In this recent Medscape article, the FDA has announced that the heat-based device Renuvion/J-Plasma, which has been used for skin tightening after tummy tucks or liposuction, “has not been determined to be safe or effective for any procedure intended to improve the appearance of the skin.” 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 as with many devices or medications, it is being used for a purpose other than what it is approved for. This isn’t illegal. It’s considered an off-label use. Consider BOTOX® Cosmetic. Doctors routinely administer it to consumers for the 11’s in between the eyebrows, forehead and crow’s feet. But it’s also used off-label for the lip flip or sweaty palms. Not illegal but not was it was cleared for, but since it provides a safe treatment for those off-label uses, it’s considered kosher.
However, heat-based devices to tighten the skin aren’t always safe, especially in untrained hands. These heat-based devices like Renuvion/J-Plasma can cause burns under the skin. In fact, that’s what the FDA reported. The agency received reports such as “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.”
The Medscape article goes on to mention 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.” The last one, “air or gas accumulation” refers to terms you may be more familiar with like “gas gangrene” or “necrotizing fasciitis” aka infections from flesh-eating bacteria. Yes, this is serious stuff.
The reason I do not and will not offer this heat-based device to my patients is the same reason I avoided other heat-based devices like laser lipo. This clever sounding name describes using heat in the form of a laser to melt fat and then suck it out through a metal cannula. The heat from the laser was also promoted to tighten skin. But as you can see below and in this article that I wrote for a peer-reviewed publication, it also caused strange contractions of skin as well as 2nd and 3rd degree burns. To be clear, the photos below are not due to the heat-based Renuvion/J-Plasma device but from a related heat-based “laser lipo” device.
I know it sounds petty to say “I told you so.” But after years of the company attempting to get me to buy their equipment or patients asking if I offer J-Plasma (great marketing, I can’t argue that point), I feel vindicated that I avoided this class-action lawsuit.