FDA issues alert over fluid-filled intragastric balloons: 4 key notes

After receiving multiple adverse events reports, the FDA wrote a letter to providers urging for heightened patient monitoring.

Here's what you should know.

1. Providers reported two adverse events. The first involved the balloons over-inflating with air or fluid in a patient's stomach. The second involved patients developing acute pancreatitis. Both events result in premature device removal.

2. The FDA received reports about the ReShape Integrated Dual Balloon System and the Orbera Intragastric Balloon System, both FDA-approved devices.

3. The agency recommends providers familiarize themselves over inflated balloons symptoms and perform confirmatory diagnostic studies as needed.

The FDA also recommends following manufacturer's instructions regarding device returns or evaluations and reporting any adverse events.

4. The FDA will continue working with the manufacturers to get to the problem's root.

More articles on gastroenterology:
Allergan expects solid 2017 under Trump administration; Takeda faces antirust suit & more —3 GI companies making waves
GI leader to know: Dr. Brij Dewan of Kalamazoo Gastroenterology
Pediatric irritable bowel syndrome patients often low in vitamin D: 4 key notes

© Copyright ASC COMMUNICATIONS 2019. Interested in LINKING to or REPRINTING this content? View our policies by clicking here.


Top 40 Articles from the Past 6 Months