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In February 2017, August 2017, June 2018, and April 2020, the FDA issued letters to well being care providers primarily based on reports of affected person problems related to liquid-filled gastric balloon methods, together with demise. Other issues included a hole in the abdomen ; sudden irritation of the pancreas, which usually causes a sudden and severe stomach ache ; and balloons filling with air and enlarging, causing discomfort . On September 5, 2019, the FDA revealed a discussion paper, Consideration of Benefit-Risk Approaches for Weight-Loss Devices.
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