FDA Approves Stomach Pump Device for Weight Loss

On Tuesday, the FDA approved a stomach pump, described by some as a “reverse feeding tube,” to help people lose weight. The strange weight-loss device is basically an external pump that dumps part of the stomach contents into the toilet.

The AspireAssist device is approved for use in morbidly-obese people, and helps them lose an average of 12% of body weight, which is significantly more than pills or most diets.

AspireAssist is considered minimally-invasive and includes a tube that goes from the inside of the stomach to a port on the outside of the abdomen. Patients can attach the pump to the outside port as needed to remove about 1/3 of the stomach’s contents at a time. If you can’t handle the sight of vomit, this might not be the device for you.

Dr. William Maisel, deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health, said in a press release obtained by CNBC:

“The AspireAssist approach helps provide effective control of calorie absorption, which is a key principle of weight management therapy. 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.”

Dumping the stomach’s contents before they can be absorbed by the body…wait, isn’t there already a “weight-loss method” like that? This sounds an awful lot like bulimia. I’m not alone in that assessment. In fact, some experts are very disturbed that the FDA agreed to approve a device that, they say, is the equivalent of “assisted bulimia.” Even the FDA sees the potential danger.

In a statement to CNBC News, the agency said:

“The AspireAssist device should not be used on patients with eating disorders, and it is not intended to be used for short durations in those who are moderately overweight.”

“It is intended to assist in weight loss in patients aged 22 and older who are obese, with a body mass index of 35 to 55, and who have failed to achieve and maintain weight loss through non-surgical weight-loss therapy.”

Not all doctors are convinced the device will work, or that it’s safe to use. In a 2013 ABC News article, a nutritionist called the device “an enabling device, not a helping device.”

Stacy Brethauer, a bariatric surgeon at the Cleveland Clinic and president-elect of the American Society for Metabolic and Bariatric Surgery, told Philly.com the long-term value of the AspireAssist has yet to be determined.

In clinical trials of the device, both the AspireAssist group and the control group had small improvements in obesity-related health conditions, such as diabetes and high blood pressure. And those improvements might not have been the results of the device, but of lifestyle therapy, including nutrition and exercise counseling, and did not necessarily teach patients to change their behavior.

AspireAssist does come with side effects, including occasional indigestion, nausea, vomiting, constipation, and diarrhea.