Eric J Vargas, Carl M Pesta, Ahmad Bali, Eric Ibegbu, Fateh Bazerbachi, Rachel L Moore, Vivek Kumbhari, Reem Z Sharaiha, Trace W Curry, Gina DosSantos, Ramsey Schmitz, Abhishek Agnihotri, Aleksey A Novikov, Tracy Pitt, Margo K Dunlap, Andrea Herr, Louis Aronne, Erin Ledonne, Hoda C Kadouh, Lawrence J Cheskin, Manpreet S Mundi, Andres Acosta, Christopher J Gostout, Barham K Abu Dayyeh
BACKGROUND & AIMS: The Orbera intragastric balloon (OIB) is a single fluid-filled intragastric balloon approved for the induction of weight loss and treatment of obesity. However, little is known about the effectiveness and safety of the OIB outside clinical trials, and since approval, the Food and Drug Administration has issued warnings to health care providers about risk of balloon hyperinflation requiring early removal, pancreatitis, and death. We analyzed data on patients who have received the OIB since its approval to determine its safety, effectiveness, and tolerance in real-world clinical settings...
July 2018: Clinical Gastroenterology and Hepatology