A former official with the Food and Drug Administration has joined a growing number of voices calling for the recall of the Wingspan stent system manufactured by Stryker.  This medical device has been associated with an increased risk of suffering strokes and death.

According to consumer safety group Public Citizen, a recent study conducted by the National Institutes of Health found that persons with a Wingspan stent have a 2.5 times increased risk of suffering a stroke or death.  Public Citizen has asked the Food and Drug Administration to have the device removed from the market.

The study investigated 150 patients who suffered a stroke, and were then treated with the Wingspan stent system.  These patients were monitored for a period of 6 months.  According to the study published in the New England Journal of Medicine, patients who were treated with the Wingspan stent system were more likely to suffer a second stroke or die after a period of 30 days, when compared to those patients who had been treated with blood-thinning medications.

The device was approved in 2005 under the Food and Drug Administration’s fast-track approval process.  This procedure has come under great criticism by Houston defective product attorneys and consumer safety groups.  The 510 (k) approval process allows companies to get their medical devices approved quicker, if they can prove that the device is very similar to one that is already approved and on the market.  The number of devices being approved through the 510 (k) processes has increased substantially as abuse of the process has led the approval of unsafe devices.

Vuk Vujasinovic is a Board Certified Houston personal injury attorney who practices Houston auto accident and other personal injury cases.

For more info on how Vuk can help you with your potential case please call him at (877) 724-7800 or fill out the contact form on the right.

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