NON-LIPOSUCTION FAT REDUCTION APPROACHES

NON-LIPOSUCTION FAT REDUCTION APPROACHES

Frequently and aggressively marketed as “non-invasive” or “non-surgical” approaches to fat reduction, these methods are most commonly performed by non plastic surgeons (such as gynecologists, family physicians, general practitioners, retired emergency room doctors, etc) who likely took a short instructional course sponsored by the manufacturer of the machine. Many times these physicians are trying to simply increase cash flow to their practice by adding some type of “fat reduction treatment” to their services even though cosmetic procedures are totally unrelated to the actual field (specialty) they were formally trained in.

These non-liposuction fat reduction methods usually lure in patients with a relatively low up front cost (for the first treatment) and claims of “non-invasiveness” and “safety”. Frequently there are also claims of “no down time” which is very appealing to the consumer. What potential clients frequently fail to understand, however, is that the effectiveness of the actual procedure is usually highly questionable. Even if it is relatively cheap, is it really a good deal if the effectiveness of the treatment is minimal or extremely poor? As far as the aggressive marketing claims made by the manufactures (and by the physicians who are trying to advertise their newly purchased machines), astute consumers might be correct to sometimes think “If it sounds too good to be true, it’s probably not true.”

Consumers should definitely not consider an “FDA” stamp on any of these devices as a guarantee of device effectiveness. The FDA is an agency that basically conducts a risk-benefit analysis that allows an item to be marketed for particular indications – sometimes requiring little or no testing. The vast majority of devices that undergo FDA review are moderate-risk Class 2 devices such as medication pumps, some surgical lasers and fat reduction devices. Many are granted FDA clearance through a controversial process called 510(k). (Low-risk Class 1 devices, like stethoscopes and gauze, are exempt from review.) Products get FDA 510(k) clearance if they’re found to be “substantially equivalent” to a legally marketed device, meaning they have the same intended use and technological characteristics — or, if not, that the differences don’t raise serious concern. There’s no requirement of actual clinical testing to determine the safety and effectiveness of 510(k) submissions, though the FDA does ask for clinical data in only about 10 percent of cases (according to a Chicago Tribune article). Unfortunately, consumers immediately assume that an “FDA” stamp on a device means that the device is very effective and works extremely well. Obviously, this is simply not true. Consumers should not fall for this marketing tactic.

Some consumer advocates also worry that insufficient FDA testing in the FDA 510(k) system lets unsafe or ineffective products slip through. As the chain of “substantially equivalent” devices grows, the less likely it is the new ones bear any resemblance to the original, and usually there’s been no evaluation of safety or effectiveness in between, said Dr. Michael Carome, deputy director of the Health Research Group at Public Citizen, a nonprofit consumer rights group. Devices later found faulty or even recalled aren’t automatically removed from the list, Carome said, so new products could be cleared based on tainted precedents.

Another marketing tactic is to present data from a “research study” that claims effectiveness. Physicians were formally trained in medical school on how to analyze a “research study” and how to determine if the results from a research study are truly meaningful. The general public, however, is not trained on how to actually analyze a scientific research study. One important consideration when reviewing any “research study” is to look at who actually funded the research study in the first place. Their is a huge conflict of interest if the study was funded (and the researchers were directly paid) by the same company that basically showed effectiveness of their machine in the study. In addition, was the study actually published in a peer reviewed respected medical journal, such as the famous plastic surgery journal known as Plastic and Reconstructive Surgery? If a study makes it to actual publication in this level of a medical journal, be assured that the study was actually reviewed by a committee of professional reviewers before it was allowed to be published. Many studies are rejected after review by this committee if the methods used in the study were poor or questionable. There are, however, many less respectable journals, magazines and even websites that would easily allow publication of any research study that may have been rejected elsewhere.

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