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BaroNova?

Well this is something interesting?

  • FDA has granted premarket approval to BaroNova for a device to treat obesity that is inserted into the stomach, where it delays gastric emptying. It is removed after 12 months.
  • The device, called the TransPyloric Shuttle system, is placed and removed through the mouth in an endoscopic procedure.
  • Approval was based on the company’s 270-patient pivotal study in which people treated with the device lost three timesmore weight on average than patients who had a sham procedure in the control group.

Dive Insight:

Despite obesity prevalence at 39.8% in 2015-16, affecting about 93.3 million U.S. adults, according to the Centers for Disease Control and Prevention, therapeutic options have not made a dent. Conditions linked to obesity include heart disease, stroke, Type 2 diabetes and some forms of cancer.

Stubbornly high rates globally show the need for an effective treatment, despite substantial public health efforts to address the problem. Optimism at the start of the decade about progress has been tempered, according to a 2018 editorial in the Journal of the American Medical Association. The AMA recognized obesity as a disease in 2013. 

When lifestyle modifications are not enough, physicians may prescribe weight-loss medications or suggest weight-loss surgery. BaroNova’s system offers a non-surgical option.

The BaroNova device is indicated to treat obesity in patients with a body mass index of 30-40 kg/m2. The company’s clinical study met its primary endpoints for percent total body weight loss 12 months after the procedure and the proportion of subjects in the treatment groupachieving 5% total body weight loss. Approximately 67% of people treated with the device lost 5% or more of their body weight, exceeding the pre-specified performance target of 50%. Forty percent (40%) of those treated with the device lost 10% or more of their weight.

The Mayo Clinic lists several surgical options to treat obesity. They include gastric bypass, in which the surgeon creates a pouch at the top of the stomach that is connected to the small intestine, allowing food and liquid to bypass most of the stomach. Other surgical approaches include gastric banding, where bands are placed at the top of the stomach to leave a small portion available for food. Biliopancreatic diversion and gastric sleeve procedures both involve removing part of the stomach.

Last week, FDA granted De Novo clearance to an edible hydrogel capsule that releases absorbent particles that swell in the stomach to create gel pieces with the firmness of plant-based foods, meant to create a feeling of fullness. The mechanical modes of action involve mean it’s regulated as a medical device.

In 2015, FDA approved an implantable, vagus nerve blocking neuromodulation device from EnteroMedics, now known as ReShape Lifesciences. A pulse generator implanted under the skin in the abdomen sends electrical signals via wire leads and electrodes to the vagus nerve. 

Also in 2015, FDA approved two intragastric balloon devices sold by manufacturers ReShape and Apollo Endosurgery. In 2016, FDA approved a third balloon system, made by Obalon, that delivers three balloons in a swallowable capsule that are filled with air. 

In 2017, FDA alerted the public to complications with the liquid-filled devices, including four deaths tied to the Orbera balloon made by Apollo and one death linked to the ReShape balloon.

Other device-based treatments on the market include Aspire Bariatrics’ AspireAssist that uses a surgically placed tube to drain some stomach contents and PureTech’s edible hydrogel capsule, called Plenity, intended to create a feeling of fullness.

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14 Years.

I didn't make a 12 or 13 year update?  Really?  It might be the distracted distraction: 
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It occured to me that I don't have photos to share, partly because I have been sitting at the same. exact. weight. (within five or so pounds) for two-and-a-half years (*see distraction) and there's really nothing to update in that aspect.  
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I started "this journey" more than 15 years ago.
 
My highest weight was 320 pounds.  I have reached a low weight of 145 lbs, once.  I gained over 210 lbs. while pregnant in 2006 and 2015. 
 
I have spent the majority of the last 14 years at or about 170 lbs.  
 
All of this is in the history here on the blog.
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Self – last week
 
I would say that 170 is my eat-what-you-want and "don't do jack shit for cardio aside from chasing a hyperactive toddler/house cleaning and seizure" weight.
 
What do I eat?
 
Old-lady food.  I still loathe cooking.  I would not cook a thing, ever, if there weren't kids here.  I don't cook much anyway, since I was told "not to ever use a knife unattended" or "a stove," so, I just … do, but I don't.  If money were no object, I'd be all over home delivery.
 
Coffee with almond milk, tea, whole grain toast, probiotic cottage cheese, frozen meals, chicken salad.
 
I mix it up with a take out meal about once a week, usually a cold sandwich like roast beef and all the veggies or a BLT.  
 
I regret most meals eaten away from home, so I am careful about food choices if we go out.  I trust no one not to kill me.  I dump on the most random things, or have awful reactions later, so I stick with what Should Work.  
 
I'd say I take in 1500 or so calories most days. Today?  
  • Dave's Killer Bread + Light Butter
  • Two bites protein cookie, the rest donated to the kid
  • Frozen chicken a la king, tossed some of the chicken away
  • And it's nearing 5pm.  Typical.  I'll eat dinner at bedtime.
 
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Bob and I at his police graduation, 2017, his 14 years is next month
 
I have that excess 20- 25 lbs hanging around.  I know how to lose it. I don't do it. At least I have not in the last few years. With my last (POST WLS!) baby who is now eleven, I would get walking for miles, but I don't anticipate that happening anytime soon with my special-fall-on-the-ground-head-crack seizures that developed in the last few years (*see the timing correlation?) Well, at least I did it back then and did not realize I was falling down.
 
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Christmas Day, 2017 – Myself and all the "kids"
 
I have two cardio machines in the house. I'm not using them and my excuse is the youngest child that climbs on them with me. (YOU HAVE TO KNOW HIM.  HE IS THAT CHILD.)  Getting up before he does or climbing out of bed after he sleeps to exercise is … not tempting. I'm just not that into it, yet.  Clearly exercise is not a priority. 
 
I think that remaining upright — is?
*On that topic which some of you don't like to read, but it's a huge part of my life/day — I'm taking lots of medications, which need a little tinkering (again, usually once a year I'm in the hospital for a tune up) since I am obviously having lots of seizure activity.   I currently take ONFI, Topamax, Banzel, and as needed Lorazepam.  They are treating my various types of seizures.  I just tapered off of a huge amount of Keppra. I suspect these will change in the near future, because me.
 
People ask me if I blame my gastric bypass for this "condition" or it's increasing changes/etc.  No.  I was born with the brain malformation that causes seizures, and at this point in my life I believe I had seizure activity longer than anyone knew (maybe since I was very small, in the form of smaller seizures that no one noticed, I understand the symptoms now) — but the gastric bypass caused a trigger by changing my gut.  The science shows that the gut can affect the brain — and I feel that in some way the WLS lowered my seizure threshold by altering my gut, and making my malformation — "turn on" and show it's full power.  I feel that there's a cure in my lifetime, if it's fecal transplants, brain stimulators or who knows what else – because there are many of us out there with post WLS seizures
 
What do you want to know about "long term" post weight loss surgery life?  
 
Any questions, I am a too-open book.  Ask here or Facebook.  Just don't sell me anything unless you plan on sending it to me free.
 
 

Worth a read. New York Times article about a year in the life of bariatric surgery

Worth a read, and worth a watch.  This mimics a bit of my experience, my family's experiences, and brings up some (deeper) questions.  As someone who's had gastric bypass in 2004, I'm always intrigued at any new science that's discovered about the gut – brain connections.

"Nearly 200,000 Americans have bariatric surgery each year. Yet far more — an estimated 24 million — are heavy enough to qualify for the operation, and many of them are struggling with whether to have such a radical treatment, the only one that leads to profound and lasting weight loss for virtually everyone who has it. Most people believe that the operation simply forces people to eat less by making their stomachs smaller, but scientists have discovered that it actually causes profound changes in patients’ physiology, altering the activity of thousands of genes in the human body as well as the complex hormonal signaling from the gut to the brain."

Article – New York Times

©geballe-sitting

A very powerful self-photography project of weight loss surgery.

Finally.  Something I can post.

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"Currently, Samantha's work focuses on conceptual portraiture, allowing her to explore human emotion from the inside out. She is working on an on-going self-portrait series focused on body image and healing that challenges viewers to question what is means to accept oneself. "

©geballe-stomach

 

Her photos are shocking if not absolutely realistic and raw if you have lost hundred(s) of pounds with weight loss surgery

If you have yet to do so, I would not be alarmed.  Question the photos.  Dig into them.  Feel it.  This is is what we know.

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Cropped image. 

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12 years.

It is that time again. Time to “celebrate” my big tool on my surgiversary, and reset my pouch by “going back to basics.”

I know.  Bullshit.  What is different this year?  Nothing has changed. I am exactly the same physical weight I was last year, but this year I have a sack-of-potatoes baby, too!

No, not the first baby, he’s turning seventeen in a week and a half, and six foot two.  The one in the second photo.  He’s five months.  

Oh, since you’re here – you can find my yearly updates in the archives.  Dig, dig, dig:

 
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From and including:

Monday, April 5, 2004 to, but not including Tuesday, April 5, 2016

12 years 4383 days

378,691,200 seconds

6,311,520 minutes

105,192 hours

Posted by Melting Mama on Tuesday, April 5, 2016


FDA approves non-surgical temporary balloon device to treat obesity –

And I sigh.  I feel like this is asking for an eating disorder, but what do I know. 

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The U.S. Food and Drug Administration today approved a new balloon device to treat obesity without the need for invasive surgery. The ReShape Integrated Dual Balloon System (ReShape Dual Balloon) is intended to facilitate weight loss in obese adult patients. The device likely works by occupying space in the stomach, which may trigger feelings of fullness, or by other mechanisms that are not yet understood.

The ReShape Dual Balloon device is delivered into the stomach via the mouth through a minimally invasive endoscopic procedure. The outpatient procedure usually takes less than 30 minutes while a patient is under mild sedation. Once in place, the balloon device is inflated with a sterile solution, which takes up room in the stomach.

The device does not change or alter the stomach’s natural anatomy. Patients are advised to follow a medically supervised diet and exercise plan to augment their weight loss efforts while using the ReShape Dual Balloon and to maintain their weight loss following its removal. It is meant to be temporary and should be removed six months after it is inserted.

“For those with obesity, significant weight loss and maintenance of that weight loss often requires a combination of solutions including efforts to improve diet and exercise habits,” said William Maisel, M.D., M.P.H., acting director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health. “This new balloon device provides doctors and patients with a new non-surgical option that can be quickly implanted, is non-permanent, and can be easily removed.”

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