The FDA reviewed results from a clinical trial of 111 people using the device along with "appropriate lifestyle therapy," compared with a 60-person control group who received lifestyle therapy without the device. The AspireAssist group lost an average of 12.1 percent of their body weight after a year, compared with a loss of 3.6 percent of body weight for the control group.
"The AspireAssist approach helps provide effective control of calorie absorption, which is a key principle of weight management therapy," said Dr. William Maisel, deputy director for science and chief scientist at the FDA's Center for Devices and Radiological Health, in the release. "Patients need to be regularly monitored by their health-care provider and should follow a lifestyle program to help them develop healthier eating habits and reduce their calorie intake."
There is, of course, a bevy of possible things that can go wrong while wearing the device. The FDA statement warns of side effects including "occasional indigestion, nausea, vomiting, constipation and diarrhea," as well as side effects from the placement (or removal of the tube, including symptoms ranging from sore throats to bleeding and pneumonia, and irritations or conditions around the valve on the outside of the body.
Reactions to the device have varied from enthusiasm to condemnation. "This is it for me," one patient told ABC News in 2013. But a nutritionist quoted in the same article called the device "an enabling device, not a helping device."