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?
February 9, 2017 – FDA sent a letter to healthcare providers Thursday warning that fluid-filled intragastric balloons manufactured by ReShape Medical and Apollo Endosurgery have been linked to dozens of the following complications:
- Over-inflation – FDA has received “several dozen” reports of intragastric stomach balloon overinflation, which have occurred as little as 9 days after implant surgery. Symptoms include severe abdominal pain, swelling of the abdomen (abdominal distension), difficulty breathing and/or vomiting. This event may require premature removal of the weight-loss balloon to resolve symptoms.
- Acute Pancreatitis – Complication linked to the compression of gastrointestinal structures by the stomach balloon. Symptoms of acute pancreatitis from intragastric balloon system include severe abdominal and back pain. All cases required premature removal of the device, and 4 patients required hospitalization. Pancreatitis can occur as soon as three days after weight-loss balloon implantation, according to the FDA.
Neither over-inflation nor pancreatitis are listed on the labeling information for the Orbera or ReShape balloon systems. Therefore, healthcare providers may be unaware these complications could develop following balloon placement. This could lead to unsuitable or delayed treatment, according to the FDA.
Can I File a Class Action?
The Medical Device Litigation Group at Schmidt & Clark, LLP, is not currently filing a class action lawsuit on behalf of people injured by intragastric weight loss balloons. In some instances, a class action may offer some advantages to plaintiffs, but in complex medical device litigation, these types of lawsuits often result in lowball settlements and higher attorney fees for class members.
This doesn’t mean you’re out of luck if you’ve been injured. Our lawyers are now accepting potential individual claims for people who suffered complications of weight loss surgery. Contact us today to learn more about your legal rights.
Do I Have a Intragastric Balloon Lawsuit?
The Class Action 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 lawsuit and we can help.