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The device is cleared by the FDA for “general use of cutting, coagulation, and ablation of soft tissue during open and laparoscopic surgical procedures” but it “has not been determined to be safe or effective for any procedure intended to improve the appearance of the skin,” according to the March 14 statement from the FDA. The statement adds that the agency has received reports describing “serious and potentially life-threatening adverse events with use of this device for certain aesthetic procedures,” including some that have required treatment in an intensive care unit. The statement does not mention whether any cases were fatal.
Adverse events that have been reported include second- and third-degree burns, infections, changes in skin color, scars, nerve damage, “significant bleeding,” and “air or gas accumulation under the skin, in body cavities, and in blood vessels.”
Manufactured by Apyx medical, the device includes a hand piece and generator and uses radiofrequency energy and helium to generate plasma, which is used to “cut, coagulate ... and eliminate soft tissue with heat during surgery,” according to the FDA.
The FDA is advising health care providers not to use the device for dermal resurfacing or skin contraction “alone or in combination with liposuction.”
The statement also advises consumers who are considering an aesthetic skin treatment with this device to consult their health care providers regarding its use – and if they have any problems or are concerned after being treated with this device, to “seek care from a licensed health care provider.”
The FDA is working with Apyx to evaluate information about the use of the device for aesthetic skin procedures and to inform consumers and health care providers about the warning.
Health care providers and consumers should report problems or complications associated with the Renuvion/J-Plasma device to the FDA’s MedWatch program.
A version of this article first appeared on Medscape.com.