Five More Patients Have Died since FDA's Last Warning against Stomach Balloons for Weight Loss

June 25, 2018 | Strategic Insights for Ambulatory Care


​The U.S. Food and Drug Administration (FDA) is warning healthcare providers of the risk of death for patients who have liquid-filled intragastric balloons designed to aid weight loss, according to a June 4, 2018, FDA safety alert. Five more patients have died since FDA's last warning, bringing the deaths since 2016 to 12. Four of the five recent deaths resulted from perforation of the balloon between 1 day and 3.5 weeks after it was placed in the patient; full information is not yet available regarding the fifth death. FDA approved two intragastric balloons in 2015, according to the article.

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