Published by The U.S. Food & Drug Administration (FDA) has released a Safety Alert stating that there have been at least 5 unexpected deaths among patients who had liquid-filled intragastric balloons implanted for weight loss.
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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Update: FDA Says 18 Deaths Linked to Gastric Balloons
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 [1].
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.
FAQs
Who can file a lawsuit related to weight loss balloon deaths?
Families of individuals who have died due to complications from weight loss balloons can file a lawsuit. Consulting with a personal injury lawyer specializing in medical device litigation can help determine eligibility and guide the legal process.
What complications are associated with weight loss balloons?
Complications associated with weight loss balloons include stomach perforation, infection, pancreatitis, bowel obstruction, and in severe cases, death. These adverse effects can lead to significant medical treatment and emotional distress for affected families.
Can I join a class action lawsuit if my loved one died from a weight loss balloon?
Yes, families of individuals who died from weight loss balloons may join a class action lawsuit if one is available. Class action lawsuits allow multiple plaintiffs to combine their cases, providing a stronger collective legal action against the manufacturer.
How long do I have to file a weight loss balloon death lawsuit?
The time limit to file a weight loss balloon death lawsuit, known as the statute of limitations, varies by state. It’s crucial to consult with a lawyer promptly to ensure your claim is filed within the legal timeframe to preserve your rights.
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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.