A weight-loss device approved by the FDA last week has some doctors up in arms, with one even attempting to put together 4,000 physicians to sue the agency. That’s because they say the device, which lets patients pump some of the food they’ve just eaten directly from their stomachs into the toilet, isn’t safe and 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,” says Joseph Gutman, an endocrinologist and diabetologist in Pembroke Pines, Florida, who has treated patients with obesity for over 30 years. Gutman says he’s put together a group of 750 physicians who want to sue the FDA to take the device off the market; his ultimate goal is to get 4,000 doctors to join him. “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.”
The device, called AspireAssist, was approved by the FDA based on a one-year study of 111 people. The approval is for people with a body mass index (BMI) of 35 to 55 who have failed to lose weight with non-surgical therapies. (BMI is a measure of body fat based on height and weight; for a person who’s 5 feet 9 inches, the 35 to 55 BMI range translates to about 236 to 365 pounds.) AspireAssist also shouldn’t be used on patients who have eating disorders, the FDA says.
A person with AspireAssist has a tube surgically implanted through the abdomen into the stomach; it enters using a “port valve,” an opening just above the belly button that patients can open or close to drain the food. After a meal, the patient waits 20 to 30 minutes before connecting the pump to the valve; the food is drained and dumped into the toilet. The process takes about 10 minutes and the device can remove up to 30 percent of the calories consumed with a meal, according to Kathy Crothall, president and CEO of Aspire Bariatrics, which makes the device and is based in King of Prussia, Pennsylvania.
There are some obvious side-effects: the port valve can cause infections and the tube can leak. But some experts fear that the device itself might trigger eating disorders. That’s because the device, in some sense, mimics bulimia — a disorder where people binge eat and then throw up. “Instead of throwing up through the throat, you throw up through the tube,” Gutman says. “This is mechanized bulimia. It’s a device that makes bulimia okay.”
The company says that binge eating on the device isn’t possible; patients must chew their food too thoroughly to binge. If they don’t chew long enough, the food gets stuck in the tube, which is no bigger than a straw, says Shelby Sullivan, who led one of the trials of the device on 17 people at the University of Washington in St. Louis with funding from Aspire Bariatrics. Lotta Frisk, 52, who lost 148 pounds over four years thanks to the device, says she chews every bite from 55 to 75 times. “I can’t put in food and throw it out,” she says. “I need to chew.”
Because patients have to chew longer, they eat more slowly and often feel full faster, Sullivan says. And that may make patients eat less. “At some point they just get tired of chewing,” she says. “So they are feeling that full sensation with less food because they’re eating slower and they’re also literally just getting sick and tired of chewing.”
Eric Wilcoxon, 44, who’s had the device since 2013, agrees. Because of all the chewing, Wilcoxon says he has smaller meals and also eats more fruits, steamed vegetables, and grilled chicken, which are all easier to chew and aspirate with the device. “You have to chew your food beyond comprehension,” he says. “I mean, you just don’t grasp how much you have to chew your food.”
Wilcoxon, from Poplar Bluff, Missouri, lost 128 pounds with AspireAssist. He was 389 pounds when he decided to get the device in the clinical trial at Washington University, after ruling out bariatric surgery for fear of the complications. AspireAssist was more appealing, because it’s reversible. He also saw one of his best friends lose a lot of weight with a gastric band, a silicone device wrapped around the stomach that restricts the amount of food a person can eat — only to gain it back once the band was removed.
He plans to keep the device indefinitely, he says. That’s because it still lets him enjoy his favorite foods. “If we want to go out tonight after my boy’s ball game and if I want to have a great, big ribeye, I can,” he says. “I don’t have to aspirate every meal.”
Chewing isn’t the only behavioral change, Sullivan says. She argues that people who use the device make healthier choices for meals because they actually see what comes out of their stomachs and think twice about it. “Healthy food doesn’t look that bad. It looks about the same as it came in, it’s just chewed up,” she says. “Things like hamburgers and french fries, now that does not look good.”
The FDA approved the device based on a small clinical trial that only ran a year. That makes some experts nervous about the long-term effects for patients like Wilcoxon. “There’s no scientific basis in the long term as to what this does,” Gutman says. “The studies are incomplete.” It’s also hard to know how the patients will react once the device is removed. Will they regain all their weight back, as it’s often the case with temporary obesity treatments? “If the Aspire device is meant to be there for a year or two, the moment you remove it, patients will have a 98 percent chance to regain all the weight back,” says Raul Rosenthal, president of the American Society for Metabolic and Bariatric Surgery. That’s because most people regain weight after diets, often because they go back to unhealthy behavior.
Others worry that the device will give patients the impression that they can eat as much as they want, because they can just pump the food out afterwards. Instead, curing obesity means changing eating habits, teaching patients to eat less and eat healthier foods, combined with exercise. “I find it difficult to see how this won’t be seen as an easy way out, to the sense that people can eat more and not absorb the calories,” says Konstantinos Spaniolas, a bariatric surgeon at the Brody School of Medicine at East Carolina University.
In the clinical trial reviewed by the FDA, participants used AspireAssist along with nutrition and exercise counseling. They lost, on average, 12 percent of their starting weight; people who only received counseling lost just 4 percent of their weight. While AspireAssist did perform better than counseling alone, the amount of weight patients lost isn’t impressive when you take into account how invasive the device is, Spaniolas says. The device is implanted with a 15-minute procedure and does not require general anesthesia. Both Frisk and Wilcoxon said they were in a lot of pain for about two weeks after getting the tube. And the FDA warns that the procedure comes with risks of infection, bleeding, vomiting, nausea, and sores on the inside of the stomach.
Other surgical procedures produce more impressive results. The sleeve gastrectomy, a surgery that involves removing about 80 percent of a person’s stomach, can help patients lose about 30 percent of their weight. Gastric bypass, which basically “bypasses” most of the stomach and lets food go directly into the intestine, can help people lose about 35 percent of their weight. (Both surgeries are irreversible and can have serious complications.)
“Losing 12 percent of your weight is a good goal but doing so with a device that is invasive and leads to a gastrostomy tube, which is a connection between your skin and your stomach, sounds like a long run for a short slide to me,” Spaniolas says.
Treating obesity also isn’t just about losing weight, and more traditional surgeries have advantages there, too. Bariatric surgeries prompt changes in hormones that can influence complications from obesity, such as diabetes, high cholesterol, and hypertension, says Rosenthal. “The Aspire device doesn’t change either the appetite of the patient nor does it expedite rapid emptying,” he says. “There is no hormonal effect with this new device compared with the other well-established bariatric procedures.”
But for some patients like Frisk, who got the device in 2012 when she lived in Sweden, losing weight is enough to improve their overall health. Frisk says she had hypertension, type 2 diabetes, and depression when she weighed 320 pounds. She currently weighs 172 pounds and uses the device only once a day. She says she’s not taking any blood pressure and diabetes medication, and she’s not depressed anymore. “I really got a new life back,” says Frisk, who now lives in Delray Beach, Florida. “Everything changed and I got happy.”
Crothall, Aspire Bariatrics’ CEO, says that about 500 people worldwide have already used the device — and that it’s safe and effective. (AspireAssist is already in use in Europe and the company plans to soon expand to Australia, Canada, New Zealand, and South America.) The device is also very similar to the feeding tubes we’ve been using for decades, Sullivan says. AspireAssist just sucks the food out instead of pumping it in, but the concept is the same. “We have many years of experience and we can say without a doubt that having a tube in your abdomen for a long period of time is fine,” she says.
That argument doesn’t convince physicians like Gutman, who is trying to organize the lawsuit against the FDA. The device could create all kinds of complications, like infections, bleeding, and leaking. He says he wrote a letter of complaint to the FDA. “I think that the logic of the device is insane. I don’t think it makes any medical or physiologic sense,” he says. “It’s crazier than Trump for president.”
With almost 79 million Americans who suffer from obesity — 35 percent of the population — it’s important to see new devices enter the market, so that more treatment options are available, says Rosenthal of the American Society for Metabolic and Bariatric Surgery. But with every new device, it takes time to determine whether it’s going to be successful. “FDA-approval means that a device or medication is considered safe, but by no means it should be seen as the best treatment modality.” Rosenthal says. “And when something gets approved by the FDA it doesn’t mean that it should be applicable to everyone.”