Do Not Use Renuvion/J-Plasma Device For Cosmetic Surgery Due To Life-Threatening Injury Risks: FDA

Cosmetic skin surgery complications from Renuvion/J-Plasma devices may include burns, nerve damage, and other injuries the FDA warns.

Federal health regulators are warning physicians to stop using certain Apyx medical devices to treat skin wrinkles, after receiving multiple reports involving severe burns, nerve damage and other potentially life threatening injuries.

The FDA issued a Renuvion/J-Plasma safety communication on March 14, indicating that the devices have not been approved for aesthetic skincare procedures, and urging doctors to stop using them for such purposes immediately to avoid causing serious harm to patients.

The Renuvion/J-Plasma systems by Apyx Medical use radiofrequency energy and helium to generate plasma, which is used to cut, coagulate and eliminate soft tissue with heat during general surgical procedures.

While the devices have been cleared by the FDA for use during open and laparoscopic procedures, the agency has become aware of multiple reported injuries arising from healthcare providers using these devices during cosmetic skin procedures, which the devices have not been approved for use, nor are they intended to offer aesthetic benefits to the skin.

According to the warning, the FDA has received multiple reports indicating patients who underwent aesthetic skin care procedures using the Renuvion/J-Plasma devices suffered serious and potentially life-threatening adverse events.

Injuries from the Renuvion/J-Plasma devices included 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. The FDA has become aware of several incidents in which injuries caused by Renuvion/J-Plasma required treatment in an intensive care unit (ICU).

The agency recommends healthcare providers and physicians not use the Renuvion/J-Plasma device for dermal resurfacing or skin contraction, alone or in combination with liposuction, and to discuss the benefits and risks of all available aesthetic skin procedures with patients.

The FDA announced it will continue to work with the manufacturer to evaluate the reported patient injuries. Patients who have undergone aesthetic skin procedures using Renuvion/J-Plasma systems by Apyx Medical are encouraged to report any adverse outcomes or injuries to the FDA’s MedWatch Adverse Event Reporting Program.