UPDATE: The FDA continues to work with the manufacturers to evaluate reports of deaths in patients with liquid-filled intragastric balloon systems used to treat obesity. Since the August 2017 update:
- The FDA has received reports of five additional deaths that occurred worldwide since 2016. Four of these deaths (three with the Orbera Intragastric Balloon System manufactured by Apollo Endosurgery, and one with the ReShape Integrated Dual Balloon System manufactured by ReShape Lifesciences) occurred following gastric perforation one day to 3.5 weeks after balloon placement. The fifth death was reported for a patient who had the Orbera Intragastric Balloon System. The report does not mention a perforation event and the manufacturer is still investigating this death.
Since 2016, the FDA has received reports of a total of 12 deaths that occurred in patients with liquid-filled intragastric balloon systems worldwide. Seven of these 12 deaths were patients in the U.S. (four with the Orbera Intragastric Balloon System, and three with the ReShape Integrated Dual Balloon System).