FDA Reports 5 Additional Deaths in Patients with Liquid-Filled Intragastric Balloons




WASHINGTON, D.C. — The Food and Drug Administration has reported five additional deaths in patients who were implanted with liquid-filled intragastric balloons manufactured by Apollo Endosurgery and ReShape Lifesciences died after experiencing ruptured bowels.

According to a June 4 Letter to Health Care Providers, four of the patients had been implanted with the Apollo Orbera Intragastric Balloon System, and one with the ReShape Integrated Dual Balloon System.

“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,” the letter …






UPCOMING CONFERENCES




HarrisMartin's New Jersey Asbestos Litigation Conference

February 27, 2025 - New Brunswick, NJ
Hyatt Regency New Brunswick

MORE DETAILS



HarrisMartin’s Artificial Stone Silicosis Epidemic Litigation Conference

January 10, 2025 - Long Beach, CA
The Westin Long Beach

MORE DETAILS