Intragastric stomach balloons used for weight loss surgery have been linked to adverse health complications including acute pancreatitis and over-inflation which may require early removal, according to the U.S. Food & Drug Administration (FDA).
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.
What’s the problem?
FDA on Feb. 9, 2017, sent a letter to healthcare providers concerning risks associated with fluid-filled intragastric balloons manufactured by ReShape Medical and Apollo Endosurgery. The agency’s letter came in response to dozens of adverse event reports with the devices, which included the following major injuries:
- Acute Pancreatitis – Condition reported to occur in as little as 3 days after stomach balloon implantation, linked to the compression of stomach organs by weight-loss balloon. Symptoms include severe abdominal and back pain. All cases of pancreatitis in intragastric balloon patients required early removal of the device, and 4 patients required hospitalization.
- Over-inflation – When intragastric stomach balloons are over-inflated before implantation, they may cause severe abdominal pain, swelling of the abdomen (abdominal distension), difficulty breathing and/or vomiting, which may require premature removal of the device. Symptoms of weight-loss balloon overinflation have been reported to occur as little as 9 days after implant surgery.
I’ve Been Injured by a Weight-Loss Balloon. Can I Participate in a Class Action?
Due to the potential for “lowball settlements” to clients in this type of complex medical device litigation, the law offices of Schmidt & Clark, LLP, are not currently filing a intragastric balloon class action lawsuit. We are only filing individual claims for injured parties and their families. If you’ve been injured after weight-loss surgery with a stomach balloon, you may be entitled to compensation to assist with medical bills, lost wages, pain and suffering, and other damages.
Have There Been Any Settlements?
Intragastric balloons have only been on the U.S. market a short time (the ReShape Balloon and Apollo Orbera Intragastric Balloon System were approved by the FDA in 2015), and injury reports associated with these devices are only just now emerging. Therefore, there have been no reports of settlement offers from ReShape or Apollo. However, as more lawsuits are filed, the greater the likelihood the manufacturers will be forced to settle some or all of the cases.
Do I Have an 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 had an injury after weight-loss surgery with an intragastric balloon, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and we can help.