The U.S. Food and Drug Administration (FDA) has issued a safety warning about potential risks with certain radiofrequency (RF) microneedling devices.
RF microneedling is a cosmetic procedure for “facial rejuvenation.” The device uses tiny needles to penetrate the skin and cause micro-injuries, while also delivering RF energy to heat deeper layers of skin.
The procedure is intended to stimulate the body’s natural healing processes, including the production of elastin and collagen. This is advertised to improve the appearance of fine lines and wrinkles, skin tightening, acne scars, improving skin texture or tone, and more.
RF microneedling is advertised as a “minimally invasive procedure with minimal downtime,” and plastic surgeons claim that most patients experience only a few days of redness and swelling.
There are also many RF microneedling device on the market, including Morpheus8, Vivace, Potenza, Morpheus8, Agnes, EXION, and Lutronic Genius.
However, the FDA is urging patients to be aware of the risks, which may include permanent disfigurement and scarring:
“Be aware of reports of serious complications such as burns, scarring, fat loss, disfigurement, and nerve damage, with use of RF microneedling devices for dermatologic and aesthetic skin procedures.”
The FDA recommends that patients thoroughly discuss the benefits and risks of this procedure with your healthcare provider.
The FDA is also urging patients to report any problems or complications you experienced from skin procedures with RF microneedling devices to the FDA MedWatch reporting system.
Source: Potential Risks with Certain Uses of Radiofrequency (RF) Microneedling – FDA Safety Communication