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FDA approves AspireAssist, device that pumps food out of stomach for weight loss

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FDA approves AspireAssist, device that drains food out of stomach for weight loss
WATCH: How does the FDA approved device meant to flush out your stomach's content work? – Jun 15, 2016

If you’re in the middle of eating lunch, you should probably stop reading this story. Health officials in the U.S. approved a quirky new weight loss device called AspireAssist that vacuums food right out of the stomach before meals are digested.

It’s incredibly controversial: while it’s meant to help those grappling with obesity, critics have called it “assisted bulimia.”

The U.S. Food and Drug Administration approved the device, called AspireAssist, on Tuesday. Surgeons insert a tube in the stomach via a small incision in the abdomen. Then, a “skin-port” about the size of a poker chip is installed – that’s where users attach an external tube to flush food after mealtime.

After 20 to 30 minutes after eating, users pump food out of their stomachs and into their toilets. It takes about five to 10 minutes.

The device allegedly gets rid of roughly 30 per cent of the calories consumed.

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“The AspireAssist approach helps provide effective control of calorie absorption, which is a key principle of weight management therapy,” Dr. William Maisel, deputy director for science at the FDA, said in a statement.

“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.

The device isn’t meant for people with eating disorders or for “short durations.” The FDA says the ideal candidate is 22 and older, obese, with a body mass index of 35 to 55, and has struggled with weight loss through non-surgical means.

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Doctors need to monitor their patients closely to make sure the disk port stays in place on their skin. The device even has a safety feature that keeps counts of how many times the drain tube is connected to the port and stops after 115 cycles – about five to six weeks of usage. Then patients have to go back to their doctors for a replacement part for the device.

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The approval was based on results of clinical trials. In one case, 111 people were treated with AspireAssist while 60 control patients received therapy on making lifestyle changes. After one year, those using AspireAssist lost about 12.1 per cent of their total body weight while control patients lost only 3.6 per cent on average.

There are some side effects, though: nausea, vomiting, constipation and diarrhea, for example. The port could also lead to sores on the inside of the stomach, “unintended puncture of the stomach,” and infection, the FDA warned.

In 2013, the device was already available in some parts of Europe, Saudi Arabia and New Zealand.

At the time, doctors were incredibly skeptical, suggesting the device resembled a “bulimia machine.”

READ MORE: Why diet soda may be making you eat more

Other reports warned that “clogging” was an issue, especially when the pump tries to break down large foods. Patients had to avoid eating cauliflower, broccoli, Chinese food, pretzels, chips and steak.

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But Dr. Shelby Sullivan, a Washington University scientist who tested AspireAssist, told NBC News it’s a viable options for those who are obese and are trying to lose weight.

“There is no such thing as medical bulimia or assisted bulimia…patients eat less with this therapy then they did before. People think patients can eat whatever they want and then aspirate it and that’s just not true,” she said.

Read more about the FDA’s approval of AspireAssist. Health Canada did not yet respond to request for comment about the device. 2013 reports suggest the federal agency received an application for approval at the time.

carmen.chai@globalnews.ca

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