https://www.fda.gov/MedicalDevices/Safety/LetterstoHealthCareProviders/ucm609597.htm
I suspect this "option" won't last long.
I suspect this "option" won't last long.
UPDATE: Potential Risks with Liquid-filled Intragastric Balloons - Letter to Health Care Providers
- Thread starter southernlady
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Munchkin
Full of Fairy Dust
Yikes!!!
Larra
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I've said for years that the intestines and gadgets are not a good mix. What would be helpful to know regarding these deaths is not just how many deaths but how many balloons were placed total, i.e. a death rate. This is one of those things that sounds safe because there is no surgery needed, but the more we learn, the more we know that isn't the case. What scares me the most about this is that, somewhat like with lap band, some of the serious complications occur well after the device is placed.
For the ORBERA (Apollo):
Global Rate (as of March 31, 2017) Global Rate (as of March 31, 2018)
Mortality Rate 0.01% <0.01%
Gastric Perforation 0.01% 0.01%
Esophageal Perforation <0.01% <0.01%
Pancreatitis <0.01% <0.01%
Spontaneous Hyperinflation 0.04% 0.07%
For the ReShape:
These three deaths occurred out of more than 5000 balloons implanted around the world, including those in our clinical trial (265) and those sold commercially. The occurrence rate, expressed as a percentage of all the ReShape Balloons implanted through April 30, 2018, is 0.06%1.
Global Rate (as of March 31, 2017) Global Rate (as of March 31, 2018)
Mortality Rate 0.01% <0.01%
Gastric Perforation 0.01% 0.01%
Esophageal Perforation <0.01% <0.01%
Pancreatitis <0.01% <0.01%
Spontaneous Hyperinflation 0.04% 0.07%
For the ReShape:
These three deaths occurred out of more than 5000 balloons implanted around the world, including those in our clinical trial (265) and those sold commercially. The occurrence rate, expressed as a percentage of all the ReShape Balloons implanted through April 30, 2018, is 0.06%1.
Munchkin
Full of Fairy Dust
Seriously, how would a balloon 'spontaneously hyperinflate'?
Larra
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I was wondering about that too.
It's a very low mortality rate compared to surgery, but then again, it isn't surgery, so it should have an extremely low mortality rate, and these deaths are disturbing. I can easily see how a potential patient would look at this and think it sounds so much less scary than major surgery. But the success rate also needs to be considered, because what is the point of taking even a small risk if the procedure doesn't create lasting success, and it is also my understanding that the device is supposed to be removed after 6 months, which leaves the patient with...nothing.
It's a very low mortality rate compared to surgery, but then again, it isn't surgery, so it should have an extremely low mortality rate, and these deaths are disturbing. I can easily see how a potential patient would look at this and think it sounds so much less scary than major surgery. But the success rate also needs to be considered, because what is the point of taking even a small risk if the procedure doesn't create lasting success, and it is also my understanding that the device is supposed to be removed after 6 months, which leaves the patient with...nothing.
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