FDA Warns Against Using Renuvion/J-Plasma Device for Certain Aesthetic Procedures

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.

Consumers:

• Be aware that the use of Renuvion/J-Plasma for any aesthetic procedure to improve the appearance of the skin has not been cleared or approved by the FDA.
• Discuss the benefits and risks of all available aesthetic skin procedures with your health care provider.
• If you are considering any aesthetic skin procedure, ask whether your provider plans to use the Renuvion/J-Plasma device during the procedure.
• If you are considering liposuction, ask whether your provider plans to use the Renuvion/J-plasma device during the procedure.
• If you experience any problems or are concerned after a procedure using Renuvion/J-Plasma, seek care from a licensed health care provider.
• Report any problems or complications experienced from procedures with Renuvion/J-Plasma to the FDA. Your report, along with information from other sources, can provide information that helps improve patient safety.

Health Care Providers:

• Be aware that the use of Renuvion/J-Plasma is not cleared or approved by the FDA for any aesthetic skin procedure.
• Be aware that the use of Renuvion/J-Plasma for aesthetic skin procedures may result in serious and potentially life-threatening AEs.
• Do not use the Renuvion/J-Plasma device for dermal resurfacing or skin contraction, alone or in combination with liposuction.
• Discuss the benefits and risks of all available aesthetic skin procedures with your patient. If you are performing an aesthetic procedure, inform your patient which devices you plan to use.
• Review the ApyxRenuvion/J-Plasma labeling and user manual for proper use of this medical device.
• Report any problems or complications experienced by patients from a procedureusingRenuvion/J-Plasma to the FDA.

Reference:

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