AUGUST 14, 2017

FDA Reports 5 Patient Deaths Linked to Intragastric Balloons

Five patients have died since 2016 after receiving liquid-filled intragastric balloons to promote weight loss, according to the FDA

Four of the patients were reported to have died after having an ORBERA Intragastric Balloon System (Apollo Endosurgery Inc.) placed; another death was associated with a ReShape Integrated Dual Balloon System (ReShape Medical Inc.). 

“At this time, we do not know the root cause or incidence rate of patient death, nor have we been able to definitely