FDA Warns on Using Surgical Device for Aesthetic Skin Procedures

The FDA on Monday warned against using the Renuvion/J-Plasma device for dermal resurfacing or skin contraction procedures, describing serious and potentially life-threatening adverse events (AEs) following its use for such purposes.

Renuvion/J-Plasma — which uses radiofrequency energy and helium to generate a hot gas-like substance (plasma) that can cut through tissue — is cleared for cutting, coagulation, and ablation of soft tissue during general surgery. But “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 agency explained in a statement.

The FDA detailed a host of serious AEs after use of Apyx Medical’s device for aesthetic skin procedures (with or without liposuction), including “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, the AEs were serious enough to land patients in intensive care.

“Do not use the Renuvion/J-Plasma device for dermal resurfacing or skin contraction, alone or in combination with liposuction,” FDA warned healthcare providers. “If you are performing an aesthetic procedure, inform your patient which devices you plan to use.”

Apyx Medical had previously sought clearance for use of the system — which includes the Plasma/RF Handpiece and Plasma Generators — in dermal resurfacing procedures, but in 2019 scrapped the idea after a trial of the device in this setting missed its primary efficacy endpoint.

FDA is asking providers to report any problems or complications with Renuvion/J-Plasma to its MedWatch reporting program.