The intragastric balloon systems are weight-loss systems that function by taking up space in a patient's stomach, according to the FDA. In a minimally invasive endoscopic procedure, the balloons are placed into the patient's stomach through the mouth. Once in place, the balloon is filled with saline solution. An additional five patients have died in association with intragastric balloons for the treatment of obesity, bringing the total number of deaths to 12 worldwide since 2016, the US Food and Drug Administration said in an alert.
4 of the 5 new cases are related to the Orbera Intragastric Balloon system made by a endosurgery company. 5 deaths reported while using weight loss balloon treatment, FDA says. In four of the cases, including the one for the ReShape device, death was preceded by a gastric perforation, or hole in the stomach wall, that occurred within 3½ weeks of surgical…
