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# FDA Intragastric Balloon Alert
- URL: https://www.fdaweb.com/fda-intragastric-balloon-alert/
- Published: 2017-02-09T12:00:00.000Z
- Updated: 2026-09-14T22:05:51.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5137938

FDA says it has received multiple reports of two different types of adverse events associated with fluid-filled intragastric balloons used to treat obesity. An [alert](http://www.fda.gov/MedicalDevices/ResourcesforYou/HealthCareProviders/ucm540655.htm?ref=fdaweb.com) to healthcare providers says the first type of adverse event involves the balloon over-inflating with air or with more fluid in patients’ stomachs, resulting in the need for premature device removal. The second adverse event is development of pancreatitis, also resulting in the need for premature device removal.

The agency recommends that healthcare providers closely monitor patients with these devices for the adverse events. Two intragastric balloon systems approved by FDA in 2015 are ReShape Medical’s ReShape Integrated Dual Balloon System and Apollo Endo-Surgery’s Orbera Intragastric Balloon System.