The U.S. Food & Drug Administration (FDA) has issued a Safety Alert indicating that at least 5 weight-loss patients died unexpectedly after receiving liquid-filled intragastric balloons.
Free Confidential Lawsuit Evaluation: If you or a loved one suffered complications following weight-loss balloon surgery, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and our lawyers can help.
What’s the Problem?
August 10, 2017 - FDA said 4 of the deaths occurred in patients implanted with the Orbera Intragastric Balloon System, manufactured by Apollo Endosurgery, and the other with ReShape Medical’s Integrated Dual Balloon System.
All of the deaths occurred within 1 month of intragastric balloon placement, and in several cases the death came in as little as 1 to 3 days after surgery, according to the Safety Alert.
FDA is still unable to determine the cause of death in weight-loss balloon patients, nor has it been able to definitively link the deaths to the devices or insertion procedures.
The agency has also received at least 2 additional reports of death during the same time period associated with complications of intragastric balloon treatment (1 gastric perforation with the Orbera Intragastric Balloon System and 1 esophageal perforation with the ReShape Integrated Dual Balloon System).
FDA in February issued a letter to healthcare providers recommending close monitoring for acute pancreatitis and spontaneous over-inflation in patients with gastric balloon systems used to treat obesity. Since then, both Apollo Endosurgery and ReShape Medical Inc. have revised their product labeling to address these risks.
Do I have a Weight Loss Balloon Lawsuit?
The Products Liability Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in intragastric balloon lawsuits. We are handling individual litigation nationwide and currently accepting new injury and death cases in all 50 states.
Free Case Evaluation: Again, if you had problems after a gastric balloon procedure, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and we can help.