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FDA approves "abdominal vomiting" weight-loss device

Philadelphia Inquirer (PA) - 6/14/2016

June 14--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 it is meant for the moderately overweight. Rather, it is intended for patients aged 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 it 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'sCenter for Device and Radiological Health in a release issued Tuesday.

When news of the product first came out last year, TV's 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.

The FDA's announcement Tuesday comes one week after a report in the Journal of the American Medical Association finding 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 contents.

Within 5 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 only got the lifestyle therapy.

After a year, the people using AspireAssist lost an average of 12.1 percent of their total body weight compared to 3.5 percent for the control patients.

The trial results also suggested that both groups had small improvements in conditions associated with obesity, like diabetes and hypertension. Those improvements, the release noted, may have been due to the lifestyle therapy, which included nutrition and exercise counseling.

As weight is lost, the AspireAssist tube must be shortened so the disk remains flush against the skin. Cost information was not immediately available.

Side effects included occasional indigestion, nausea, vomiting, constipation and diarrhea. Risks associated with the tube placement included pain, abdominal bloating, indigestion, bleeding and infection.

This story will be updated later this afternoon.

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