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FDA approves non-surgical temporary balloon device to treat obesity



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This is a press release from the FDA:

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.”

The ReShape Dual Balloon is indicated for weight reduction in obese adult patients with a body mass index (BMI) of 30 to 40 kg/m2. The device is limited to patients with one or more obesity-related conditions such as high blood pressure, high cholesterol, and diabetes. It is intended for patients who have failed previous attempts at weight loss through diet and exercise alone.

There are currently two other FDA-approved devices to treat morbid obesity: the LAP-Band and the Maestro Rechargeable System.

The ReShape Dual Balloon was studied in a clinical trial with 326 obese participants aged 22 to 60 (with a BMI of 30 kg/m2 to 40 kg/m2) who had at least one obesity-related health condition. In the study, 187 individuals randomly selected to receive the ReShape Dual Balloon lost 14.3 pounds on average (6.8 percent of their total body weight) when the device was removed at six months, while the control group (who underwent an endoscopic procedure but were not given the device) lost an average of 7.2 pounds (3.3 percent of their total body weight).

Six months following the device removal, patients treated with the ReShape Dual Balloon device kept off an average of 9.9 pounds of the 14.3 pounds they lost.

Potential side effects for the procedure include headache, muscle pain, and nausea from the sedation and procedure; in rare cases, severe allergic reaction, heart attack, esophageal tear, infection, and breathing difficulties can occur. Once the device is placed in the stomach, patients may experience vomiting, nausea, abdominal pain, gastric ulcers, and feelings of indigestion.

This device should not be used in patients who have had previous gastrointestinal or bariatric surgery or who have been diagnosed with inflammatory intestinal or bowel disease, large hiatal hernia, symptoms of delayed gastric emptying or active H. Pylori infection; those who are pregnant or use aspirin daily should also avoid the device.The ReShape Dual Balloon is manufactured by ReShape Medical Inc., in San Clemente, Calif.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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I was reading on a hospital website that it can be used to help a patient get down to a weight where WLS can be safely performed.

It looks like relatively minimal weight loss compared with having to go under anesthesia twice in 6 months. I know for many of us we can lose some weight and sometime large amounts of weight but without the WLS it eventually come back. I know I lost 45 pounds on my last big diet. I kept it off for 3 years. I just don't see it being a great long term weight loss solution once it is removed. They only kept 3/4th of the weight they lost off for only 6 months. I wonder where they will be in 1 year.

I wish the article had reported the weight loss as percent of excess rather than percent of body weight. 6.8% of a 5'4" individual that is 250 pounds is way different than 6.8% of a 6' individual that is 250 pounds.

Just my knee jerk reaction to this procedure.

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That's a good option for someone who is not ready to go permanent. I wouldn't want it because I like the convenience of having the sleeve done and not having to deal with it, plus once that puppy came back out I'd probably gain it back :( seems to be the cycle of my life. I'm curious to see how well it works for people!

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They use something like this in Britain. If you watch Fat Doctor on Hulu, the surgeon uses it in patients who need to get to a lower weight to safely have other WL surgeries.

Susan

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My Zumba instructor was telling me about something similar that she had read about. It is like a funnel type thing. Not sure if this is the same as above article.

This article below talks about a device called "full sense device"

http://www.buzzfeed.com/joeloliphint/the-invention-that-could-end-obesity#.rhAGAn1YGM

Edited by Dream4tc

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My Zumba instructor was telling me about something similar that she had read about. It is like a funnel type thing. Not sure if this is the same as above article.

This article below talks about a device called "full sense device"

http://www.buzzfeed.com/joeloliphint/the-invention-that-could-end-obesity#.rhAGAn1YGM

She's most likey referring to the Endobarrier. It hasn't been approved by the FDA as of yet and won't be for another year or two at a minimum.

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Booked mine for next week! Can't wait!

Very exciting!! Dr. Garber is putting it in for you? How much is he charging? Are you going with the Orbera or Duo?

Send him my regards and please keep us updated on your progress.

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Booked mine for next week! Can't wait!

Very exciting!! Dr. Garber is putting it in for you? How much is he charging? Are you going with the Orbera or Duo?

Send him my regards and please keep us updated on your progress.

Thanks for your responses Alex. Yes, Dr. Garber himself is performing the procedure, in his new Roslyn office. I chose the ReShape Duo - it makes more sense to me and takes up more area (750cc) than the Orbera - and the social aspect. The cost is $8500, including the 12 months of nutritionist, FitBit, FitBit scale, Social Portal. I tried to get Cigna to bite off on a bit of it but they wouldn't do it. Tried to explain to them that they'd be saving tens of thousands of dollars as opposed to Gastric. :D

Anyway, I dont care, its an investment in my life, my future.

I will send him your regards next week - and of course, be updating my progress.

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Please keep updating. Id like to see how it all goes for you. Question. Why have you chosen the balloon as opposed to the sleeve or band etc. Just curious. Right now I am in the 6 months weigh in stages before sleeve surgery myself.

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Hi Cindy

Just so I'm not writing two sets of responses, here's the link to my original post.

http://BariatricPal.com/index.php?/topic/349876-ReShape-Balloon-Procedure-Booked%21

I chose the balloon because of a few reasons:

1. I CAN have the sleeve AFTER the balloon if I think it's necessary. I CANT have the sleeve and then a balloon.

2. Non-invasive procedure teaching me good habits.

3. I didn't think I had an option, actually because my starting BMI was 43.4. He agreed to do it because of my fast metabolism and active lifestyle.

The whole concept just resonates with me much more than surgery - for now.

Feel free to PM me with any questions.

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The gastric balloon was my first option because I wanted to try and achieve my weight loss goals with the least invasive procedure other than simple diet/exercise modification - because we wouldn't be here if it were that simple, right?

It's interesting that it is now approved by the FDA. Over here in Europe they've been offering this procedure for quite a while, and it was my first choice of procedures, but after contacting several surgeons in Belgium about the procedure they all responded that they (the surgeons I contacted) have stopped doing the gastric balloon because of the long term effectiveness.. well, lack thereof. I ended up selecting RNY - which wasn't even on my radar when I was first researching weight reduction procedures - because of its long term effectiveness.

I'm sure the gastric balloon will work for a lot of you, as long as you can keep the changed mindset on food after the device is removed. It seems like it can be a great tool for those who cannot afford the surgical approaches or are uninsured, those who have to lose weight before another procedure can be done, or those with insufficient BMI to qualify for weight reduction surgeries.

Like Thomas Jefferson said, "Nothing can stop the man with the right mental attitude from achieving his goal; nothing on earth can help the man with the wrong mental attitude."

Just my two cents.

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