The US Food and Drug Administration (FDA) has issued an update on the safety of the Renuvion Dermal Handpiece for dermal resurfacing, which has been cleared for use with the Renuvion/J-Plasma device system by Apyx Medical.
The update states that the Renuvion Dermal Handpiece, which will be available shortly, was cleared on May 25 for use with the Apyx Medical Helium Plasma Generator for the treatment of moderate to severe wrinkles and rhytides in patients with Fitzpatrick skin types 1, 2, or 3.
The treatment, the manufacturer states, is called “facial renewal” and is performed with controlled heating of the outer skin layers so that “part or all the epidermis becomes non-viable and there is controlled thermal modification to the underlying dermis.”
However, the Renuvion/J-Plasma device system has not been found safe or effective for any other aesthetic skin procedures, including minimizing appearance of scars.
The Renuvion/J-Plasma system by Apyx Medical includes a handpiece and plasma generator. The system uses radiofrequency (RF) energy and helium to generate plasma with high heat.
In March, Medscape reported that the FDA issued a warning about the off-label use of the Renuvion/J-Plasma device for dermal resurfacing and skin contraction.
Labeling and training for the new handpiece include instructions for power settings and number of treatment passes. “This is separate from existing Renuvion/J-Plasma handpieces that are cleared for general use of cutting, coagulation, and ablation of soft tissue during open and laparoscopic surgical procedures,” the update states.
The FDA guidance includes a warning against using Renuvion/J-Plasma for skin contraction alone or in combination with liposuction. Using Renuvion/J-Plasma for skin contraction “may result in serious and potentially life-threatening adverse events,” the update states.
Reports to the FDA have included serious and potentially life-threatening adverse events after the device was used for skin contraction, including second- and third- degree burns, infection, scars, nerve damage, significant bleeding and change in skin color. Some cases have resulted in transfer to intensive care units.
In some cases, air or gas accumulated under the skin, in body cavities, and in blood vessels.
The FDA adds that providers should discuss the benefits and risks of all available aesthetic skin procedures with patients and inform them of which device will be used. In addition, patients considering liposuction should ask whether the provider plans to use Renuvion/J-plasma during the procedure.
Any patient who experiences any problem or is concerned after a procedure using Renuvion/J-Plasma should seek care from a licensed health care provider, the FDA advises.
The FDA is continuing to monitor reports of adverse events. Healthcare professionals, patients, and consumers can report adverse events associated with this device to the FDA’s MedWatch program.
Marcia Frellick is a freelance journalist based in Chicago. She has previously written for the Chicago Tribune, Science News, and Nurse.com, and was an editor at the Chicago Sun-Times, the Cincinnati Enquirer, and the St. Cloud (Minnesota) Times. Follow her on Twitter at @mfrellick
Source: Read Full Article