FDA warns on over-inflation, pancreatitis risks with ReShape, Apollo intragastric balloons

The FDA today warned of potential risks associated with fluid-filled intragastric balloons, produced by ReShape Medical and Apollo Endosurgery, which are used to treat obesity. The federal watchdog said it has received multiple reports of 2 different types of adverse events associated with the balloons, including over-inflation requiring premature removal and the development of acute pancreatitis, also requiring premature device removal. The balloon devices are designed to be placed in the stomach through the mouth in a minimally invasive endoscopic procedure and then filled with fluid, and stay in the stomach for a period of 6 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. A 3rd balloon system which uses air to inflate, the Obalon system, was approved last year but the FDA said it has not received adverse event reports associated with the air-inflated system. The agency said it has received “several dozen” adverse event reports of issues related to balloon over-inflation, most of which involved Apollo’s Orbera system, though the same issue has been reported with the ReShape system. Symptoms of over-inflation include intense abdominal pain, abdominal dissension with or without discomfort, difficulty breathing or vomiting, and may require the premature removal of the balloon to resolve the ...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Food & Drug Administration (FDA) Weight loss Apollo Endosurgery ReShape Medical Source Type: news