F.P. Report
WASHINGTON: The U.S. Food and Drug Administration (FDA) is warning consumers and health care providers against the use of the Renuvion/J-Plasma device by Apyx Medical for certain aesthetic procedures.
Specifically, the FDA is warning against the use for procedures intended to improve the appearance of the skin through dermal resurfacing (a procedure on the skin to treat wrinkles) or skin contraction (a procedure under the skin that can be performed either alone or in combination with liposuction to achieve skin effects, such as “tightening”).
The Renuvion/J-Plasma device is FDA cleared for general use of cutting, coagulation, and ablation of soft tissue during open and laparoscopic surgical procedures. The use of this device has not been determined to be safe or effective for any specific procedure intended to improve the appearance of the skin. The FDA has received reports describing serious adverse events when the Renuvion/J-plasma device was used directly on the skin and potentially life-threatening adverse events when the Renuvion/J-plasma device was used under the skin.
Recommendations for 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.
Recommendations for 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 adverse events.
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.
Device Description
The Renuvion/J-Plasma system by Apyx Medical, which includes the Plasma/RF Handpiece and Plasma Generators, are medical devices cleared for general surgery procedures. These devices use radiofrequency (RF) energy and helium to generate plasma (gas-like substance with high heat). The plasma can be used to cut, coagulate (stop bleeding), and eliminate soft tissue with heat during surgery. The use of the device has not been determined to be safe or effective in any specific procedures, including aesthetic skin procedures.
Risks Associated with Use of Renuvion/J-Plasma for Aesthetic Skin Procedures
The FDA has received reports describing serious and potentially life-threatening adverse events after the device was used for aesthetic skin procedures. Reported events include 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. In some cases, adverse events required treatment in an intensive care unit (ICU).
FDA Actions
The FDA is working with the manufacturer to evaluate all available information about the use of Renuvion/J-Plasma for aesthetic skin procedures and to inform patients and providers that the device has not been determined to be safe or effective for these procedures.
The FDA will continue to monitor reports of adverse events. The FDA will keep the public informed if significant new information becomes available.
Reporting Problems with Your Device
If you think you had a problem with your device, the FDA encourages you to report the problem through the MedWatch Voluntary Reporting Form.
Health care personnel employed by facilities that are subject to the FDA’s user facility reporting requirements should follow the reporting procedures established by their facilities.
