Deaths prompt renewed FDA warning on intragastric balloons

The FDA yesterday updated its warning of the risks associated with fluid-filled intragastric balloons after receiving new reports of the deaths of patients implanted with the devices. Intragastric balloons, made by Apollo Endosurgery (NSDQ:APEN) and ReShape Medical, are used to treat obesity. Placed in the stomach orally in a minimally invasive endoscopic procedure, they’re designed to be filled with fluid and stay in the stomach for six months. Apollo’s Orbera intragastric balloon system is composed of a single balloon which is filled with saline, while ReShape’s integrated dual balloon system uses 2 balloons filled with saline and methylene blue dye. Earlier this year the federal safety watchdog warned of the risk of two types of adverse event associated with the balloons, including over-inflation requiring premature removal and the development of acute pancreatitis, also requiring premature device removal. Yesterday the FDA said it received five reports of “unanticipated” deaths since 2016 in patients treated with the balloons, four with Apollo’s Orbera and another with ReShape’s dual-balloon system; in a press release, Apollo said there have been five deaths of Orbera patients since the agency approved the device in August 2015. The FDA said the reports it received since 2016 indicate that the patients died within a month of implantation, with three as soon as three days later. The root causes for the deaths are unknown, the agency s...
Source: Mass Device - Category: Medical Devices Authors: Tags: Food & Drug Administration (FDA) Regulatory/Compliance Wall Street Beat Weight loss Apollo Endosurgery ReShape Medical Source Type: news