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.
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The FDA in April 2020 sent an update to healthcare providers regarding the potential hazards linked to liquid-filled intragastric balloon devices used for weight loss treatment, according to MedTech Dive .
The agency said at least 18 deaths worldwide have been associated with gastric balloons since their introduction in 2015. The FDA’s update marks the 4th communication from the agency addressing complications with Apollo Endosurgery’s Orbera and ReShape balloons.
The message comes on the heels of Apollo Endosurgery’s announcement earlier in the month that it had completed the 258-patient post-approval study for Orbera; a final data summary from the ReShape balloon post-approval study was made available in December 2019.
FDA recommends healthcare providers monitor patients closely and make them aware of symptoms of potential complications, which include acute pancreatitis and over-inflation of the balloons.
What’s the Problem?
August 10, 2017 – The 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.
What is the Mortality Rate with Gastric Surgery?
The agency has also received at least 2 additional reports of death during the same 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.
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Do I have a Weight Loss Balloon Lawsuit?
The Products Liability Litigation Group at Schmidt & Clark, LLP 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 have 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.