New research has found that the Wingspan Brain Stent may increase a person’s risk of suffering a stroke or death. In 2012, the FDA restricted use of these implants to a very small number of high-risk patients.
Do I Have a Wingspan Brain Stent Lawsuit? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you or a loved one has been injured by the Wingspan Brain Stent, you should contact our lawyers immediately. You may be entitled to compensation by filing a Wingspan Brain Stent lawsuit.
UPDATE: Study Confirms Link Between Brain Stents and Stroke
October 13, 2014 — The safety risks of brain stents have been highlighted in a study confirming an increased risk of stroke compared to patients who received drug treatment alone. The largest and most relevant clinical study, the SAMMPRIS trial, involved 451 patients. Of these, 59 patients (26.3%) who were implanted with a stent had a stroke, compared to 42 patients (18.5%) who were only given medications. Click here to read more.
August 9, 2012 — After finding the Wingspan associated with an increased risk of death and stroke in many patients, the FDA has published a Safety Communication to limit the approved indication of the Wingspan brain stent. The device is now only approved for people who have recurrent strokes due to severe intracranial stenosis who do not respond to other treatments and also have not had a stroke in the last 7 days. Click here to read more.
The Wingspan Brain Stent System with Gateway PTA Catheter is a medical device used to prevent a stroke in the brain. It received approval from the FDA in 2005 to prevent strokes in people who had suffered a stroke in the brain caused by a narrowing of the blood vessels. A debilitating or deadly stroke can occur when these narrow blood vessels become blocked (usually by a blood clot). At least 55,000 people suffer this type of stroke every year, according to the National Institute of Neurological Disorders and Stoke.
The Wingspan Brain Stent is a narrow mesh tube that is inserted in the delicate blood vessels in the brain to keep them from narrowing. Similar devices are also used to prevent blockages in other parts of the body, such as the heart, but these stents are significantly larger.
What is the problem with Wingspan Brain Stent System?
The Wingspan Brain Stent was approved in 2005 through a loophole in the FDA approval process known as a humanitarian exception, which allows some medical devices to be approved without solid safety data. The manufacturer of the brain stent submitted safety data based on a small, 45-person clinical trial. There was no control group in the trial to compare results, safety, or effectiveness.
The FDA approved the device based on this data. After the brain stents were approved, surgeons began using the brain stents in thousands of people who were at risk of suffering a stroke.
A rigorous, scientific study of the safety of the brain stent devices was not conducted for six more years. In April 2011, The National Institute of Neurological Disorders and Stroke funded a 450-person study. The patients were randomly assigned to receive either brain stent or another treatment, which included medication and lifestyle changes. Unfortunately, the study was never completed — it had to be aborted prematurely, because the researchers found that the patients with the brain stents had an unacceptably high risk of serious complications or death: Patients who received the brain stents were 2.5 times more likely to suffer a stroke or death within 30 days of surgery.The researchers found that 15% of people with the brain stents suffered strokes within 30 days of surgery, versus 6% of people on medication and lifestyle therapy alone.
Humanitarian Device Exemption
How did the Wingspan Brain Stent reach the open marketplace without conducting stringent clinical trials to establish safety and effectiveness?
The Wingspan Brain Stent was approved under a loophole to the FDA’s approval process known as the Humanitarian Use Device (HUD) exception. This exception is meant to be used by medical devices for the treatment, prevention, or diagnosis of diseases that affect fewer than 4,000 people in the United States every year.
According to the FDA, medical devices approved under the Humanitarian Use exception do not need to conduct scientifically valid clinical investigation to demonstrate that the device is effective for its intended purpose. The manufacturers must only show that the device does not pose an unreasonable risk of harm to a patient.
FDA Under Scrutiny for Approving Dangerous Medical Devices
The FDA has recently come under fire from consumer advocates and members of Congress regarding its approval process for medical devices. There has been a wave of criticism of unsafe medical devices: Allergan’s Lap-Band, Johnson & Johnson’s transvaginal mesh, defective DePuy hip implants, and brain stents. In November 2011, the Institute of Medicine recommended that the FDA conduct a serious overhaul of its medical device review process.
Need a Texas Brain Stent Injury Lawyer?
For a free consultation, please contact Collen A. Clark at The Clark Firm, LLP immediately. You may be entitled to compensation by filing a lawsuit.
Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”
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