The FDA reviewed “results from a clinical trial of 111 patients treated with AspireAssist and appropriate lifestyle therapy, and 60 control patients who received only the lifestyle therapy.”
AspireAssist patients lost an average of 12.1 percent of their total body weight over a year period, compared to 3.6 percent for the control patients, the FDA said. Both groups of patients experienced “small improvements” in obesity-related conditions like diabetes, which could be “attributable to lifestyle therapy” such as nutrition.
“The AspireAssist approach helps provide effective control of calorie absorption, which is a key principle of weight management therapy,” said William Maisel, M.D., M.P.H., deputy director for science and chief scientist in the FDA’s Center for Devices and Radiological Health.
However, Maisel also indicated that the device should not be relied on as a catch-all treatment for weight management and that patients should incorporate other measures such as healthier eating.
“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,” he said.
Frequent medical care visits are necessary as there a number of side effects and risks associated with AspireAssist.
Some of the greater risks associated with the surgical placement of the gastric tube are pneumonia, unintended puncture of the stomach or intestinal wall, and even death.
There are also risks related to the abdominal opening for the port valve and the removal of the device.
A number of nutritional experts have blasted the new weight loss alternative, with some calling it “assisted bulimia.”
“I heard about this device about a year or two ago at one of our meetings and I was shocked. It’s like giving someone bulimia, basically, you can just vomit out this tube,” Dr. Sajani Shah, gastric band surgeon at Tufts Medical Center, told CBS News.
Dr. Shelby Sullivan of Washington University in St. Louis, who helped test the medical devices disputed this criticism, telling NBC News: “There is no such thing as medical bulimia or assisted bulimia.”
“People think patients can eat whatever they want and then aspirate it and that’s just not true. It has to be liquid enough and the particles have to be small enough to get through the tube.“