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Between the Hope of Major Weight Loss and the Risk of Medical Complications: How Safe is the Gastric Balloon for Patients? A Case Study

Abstract:
Two gastric balloons were given approval for the US market by the American health authority FDA (Food and Drug Admin- istration). The approved balloons were the fluid-filled intragastric balloons Orbera (produced by Apollo Endosurgery) and ReShape (produced by Re- shape Medical, later acquired by Apollo Endosurgery).2 These were the first two intragastric balloons to be approved for the treatment of obesity in the US since 1985. In 1985 the Garren-Edwards Gastric Bubble became the first gastric balloon to be approved in the United States.