It’s also been called a potentially useful obesity treatment.
This may sound extreme, but not long ago bariatric surgery also seemed barbaric — and it has quickly become a common treatment for extreme obesity.
Early initial reports about AspireAssist actually show some promise (with several caveats, of course).
Here’s what we know about the device, what we don’t know, and what it may mean for obesity — one of the hardest-to-treat chronic diseases we now face.
How the AspireAssist works
The device, which was approved by the FDA in mid-June, has been around since 2013, when it was patented by Aspire Bariatrics in King of Prussia, Pennsylvania. But it is the brainchild of several obesity doctors — as well as Dean Kamen, the inventor of the Segway. (The fact that the creator of a machine that helps people avoid walking also invented a machine that helps people remove food from their stomachs was not lost on critics when AspireAssist began to make the media rounds several years ago.)
You can think of the device as a reverse feeding tube that’s surgically implanted into the stomachs of obese patients. Instead of sending food into the body, it drains (or "aspirates") up to one-third of the calories from every meal into the toilet.
The procedure begins with an incision in the abdomen. After the tube has been inserted, it’s connected to a valve that sits on the abdomen. The valve normally stays closed — until it’s time to drain the stomach.
Patients need to carefully chew their food at every meal if they want to "aspirate" it. Then they need to get to a bathroom within 20 or 30 minutes of eating, before calories are absorbed into the body. At that point, they attach an external device (including tubing and a water-filled reservoir — see photo above) to open the valve, and gravity helps the contents of the stomach flow out through a tube and into the toilet. They then need to flush the stomach with water and drain the stomach again.
This cycle takes about 10 minutes to complete.
Some find this idea appalling
Unsurprisingly, many of the reactions to the device have been negative — even horrified.
Some are writing it off as a way for people to gorge "at the buffet only to dip into the bathroom for fifteen minutes to drain the deep-fried goodness."
The FDA has approved an easier alternative to bulimia. AspireAssist. Good job guys.— Jett Micheyl (@JettStars) June 20, 2016
It’s also raising eyebrows among some obesity doctors. As The Verge reported, Joseph Gutman, a doctor in Florida, has persuaded more than 750 of his peers to sign a petition to sue the Food and Drug Administration and get the device taken off the market.
Some doctors who treat eating disorders are skeptical, too. They say the device is a little too reminiscent of bulimia, and could potentially contribute to disordered eating habits. As Dina Zeckhausen, a psychologist and founder of the Eating Disorders Information Network, told Psychiatry Advisor, "The entire concept offends, disgusts, and saddens me — I think the device is a form of assisted bulimia."
But there’s also some compelling evidence to consider about how it could help obese people.
The evidence suggests this could be a promising tool — with some big caveats
Before a medical device can be marketed in the US, the FDA requires manufacturers to submit safety and efficacy data from clinical studies. And we now have two small published studies on the device, and one larger clinical trial that’s yet to be published.
Let’s get the caveats out of the way first. Two of the three studies on the AspireAssist were designed and/or funded by the maker of the device — which always raises concerns about conflicts of interest. (Researchers have found that studies of drugs and devices that are sponsored by manufacturers are more likely to show favorable results compared with independent studies.)
The largest of the studies, a clinical trial involving 111 patients, was the one the FDA relied on for its approval. It was also sponsored by the device maker and hasn’t yet been peer-reviewed or published.
In that study, half the patients dropped out after one year. Their reasons varied: from lack of time and motivation to aspirate to nausea, discomfort, or pain — or even because of complaints that the tube interfered with intimacy. Some also suffered nutrient deficiencies.
The two other studies that were published were pretty small and limited, involving no more than 25 participants each. (One of the studies also had no control group). The first, which was sponsored by the device company and designed by an AspireAssist investor who holds the patent for the device, reported a "100 percent success rate" in placing the tube in patients. The second, which appears to be independent, reported that around 10 percent of patients could not have the tube safely placed in their bodies.
Though researchers didn’t find that the device triggered disordered eating behaviors in patients, it does carry other significant side effects. According to the FDA, using this device can lead to indigestion, vomiting, constipation, and diarrhea. And the surgery carries risks, including: "sore throat, pain, abdominal bloating, indigestion, bleeding, infection, nausea, vomiting, sedation-related breathing problems, inflammation of the lining of the abdomen, sores on the inside of the stomach, pneumonia, unintended puncture of the stomach or intestinal wall and death."
But these serious side effects in the trials seemed to be pretty rare — at least in these small, preliminary studies.
The good news: People who used the device lost dozens of pounds, at least in the short term
Now here’s the good news. If we accept the caveats above, then the research also demonstrates that the device helps some people lose weight.
The participants who stuck to using the device lost, on average, dozens of pounds. In one of the studies, which followed participants for six months, the patients using AspireAssist lost an average of 36 pounds. In the 2013 pilot study, after one year the folks who used it lost on average about 19 percent of their body weight compared with 6 percent for those in the control group, which used lifestyle therapy only. And in that (unpublished) trial, patients lost an average of about 30 pounds after a year.
So basically, according to preliminary, mostly industry-sponsored research, some people who use the AspireAssist device over several months really do lose a significant amount of weight. According to the company, as a one-day surgery, it’s also a simpler — and reversible — option, compared with bariatric surgery.
Keep in mind, though: The study participants had a lot of support. They were carefully selected and then closely monitored and supported by health professionals. All the studies also incorporated some type of dietary and cognitive behavioral counseling. So patients' experience would likely be better than average, and perhaps their results were more dramatic.
Then there’s the big question of what happens for the rest of their lives. "We don’t have follow-up of greater than one year, let alone five- or 10-year follow-up, to know what’s going to happen to these patients," said University of Alabama obesity researcher Jayleen Grams. "Maybe in select patients, certain people could be helped. But if nearly 50 percent of people are dropping out [after] one year, I’m not sure those are good odds."
For now, the company is working to roll out the device in the US, where it is expected to cost up to $13,000, according to the company CEO. The FDA has approved AspireAssist for obese patients (with a body mass index of 35 to 55) ages 22 and older who don’t have eating disorders (bulimia, binge eating disorder, and night eating syndrome are all contraindicated). Patients also need to demonstrate that they’ve failed to maintain weight loss after trying other non-surgical methods.
It’s possible that as more people use it, we’ll learn that the AspireAssist is useful in the long term. It’s also possible this will be like many, many other failed obesity therapies — including dieting — which work for a short time and then lead people to gain back their weight, and sometimes more. It could also turn out to be unsafe, or even harmful.
For now, obesity doctor Yoni Freedhoff says he’s keeping an open mind. "Ultimately, if over time it’s shown to be both safe and effective and to effect a weight loss sufficient to improve quantity or quality of life ... why would anyone question it?" he says. On the other hand, if we find out the device causes harm or leads to only temporary losses, "hopefully it’ll be relegated to the dustbin of bad ideas," he added.
Correction: This update corrects a misstatement about the number of dropouts in a study after one year of therapy with AspireAssist. (Half dropped out after — and not at — one year on the device.)