Ohio Product Defect Lawyers: FDA restricts use of Stryker brain stent
Posted in Drug & Medical Devices on August 10, 2012
The FDA has restricted the use of the Wingspan brain stent after evidence surfaced that the device may increase the risk of stroke and death. The Ohio medical malpractice lawyers of Elk & Elk want to make you aware of the possible danger involved in using these stents.
The U.S. Food and Drug Administration is restricting use of a brain stent manufactured by Stryker that props open clogged brain arteries.
The Wingspan stent was approved by the FDA in 2005 for use in patients with plaque-filled arteries in the brain – a condition which can lead to strokes. After looking at data suggesting the stent can actually increase stroke and death in some patients, the FDA now says the device should only be used only for a small segment of patients who have experienced multiple strokes but have not had any stroke symptoms in the last week.
The Wingspan stent is made up of a small, mesh tube that is secured via an inflatable tube, promoting blood flow thorough the arteries to the brain.
A petition filed last year by Public Citizen, a public safety advocacy group, called on the FDA to remove the device from the market. The group’s petition referenced a study that found a 2.5-fold increase in stroke or death among patients with the Wingspan stent, compared to patients taking only blood-thinning medications.
The FDA admitted that those risks were a concern, but said the device still may be beneficial to some patients who have not responded well to other therapies.
If you or a loved one has suffered an injury due to a medical product defect or recall, contact the medical malpractice lawyers of Elk & Elk today. Call 1-800-ELK-OHIO and find out how we can help you get the compensation you deserve.