Diet & Weight Magazine

New Horrifying Medical Device for Weight Loss – The Full Sense Device

By Danceswithfat @danceswithfat

Gastro DeviceThe always brilliant Marilynn Wann posted on Facebook about a piece on Buzzfeed today that discusses a surgical implant created for the purpose of manipulating body size (I would recommend avoiding the comments unless you want to read internet armchair psychiatrists waxing poetic about why people are fat.)  I was going to just blog about it but it is so representative of so many things that I think are wrong with the medical view of weight and health that I decided to break it down including the original article. I want to be clear that I have no desire to stigmatize people who have chosen weight loss surgery (underpants rule!), but I have a strong desire to examine whether or not the type of surgery should actually be offered under the guidelines of ethical, evidence-based medicine and informed consent.  The original article is indented, it may be triggering, you can skip it and still understand the point of my post.

Bonnie Lauria was miserable. She was subsisting on liquids and a handful of foods her stomach could handle. Ever since she’d undergone gastric bypass surgery in the ’80s, foods like meat and bread that went down her throat in a lump would come right back up. “I knew where every bathroom was in every restaurant in the state,” Lauria says from her home in West Branch, Michigan. “It was horrendous.”

So if you partially amputate someone’s stomach and reroute their digestive system bad things can happen? I am Ragen’s complete lack of surprise.

During gastric bypass surgery, the stomach is reduced to about the size of a walnut and attached to the middle of the small intestine. Lauria’s complications from the surgery weren’t normal, so she went under the knife a second time. Still, her condition didn’t change. She switched doctors several times, but no one could help. Eventually, someone recommended bariatric surgeon Dr. Randy Baker in Grand Rapids in 2004.

When he says that the complications “weren’t normal” he means that they wouldn’t happen in doctor dreamland.  In reality this, and other “complications”  including death, are well known side effects of the surgery.

Baker ran some tests and saw that the spot where Lauria’s walnut-size pouch met her small bowel was tightening. Previous doctors had tried to widen the passage so that food could pass through, but the stricture had returned. Complicating Lauria’s condition were those multiple surgeries, which left so much scar tissue that operating again would be too difficult and too dangerous.

Well done y’all, that’s some good doctoring.

Baker was at a loss. Then he started thinking about esophageal stents. Just like a coronary stent keeps an artery open, an esophageal stent holds the esophagus open and is often used in patients who have difficulty swallowing. What if one of those could prop open the small bowel too?

Nothing drives innovation like mutilating fat people to make them thin and leaving them with horrible side effects!

As far as Baker knew, no one had ever attempted a procedure like that before. But Lauria was out of options, so Baker told her his strategy. She agreed; he inserted the stent and hoped for the best.

Let’s be clear that Lauria was “out of options” because doctors cut the options out of her.

“She came back to my office two weeks later and said, ‘Dr. Baker, I’m feeling great. I can eat sloppy Joes!’” Baker says. “Here’s a lady who could only do liquids, and now she can eat solids. And she’s losing weight.”

I’m horrified to think what they would have done to her if she could eat solids but wasn’t losing weight.

Lauria didn’t have an explanation; she told Baker she simply wasn’t hungry anymore. Baker wondered if he and other bariatric surgeons had been going at it all wrong. The stent, he theorized, was putting pressure at the top of Lauria’s pouch and sending signals to her brain saying, “I’m full.” It was doing what food does, but without actual food.

Food…Pfft, who needs it!

Which raised some questions: What if we don’t need invasive surgeries that cut away portions of the stomach and rearrange the digestive tract and intestines? What if all we need is a device that puts pressure near the top of the stomach?

Oooh ooh, pick me, I know the answer – We don’t need either of these.

Baker set out to test his hypothesis, teaming up with a former product specialist from W.L. Gore (creators of Gore-Tex) and two surgeons at his Grand Rapids practice to create the Full Sense Device — a nitinol wire-mesh funnel coated in silicone that can be inserted through the mouth and placed in less than 10 minutes. Current plans would allow the device to remain for up to six months before removal, though in the future that time may be longer. In the company’s trials, every patient implanted with the device lost weight and continued to lose weight until the device was removed. Baker calls the phenomenon “implied satiety.” At six months, average patients lost 75% of their excess body weight — significantly more and at a faster rate than any bariatric procedure, and all, Baker says, with no “severe adverse side effects.”

Let’s look at some keywords in this paragraph:

Severe Adverse Side Effects:  Here is a list of what constitutes a severe adverse side effect. There are plenty of life-alteringly horrible side effects that would not make this list.

Until the device was removed:  So when you take away medically induced disordered eating, what happens?  There doesn’t seem to be any follow up analysis despite the fact that what we’ve learned from studies on surgical interventions like the lap band (which works through the same model of created a medically induced starvation situation) is that patients regain the weight.

The Institute for Health Metrics and Evaluation estimates that 160 million Americans — nearly half — are overweight as indicated by their body mass index, which is calculated from a person’s height and weight. (A BMI between 25 and 29.9 is considered overweight; 30-plus is obese.) Of those people, 24 million are estimated to be morbidly obese, meaning they have a BMI over 40 and are at higher risk for serious, life-threatening illnesses, including heart disease, diabetes, degenerative arthritis, and cancer.

Estimated numbers and “higher risk” do not justify dangerous medical interventions.

Bariatric surgeries can and often do lead to impressive weight loss, yet only 1% of obese Americans opts for the invasive and costly procedure — usually $20,000 to $30,000. (Rex Ryan, Roseanne Barr, Carnie Wilson, Al Roker, Chris Christie, Randy Jackson, and Star Jones are reported to be among the 1%.)

The use of the word “yet” in the first paragraph tells you everything you need to know about how screwed up the world of bariatric surgery is.  This reporter has just told the story of a woman who had to have a completely experimental procedure because her weight loss surgery (and the two follow up surgeries it required) left her vomiting constantly and unable to eat solids, and she’s lucky since plenty of people die from the surgery, yet only 1% of people opt for the surgery.  My questions is, how can we get that number down?  Of course celebrities are choosing the surgery – they are under a magnifying glass with white hot fatphobia shining through it making their lives miserable and limiting their upward mobility in their careers, they can survive the surgery and based on what I’m hearing from people who’ve been pitched this surgery – and from the doctors who have pitched me – they are not that forthcoming with the details about the side effects.

“There are a bunch of things that contribute to that,” says Randy Seeley, an obesity researcher and professor of surgery at the University of Michigan. “One is the ick factor — ‘someone is going to chop up my GI tract.’ Some of it is cost — it’s still not universally covered. Third is stigma. The implication is that it’s the easy way out — you’re cheating somehow by taking that option — which goes to our societal biases about obesity.”

A doctor tells you that she actually thinks you are best served by the partial amputation of your perfectly healthy stomach in a way that will leave you in a perpetual state of malabsorption and starvation, with eating habits that, were you a thin person, would properly be diagnosed as disordered.  But you’ll probably, at least for a while, be thin. Also you may vomit all the time, or die. “Oh, ick” said nobody ever. Plenty of people have said  “Are you fucking kidding me with this?” but “ick” doesn’t begin to cut it. Also, I think it’s worth examining how the societal biases about obesity lead to a situation where doctors are chopping up people’s GI tracts.

Dr. Baker has come up with a nonsurgical device that he says will enable obese patients to lose substantial weight, and at a fraction of the cost of surgery — in the neighborhood of $5,000 at an outpatient center. A company claiming to have found a simple solution to drastic, easy weight loss is, of course, nothing new; in fact, it’s big business. (See: late-night infomercials.) Some surgeons and researchers are skeptical of Baker’s pressure theory, and at least one patient experienced chronic acid reflux after the device was inserted.

Pop Quiz, what is wrong with this statement:  “At least one patient” Answer:  How flimsy is the follow up that they don’t even know how many patients suffered side effects?

But more than 10 years after the eureka moment, Baker is hopeful that doctors in Europe could begin using the Full Sense Device this year and in Canada and Mexico soon after. Americans will have to wait longer; Food and Drug Administration approval is unpredictable and likely still years away.

We have a 6 month trial which wasn’t even able to accurately assess how many people suffered side effects while the device was implanted and absolutely no follow up after the device was removed, let’s get this baby on the shelves! This just smacks of good science and medical ethics doesn’t it? Though it’s nice to see the fact that the FDA is in the pocket of pharmaceutical companies has an upside.

Baker’s concern, though, is that the Full Sense Device might work too well. If it’s effective, easy, and cheap, what’s to stop people from abusing it? “When this hits the market, there’s not going to be just 10,000 to 15,000 people having it,” says Fred Walburn, president and sole employee of Full Sense Device’s parent company, BFKW. “There’s going to be hundreds of thousands. Millions per year.”

That’s a damn good question, though the idea that millions of people would be using it is completely horrifying since simply the implantation of a device meant to induce starvation could, and I think should, be considered abuse in and of itself.

I’m going to stop here because the rest of the article just belabors the points that I’ve already made.  The connection between body size and health issues has been massively overblown (a lot of it by companies that make tons of money doing so – bariatric surgery costs about $19,000 and takes about an hour.)  The prevailing belief becomes that life as a fat person is so absolutely horrible that it’s worth risking our lives, and our quality of lives, on the chance that we could become thin even if it means a life of constant starvation, vomiting and other gastrointestinal issues, even though after having our stomachs amputated there is a good chance that we’ll end up fat again, still suffering from malabsorption and other side effects.

Surgery is considered a “last resort” but let’s look at the options that aren’t typically considered before it is suggested that a fat person undergo dangerous surgery:

Focusing on goals (including health goals) rather than weight loss:

Goals could focus on aspects of health like getting good sleep, decreasing stress.  They  could include improving strength, stamina, and flexibility – all of which can be done independent of a weight loss attempt.  Focus on the things that research has shown can support health in people of all sizes.

Fixing Social Stigma

So-called “benefits” of the surgery like improved self-esteem, “I like what I see in the mirror” etc. are not actually benefits of weight loss.  They are benefits of moving (at least temporarily) out of an oppressed class.  Fat people should not have to have dangerous surgery to improve our self-esteem.  While each individual is allowed to make choices for themselves, from a social perspective the cure for stigma is not for the stigmatized people to change themselves, it’s for people to stop stigmatizing them.

There are healthy and unhealthy people of all shapes and sizes and making one person look like another person will not guarantee the same health outcomes. Just like making bald men grow hair won’t prevent heart attacks, and removing ice cream from the shelves won’t bring down the murder rate in August. The Association for Size Diversity and Health has created a video to better explain this concept (Not to mention that health is not a barometer of worthiness, obligation, or entirely within our control at any size.)

I imagine they’ll keep developing these ridiculous and dangerous gadgets and surgeries (and diets etc.) as long as they are profitable.  We can fight to keep these things from getting approval, or having their current approval rescinded.  That’s a long fight and it’s worth fighting and in the meantime we can opt out.  If people stopped paying for this, it wouldn’t matter if the FDA approved it. We can demand that our doctors do their jobs, and their ethical duty, by providing us, evidence-based medicine, and interventions that will not kill us, and an opportunity to give proper informed consent.  And when they say “have you considered surgery” we can say “Yes, and it’s out of the question.”

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