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Critics urge FDA rethink on stomach-draining weight loss device

Wednesday, July 27, 2016 - 03:00

Critics of a newly approved weight loss device that uses a tube inserted into the stomach to drain food after a meal say it could lead to dangerous eating disorders. Advocates argue it's a less invasive option to bariatric surgery and a powerful new weapon in the global fight against obesity. Ben Gruber reports.

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STORY: Lotta Bosynak is enjoying a yogurt. She's spends extra time chewing the blueberries very carefully. If she doesn't the device she credits with saving her life won't work. (SOUNDBITE) (English) ANNA LOTTA BOSNYAK, ASPIRE ASSIST PATIENT, SAYING: "The most important thing to do in this method is to learn how to chew your food and that is the crucial point because you really, really need to it, otherwise you can't use the tube." The tube Lotta is referring to has been implanted into her stomach. She turns a valve…and out comes the yogurt. The device called AspireAssist, was recently approved for use in the United States. But critics are appealing to the FDA to reverse its approval arguing the device is dangerous because it mimics, promotes and could lead to eating disorders. This was Lotta 4 years and 150 pounds ago…she was depressed, suffered from high blood pressure and type 2 diabetes. She was about to undergo bariatric surgery when she was offered to participate in a trial to test out an alternative. The device comprises a tube that is inserted into the stomach during a 15 minute minimally invasive procedure. That tube connects to a small opening in the belly where a device that includes a water bag and draining tube is attached. The user squeezes water into the stomach and then drains it along with 1/3 of a recently eaten meal into a toilet bowl. (SOUNDBITE) (English) DR. CHRISTOPHER THOMPSON, DIRECTOR OF THERAPEUTIC ENDOSCOPY AT BRIGHAM WOMAN'S HOSPITAL & AN ASSOCIATE PROFESSOR OF MEDICINE AT HARVARD MEDICAL SCHOOL, SAYING: "It's one of the best ways to change your relationship to food because it does require a lot of work on the patient's part. It's not just a procedure that's done and then they're off and they don't think about it anymore. This is something the patient is going to be thinking of every day, multiple times a day. This is something that they are living with and it's a tool for them to lose weight and to kind of get a better understanding on how to eat properly." Lotta Bosnyak said learning that lesson was the hard part. She her 'ah ha' moment came when she realized she was eating a lot less because of the time it took to chew her food small enough to pass through the tube. Christopher Thompson, who led the successful trial of the device, says that unlike other weight loss procedures, this one is reversible - meaning the tube can be taken out after the patient reached a healthy weight. (SOUNDBITE) (English) DR. CHRISTOPHER THOMPSON, DIRECTOR OF THERAPEUTIC ENDOSCOPY AT BRIGHAM WOMAN'S HOSPITAL & AN ASSOCIATE PROFESSOR OF MEDICINE AT HARVARD MEDICAL SCHOOL, SAYING: "You leave a large number of patients with no treatment options. Prevention has failed, medicines don't work terribly well so it's just wait until you are obese enough to have surgery and that is not a solution." In the United States alone, 35 percent of the population is obese. It's a condition connected to heart disease, strokes, certain cancers and type 2 diabetes. But critics led by the Academy of Eating Disorders say the device is a barbaric way to deal with obesity. The academy plans on submitting a formal letter to the FDA urging to reverse its approval next week. Lotta says her device has been a lifesaver. She said she had an eating disorder but thanks to her tube, she's cured.