STORY FROM: Drugs & Medical Devices
FDA Reports 5 Additional Deaths in Patients with Liquid-Filled Intragastric Balloons
June 5, 2018
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 ...