The balloon is created to stay in place for several months to help the patient lose weight.
Since the FDA's OK, there have been five reported deaths in patients who received the ORBERA intragastric balloon in four countries, one in the U.S. The company reported all five cases under its Global Product Surveillance program.
Today's FDA warning follows another alert in February 2017, after dozens of patients suffered life-threatening side effects when their balloon spontaneously over-inflated with air or fluid.
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Three died one to three days after the balloon placement. The other is a dual balloon system made by ReShape. Both systems can be placed in the stomach for up to 6 months to help obese people lose weight.
In an August 10 letter to health care providers, the FDA says all five reports indicate that the deaths occurred within a month or less of balloon placement.
"Serious adverse events observed in global product experience with Orbera and from literature reviews, but not seen in the USA clinical study include: ulcerations/erosions, balloon deflation/migration, esophageal perforation, cardiac complications/cardiac arrest, and death", it says on its website. The exact causes in three of the deaths remained unknown.
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The company has not received product-liability claims as a result of any of the deaths, it said.
A fourth patient died from a stomach hole and a fifth from a tear in the esophagus.
This is less than 0.01 percent of the more than 277,000 Orbera balloons distributed during that time period, their statement said.
The FDA recommends health providers monitor patients closely for pancreatitis - inflammation of the pancreas - and spontaneous overinflation of the inserted bag.
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