FDA Approval Difficult for Weight Loss Devices

non surgical devicesA recent article in the New York Times discusses the development of surgery-free, weight loss devices to treat obesity. With potentially less risk and fewer side effects than current weight loss surgery options, an incision-less, non-surgical device could provide an alternative solution to those squeamish about going under the knife. The article discusses several devices that have been developed, but fail to meet the Food and Drug Administration’s weight loss standards in clinical trials.

One of such products, deemed a “scar-less” weight-loss surgery, was developed by a company called Satiety, Inc. It works by shrinking the stomach using a stapler inserted through the mouth, rather than by cutting open a person’s stomach. When the results of a clinical trial came in, the procedure resulted in significantly less weight loss for patients than the company had expected. According to the article, “the failure of the procedure, called transoral gastroplasty, pushes back the availability of any incision-less procedure to millions of obese Americans for several years, a disappointment to companies trying to find the next best thing to major surgery.

The makers of these non-surgical devices hope that by going in through the mouth using an endoscope, they can eliminate the infection risk from incisions, and possibly the need for general anesthesia. This could decrease the current cost for bariatric surgery. Device developers argue that perhaps more obese people would undergo weight loss procedures if they were made less expensive and less forbidding. According to the article, while more than 20 million Americans are overweight enough to qualify for bariatric surgery, only about 200,000 have the operation annually.”

Meanwhile, weight loss surgery has become safer, and is often now performed with tiny incisions, and no cutting of the stomach. Just recently, the Food and Drug Administration lowered the BMI requirement for the Lap-Band system, making more than 26 million additional people eligible to have it implanted.

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