Here are six things to know:
1. Four of the five new cases are linked to Apollo Endosurgery’s Orbera Intragastric Balloon system and one is associated with ReShape Lifesciences’ ReShape Integrated Dual Balloon System.
2. In collaboration with the manufacturers, the FDA approved new labeling for the Orbera and ReShape balloon systems with more information about potential risks associated with the use of these devices.
3. In four of the cases, including the one involving the ReShape device, death was preceded by a gastric perforation that occurred within three and a half weeks of surgical placement of the balloon. Apollo Endosurgery is still investigating the fifth death.
4. The American Society for Metabolic and Bariatric Surgery has approved intragastic balloons as a safe and effective treatment for obesity.
5. ReShape Lifesciences said that the occurrence rate of death for all ReShape Balloons implanted through April 30, 2018, is 0.06 percent.
6. Apollo Endosurgery reports that as of March 31, the U.S. mortality rate of Orbera patients is 0.036 percent, or less than four deaths per 10,000 patients.
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