August 11, 2017 — The FDA is warning healthcare providers after the deaths of 5 patients with fluid-filled weight-loss stomach balloons.
Four out of the 5 deaths involve the Orbera® Intragastric Balloon System (Apollo Endosurgery) and 1 death involves the ReShape® Integrated Dual Balloon System (Reshape Medical).
All of the patients died within less than 1 month of receiving a weight-loss balloon, and three of them died within 1-3 days of placement.
The deaths are still under investigation, according to the FDA:
“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 FDA is also investigating 2 additional deaths related to weight-loss balloon complications, including 1 stomach perforation associated with Orbera and 1 esophageal perforation associated with ReShape.
The FDA issued a previous warning about weight-loss balloons in February 2017, following dozens of reports of injuries when a stomach balloon spontaneously over-inflated with fluid or air.
Furthermore, 4 patients were hospitalized with acute pancreatitis (pancreas inflammation), a life-threatening complication that occurs when the fluid-filled balloon compresses gastrointestinal organs.
The symptoms of balloon over-inflation and pancreatitis may include severe stomach pain, back pain, abdominal swelling, breathing problems, fever, or vomiting. Because pancreatitis and balloon over-inflation were not on the labels for ReShape or Orbera until February 2017, patients may not be aware of these life-threatening side effects.
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