FDA-approved stomach-draining device may face lawsuit

The Food and Drug Administration has approved several new weight loss interventions in the past year, but one in particular seems to be raising eyebrows among physicians.

Their target is a newly approved device called AspireAssist. Using a surgically-implanted tube running from the stomach, patients can connect the device to a port valve placed in the abdomen and drain part of the stomach’s contents about 20 minutes after finishing a meal. The draining takes about 10 minutes, and then the contents can be discarded in a toilet.

The end result, according to the FDA, is about 30 percent of the calories consumed during a meal are removed.

“The AspireAssist approach helps provide effective control of calorie absorption, which is a key principle of weight management therapy,” William Maisel, MD, MPH, deputy director for science in the FDA’s Center for Devices and Radiological Health, said in a statement. “Patients need to be regularly monitored by their healthcare provider and should follow a lifestyle program to help them develop healthier eating habits and reduce their calorie intake.”

The FDA based its approval off a clinical trial, which found obese patients using the device while receiving lifestyle therapy for a year lost 12.1 percent of their body weight on average.

The treatment isn’t for everyone—the FDA’s approval said it’s meant for people with a BMI between 35 and 55, and isn’t intended for short-term use for those who are only moderately overweight—but healthcare professionals are concerned about how it will be used. Joseph Guttman, MD, a Florida endocrinologist, told The Verge he’s putting together a group of hundreds of physicians to sue the FDA to remove the device from the market, arguing it may lead to eating disorders.

“This is the first time that I look at a device that was approved by the FDA and I am absolutely, utterly and totally appalled that it was approved,” Gutman said to The Verge. "It is the most pathetic exhibition of ignorance on the part of our agency, the FDA. It is nothing but a bad trick. It’s like a bad joke.”

Gutman went as far as to call the device “mechanized bulimia.”

The FDA’s approval did state the treatment isn’t meant for bulimia patients, along with those diagnosed with binge eating disorder.

Along with AspireAssist, other recently approved interventions included two different kinds of intragastric balloons, which are inserted in the stomach with an endoscope and then filled with saline, leaving less space in the stomach for food.

Weight loss specialists told the Wall Street Journal that treatments like these balloons or AspireAssist may reach more moderately obese patients who aren’t candidates for typical bariatric surgery.

“We had lots of patients contacting us with BMIs between 30 and 40 and we had nothing to offer them, and many people who are candidates for gastric bypass are petrified of the surgery,” said Shawn Garber, director of the New York Bariatric Group.