The U.S. Food and Drug Administration has issued an alert regarding intragastric balloon surgery, saying 12 deaths are linked to this procedure since 2016. The patient deaths are associated with two different types of gastric balloon devices, the Orbera Instragastric Balloon System and the ReShape Integrated Dual Balloon System. Both these devices are used to treat obesity. Other complications intragastric balloon patients could face are perforations of the stomach and/or esophagus and/or inflammation of the pancreas (acute pancreatitis). The balloon could also fill with air and become enlarged while inside the patient’s gastrointestinal tract. The FDA has approved a change to the information and warning labels on these devices to warn potential patients of these risks, and they will continue to monitor any reported complications related to intragastric balloons.
If you or a loved one has experienced complications or injury related to intragastric balloon surgery, the attorneys at the Gutierrez Law Firm can help. You may reach us at (361) 664-7377 or (713) 588-3300. You may also send an email to email@example.com. Your initial consultation is always free.