The Food and Drug Administration (FDA) has approved updates to the Orbera Intragastric Balloon System (Apollo Endosurgery, Inc.) labeling to improve patient safety.

Specifically, the hepatic insufficiency or cirrhosis contraindication has been updated to clarify for which patients the therapy is contraindicated. “Hepatic insufficiency or cirrhosis has been clarified so that it is not interpreted incorrectly as disallowing Orbera’s use in a broad spectrum of liver disease patients including nonalcoholic fatty liver disease (NAFLD) and its subtype nonalcoholic steatohepatitis (NASH),” said Dr. Christopher Gostout, Apollo’s Chief Medical Officer. Orbera is contraindicated in patients with: acute liver failure and advanced cirrhosis with encephalopathy muscle wasting and anasarca; large esophageal varices with red color signs and gastric varices; and severe portal hypertensive gastropathy with or without gastric antral vascular ectasia.

The updated labeling also includes a precaution regarding the use of anticholinergic or psychotropic medications that are known to delay gastric emptying.

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With regard to safety, new data has been added to the US adverse events tables. Since the FDA approval, acute pancreatitis, spontaneous hyperinflation, and death have been reported in patients with Orbera; these adverse events were not identified in the US pivotal study.

Orbera is currently indicated for use in obese adults with body mass index (BMI) of ≥30 and ≤40kg/m2 who have failed more conservative weight reduction alternatives, such as supervised diet, exercise and behavior modification programs.

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