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Is Zerona the only evidence-based medical device?

Q:

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?

A:

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.

Best,

Gary R. Culbertson, MD, FACS

A:

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.

 

A:

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. 

 

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