Following at least a dozen deaths over the past two years, federal health officials are requiring new labeling warnings for intragastric balloon systems used for weight loss surgery.
On June 4, the FDA issued new warning labels for the Orbera and ReShape liquid-filled intragastric balloon systems. The warnings include information about possible complications, and the risk of death associated with the use of the weight loss balloons.
The new label warnings follows an FDA report that linked at least 12 deaths to the liquid-filled balloon systems.
Orbera and ReShape balloon systems are designed to help obese individuals lose weight. The balloons are made of soft silicone and are implanted in a patient’s stomach for about six months, to take up enough space to help patients adapt to healthier portion sizes.
The weight loss balloon systems are advertised as a less invasive procedure than other types of bariatric surgery, since they are inserted orally through the esophagus, which eliminates scarring.
Although the devices appear convenient and effective in many cases, serious risks of injury and death have been reported in relation to the weight loss balloons.
According to the intragastric balloon injury and fatality reports recorded by the FDA, patients have been observed suffering from perforation of the stomach wall or esophagus, inflammation of the pancreas (acute pancreatitis) and the balloon filling with air and enlarging (spontaneous hyperinflation).All of these adverse events pose a series of serious and potentially fatal health hazards for patients.
The FDA issued a warning letter in February 2017, warning of adverse health consequences reported in relation to the Reshape and Obrera balloon systems. In August 2017, the FDA issued a subsequent warning letter to healthcare professionals citing several adverse events involving five unanticipated deaths after the use of the Obrera and Reshape intragastric balloon systems.
The FDA is mandating the manufacturers Reshape Medical Inc. (Reshape) and Apollo Endo-Surgery (Obrera) update their product labeling to include risks of death associated with the use of the products.
In addition, the FDA is advising health care providers to inform patients of the potentially life threatening injuries that can occur, and to monitor them closely during the entire term of treatment with liquid-filled balloon systems.