The U.S. Food and Drug Administration (FDA) has issued several alerts to healthcare providers to report the deaths of patients with liquid-filled intragastric balloon systems. In these communications, the FDA has urged doctors to closely monitor these patients for the risk of life-threatening complications, including pancreatitis and spontaneous over-inflation. Since 2016, the FDA has received reports of a total of 12 deaths that occurred in patients with liquid-filled intragastric balloon systems worldwide. Both the Orbera Intragastic Balloon System and the ReShape Integrated Dual Balloon System have been associated with causing death.
Intragastric balloon systems are weight-loss systems used to treat obesity. The device is placed within the stomach using a minimally invasive surgery. The devices are then filled with saline or saline and dye, which causes the balloon to swell and take up space in the stomach. The FDA approved the ReShape and the Orbera balloon systems for use in the United States in 2015. Since their approval, the FDA received several dozen adverse event reports regarding over-inflation, which can cause intense abdominal pain, swelling of the abdomen, difficulty breathing, and/or vomiting, acute pancreatitis, which can cause severe abdominal and back pain and require hospitalization, and even death. In fact, by August 10, 2017, the FDA reported that it had received five reports of deaths within a month of balloon placement, and by June 4, 2018, the number of deaths associated with these devices reached 12.
Are these devices safe?
These devices have only been approved for use since 2015, and have already been associated with serious complications, including death. Despite the risk of serious complications and death, the FDA has not yet issued a recall on these intragastric balloon systems. Unless a recall is issued, physicians are still able to use these devices. Although the FDA will continue to monitor the safety and effectiveness of the devices by monitoring death reports, there is no way to know how long it will allow these dangerous devices to remain on the market. If you or a loved one underwent intragastric balloon placement surgery and experienced symptoms of over-filling, acute pancreatitis, or death as a result, you may be able to receive compensation. Contact our firm today to discuss your potential claim with an experienced attorney by calling 800-698-4054 or sending us an email at [email protected].