Potential Risks with Liquid-filled Intragastric Balloons
April 27, 2020
The FDA is providing an update on the potential risks of over-inflation (spontaneous hyperinflation), acute pancreatitis, and deaths in patients with Orbera and ReShape liquid-filled intragastric balloons used for weight loss in adult patients with obesity.
The FDA first communicated on the potential risk of hyperinflation and acute pancreatitis with liquid-filled intragastric balloons in February 2017. Since then, the FDA provided updates in August 2017 and June 2018 about the potential risk of death with liquid-filled intragastric balloons, and in December 2019 announced the availability of the final data summary for the Reshape balloon post-approval study (PAS).
Recommendations
- Instruct patients about the symptoms of potentially life-threatening complications such as balloon deflation, gastrointestinal obstruction, ulceration, and gastric and esophageal perforation and advise them when to seek medical attention.
- Monitor patients closely during the entire duration of treatment with liquid-filled intragastric balloon systems for potential complications, including acute pancreatitis, spontaneous hyperinflation, and other potentially life-threatening complications.
- Report any adverse events related to intragastric balloon systems
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