A recent Food and Drug Administration report reveals that 5 obesity treatment patients, who underwent stomach balloon placement, have died over the last 18 months.
Four of the 5 had what is called the Orbera Intragastric Balloon System inserted. The other underwent a procedure involving the ReShape Integrated Dual–Balloon System.
All of the patients died within 30 days of the balloon insertions, and several died in less than a week.
And doctors say they have no idea what went wrong.
The balloon insertion procedure involves placing either one or two un-inflated balloons through the patient’s mouth and into the stomach. Sterile salt water is then squirted into the balloons. The usual plan is for the balloons to lay in the stomach for 6 months. The result is that patients eat far less because they feel “full.”
The FDA says they are working to determine the exact causes of the deaths. They are looking into possible complications such as sudden over-inflation.
“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,” the FDA said in a safety alert issued Thursday.
The FDA announced they are also investigating 2 other patient deaths, that could be related to possible complications of gastric balloon treatment.
In those cases, there were accidental punctures of the throat and the stomach.
In total, there have been 21 known deaths over the last decade.
Here’s more from the FDA:
Most of the over-inflation reports involved the Orbera System that uses a single balloon, although some reports involved the ReShape Dual Balloon System that uses two balloons. Neither product mentions over-inflation risk. “At this moment there is not enough information to determine what is causing the balloon to overinflate.”
Other side effects involved sudden pancreatitis caused when the balloons compress other abdominal organs. Both the Orbera and ReShape products are associated with pancreatitis, Neither company lists pancreatitis as a potential complication. Pancreatitis was reported as early as 3 days after implantation, and symptoms included severe back and abdominal pain.