RIP to the AspireAssist

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I received a reader question from Annilyn who said:

“My doctor just suggested that I try the AspireAssist to lose weight. I didn’t want to Google it because I think it will be really triggering but based on what he described, I just don’t think this thing can be real, can it? Will you write about it?”

I’m happy to write about this weight loss device Annilyn, and mostly I’m happy because it seems to be off the market, but we’ll get to that. I think it’s worth looking at the history and research around this thing as an example of what happens in a “thin by any means necessary” healthcare culture.

Content note for discussions of eating disorders and surgical procedures.

In 2016 the FDA approved a device called the AspireAssist, in which a thin tube is placed inside the patient’s stomach that connects to a button on the outside of their stomach.  After each meal the patient uses the tube and a handheld device to pump up to 30% of the meal out of their stomach and into the toilet or another receptacle.

As always, I have a firm commitment to bodily autonomy. What I’m against is a for-profit company misleading people about what this device can do, while making money off the backs of anti-fat panic, not concerned with the fact that one of the side effects of their contraption is death.

Now, let’s talk about what the company who created these devices said, and what is actually true (Note: the indented paragraphs contain weight stigma.)

The AspireAssist has been studied in hundreds of patients in both the US and in Europe. In a large U.S. clinical trial with 171 participants, people using the AspireAssist lost 3 times as much weight as people who received only lifestyle counseling. The most successful patients – those who aspirate regularly and learn to make healthier choices – have lost 100% of their excess weight with the AspireAssist and have maintained that weight loss for more than four years so far. Compared to other approaches, the AspireAssist has similar results without requiring invasive alterations to the anatomy or digestive process.

Sources: US PATHWAY Study (n=171): Data presented at Digestive Disease Week, May 2016 by C. Thompson; Pending publication; Completers only. European data collected from Sweden, Spain, Czech Republic, Germany, Austria, Italy. N=80 at year 1 and n=25 at year 2 (ongoing studies, completers only included).

Now, is 171 a really large clinical trial? No.

But, is the study high quality in it methodology and analysis? Also no.

They are using the most common tricks that weight loss companies use to mislead us about outcomes. The first is to only study patients for a short time (from a few months to a couple of years) but define that as “long term” when, in fact,  most people are able to temporarily change their weight during a year, and then they gain the weight back between years 2 and 5, often regaining more than they lost.

The second trick is to only include those who completed the trial so there is no follow up with those who dropped out (and possibly didn’t lose weight, or began to regain, or had side affects so horrible that they didn’t think any outcome was worth it.)  They cite a two year study that included 80 people in the first year, but was down to 25 people at year two, which means they want us to be convinced by the average of what happened with 31.25% of the participants and ignore what happened to 68.75%.  As to their claim of people who have lost 100% of their “excess weight” and maintained it for four years, I can find absolutely no research anywhere on their site or anywhere else to back up that claim. I’m left to wonder if they are holding up a couple anomalies as the norm, or just completely making stuff up?

The AspireAssist allows patients to remove about 30% of the food from the stomach before the calories are absorbed into the body, causing weight loss. You’ll also need to chew carefully and eat mindfully, which helps give time for the fullness signals from your stomach to reach your brain.

Because aspiration only removes a third of the food, the body still receives the calories it needs to function.

First let’s realize that they are just assuming that fat people don’t need the nutrition from 30% of what we eat, regardless of what we eat, how much, our physical activity level etc. Well, either that or they just think it’s fine for us to be malnourished as long as we’re becoming thinner.  Second, when they say you need to “chew carefully” it’s because the tube is only 6mm  and larger chunks of food can get stuck in the tube which, if the patient can’t clear it with water, requires another trip to the doctor.

In addition to the machine, people also get “lifestyle counseling”

This therapy is used in conjunction with lifestyle counseling. This program combines one-on-one counseling and group support meetings to encourage healthier food choices, smaller portion sizes, and increased physical activity.

There is not a single study that suggests that this type of counseling leads to long term weight loss or better health.

Next they claim:

Consider your schedule at work, at home, on weekends, and with your family or friends. Although missing an aspiration occasionally is OK, the most successful patients aspirate three times per day, almost every day.

You have to wait 20-30 minutes after each meal, and it then takes 5-10 minutes to drain the food into the toilet or other receptacle (and that’s after people gain competency, it takes longer in the beginning,) which they recommend patients do three times a day.  At 5-10 minutes per time, that’s 7.5 to 15 HOURS A MONTH that a patient will spend in the bathroom. I don’t know about you, but I haven’t been sitting around thinking “Man, I have 7.5-15 hours a month that I would love to spend in the restroom.” Plus there’s the time and expense of having to go back to the doctor every 5-6 weeks because of a part that requires replacement.

Let’s talk about side effects. Here’s what the FDA press release said:

Side effects related to use of the AspireAssist include occasional indigestion, nausea, vomiting, constipation and diarrhea.

The endoscopic surgical placement of the gastric tube is associated with 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.

Risks related to the abdominal opening for the port valve include abdominal discomfort or pain, irritation, hardening or inflammation of the skin around the site where the tube is placed, leakage, bleeding and/or infection around the site where the tube is placed and device migration into the stomach wall. All have the potential to necessitate removal of the device. After device removal, there may be a risk of persistent fistula, an abnormal passageway between the stomach and the abdominal wall.

A study in 2018 called “Aspiration Therapy As a Tool to Treat Ob*sity: 1- to 4-Year Results in a 201-Patient Multi-Center Post-Market European Registry Study” by Nystrom et al (two of the eight authors had received money from the device manufacturer) claimed that “aspiration therapy is a safe, effective, and durable weight loss therapy”

Let’s take a look. Their results state that:

Mean percent total weight loss at 1, 2, 3, and 4 years, respectively, was 18.2% ± 9.4% (n/N = 155/173), 19.8% ± 11.3% (n/N = 82/114), 21.3% ± 9.6% (n/N = 24/43), and 19.2% ± 13.1% (n/N = 12/30),where n is the number of measured participants and N is the number of participants in the absence of withdrawals or lost to follow-up

Let’s clarify this a bit. They started with 201 participants but 2 are listed as “gastronomy aborted,” so 199 had the AspireAssist tube placed.

155 completed one year.

82 completed two years.

24 completed three years.

12 completed four years.

I’ve got to be honest here, an attrition rate of 94% isn’t really giving “effective and durable” as far as I’m concerned.

Here’s the good news (at least as far as I’m concerned,) the AspireAssist is off the market.

Their website explains

Aspire Bariatrics, Inc. regrets to inform you that we are winding down all operations at the Company. As a result, we are withdrawing the AspireAssist from the market, effective April 8, 2022. Due to the financial impact of the COVID-19 pandemic, we can no longer afford to continue operations at the Company.

Bye.

In a letter to patients they explain that patients may choose to continue until supplies run out or expire, and the last date of expiration was December 17, 2023 so I’m not sure why Annilyn’s doctor is still recommending it but the bottom line is, though it was real, it’s no longer on the market.

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More research and resources:
https://haeshealthsheets.com/resources/

*Note on language: I use “fat” as a neutral descriptor as used by the fat activist community, I use “ob*se” and “overw*ight” to acknowledge that these are terms that were created to medicalize and pathologize fat bodies, with roots in racism and specifically anti-Blackness. Please read Sabrina Strings’ Fearing the Black Body – the Racial Origins of Fat Phobia and Da’Shaun Harrison’s Belly of the Beast: The Politics of Anti-Fatness as Anti-Blackness for more on this.