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.

Tens of thousands of 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, patients with weak or defective heart valves did not undergo the removal surgery, leaving the potentially defective heart valves implanted. 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 claim

Last updated on Feb-14-12

BJORK SHILEY HEART VALVE LEGAL ARTICLES AND INTERVIEWS

Bjork-Shiley Heart Valve: Was Shiley Unethical in its Handling of the Fractures?

December 18, 2012

Issues with defective devices such as the Bjork Shiley Heart Valve bring to mind problems with the device itself. But how a company handles serious issues, such as problems with the Bjork Shiley valve, can add to the defective nature of the product. As issues with the defective Bjork Shiley heart valves grew in severity, claims arose that Shiley??"manufacturer of the valve??"was misleading patients and the FDA about its device. READ MORE

Bjork Shiley Lawsuits Settled Decades Ago, Could More be Filed?

October 26, 2012

With the Bjork Shiley heart valve removed from the market in 1986, it makes sense to think that all lawsuits related to the Bjork Shiley valve would already have been filed and cleared from the courts. And indeed, some Bjork Shiley lawsuits have been settled. But that does not mean that people who suffer a failure of the Bjork Shiley valve today could not file a lawsuit. READ MORE

Who Actually Pulled Bjork Shiley BSCC Heart Valve Off the Market?

September 24, 2012

Deep in the bowels of an archive maintained by the New York Times is a compelling investigative piece that aims to shed light on the Bjork Shiley Heart Valve, a mechanical device removed from the market in 1986 after too many patients experienced problems with the device. Many, numbering in the hundreds, died. READ MORE

MORE BJORK SHILEY HEART VALVE LEGAL NEWS

READER COMMENTS

Posted by
David bjork shirley valve recipient
on January 25, 2019

The above comment about Australia.regarding the Bjork Shiley faculty valve.The killed 7000 people in Australia before trying it in the USA. Everywhere they tried it till deaths made them try in another country. I've been blessed with mine,of which only seven were made the made a bit different. It's still going to be what kills me, baring a traffic accident etc. So check out facts, Bojork shiley now owned by Pfizer will not share this information. Currently No Records are available of my surgeries. The Gospital claims they failed to put on computer. Is this legal?. After 1 visit my "primary" doc who then this referred me to others about my heart related problems. One ordered an MRI, well that destroys the valve. And I die,period. Have since had cardiovascular doctors request my records from hospital that did surgery.Was told by hospital they dont have them. Isn't this illegal due to sensitive nature of valve,serial numbers of valve etc. Its already almost got me inactive death situation for ignorance if valve. Fed Up.

Posted by
Anonymous
on January 16, 2015

I was 13 when I had open heart surgery to replace my faulty aortic valve back in 1977. When the surgeon put the valve inside of me they noticed it was cracked. It was a Bjork shiley valve. It is now 2015 & it has lasted me this long, I have been lucky so far. My cardiologist said he has never known a valve of this type to last this long. I will need surgery to replace the valve at some point in my life as artificial valves don't have a lifetime guarantee, but so far it has held up well. It has been through 2 pregnancies, & other operations without complications. I am from Australia & have not heard of the valve being pulled from the market over here, so was surprised to hear that it was pulled of the market in the US. A lot of doctors I have seen have not heard of a Bjork shiley type of valve until they examine me. They are quite intrigued. Especially when they get close & here the ticking noise the valve makes. I hope people that read this know from my experiences that they do not have to worry as I have had no problems with mine even with a crack.

Posted by
Alabama
on November 28, 2012

I am writing this for the recepient's son and he has lost his mother and been through a lot of pain and anguish before and after her death due to the possibility that she could pass away at any time. She was unable to have this replaced due to so many surgeries in the past.

Posted by
Alabama
on April 25, 2011

I have heart surgery four times, due to a car accident as a passenger, and have been told by multiple cardiac doctors that they could not replace the valve because of already having had the heart operated on too many times, and that I would not survive another one.