United States

FDA investigating deaths of patients who had gastric balloon procedure for obesity

The U.S. Food and Drug Administration has alerted physicians and surgeons who treat obesity that it is investigating whether there is a link between gastric balloons — new-generation weight-loss devices — and the deaths of five patients.In an alert issued Thursday, the FDA said that from 2016 to the present, five “unanticipated deaths” had occurred within a month or less in patients who had liquid-filled gastric balloon systems implanted in their stomachs. In three of the cases, the agency said patients died between one and three days after the weight-loss device had been put in place.“At this time, we do not know the root cause or incidence rate of patient death, nor have we been able to definiti ...