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.

Russell Maas

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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.

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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.

Russell Maas
Written by: Russell Maas

Managing Editor & Senior Legal Journalist

Russell Maas is a paralegal and the Managing Editor of AboutLawsuits.com, where he has reported on mass tort litigation, medical recalls, and consumer safety issues since 2010. He brings legal experience from one of the nation’s leading personal injury law firms and oversees the site’s editorial strategy, including SEO and content development.

Tags: Burns, Cosmetic Surgery, Infections, Nerve Damage, Plastic Surgery, Skin Reactions

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8 Comments

N
I had Renuvion procedure done in 2019, to my upper abs my arms and my knees face and neck. While the face procedure was fine, I was left us a great deal of scar tissue. And the results only lasted for a year I did not see results that were at all good for four months. My knees are still numb and look far worse than they did before the procedure -they improved briefly for about three months, and then went drastically downhill. I now have knees that do not allow me to wear shorts without feeling incredibly self-conscious, when before I just had a few wrinkles. Now I have a divet in my knees. I went to another plastic surgeon and he told me it would cost $15-$30,000 to repair my knees with either filler and or Reneva which I cannot afford. Also there is a definitive line at the top of my thigh where you can see where there was a stopping of treatment. In short they look horrible. My upper Abs looked better for about three months and then slid downhill, the only thing that helped was to build up more muscle in my upper abs to undo the unevenness caused by the Renuvion. My arms are worse (my upper arms), and still had numbness and very uneven texture and tone. Weight training which I don’t like to do, is the only thing that made my arms look better. I’m sure this treatment works fine for people with liposuction it does not work on athletic or Those with very little body fat. I have spoken with two other people who receive this same treatment, with similar body types as mine, thinner, low fat and we all say the same thing we could no longer wear shorts because it made everything worse. I don’t expect anybody is going to fix anything but I do want to let you know that this treatment is being used very unsuccessfully on a large number of people with very disappointing results To continue doing this procedure on people giving them false hope is wrong as well.
Soori
Warning. Do not do a J plasma. This is a dangerous procedure and damaged my nerves, neck, back and arms
Myong
I literally didn’t need it, didn’t want it. I never been pregnant. No saggy skin, or wrinkles, cellulite… I just wanted little bit off my abdomen. I went in 130 lbs 5′ 4″ Nurse won’t take NO for an answer. She hounded me for an hours like a used car sales person, I ended up saying yes. The biggest mistake I ever made in my life. I had a 3 rd degreed burnt, disfigurement, inside my stomach was bleeding for over 6 months… It’s been over year I am still messed up, and looking for a doctor to fix me. Because the shady doctor & nurse abandoned me. I wish I could go back to before I had the surgery done. I am still suffering. DO NOT GET THE RENUVION DONE!. YPU WILL BE BURN…ETC. discoloration.
Jaime
I had a procedure in May 2021 Lipo 360 with Jplasma, I endedup looking disfigured in my abdomen area. I had a huge bump and pocket literally looked like I had a baby alien or large worm in my stomach. I fought to get an ultrasound done as it was not going down or away months later and with constant lymphatic massages. After the ultrasound with the doctors fought me on, I got a call 2 days later scheduling me for surgery. I did a Lipo revision again with Jplasma not knowing any of this was a danger. I was awake during the procedure same as the first. This time shortly after entering the pocket area I got extremely sick, blood pressure dropped and I needed oxygen. I was shaking, pale, cold and literally felt like I was dying. After reading this I’m beginning to wonder if Jplasma was to blame. Just don’t do it. They pushed it on me probably for the additional money saying I’d get the most optimal results with it. At no point was I told this was not a fda approved device.
Catherine
I was in search of something to tighten the loose skin on my neck. The plastic surgeon offered a lower face lift or a less invasive treatment with renuvion and a very small amount of liposuction. When I asked MD about FDA warning he reassured me the warning was only meant for skin resurfacing and not skin tightening. I went forward with the procedure and have full thickness 3rd degree burns on my neck!!! DO NOT HAVE THIS PROCEDURE
Sandy
Do not have this procedure!!!! Forget it if you lost a deposit. I am disfigured from renuvion and bodytite – done by the same surgeon trying to tighten up for my sons wedding / I am having to spend another $17,000 to have a tummy tuck and fix the implants that have already fallen and not symmetrical/ within a years time .
Deborah
I also booked this procedure on March 11th before this came out and put a large deposit down. I hope I will be able to get a full refund.
Maria
I recently booked this procedure a month before this warning. My doctor received a non-refundable down payment. I wonder if she will refund me?

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