Weight Loss Intragastric Balloons Linked To Five Deaths

The liquid-filled intragastric balloon systems have been used as a treatment for obesity, said the FDA alert issued on Thursday. Four of the deaths occurred after patients used the Orbera Intragastric Balloon System, manufactured by Apollo Endo Surgery, and one took place after a patient used the ReShape Integrated Dual Balloon System, which is made by ReShape Medical Inc.

Apollo Endo-Surgery said, per NBC News, that worldwide sales of gastric balloons were estimated to total about $120 million in 2015, driven by broad use in Brazil, Mexico and Europe, and the death reports came from all around the world, and did not necessarily include USA patients. The balloon is created to remain in place for several months.

Earlier this year the federal safety watchdog warned of the risk of two types of adverse event associated with the balloons, including over-inflation requiring premature removal and the development of acute pancreatitis, also requiring premature device removal.

The U.S. Food and Drug Administration (FDA) revealed on Thursday that at least five people have died after they were fitted with liquid-filled intragastric balloon created to help people lose weight. Neither the devices nor the insertion procedures (eg, gastric and esophageal perforation, intestinal obstruction) have been directly attributed to the patient deaths.

Three died one to three days after the balloon placement.

Image credit Dr Dirk

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.

Apollo said it reported all five deaths of Orbera patients in the U.s., Mexico, Brazil and Great Britain to the FDA and has had no indication that any were related to the device or its insertion procedure. It has not received any product liability claims in connection with the five deaths. "Patients with questions about this FDA update should contact their physicians directly".

"The FDA's letter reinforces the fact that complications and adverse events can occur within patients having obesity-related co-morbid conditions". What are the potential side effects of intragastric balloons?

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