Five deaths reported due to gastric balloon devices
The FDA has warned health care providers about deaths related to intragastric balloon systems developed by both Apollo Endo-Surgery and ReShape Medical.
The devices - used to treat obesity – are inserted into the stomach through the mouth and are then filled with saline until they expand, leaving the patient feeling full to help them lose weight.
The FDA states that all five deaths occurred within a month of balloon placement, with three patients dying as soon as one to three days after being fitted with the device.
The FDA said in a statement: “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 oesophageal perforation, or intestinal obstruction).”
The FDA is also aware of two more deaths in the same time period which are related to potential complications associated with balloon treatment.
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