More Patients Are Dead After Weight-Loss Balloon Surgery

FDA is still keeping tabs on two liquid-filled intragastric balloon systems used to treat obesity as at least a dozen patients have died in the past two years after receiving one of the devices. The agency first alerted physicians about deaths possibly associated with the devices last year after five patient deaths had been reported. FDA has also approved labeling changes to reflect this information. The agency said it also continues to monitor complications related to the placement and use of these devices, including perforation of the stomach wall or esophagus, inflammation of the pancreas, and the balloon filling with air and enlarging (spontaneous hyperinflation). The devices on FDA's radar include the Orbera Intragastric Balloon System made by Austin, TX-based Apollo Endosurgery, and the ReShape Integrated Dual Balloon System made by San Clemente, CA-based ReShape Lifesciences. Both balloon systems were among a rash of devices FDA approved in 2015 aimed at tackling the obesity epidemic. The monitoring does not appear to include the Obalon system made by San Diego, CA-based Obalon Therapeutics. That device, approved in 2016, uses gas instead of liquid to inflate the balloon. ReShape said there has been one reported death following the implantation of its device since August 2017 FDA letter. That patient died from a pulmonary embolization secondary to a surgical repair of a gastric perforation, the company said, and there have been no product liability-related claims i...
Source: MDDI - Category: Medical Devices Authors: Tags: Regulatory and Compliance Source Type: news