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.