Most of the adverse events involve Obera, which uses saline to fill a single stomach balloon, as opposed to the ReShape system that uses 2 balloons filled with saline and a blue due. The balloons remain in the stomach for six months to help facilitate weight loss before being removed during an outpatient endoscopy. Three patients died 1 to 3 days afterward.
The agency says they don't know the root cause or the incidence rate of death with these devices, nor have they confirmed that the balloon systems definitely caused the deaths.
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. The fifth was using the ReShape Integrated Dual Balloon System, made my ReShape Medical Inc.
The FDA said that they also received two other reports of fatal cases in the same period which were associated with potential complications linked to balloon treatment. Four of them, named Orbera Intragastric Balloon Systems, were manufactured by Apollo Endo Surgery, while the other one, named ReShape Integrated Dual Balloon System, was fabricated by ReShape Medical Inc. The agency recommends that doctors closely monitor patients who are using these devices.
"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", said Apollo Endosurgery CEO Todd Newton in a statement.
An Apollo spokesperson said that the reports were from around the globe and did not necessarily involve patients residing in the United States.
'The FDA letter is an important reminder to the physician community that obesity is a serious disease and many obese patients are affected by one or more co-morbid conditions due to their obesity'. Symptoms include intense abdominal pain, swelling of the abdomen, difficulty breathing and vomiting.
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