22/06/2023
On August 10, 2017, the FDA released a letter addressed to Health Care Providers concerning potential risks associated with liquid-filled intragastric balloons, including the ORBERA intragastric balloon. You can access the letter here.
Recently, the FDA provided an update to physicians regarding five cases of unexpected deaths that occurred between 2016 and the present in patients who had undergone treatment with liquid-filled intragastric balloons for obesity. Additionally, two more reports of deaths during the same period were linked to potential complications related to balloon treatment. Among these cases, five patients had specifically received the ORBERA intragastric balloon, and Apollo, in compliance with its reporting obligations, self-reported all five cases to the FDA.
Link here:
Worried About Gastric Balloon Safety This article explains in detail the safety surrounding the ORBERA Gastric Balloon.