On March 14, the FDA released a warning for both consumers and health care providers against the use of the Renuvion/J-Plasma device (Apyx Medical) for dermal resurfacing or skin contraction.
The Renuvion/J-Plasma device (Apyx Medical) is FDA cleared for general use of cutting, coagulation, and ablation of soft tissue during open and laparoscopic surgical procedures, a statement from the FDA clarified, using this device has not been determined to be safe or effective for any specific procedure intended to improve the appearance of the skin. That is why the FDA is warning both health care professionals and consumers about using the device for dermal resurfacing or skin contraction.
The Renuvion/J-Plasma device uses radiofrequency (RF) energy and helium to create plasma which can be used to cut, coagulate, and eliminate soft tissue with heat during surgery, the FDA explained.
According to the release, the FDA has received reports describing serious adverse events (SAEs) when the device is used directly on the skin and potentially life-threatening AEs when it was used under the skin. The AEs reported were second- and third- degree burns, infection, change in skin color, scars, nerve damage, significant bleeding, and air or gas accumulation under the skin, in body cavities, and in blood vessels. Additionally, the FDA stated that there were SAE cases where patients were admitted to the intensive care unit.
The FDA created a list of recommendations for both consumers and health care providers.
Health Care Providers:
FDA warns against use of Renuvion/J-Plasma device for certain aesthetic procedures: FDA safety communication. FDA. Published online March 14, 2022. Accessed March 14, 2022. https://www.fda.gov/medical-devices/safety-communications/fda-warns-against-use-renuvionj-plasma-device-certain-aesthetic-procedures-fda-safety-communication