How "New" Are New Procedures and Equipment?

Buttock and Breast Augmentation (NYC), Park Plaza Plastic Surgery New York (NY)

During last year's recession, many plastic surgeons found themselves struggling to keep business. Some surgeons could rely on their reputation and a steady stream of referrals based on quality results, but others had a harder time.  Some surgeons offered deep discounts to draw in patients. Others sought to draw in new business by purchasing and promoting new technologies that supposedly offer significant benefits over older technologies and techniques.

Body-Jet is one such technology, and it reveals something important that every patient should investigate when considering getting a radical new procedure. Body-Jet is a new liposuction machine marketed by Human Med AG.  The copy on the Body-Jet website asks the question:  "Why is Body-Jet the superior way to remove fat?" and answers not with a description of the mechanism that makes Body-Jet a superior technology, but with, "Body-Jet Liposuction is the newest state-of-the-art liposuction technology."

However, a little investigation reveals that Body-Jet received FDA approval for marketing in the United States not after extensive evaluation with clinical trials to prove its safety and effectiveness, but under the cover of a 510(k) application, which allows devices that are "substantially equivalent" to already-approved devices to receive approval without supporting studies. In fact, in its approval letter, the FDA states, "the device is substantially equivalent (for the indications for [aesthetic body contouring]) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976."

This is not to question the safety or effectiveness of Body-Jet.  It is merely to point out the paradox that on the one hand Human Med AG represents Body-Jet as a radical new technology and on the other it represents it as technologies that have already been in use for the same purpose for more than thirty years.

If you are considering liposuction or some other body contouring technique with a "new and improved" technology, you should ask just how new that technology is.  You should look for clinical studies supporting the safety and effectiveness of the machine.  And you should ask yourself, what do I trust more: a machine or a doctor whose years of knowledge and experience have honed his skill?

To learn more about how New York plastic surgeon Dr. George Lefkovits can help you get the body contouring results you desire, please schedule a consultation today.

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