August 11, 2017 — Five deaths have been linked to fluid-filled stomach balloons since 2016, according to an FDA warning to healthcare providers and patients.
Four of the deaths involve Apollo Endosurgery’s Orbera® Intragastric Balloon System and 1 death involves Reshape Medical’s ReShape® Integrated Dual Balloon System.
Three victims died within 1-3 days of balloon placement. The other two patients died within less than 1 month of balloon placement.
Two additional deaths were linked to weight-loss balloon complications, including 1 person who died of a stomach perforation after receiving Orbera and 1 person who died of an esophageal perforation after receiving ReShape.
The FDA said it is still investigating the deaths:
“At this time, we do not know the root cause or incidence rate of patient death, nor have we been able to definitively attribute the deaths to the devices or the insertion procedures for these devices (e.g., gastric and esophageal perforation, or intestinal obstruction).”
The warning follows a previous alert in February 2017 after the FDA received dozens of reports of pancreatitis (pancreas inflammation) and spontaneous balloon over-inflation with fluid or air.
Pancreatitis is believed to occur when the fluid-filled balloon compresses the pancreas and other organs in the abdomen. At least 4 patients were hospitalized with this life-threatening side effect.
Stomach balloon over-inflation and pancreatitis were not on the label until February 2017, so patients may not be aware of the risk. The symptoms of these side effects may include severe stomach pain, back pain, abdominal swelling, breathing problems, fever, or vomiting.
Do I have a Weight-Loss Balloon Lawsuit?
The Schmidt Firm, PLLC is currently accepting weight-loss balloon induced injury cases in all 50 states. If you or somebody you know has been injured by a fluid-filled stomach balloon, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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