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

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 creating 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 and treated as a problem.  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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Published in: on March 2, 2015 at 11:36 am  Comments (53)  

53 CommentsLeave a comment

  1. My appetite would be nil knowing I had “a nitinol wire-mesh funnel coated in silicone” inside of me.

    That thing looks like it would be uncomfortable placed inside someone and might even do harm to one’s insides.

    **shudder**

    • The word “mesh” in the description makes me think of all the ads I’ve been seeing about some mesh sling that’s (maybe?) been recalled and (probably?) resulting in a lot of horrible problems for people who are now being encouraged to sue the manufacturer. I have no idea if the two are even remotely related, but whenever I see the ad I think that it makes sense some kind of mesh being surgically placed into your body might result in your body, you know, freaking out.

      • That’s what I was thinking, too. Class action lawsuit in 5…4…3….2…

      • The other mesh thing has to do with the bladder or vagina or something. Medical things that people might want fixed. Not being fat.

        • True! But if putting something foreign made of “mesh” inside your body in your bladder area makes your body freak out and do bad things, it doesn’t seem unreasonable that it might also do the same if it’s put in your digestive tract area.

          • This doc says he is basing it off the kind of stents used to hold arteries open. My mother has them and they work. It isn’t the idea per se, it has to do with the particular device and the individual involved. Whatever they did with the bladder mesh thing turned out to be a bad idea. Supporting a sagging bladder is not, by itself, a bad idea. Some hip joints have been recalled, but not all hip joint replacements are bad.

            I know that some people have a condition where they always feel hungry, if somehow, this stomach stent helped that, I would be okay with giving them relief from hunger pains that aren’t related to actual hunger, but due to a messed up feedback system between the stomach and the brain.

            This whole making people thin is focused solely on eating, with no regard to nutrition or the actual needs of an individuals body. That in and of itself makes me reject this stent, and any other of these ‘weight loss’ systems.

  2. You forgot the part where Buzzfeed opened the article saying millions of obese people are refusing a life-saving procedure. I unfollowed Buzzfeed at that point.

    “42” -The answer to life, the universe, and everything

    >

    • They are, indeed, WAY past their sell-by date.

    • Since when is “weight loss” surgery a “life-saving procedure”?!!!! I think I will continue to refuse it (and probably save my life by doing so).

    • And the question is not “how many roads must a man walk down?” but “what percentage of body fat should you lose to become a worthwhile person?” The mice will see you now.

  3. My question is always this: How can we get the medical establishment to change? That is, the official wisdom at this time is that ANY amount of weight that puts your BMI over 25 makes you unhealthy. Until this changes, this kind of thing will continue to be pushed.

    I’ve thought of at least writing some letters, but I have no scientific or medical background at all, so I’m sure it wouldn’t mean much coming from me. Is anyone out there qualified? Could we start a petition?

    • Hi Harriet, I have some ideas. I have been collecting comments from our communities of higher-weight people to form a set of “Best Practices” for healthcare providers and I would love for people from this community to offer their thoughts. Here is the link:
      https://www.surveymonkey.com/s/bmibs
      THANKS TO ALL!

      • Ok – done! I hope this leads to some action.

      • Done! Some of my answers:

        1. What would you include in a set of best practice guidelines for higher-weight people?

        Evidence based care. Equipment designed to accommodate people of size. Doctors consciously focused on treating the ailment and not the body size.

        2. Can you think of anything else that should be part of a set of best practice guidelines?

        Training and testing to assess the level of prejudice or weight bigotry present in physicians and medical personnel – and if need be a course that address and corrects ideals and beliefs centered on weight stigma, bias, and prejudice. No person should be “under the care” of someone who has very negative views and attitudes toward said person based solely on their body size.

        3. How should health care change so that higher-weight people with intersecting identities (experiences related to age, disability, medical or psychological conditions, indigenous heritage, national origin, race, religion, sexual orientation, gender expression, social class, immigration status, and other social identities) are well-served?

        Mandatory courses for doctors and medical personnel on cultural bias and stigma (because, lets face it, no one who is at least half paying attention in today’s society is going to escape the messages we are bombarded with on a daily basis that reinforce and promote prejudices and bigotry).

      • I took the survey.

  4. Thank you for putting words to the incomprehensible angry yelling that spewed from my mouth when I saw this article last week. I was so disgusted and angry I couldn’t comment on the article, I just re-tweeted and sputtered at my phone in frustration.

  5. Wow. A six-month study that didn’t keep track of basic information such as side effects with zero follow up. Now THAT’S a damn fine piece of evidence for the FDA to consider!

    Every time I think they’ve hit rock-bottom in coming up with ways to oppress us, they find another layer of rock to mine.

  6. Not really seeing how mutilation = health.

    Maybe it’s like WAR IS PEACE, FREEDOM IS SLAVERY, and IGNORANCE IS STRENGTH?

    • Yes, there’s a lot of Newspeak in the world of weight loss enforcement.

      • Sometimes I feel like we’ve sailed past Orwell and straight into Kafka.

        • Well put. Very well put.

        • “Sometimes I feel like we’ve sailed past Orwell and straight into Kafka.” That’s the wittiest, funniest, most brilliant comment I have read for ages. May I spread it?

          • Thank you, and certainly.

  7. Ragen, thank you for mentioning the Poodle Science video that ASDAH supported! I want folks here to use it far and wide to help people understand how the science of weight and health needs to be interpreted cautiously. Thank you for all you do to help us become skilled in understanding what is science and what is bias! And folks, please share the link where it is useful:

    • Wow, thanks for sharing this video. It’s really a shame that it’s got so many thumbs down already …

      • Yes, if you can leave a thumbs up that would be much appreciated! I have been watching it over the last week it’s been up and those thumbs down all came at once which makes me think there was a particular community that must have seen it and rallied in defense of fat hate. : ( But you know, the phrase, if you’re not getting sh*t you’re not doing sh*t, helps me in that situation . . . that, and Ragen’s brilliant skills at monetizing fat hate . . .

      • This is a great video; it reminds me of Kate Harding’s essay “The Dog Theory of Fatness” at the late great Shapely Prose. As for the downvotes, maybe they’re from people who just don’t want to give up the Fantasy of Being Thin.

  8. This is anecdotal, but the one person I know who has successfully kept off a large weight loss from lapband surgery did it by developing an eating disorder. To the point where she needed treatment for the SD because it was getting dangerous.

    Oh, and she still hates the way her body looks, she puts herself down all the time.

  9. Thanks so much for writing this. I tried reading the article but just couldn’t get through it. I definitely gained more from reading your take on it. Ironically, I think you stopped analyzing it about the same place I stopped reading it – good to know I didn’t miss anything!

  10. “It was doing what food does, but without actual food.”

    This just seems like the crux of the whole problem, in a way. Signalling satiety is almost a side effect of what food actually does, to let you know that you don’t currently need any more food. What food does is PROVIDE NUTRIENTS SO YOU DON’T STARVE.

    • Yes, it makes me wonder if people who are losing weight at a fast rate (because they feel full when they are not) are having problems because they are starving themselves! Do they feel dizzy? Get headaches? Faint? Run out of energy just walking around the house? Get rickets, for god’s sake? This idea sounds totally, completely awful. Although, as a temporary measure, it’s sounds a hell of a lot better than “weight loss” surgery!

  11. I’m confused by their worry over people “abusing” the device. If it is inserted into the body and worn continuously, and has to be replaced in order to maintain the loss, what exactly could you do with it that would constitute abuse? Someone not showing up for their removal appointment maybe? Doctors prescribing it for people who are already below a BMI of 30?

    Something definitely doesn’t smell right with how they are talking about this. In one paragraph they say that half of Americans are overweight with tens of millions morbidly obese and in another they are shocked, SHOCKED! that the market for this device would be millions of people instead of thousands. If you’re that worried about the dangers of being fat you should be happy that there are millions of potential users.

    It seems like they’re not as confident about the device as they want you to think they are. There is so much not quite right in that article.

    • My guess is that people would “abuse” it by refusing to have it removed once they reach “normal” BMI, and once they reach “Underweight,” BMI, and once they reach “dangerously underweight” BMI, and once they turn into brittle little pieces of bone with a bit of skin attached, and once they turn to dust in their coffins, because the patients KNOW that as soon as that thing is removed, they’ll get fat again, and it’s better to starve to death than to be fat, right?

      After all, they can hardly tout this as a means of PERMANENT weight loss, now can they? So, people will keep it in, and refuse to have it removed, and it will become a brand-new kind of eating disorder.

  12. This is just like something from a David Cronenberg horror film.

  13. @peebs1701, I imagine that the “abuse” they are speaking of – as if the device didn’t constitute abuse in and of itself – is having it be used by people who are “normal weight.” Or (thin) people suffering from anorexia who can’t achieve their desired weight loss.

    • Wouldn’t this ‘abuse’ have to be abetted by a doctor who would agree to insert this device in a person who was not fat? I suppose that, technically, anything is possible in this ‘never too thin’ culture of ours.

      • Sadly, there are fat-phobic doctors who might do just that.

  14. One of the things (besides everything outlined here!) that bothers me about articles about WLS and procedures/devices – and weight-loss drugs, too – is that they assume/insinuate that all fat people have appetite control issues, and that’s why we’re fat. I’m so done with the assumption that we all just need to have someone pry the forks from our clenched fists.

    • Yes!

    • I wish that WordPress allowed for liking comments, because I totally agree with this.

    • I sure do have an appetite control problem! 🙂 It goes like this: First I get peckish, then I get hungry and can’t concentrate on anything, then (if I let it get that far) I get a pounding headache and the shakes, and then my stomach hurts and sends acid up at my epiglottis until I eat.

      Hunger is a sign that eating should happen. My inability to magically ignore the fact that I am hungry, damn it, is portrayed by society as a weakness. The only way to find out whether pretending not to be hungry would make me thinnety thin thin thin involves becoming a distracted, shaky, incapable mess, so not gonna, nope, I have this thing to do called being an adult with responsibilities and stuff.

      My personal health quest has involved finding out which foods actually quell my hunger, instead of providing a full stomach but not satiety, or an energy rush without sustained energy. Chance that I will ever pay $$$$dough to have something put into my stomach that mimics the effect of trying to fill up on apples: zilch.

      • POSSIBLE TRIGGER WARNING: Discusses disordered eating/ trying to maintain “normal” weight after dieting.

        Back in the very bad old days when I had twice starved (er, WW dieted) myself down to a “normal” weight according to the old charts–this was before BMI became de rigeur–the only way I managed to maintain my thin weight was by constant hunger, and I do mean constant. Hunger pangs woke me up in the small hours of the morning and sometimes I’d cry because I wanted something to eat so badly. And btw, what the chart called “normal” — 135 lbs. for 5’6″–for me was emaciated. I couldn’t sit on a hard surface because I had no rear end left and it hurt my bones to sit. I had to push my watch up nearly to my elbow because my wrist was too small for the band. But hey, the charts said I was “normal” and my WW group leaders said I was a great success.

        Along with the physical side effects (weak fingernails, headaches, hair loss, fatigue, etc.) there was also the fact that I went into a major depression. I realize this is only anecdotal and just one person, but it happened to me twice — the two times I maintained massive weight loss for about 3 years, I became severely, clinically depressed. Other times in my life when I’ve had terrible events that could well have led to depression, I *haven’t* been depressed; it really seemed to be a physiological side effect of starvation. The depression lifted when I began to gain my weight back. For me, at least, it seems that there is a great deal of truth in the old phrase “fat and happy.”

        • My sister, who AFAIK is still doing WW after decades, once dieted down to the acceptable weight shown on the old charts–a size 10 in those days. People who hadn’t seen her for months took one look at her “awesome” new self and said, “Oh, no, are you sick?!”

          Because she looked as if she’d had mono.

    • Amen. They cannot, despite all the research finding many genetic components of body size & also finding that, on average, fat people do not eat any more or exercise less than thin people, get beyond their belief that ‘fat=glutton’ & they just have to convince us poor, deluded, food-obsessed sloths to stop stuffing our faces & EVERYONE will be thin…you know, the way we are SUPPOSED to be. I refuse to be experimented on by a bunch of people who show less intelligent & power of deductive reason that average kindergarten child. Always remember that the profession of medicine is called a ‘practice’, presumably because they have so much trouble getting it right.

      • Yes, and they supposedly measure what we eat and still come out with bigotry.

    • 7 Deadly Sins in action.

  15. I can’t understand how propping open the normal esophagus doesn’t just immediately cause intractable and dangerous reflux. Maybe it does. Sheesh.

    • I mean in 100% of the patients.

      • Reflux is probably listed in the known and acceptable side effects. Constant pain is just the price you have to pay for being thin, right?

  16. I would like to translate this post to Portuguese and publish, with the credit, of course. It says so much. Thanks.

    • Of course. If you have a chance to let me know the link when it’s up that would be awesome!

  17. So the BuzzFeed article said with regard to an animal trial of this product, “They’re starving themselves to death, and they’re happy about it.”

    Um, why is this a selling point rather than a DANGER DANGER point?

    Maude help us.

    I would await the forthcoming evidence of these folks not regaining all the weight they lost and then some after this product is removed, but I have things to do between now and the end of eternity. Still, we may be able to use this device to exponentially increase the speed (and severity?) of weight cycling, so wins all around. Oh dear.

    • WHO is happy about it? The animals that are starving to death? WHAAAAAA?

      ‘Scuse me. My jaw dropped off and rolled across the room. I have to go find it.


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