Intragastric balloons used for weight loss surgery have been linked to adverse events including acute pancreatitis and over-inflation requiring premature removal, according to an FDA Warning.
Free Confidential Lawsuit Evaluation: If you or a loved one was injured by intragastric balloon complications, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and our lawyers can help.
Update: Weight-Loss Balloons Linked to 5 Deaths, FDA warns
August 10, 2017 – Intragastric balloons for weight loss made by Apollo Endosurgery and ReShape Medical Inc. have been linked to at least 5 deaths from 2016 to the present, according to an FDA Safety Alert issued Thursday. All of the deaths occurred within 1 month of gastric balloon placement, and in several cases the death came in as little as 1 to 3 days after surgery, FDA said.
Stomach Balloons Linked to Pancreatitis, Over-Inflation: FDA Warning
February 9, 2017 – FDA on Thursday sent a letter to healthcare professionals after receiving dozens of adverse event reports associated with fluid-filled intragastric balloons used to treat obesity.
“The first type of adverse event involves the fluid-filled intragastric balloon over-inflating with air or with more fluid (spontaneous hyperinflation) in patients’ stomachs, resulting in the need for premature device removal,” the agency said. “The second type of adverse event is the development of acute pancreatitis, which has also resulted in the need for premature device removal.”
Most of these complications were in patients who received the Orbera Balloon System made by Apollo Endosurgery, but reports of the same problems have been linked to ReShape Medical’s ReShape Balloon System.
What are Weight-Loss Balloons?
Intragastric balloons are weight-loss systems intended to treat obesity by taking up space in a patient’s stomach. In 2015, FDA approved the ReShape Integrated Dual Balloon System, which uses 2 balloons, and Apollo’s Orbera Intragastric Balloon System, which uses one balloon.
In 2016, FDA also approved the Obalon Balloon System, which consists of up to 3 balloons delivered to the stomach inside a swallowable capsule. To date, no adverse event reports have been associated with this device.
FDA is advising healthcare providers to watch for the above symptoms in patients who received fluid-filled intragastric balloons. If abnormalities are found, physicians should perform any confirmatory diagnostic studies. If the device is removed, follow the manufacturer’s instructions for device returns or evaluations.
Do I Have a Intragastric Balloon Lawsuit?
The Medical Device 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 suffered an injury after intragastric balloon surgery, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and we can help.