A weight-loss device lampooned on late-night TV as "machine-assisted abdominal vomiting" because it allows users to drain some of their stomach contents after eating has won federal approval.
Manufactured by Aspire Bariatrics of King of Prussia, the AspireAssist device is a surgically implanted stomach tube with a port valve outside the body. In its approval, the U.S. Food and Drug Administration noted that it is not for people with eating disorders such as bulimia. Nor is it meant for the moderately overweight.
Rather, it is intended for patients 22 or older who are obese, with a body mass index of 35 to 55, and who have not been able to lose weight and maintain the loss through lifestyle changes.
"The AspireAssist approach helps provide effective control of calorie absorption, which is a key principle of weight management therapy," said William Maisel, deputy director for science and chief scientist in the FDA's Center for Device and Radiological Health, in a release issued Tuesday.
When news of the product came out last year, TV host Stephen Colbert was among those who had a field day with the latest effort to help stem the American obesity epidemic, coming up with the "abdominal vomiting" moniker.
But it comes at a critical time, one week after a report in the Journal of the American Medical Association that 40 percent of U.S. women are obese, compared with 35 percent of men.
Here's how AspireAssist works:
A surgeon inserts a tube in the patient's stomach via a small incision in the abdomen. A disk-shaped port valve outside the body, flush against the skin, is connected to the tube.
About a half-hour after each meal, the patient attaches the device's external connector and tubing to the port, opens the valve, and drains some of the stomach's contents.
Within five to 10 minutes, food matter is drained through the tube and into the toilet, removing about 30 percent of the calories consumed, according to the FDA.
The FDA reviewed results from a clinical trial of 111 patients treated with AspireAssist and appropriate lifestyle therapy, and 60 control group patients who received only lifestyle therapy.
After a year, AspireAssist users lost an average of 12.1 percent of their total body weight, compared with 3.5 percent for the control patients.
Thomas Wadden, director of the Center for Weight and Eating Disorder at the University of Pennsylvania's Perelman School of Medicine, said the long-term effects of the device remain to be seen. However, he said, AspireAssist has a higher success rate than traditional dieting and exercise, and is less invasive than bariatric surgeries that reduce the size of the stomach, producing more weight loss.
David Tichansky, director of bariatric surgery at Thomas Jefferson University Hospital, expressed concern that the mechanics of the device mimic the eating disorder bulimia. He did give the manufacturer credit for trying to find another way to help obese patients.
Stacy Brethauer, a bariatric surgeon at the Cleveland Clinic and president-elect of the American Society for Metabolic and Bariatric Surgery, also said the long-term value of the device has yet to be determined.
The trial results found that both the AspireAssist group and the control group had small improvements in conditions associated with obesity, such as diabetes and hypertension. Those improvements, the release noted, may have been due to the lifestyle therapy, which included nutrition and exercise counseling, and did not necessarily teach patients to change their behavior.
As weight is lost, the AspireAssist tube must be shortened so the disk remains flush against the skin. As for cost, it likely will be similar to the price of a gastric balloon procedure, around $8,000 to $13,000, said Aspire spokeswoman Christy Kaupinen.
Side effects included occasional indigestion, nausea, vomiting, constipation, and diarrhea. Risks associated with the tube placement included pain, abdominal bloating, indigestion, bleeding, and infection.