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.
