The AspireAssist consists of a surgically implanted tube that runs from the stomach to a small nozzle outside of the skin, and a system to pump and refill the lost contents. After a meal, patients fill a small reservoir with water, plug the system into the nozzle, and turn a lever to pump up to 30 percent of the stomach’s content into the toilet in about 10 minutes. The system then refills the stomach with water from the reservoir.
“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,” endocrinologist and diabeteolost Joseph Gutman told The Verge. Gutman has made it his mission to get 4,000 physicians to sue the FDA for their approval of the device. “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.”
But it isn’t a joke, and some physicians support the AspireAssist. In fact, the concept was developed by three of them: Dr. Moshe Shike, a gastroenterologist from Memorial Sloan Kettering Cancer Center; Dr. Samuel Klein, a gastroenterologist from Washington University, and Dr. Steve Solomon, an interventional radiologist from Sloan Kettering.
Aspire Bariatrics CEO Kathy Crothall tells Digital Trends that, despite the objections, her company’s device has shown some promising results in trials when paired with lifestyle changes. “Patients receiving the AspireAssist and lifestyle therapy achieved 12.1 percent total body loss versus 3.6 percent who just received lifestyle therapy,” she said. That’s because, simply put, the device pumps out a significant portion of consumed food before it’s properly absorbed. Moreover, the FDA restricted the device to obese patients (BMI over 35), without eating disorders, who’ve failed to lose weight in other ways.
With these results and the recent FDA approval, Crothall says her company plans to introduce the devices to United States clinics “that have the capability to provide appropriate level of patient care.”
Putting aside the potential for infections and leakages, Gutman and other physicians in his camp are concerned that the device enables the root causes of obesity. In other words, rather than encouraging people to eat less and exercise, the AspireAssist allows them to eat more and pump their stomach without having absorbed the calories. The lingering worry is that the device may even contribute to overeating.
“The AspireAssist contributes neither to overeating nor to eating disorders,” Crothall says. “As the diameter of the tube is about ¼ of an inch, the diameter of a pencil, patients must chew their food very thoroughly in order to get food to exit the tube. We have seen no evidence that device use leads to overeating or eating disorders.”
More than a one in three American adults are considered obese, including one in six children aged six to 19.