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Bjork-Shiley Heart Valve
The Bjork-Shiley Heart Valve was introduced in 1976 and was
initially very succesful. It was when the 'improved' Bjork-Shiley
Convexo-Concave ( BSCC ) was introduced that the problems
began. Approved by the FDA for patient use in 1979, more than
86,000 devices were sold. According to the FDA, about 23,000
people in the United States and Canada have the Bjork-Shiley
Convexo-Concave (BSCC) heart valve. Due to a defect in the
valve, it can fracture, often causing death within minutes.
In the 7 years that the Bjork-Shiley Convexo-Concave heart
valve was available, there were approximately 600 reported
cases of failure.
Bjork-Shiley Heart Valve Cracks
The original model of the Bjork-Shiley heart valve was durable
and reliable. Unfortunately, Shiley, an offshoot of pharmaceutical
giant Pfizer, tried to improve the original Bjork-Shiley heart
valve by redesigning it, which led to serious damage.
The Convexo-Concave models of the Bjork-Shiley valve develops
cracks or fractures in the metal struts holding the disk in
place. Eventually, the struts break and the disk escapes.
The patient then becomes gravely ill from blood leaking back
in through the valve. About two-thirds of patients die, many
within minutes.
Bjork-Shiley Heart Valves and the FDA
The FDA pushed the Bjork-Shiley Convexo-Concave heart valve
off the market in 1986 and by 1990, there were 100 lawsuits
pending against Pfizer. In the end, Pfizer ended up spending
more in legal fees and lobbying costs than if they had replaced
the valves in the first place. In the end, Pfizer ended up
spending $20 million dollars ($10.75 million for the patients
who died as a result of the failure of the valve and $9.25
to monitor those still living with the valve).
Pfizer sold Shiley to Sorin Biomedical. Sorin Biomedical
chose not to purchase the rights to the Bjork-Shiley Convexo-Concave
heart valve.
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