Critics of Weight-Loss Device Urge FDA to Reverse Approval

An FDA spokeswoman said the agency approved the AspireAssist because 12-month clinical trial data provided by the manufacturer demonstrated that the device offered a reasonable assurance of safety and efficacy.

Advocates of the device say it is less invasive and more cost-effective than bariatric surgeries and a powerful new weapon in the global fight against obesity. “There is absolutely no medical evidence to suggest the use of this device could lead to an eating disorder,” said Dr. Shelby Sullivan, director of bariatric endoscopy at Washington University School of Medicine in St. Louis, where the device has been tested.