Critics of weight-loss device urge U.S. regulator to reverse approval

(Reuters) – Lotta Bosnyak takes extra time to chew the blueberries in her yogurt. Otherwise, she said, the device she credits with saving her life will not work. The tube Bosnyak is referring to has been implanted into her stomach. She turns a valve and, standing over a toilet, drains out the yogurt. The 52-year-old Delray Beach, Florida, resident was one of the 1st people to try the “AspireAssist” device four years ago in Sweden, where she is from. “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,” said Dr. Christopher Thompson, director of therapeutic endoscopy at Brigham Woman’s Hospital in Boston. “It’s not just a procedure that’s done and then they’re off and they don’t think about it anymore,” he added. The device, made by Pennsylvania-based biomedical company Aspire Bariatrics, was approved for use in the United States in June. However, critics are urging the Food and Drug Administration to reverse its decision, saying the device mimics, promotes and could lead to potentially life-threatening disorders such as bulimia and binge-eating. “This will likely prove to be yet another in a long line list of misguided, unsuccessful and dangerous products for losing weight,” wrote Dr. Eva Trujillo, president of the Academy of Eating Disorders, in a draft of a letter to be submitted the FDA next week. “Such a device may carry very serious physical and ...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Weight loss Aspire Bariatrics Source Type: news