There’s a lot of buzz about the new wave of non-invasive fat melting devices like Zerona™ (635nm low level laser), Lipo-Ex™ (radio frequency) and UltraShape® (selective focused ultrasound) who all lack the illustrious FDA clearance desperately needed to make a huge impact in the body sculpting arena.
Sure they possess FDA clearances for safety, but not yet efficacy in the key category of actual fat reduction. What’s the FDA’s hang up? Apparently it has to do with fat metabolism. Specifically, the FDA wants to know what happens to the fat that is expelled from the liposome after treatment, it’s ingestion by macrophages, the transportation to the lymphatic system, and the final excretion by the kidneys. The FDA wants to ensure no harm will come to a patient by this natural process of foreign body elimination. They also want to prove they work as a stand-alone therapy.
I’ve talked with many physicians at ASLMS and The Aesthetic Show and have read posted discussions by fellow MAPA members like, Dr. Lornell Hansen who is extremely proficient in the development of lasers in the U.S. and is highly regarded for his opinions. If I may quote Dr. Hansen, he states every time he asks physicians who have used, specifically the Zerona™ by Erchonia, over the last few clinical trial years if the device actually works, the answer he receives is they “think it does”. For many physicians that answer doesn’t quite cut the mustard when you're thinking of investing time, money and your reputation on a device. On the other hand, if the technology is proven to be clinically advantageous for your patients, and they finally do receive the FDA’s approval in the next few months as all companies are claiming, are you willing to “miss the boat” and sit idly by on the shore watching everyone else sail into a sea of opportunity? Or, will you get into the boat too early and risk having it sink? It’s a gamble and timing is everything.
Well, our medical spa has thought long and hard on this technology and we have come to the conclusion that if the device is positioned in the right practice and for the right patient, it can be advantageous for both our practice and the patient. Many patients we see during complimentary consultations don’t want to have a minimally invasive surgical procedures, or the multiple injections of lipodissolve. They diet and exercise regularly, but can’t seem to lose those pockets of fat that seem impenetrable by their current regimen. Our practice offers SmartLipo™, SlimLipo™, VASER® Lipo, lipodissolve and VelaShape™. Body contouring is 80% of what we do. We believe this device has a place in our practice either before or after laser lipo, or combined with the lymphatic drainage abilities of the VelaShape™. Of course, with all body contouring procedures, optimal patient selection is a must for success.
Our decision was influenced in the faith and belief in technology and also the fact that the Zerona™, unlike the UltraShape® and Lipo-Ex™, is at least FDA market cleared for laser assisted liposuction. And just think, a few years ago even laser lipolysis was scoffed at. And, who would’ve even dreamed that fractional technology would exists and prove to be beneficial? Technology will continue to advance. Sometimes it works they way you hoped it would, other times your dreams fall a little short.
So, we are very excited to take the leap of faith into the Zerona™ low level laser and look forward to only positive results for our patients. If it works like we trust it will, we all win and score one more for technology! If it falls short, the worst that could happen is that the technology will need a little more “tweaking” and we’ll sail out boat back to shore.
We’ll keep you all posted on our travels.
Author: Paula D. Young RN runs internal operations and training at Young Medical Spa and is the author of the Medical Spa Aesthetics Course, Study Guide, and Advanced IPL & Laser Training course for medical estheticians and laser technicians.
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