In September of 2017 I wrote a blog post called “RX to Swallow Balloons is Killing Fat People.” (It was a follow up to a blog post I had written a few months prior called “They Want Fat People to Swallow Balloons Now.”)
In that post I explained:
The FDA reports that five people died within a month of having the procedure, and three of the victims died within just three days. According to a safety alert from the FDA, they also received reports of two additional deaths — one from gastric perforation, the other from esophageal perforation.
At that time I pointed out that the FDA statement said:
“The FDA continues to work with Apollo Endo-Surgery and ReShape Medical Inc. to better understand the issue of unanticipated death, and to monitor the potential complications of acute pancreatitis and spontaneous over-inflation. Additionally, as part of the ongoing, FDA-mandated post-approval studies for these devices, we will obtain more information to help assess the continued safety and effectiveness of these approved medical devices.”
Note that they aren’t going to ban the practice (thus ending the unanticipated deaths), but rather they hope to better understand the unanticipated deaths. I would point out that, based on the manufacturer’s own warning labels, they knew the risk of these deaths before they happened. Even if we are OK with them feigning ignorance on that, at this point future deaths should be considered “anticipated”
And what were they risking death for?
The average participant lost 21.8 pounds in the six months they spent having adverse events (that, luckily, didn’t kill them) from a silicon balloon floating around their stomachs. The control group lost 7 pounds.
Six months later, our balloon swallowers had regained 5.6 pounds (25.69%) of the weight that they lost in the first 6 months which puts them right on track to have gained back all of their weigh (with some regaining more than they lost) within 5 years. The control group had regained .7 pounds (10%,) also on track for the weight regain that the long-term studies of weight loss tell us to expect. Of course, like almost all weight loss studies, at this point they simply stopped following the subjects.
Now the “Post Approval Studies (PAS) are completed and the FDA has released another statement.
Here’s my favorite line (sarcasm meter is an 11 out of 10)
There were no deaths reported in the Orbera and ReShape post-approval studies; however, it should be noted that neither of the studies were powered to detect rare events such as death.
My question here, I think, is WHY THE FUCKING HELL NOT?!!!!! I’m thinking that so-called healthcare treatments that are known to kill people should have to design post-approval studies that ARE powered to detect deaths – but since I’m not a former pharmaceutical company executive it’s unlikely I’ll get a position on the FDA powerful enough to call for that.
Even so, the FDA has received reports of 18 deaths worldwide. That’s 18 too many since nobody needed to swallow a balloon, and I shudder to think how many simply weren’t reported (especially considering the medical establishment is prone to blaming fat people’s deaths on our bodies whenever we die at their hands.)
Still, unsurprisingly, these balloons continue to kill fat people but apparently it’s ok because the FDA recommends that healthcare practitioners:
Instruct patients about the symptoms of potentially life-threatening complications such as balloon deflation, gastrointestinal obstruction, ulceration, and gastric and esophageal perforation and advise them when to seek medical attention.
There are two things coming together here – the complete devaluation of the lives of fat people, combined with the vast overinflation of the “dangers” of being fat.
We’ll start with the latter. We know that the research on weight and health is embarrassingly shoddy at best and created to support diet industry profits at worst. We know that claims of the “dangers” of being fat are often ridiculously overblown. We also know that anentire medical “specialty” has been built around the idea that it’s worth risking fat people’s lives to make us thin.
Which brings us to the devaluation of the lives of fat people. What we see displayed in all its horror here is the idea that being fat is so bad, that it’s better to be dead. Even if someone believes that being fat will lead to health conditions, they are still suggesting that it’s better to be dead now than to have health issues (that people of all sizes get) later. That’s how they justify calling it “healthcare” to try to convince us to risk our lives by swallowing balloons, taking dangerous drugs, or having surgery to mutilate our perfectly healthy digestive systems.
Those arguing for this “better dead than fat” medical paradigm typically ignore the fact that our lives (and very possibly our health outcomes) would improve vastly by ending fatphobia and weight stigma (in particular in healthcare where healthcare practitioners’ inability to see anything but our size can be deadly to fat people) and moving to a paradigm that actually supports our health, rather than our current system which wants us thin or dead and doesn’t seem to care much which.
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