FDA Approves Renuvion/J-Plasma Accessory For Cosmetic Surgery Following Injury Warnings
Following a warning issued earlier this year about multiple patients who suffered serious and potentially life-threatening problems with Renuvion/J-Plasma, federal health officials have approved use of the devices for a limited number of aesthetic skincare procedures.
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 U.S. Food and Drug Administration (FDA) for use during open and laparoscopic procedures, the agency became aware of multiple unapproved use-cases, in which the devices were being used for dermal resurfacing or skin contractions, which is a procedure often done alongside liposuction to tighten skin for aesthetic purposes.
The unapproved use cases were associated with healthcare providers performing cosmetic skin procedures that resulted in multiple reported patient injuries arising from 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.
As a result, the FDA issued a Renuvion/J-Plasma safety communication on March 14, urging doctors to stop using them for aesthetic skincare procedures. However, this month the agency issued a new approval of a replacement Renuvion/J-Plasma handpiece, which is approved for certain dermatological and aesthetic procedures.
A Renuvion/J-Plasma Device approval update was announced by the FDA on July 21, stating the new Renuvion Dermal Handpiece can be used for the treatment of moderate to severe wrinkles, rhytides, in patients with Fitzpatrick Skin Types I, II, or III, may also be used for certain dermatological and aesthetic procedures.
The FDA indicates the new handpiece is also approved for use in subcutaneous dermatological and aesthetic procedures to improve the appearance of loose skin in the neck and under the chin.
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“The Renuvion APR Handpiece has not been cleared or approved for use in any other aesthetic skin procedure, or in combination with liposuction” the FDA warns, and states that the device “has not been determined to be safe or effective for any other aesthetic skin procedures.”
The agency recommends healthcare professionals discuss the benefits and risks of all available aesthetic skin procedures with patients, and any patient who has 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.
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