Bjork Shiley Heart Valve

The Bjork Shiley Convexo-Concave (BSCC) heart valve was a mechanical prosthesis heart valve, used to replace either mitral or aortic valves. The BSCC valve was removed from the market due to a defect that reportedly put patients' lives at risk. Following the recall of the Bjork Shiley heart valve, lawsuits were filed alleging the companies responsible for the valve hid the risks associated with it. The Bjork Shiley valve was manufactured by Shiley and was available on the market from 1979 through 1986.

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Bjork Shiley Heart Valve Failure

In 1986, the Bjork Shiley heart valve was removed from the market due to serious safety concerns. The main concern was the risk of the outlet strut on the BSCC heart valve fracturing. That fracture could reportedly cause an uncontrollable blood flow, while also releasing a mechanical disc into the patient's blood stream that could cut off the blood flow to other parts of the body.

More than 40,000 Americans had the Bjork Shiley heart valves implanted. After the recall, not all Bjork Shiley valves were removed from patients. Because of the risk associated with removal surgery, which included an approximated death rate of about five percent, around 86,000 valves were left in patients with weak or defective heart valves. These patients must take anticoagulation medicine, like Warfarin (coumadin) to prevent deadly blood clots.

Defects of the Bjork-Shiley Convexo-Concave heart valve have reportedly lead to sudden cardiac arrest and death. Worldwide, more than 600 valve fractures have been reported to Shiley and in approximately two-thirds of the cases, it is reported the patient died following the valve fracture.

Bjork Shiley Lawsuit

In 1991, a class action lawsuit was filed against Pfizer, on behalf of patients who had received the implant and were concerned it might fracture. The lawsuit alleged Pfizer Inc hid potential defects from patients. According to The New York Times (01/25/92), the lawsuit was settled, with Pfizer expecting to pay between $155 and $205 million total. Pfizer agreed to create a fund to pay patients for a cardiac consultation and further agreed to set aside funds for research to identify which patients had a significant risk of having the heart valve fracture.

Bjork Shiley Heart Valve failure Lawsuits

If you or a loved one have a Bjork Shiley BSCC Heart Valve that has been replaced because of a strut fracture or for safety concerns, you may qualify for damages or other remedies in a Bjork Shiley Heart Valve lawsuit or class action. Please click the link below to submit your complaint to a Bjork Shiley Heart Valve lawyer for a free evaluation.

Please click here for a free evaluation of your Bjork Shiley Heart Valve case

Last updated on Jan-31-12

BJORK SHILEY HEART VALVE ARTICLES AND INTERVIEWS

Bjork Shiley Heart Valve a Ticking Time Bomb for Some

Miami, FL: It's been some time since the Bjork Shiley heart valve has been in the news, and with good reason—it was way back in 1986 that the Bjork Shiley Convexo-Concave heart valve was forced off the market by the US Food and Drug Administration (FDA) due to failures that led to hundreds of deaths. The problematic valve was replaced in some patients, but not in others after the risks for revision surgery was deemed too great.
[READ MORE]

Lethal Defects Of Bjork-Shiley Heart Valve

An estimated 25 million Americans have one kind of medical implant or another. However an analysis of implant recalls over 10 years show that the average number of recalls per year was 40 and by 2001, the number rose to 117 [READ MORE]

IN YOUR OWN WORDS

My Bjork Shiley "CC" valve was inplanted in 1980, I now have an enlarged heart due to the valve leaking.

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