A New FDA Warning Regarding Gastric Balloons

The FDA has recently issued an alert about five reported deaths that have occurred in patients within 30 days following gastric balloon placement. Four reports involve the Orbera Intragastric Balloon SystemTM, manufactured by Apollo EndoSurgery, and one report involves the ReShape Integrated Dual Balloon SystemTM, manufactured by ReShape Medical Inc. 3 patients died one to three days after balloon placement. The intragastric balloon system has been recently approved by the FDA for weight loss in patients whose BMI is between 30 and 40. Both companies Orbera and Reshape have advertised the gastric balloon as “weight loss surgery without the surgery” and as a safe solution for weight loss. Recent reports have surfaced about balloon induced pancreatitis and spontaneous balloon over-inflation. Both conditions may lead to serious consequences. Gastric distention from balloon spontaneous over-inflation can result in aspiration and possible death.

I should mention that the exact cause of death in all 5 reports has not yet been determined, and a cause effect relation between intragastric balloon and death has not yet been established. We will continue to monitor FDA input in the coming few weeks and keep our patients updated. Houston weight loss surgery center does not endorse intragastric balloon as an effective weight loss solution. Gastric balloon procedure is a purely restrictive technique without any apparent metabolic effect. We have learned over the past few years that successful weight loss surgery like sleeve gastrectomy alters several gastro-intestinal neuro-hormonal signals leading to durable weight loss. We hope more research is focused on the metabolic effects and mechanism of action of gastric bypass and sleeve gastrectomy. Only by understanding the mechanism of action of metabolic surgery we can develop newer, safer and more effective solutions for weight loss.