The FDA issued a warning letter to health care providers in the United States on June 4, 2018 regarding reports of deaths in patients with liquid-filled intragastric balloon systems used to treat obesity.
Since 2016, the FDA has received reports of a total of 12 deaths that occurred in patients with liquid-filled intragastric balloon systems worldwide. Seven of these 12 deaths were patients in the U.S. (four with the Orbera Intragastric Balloon System, and three with the ReShape Integrated Dual Balloon System). Four of these deaths (three with the Orbera Intragastric Balloon System manufactured by Apollo Endosurgery, and one with the ReShape Integrated Dual Balloon System manufactured by ReShape Lifesciences) occurred following gastric perforation one day to 3.5 weeks after balloon placement. The fifth death was reported for a patient who had the Orbera Intragastric Balloon System.
The FDA has approved new U.S. labeling for the Orbera and ReShape balloon systems with more information about possible death associated with the use of these devices in the U.S.
The FDA recommends health care providers instruct patients regarding symptoms of potentially life-threatening complications such as balloon deflation, gastrointestinal obstruction, ulceration, and gastric and esophageal perforation; monitor patients closely during the entire term of treatment with liquid-filled intragastric balloon systems for potential complications, including acute pancreatitis and spontaneous hyperinflation as stated in the FDA’s February 2017 letter to health care providers; and, report any adverse events related to intragastric balloon systems through MedWatch, the FDA Safety Information and Adverse Event Reporting program.
Apollo Endosurgery, Inc. (“Apollo”) issued the following statement (in part) on June 4, 2018: “Apollo’s last ORBERA labeling update occurred on June 6, 2017 and included information regarding adverse events of acute pancreatitis and spontaneous hyperinflation, which were not seen during the ORBERA United States pivotal study. The newly revised and approved labeling announced today provides updates for these two events and also adds information regarding the risks of gastric and esophageal perforation, aspiration, and death … World-wide four (4) occurrences of death in patients who received the ORBERA Intragastric Balloon have been reported since the FDA’s “Updated Letter to Healthcare Providers” dated August 10, 2017. One (1) of these four (4) reported events occurred in the U.S. since the FDA’s August 2017 update. In analyzing the information available for these four (4) reports, gastric perforation preceded three (3) of the deaths including the U.S. event reported on 1/12/18.”
ReShape Lifesciences also issued a statement that read, in part: “Of the three patient deaths reported in association with the ReShape Balloon, one was the result of sepsis secondary to an esophageal perforation. The second event occurred following device placement and involved severe vomiting during the 24-hour post-implant period. The third event was due to a pulmonary embolization secondary to a gastric perforation … These three deaths occurred out of more than 5000 balloons implanted around the world, including those in our clinical trial (265) and those sold commercially. The occurrence rate, expressed as a percentage of all the ReShape Balloons implanted through April 30, 2018, is 0.06%.”
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