Risk alert: FDA relabels intragastric balloon systems due to possible related deaths

June 4, 2018 Wayne Wenske

In collaboration with manufacturers Apollo Endosurgery and ReShape LifeSciences, the FDA has approved new labeling for the Orbera and ReShape balloon systems to include more information about possible deaths associated with the use of these devices.

Both of these systems consist of liquid-filled balloons used as weight loss devices to treat obesity.

The FDA is recommending that health care providers:

  • instruct patients regarding symptoms of potentially life-threatening complications such as balloon deflation, gastrointestinal obstruction, ulceration, and gastric and esophageal perforation; and
  • monitor patients closely during treatment with these systems for potential complications, including acute pancreatitis and spontaneous hyperinflation.

Health care professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program. Instructions are found on the FDA website.

 

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