If you or a loved one suffered a stroke after they received the Wingspan Brain Stent, you may have a lawsuit and be entitled to significant compensation for your injury. New research emerged in September 2011 that found people who receive the brain stents are 2.5-times more likely to suffer another stroke or death within 30 days of receiving the stent. This rate is significantly higher than people who were treated with medication and lifestyle changes.
What You Can Do & How a Wingspan Brain Stent Lawsuit Can Help
The Schmidt Firm, LLP is currently accepting Wingspan Brain Stent induced injury cases in all 50 states. If you or somebody you know has been injured by this medical device, you should contact our lawyers immediately for a free Wingspan Brain Stent lawsuit consultation. Please use the form below to contact our Wingspan Brain Stent Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.
August 9, 2012 – The FDA has published a Safety Communication to limit the approval for the Wingspan brain stent system. After finding an unacceptably high risk of death and stroke, the FDA decided that only patients who have had multiple strokes due to severe intracranial stenosis who have not improved with other treatments may be eligible for the Wingspan brain stent.
Wingspan Brain Stent Overview
The Wingspan Brain Stent System with Gateway PTA Catheter is a medical device used to open brain blood vessels in patients who have recently had a stroke caused by a narrowing of the brain blood vessels. According to the National Institute of Neurological Disorders and Stroke, every year at least 55,000 strokes are cased by blockages in the small blood vessels in the brain.
Medical stents already exist for people at risk of blockages in the heart. It was hoped that a similar, smaller device would work for people at risk of blockages in the brain. The Wingspan Brain Stent system is a wire mesh tube that is designed to be used in the small, delicate blood vessels in the brain. It is much smaller than stents that are used in the heart.
The U.S. Food and Drug Administration initially approved the device in 2005. It is approved for use in patients who have had at least one stroke and are at risk of having another stroke.
What is the problem with Wingspan Brain Stent System?
The device was approved on the basis of a humanitarian exception, which did not require stringent safety data or solid evidence that the device could prevent strokes. The manufacturer conducted a 45-person trial that lacked a control group to compare whether the brain stents were safer or more effective than other methods.
After the medical device was approved, surgeons used it on thousands of people who were at high risk of suffering a stroke.
In April 2011 — more than six years after the brain stent system started being used on people — the first controlled study was performed on 450 patients. The patients were randomly divided into two groups: one group received brain stents, and the other group received aggressive treatment with drugs and lifestyle changes. The study was funded by the National Institute of Neurological Disorders and Stroke.
The study was aborted prematurely after researchers found that patients treated with the brain stent had a 2.5-fold increased risk of suffering a stroke or dying within 30 days of surgery. They found that almost 15% of the brain stent patients suffered strokes in the first 30 days, compared with 6% of the people on medical therapy.
Humanitarian Device Exemption
A Humanitarian Use Device (HUD) is a device that is intended to be used to treat, prevent, or diagnose a disease that affects fewer than 4,000 people in the United States every year.
A device approved under the Humanitarian exception is not required to contain the results of a scientifically valid clinical investigation demonstrating that the device is effective for its intended purpose. However, the application must sufficiently show that the device does not pose an unreasonable risk to patients, and the benefits of its use outweigh its risks.
FDA Under Scrutiny for Approving Dangerous Medical Devices
In November 2011, an expert panel at the Institute of Medicine recommended that the FDA overhaul its medical device review process after it failed to establish the safety of less-risky medical devices. The FDA has come under intense scrutiny regarding several medical devices that were later found to be more dangerous than expected (including brain stents, Lap Band, defective hip implants, and transvaginal mesh).
Do I have a Wingspan Brain Stent Lawsuit?
The Schmidt Firm, LLP is currently accepting Wingspan Brain Stent induced injury cases in all 50 states. If you or somebody you know has been injured by the Wingspan Brain Stent, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Wingspan Stent System Lawsuit Group or call toll free 24 hours a day at (866) 920-0753.
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