Safety

Liquid-filled Intragastric Balloons by Apollo Endosurgery and ReShape Lifesciences: Letter to Health Care Providers - New Labeling About Potential Risks

[Posted 06/04/2018]

AUDIENCE: Gastroenterology, Risk Manager, Health Professional, Patient

ISSUE: In collaboration with the manufacturers, the FDA has approved new labeling for the Orbera and ReShape balloon systems with more information about possible deaths associated with the use of these devices in the U.S. Please see the statements from each manufacturer (Apollo Endosurgery disclaimer iconand ReShape Lifesciencesdisclaimer icon) for additional details about the new labeling.

BACKGROUND: Intragastric balloon systems are weight-loss systems to treat obesity, which function by taking up space in a patient’s stomach. In 2015, the FDA approved two intragastric balloon systems in the U.S. The ReShape Integrated Dual Balloon System is manufactured by ReShape Medical Inc., and uses two balloons. The Orbera Intragastric Balloon System manufactured by Apollo Endo-Surgery uses one balloon. Both brands are liquid-filled balloon systems, and are indicated for use in conjunction with diet and exercise.

RECOMMENDATION: The FDA recommends health care providers:

  • Instruct patients regarding symptoms of potentially life-threatening complications such as balloon deflation, gastrointestinal obstruction, ulceration, and gastric and esophageal perforation

  • Monitor patients closely during the entire term of treatment with liquid-filled intragastric balloon systems for potential complications, including acute pancreatitis and spontaneous hyperinflation as stated in our February 2017 letter to health care providers

Healthcare 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:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report

  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[06/04/2018 - Health Care Provider Letter - FDA]
[08/10/2017 - Health Care Provider Letter - FDA]
[02/09/2017 - Health Care Provider Letter - FDA]

Page Last Updated: 06/04/2018
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