Get ready to lose your lunch.
A new device that drains a portion of a person's stomach contents after every meal has just won approval from the U.S. Food and Drug Administration.
The AspireAssist device is intended for obese people at least 22 years of age who have not been able to lose weight through other approaches, excluding surgery. The device was developed by King of Prussia, Pennsylvania-based company Aspire Bariatrics.
The device consists of a pump that attaches to hose surgically implanted in a patient's stomach. The hose is connected to a "disk-shaped port valve" that sits flush against the patient's skin, according to a release from the FDA. About 20 to 30 minutes after a meal, the patient opens the valve and for the next 10 minutes drains about 30 percent of the calories consumed — right into the toilet.
Here is a video of how it works:
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."