Experts urge proper training, approved devices, and patient screening to minimise risks

he US Food and Drug Administration (FDA) recently released a safety communication alerting consumers, patients, and health care providers about ‘serious complications’ that have been reported with the use of radiofrequency (RF) microneedling devices for dermatologic and aesthetic procedures intended to improve the skin’s appearance.

‘… the FDA is aware of reports of serious complications (adverse events) including burns, scarring, fat loss, disfigurement, and nerve damage, and the need for surgical repair or medical intervention to treat injuries,’ according to the FDA.

In addition to asking patients and providers to report problems or complications related to RF microneedling treatment, the communication recommends that providers be aware of and review and discuss possible complications with patients. 

Nothing new here, but it is a reminder

Chris Croley, MD, co‑founder and medical director of Skin and Tonic, Pace, Florida, said his practice offers RF microneedling, and it’s a great option for patients with mild to moderate skin laxity, textural issues such as fine lines/wrinkles, acne scarring and pigment issues related to photoaging. 

‘The FDA announcement doesn’t reveal anything new to experienced providers. We have seen these complications before,’ Dr. Croley said. 

Daniel Straka, MD, an oculofacial plastic surgeon at pēkomd, with US offices in Ohio, including Columbus, said that the most common RF microneedling complications at his practice are patients who come in with fat atrophy and skin hyperpigmentation. 

‘Patients are seeking out corrective procedures such at fat transfers or filler injections to address the volume loss from overly aggressive RF microneedling treatments,’ Dr. Straka said. 

Fat atrophy results when the treatment is too aggressive in its depth and the total energy delivered. 

‘In addition, when performed in facial zones where fat is of utmost importance to maintain a youthful appearance (midface, temples, forehead) this complication can be much more noticeable,’ Dr. Straka noted. 

Shared best practices

Dr. Straka shared that he limits RF microneedling to 0.8 mm to 1.5 mm on most facial areas above the mandible, unless he is specifically targeting areas of extra fat like the jowl, or other specific conditions such as malar edema/festoons. 

‘Since skin thickness averages between 1–2 mm throughout the face there really is no need to penetrate any deeper than 1–1.8 mm,’ he said.

And while RF microneedling can be performed on all Fitzpatrick skin types, one must proceed with caution in skin types IV through VI, as these patients are much more prone to developing post inflammatory hyperpigmentation (PIH), according to Dr. Straka.

In patients at higher risk, Dr. Straka tends to avoid the procedure altogether in vulnerable areas, such as the cheeks, mouth, and temples/forehead. 

‘The skin of the neck below the mandible is less likely to experience hyperpigmentation. But in order to reduce the risk of PIH we decrease the power and minimise very superficial treatments (less than 1 mm), as this brings the heat very close to the dermal/epidermal junction and thus closer to the cells responsible for pigment deposition,’ he explained. ‘In skin types IV and above we often pretreat with bleaching agents like hydroquinone and continue it for a few weeks after the treatment.’

Take home messages

Dr. Croley pointed out that most adverse events occur when non-approved devices are used or when treatments are performed by providers without proper training. 

‘Like any technology, RF microneedling is safe and effective in the right hands with FDA approved/cleared devices,’ Dr. Croley said.

Dr. Croley encourages providers to follow manufacturer recommendations for their particular device, ensure all providers receive training prior to use, and only use devices that are approved or cleared by the FDA.  

It’s important to screen patients for contraindications, such as active infection, isotretinoin use, poor wound healing, and more. 

‘Second, tailor depth, energy and passes to Fitzpatrick skin type, treatment areas and indications to minimise burns, fat loss or scarring,’ he said.