The FDA has not identified a root cause for the patient deaths and can not "definitively attribute the deaths to the devices or the insertion procedures for these devices", according to an agency notice. Placed in the stomach orally in a minimally invasive endoscopic procedure, they're created to be filled with fluid and stay in the stomach for six months.
Federal officials are warning health providers about weight loss balloon devices after five people died unexpectedly shortly after being treated with them.
The FDA says it doesn't know if the devices or the surgery to implant them is to blame but issued an alert to doctors to closely monitor patients who get them.
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The FDA said the deaths occurred from 2016 to present. Intragastric balloons are created to treat obesity by taking up room in the stomach, making patients feel full. These are spontaneous overinflation, with liquid or gas, of the devices and acute pancreatitis. Apollo's Orbera intragastric balloon system is composed of a single balloon which is filled with saline, while ReShape's integrated dual balloon system uses 2 balloons filled with saline and methylene blue dye. No product liability lawsuits have been filed against it, the Austin, Texas-based company said, claiming an incident rate since the beginning of 2006 of less than 0.01%.
The other two deaths occurred within a month or less of having the procedure.
'While the cause of death has not been provided or determined in all cases, Apollo has not received any communication or indication from the attending physicians or hospitals that the deaths have been due to the Orbera device'.
"Patient safety is a key priority in everything we do at Apollo Endosurgery and we take adverse event reporting obligations related to our products very seriously. Patients with questions about this FDA update should contact their physicians directly".
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