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Is Zerona the only evidence-based medical device?
I read a post from Dr. Culbertson who said Zerona does not have any science and it is a waste of a patient's time. I had Zerona performed. As a physician, I selected a procedure that underwent a Level 1 clinical study, and surprisingly it was the only device having undergone this quality of study. If I can find the placebo-controlled, randomized, double-blind study, then why can't other plastic surgeons?
It is one thing to exclaim, it is another to disclose. Your failure to identify your reference makes me question your intention. Hopefully, as a physician you realize it is important to disclose and identify conflicts of interest such as, a financial interest in Zerona.
Gary R. Culbertson, MD, FACS
Here is another PLASTIC SURGEON FOR YOU:
Dr. Culbertson is right and honest in his reply. There is no supporting literature in a peer reviewed journal that support the claims of Zerona. LOOKING FOR EVIDENCE BASED MEDICINE, NOT ANECDOTAL CLAIMS. Otherwise we will be the first to adopt the technology.
The Zerona device, a non-surgical device designed to remove fat with no surgery and no down time DID receive an FDA clearance. However, and FDA clearance alone should not be enough to convince a physician of safety or efficacy of a device.
I have never, and will never proclaim my practice to be "First in geographic region to offer treatment x" I would much rather wait to see what side effects might occur when a product has been used by many people for a significant period of time. So, I was not the first to use Juvederm. Juvederm is a great product and my office is now are the top provider of Juvederm in Raleigh, NC, so I guess I missed some opportunities early on. . But, I was also not the first to introduce Evolence or Lipo-dissolve. I never used these products. They sounded crazy from the start. They proved to be problematic, and in some cases very dangerous.
The good news is, I believe there is at least one great treatment for non-surgical fat removal. CoolSculpting Complete. I have been interested in CoolSculpting for quite some time and after enough patients have been treated I felt the device was safe and effective. With the introduction of CoolSculpting Complete, I feel confident that we have a safe, effective non-surgical treatment for at reduction that requires no down time.
CoolSculpting Complete is not for every person, and it is certainly not a replacement for liposuction. But, for the right candidate, we feel CoolSculpting Complete can provide wonderful results. Zerona, on the other hand has been a disappointment to many patients and physicians despite an FDA clearance.