbard noted.

[The FDA’s information page on medical device reporting states that as a passive surveillance system, MAUDE “has limitations,” pointing out that while medical device reports “are a valuable source of information,” the data “is not intended to be used either to evaluate rates of adverse events, evaluate a change in event rates over time, or to compare adverse event occurrence rates across devices.” It also states that a device report alone cannot confirm “whether a device caused a specific event.”]

Fat loss was the most reported AE (n = 30), followed by scarring (n = 20) and post-inflammatory erythema (n = 18), which “might be the result of deeper penetration depths or excessive energy,” Camacho-Hubbard said.

The researchers noted that, in order to provide safe treatments, understanding skin anatomy and how it interacts with energy-based devices is extremely important. “Adjustment of settings based on the patient and indication as well as real-time energy delivery and impedance feedback mechanisms can further improve patient safety outcomes, ensuring complete needle insertion and consistent energy delivery,” they wrote.

Largest MAUDE Review

The second study included 114 RFMN-related reports from 2013 to 2025, with 224 distinct AEs. Of these reports, 55% were submitted by manufacturers, and the number of overall reports peaked in 2024.

Findings showed that the most reported AEs were textural changes (n = 56), pigmentary changes (n = 41), fat loss (n = 26), inflammatory reaction (n = 18), and burns (n = 14).

The most commonly affected region for textural and pigmentary changes was the face, followed by the neck. Of the 26 reports of fat loss, 24 occurred in the face.

Chou echoed Camacho-Hubbard in cautioning that MAUDE has several limitations. “It has underreporting, bias, and no true incidence rates,” she said.

“Overall, this was the largest MAUDE review to date of RF microneedling. And while it is generally safe, it is not without risk,” Chou said at the meeting. “Of note, the more severe outcomes were not seen in prior, more controlled clinical trials — suggesting that rigorous patient selection and counseling, as well as operator expertise, can play a significant role.”

During the follow-up Q-and-A session, Christopher Zachary, MD, UCI Health Dermatology Center, Irvine, California, noted that neither he, his work colleagues, nor any of the dermatologists sitting near him during the presentations had ever seen any sign of fat loss in patients following microneedling.

“When we hear from MAUDE that the majority of cases of complications are of fat loss, I think we need to ask questions, particularly about the parameters involved, including what density was used,” Zachary said. “I don’t think we can just say, ‘Yes, fat loss is a problem with radiofrequency.’ I’m concerned that experienced people haven’t seen it.”

Ross, who spoke after Zachary, said he had the same concerns. “I know we had the letter from the FDA, but I’ve not seen any fat loss from these devices either,” he said. He noted that he did see a few patients treated by other providers who “felt like they had fat loss, but I couldn’t see it.”

He said there is a lot of content now being posted to the internet about this issue, including cellphone photos from dubious angles, which may be leading to some patient confusion. “I don’t know where these fat-loss cases are. We can see little dots and bumps, but I haven’t seen true fat loss ever, such as a waffle or dimple, associated with these devices,” he said.

After the session, moderator Zakia Rahman, MD, Stanford University School of Medicine, Stanford, California, told Medscape Medical News that the studies showed the veracity of the MAUDE database is questionable.

“It’s quite antiquated and imprecise, so it’s challenging to be able to extract the valuable clinical information we need to counsel our patients or to change our treatment guidelines,” said Rahman, who also directs the laser and aesthetic clinic at Stanford and is a member of the ASLMS national board of directors.

She added that although she has seen cases of complications from RFMN devices, she hasn’t personally seen any cases of fat loss. Still, “I think this is something that needs to be evaluated further, and, as always, we need to really listen to our patients because they’re often the ones who help us discover new complications and new benefits. We shouldn’t just dismiss them outright,” Rahman said.

The study authors and commenters reported having no relevant financial relationships.