We have several potential cases we are looking at where the Renuvion device was used internally in conjunction with liposuction, with a goal of tightening the patient's skin.
Two of the patients suffered extensive burn-like injuries on their abdomens -- which were confirmed to actually be frostbite in at least one case. Another patient was apparently pumped full of helium somehow, leading to a pneumomediastinum and extensive subcutaneous emphysema, which stretched out her skin instead of tightening it.
All of the patients were treated with the Renuvion device before the FDA's March 2022 letter warning against using Renuvion in this way.
We would like to hear from any plastic surgeon who is familiar with the device, regardless of whether they use it for approved or off-label procedures.
Please do not post an opinion if not familiar with the Renuvion device.
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Do you believe there might have been medical error?
Although I need the medical records and photos to definitively offer an opinion, the burns more likley than not were caused by over aggressive use of the device. There are manufucturers recommendations and at least 1 peer-reviewed study describing safe settings and techniques. I need to see the records to see if these guidelines were observed. The device uses helium as a normal part of the procedure. Subcutaneous emphysema and pneumomediastinum are normal side-effects, temporary, self-resolving and do not cause skin to stretch out. There is no permanent injury caused by this. So the burns may have been malpractice and the subcutaneous emphysema/pneumomediastinum is not malpractice.
Do you believe there might have been causation (i.e. the medical error resulted in an injury)?
Not following the guidelines (standard of care) would be direct causation for the burns.
What makes you a good expert for this case?
I've done more than 100 procedures using renuvion this way. I have been formally trained and certified by Apyx Medical (the manufacturer of the device).
How often do you encounter cases similar to this one in your practice?
I perform approximately 10 renuvion/J-plasma cases per week in my practice. Ive never encountered burns. I frequently encounter subcutaneous emphysema.
Do you believe there might have been medical error?
Burn is a risk of using the Renuvion device and is often caused by using too much energy and/or not evenly or properly dispensing the energy Using too much helium can cause subcutaneous emphysema and pneumomediastinum I am not aware of how frostbite would be caused using this device unless someone directly exposed a patient to liquid helium which would be improper use of the device
Do you believe there might have been causation (i.e. the medical error resulted in an injury)?
I would need to review the medical records, but based on the summary it is possible that the patients might have been injured from improper use of the Renuvion device
What makes you a good expert for this case?
I own and use the J-Plasma/Renuvion device by Apyx Medical for skin tightening in association with and independent of liposuction. I have used it on label and off label with patient consent. I am aware of the FDA's March 2022 letter.
How often do you encounter cases similar to this one in your practice?
I routinely use the Renuvion device but have not seen any complication similar to the ones described in the summary
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Comments are accepted only from Plastic Surgery - includes all subspecialties experts.