02/08/2010 3:00 am
Is Non-Invasive Liposuction a Fat Lie? by Dr. Haideh Hirmand
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Editor’s Note: Dr. Haideh Hirmand is a noted plastic surgeon, academic and thought leader in the aesthetic and beauty arenas. She completed her Doctorate in Medicine at Harvard and is Clinical Assistant Professor of surgery at the The New York Hospital/Cornell-Weill Medical Center. She specializes in eyelid and facial rejuvenation, secondary breast surgery, body contouring and is recognized nationally as a pioneer in injection techniques. Click here to learn more about Dr. Haideh Hirmand.
I read an article in The New York Times this past week about the wonders of new "lipo" procedures that 
promise to get rid of fat — without a single incision. It is an amazing phenomenon that everyone is interested in these machines and even more amazing that the interest is so ahead of the curve of the safety and efficacy stamp for body contouring. None of the technologies presently have FDA approval for specific body contouring/fat reduction applications. Some are approved for dermatologic purposes for example. As a plastic surgeon who is familiar with these latest technologies, I have been excited about their arrival for a while, but I am also skeptical about how some of these machines are being marketed directly to the consumer ahead of their FDA approval and scientific data. In the old times, you had to first convince doctors that a machine worked by showing results and clinical data and then doctors offered it to their patients. Nowadays, it seems, the device companies have gone the way of the big pharmas with direct-to-consumer marketing.
| Nowadays, it seems, the device companies have gone the way of the big pharmas with direct-to-consumer marketing. |
Fortunately the FDA has gotten as strict with the device companies as they have with big pharmaceuticals on "compliance" with approval indications, requiring companies to only market their devices once approved and for approved applications. In fact they have gone overboard and the marketing material also has to be approved by the FDA prior to release. For example, if a machine is approved for tissue coagulation, it can’t be marketed for fat reduction. Frankly, I think this is a positive development that closes a big loophole and protects the consumer. However, it doesn’t prevent companies from making claims that have no scientific basis once they are FDA approved for the correct indication. For example, take smart lipo that was FDA approved. They were marketing the machine aggressively claiming that it could also effectively tighten way before any clinical data was out there to substantiate the claims. And by the way, the clinical data now out still doesn’t show amazing tightening but moderate amounts in good candidates.
Now we have Zerona, who has been marketing their non-FDA-approved external fat-melting machine to doctors and consumers both, and I wonder how they do it and how they get away with it. Where is the FDA when you need them? Most other companies are extremely careful about how they go about marketing and launching their devices as of late.
No doubt that non-invasive lipo is the future of body contouring, at least for a good group of those interested, but before we have a lot of disappointed consumers, best to wait for FDA approvals and good science that backs up clinical efficacy for these claims. Stay tuned for a wowOwow preview on these totally non-invasive new technologies that are going through approval now.
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Say what you will about the FDA and their slow approach at approving products for American use, but they are protecting us. As a woman who does care about my body, I would LOVE to see Zerona (if it can be proven beneficial) to be approved. But only once it has been approved by the FDA.
There are too many charlatans out there making money off of what is essentially bogus products that offer no real benefit.