Bjork Shiley heart valves were available on the market from 1979 through 1986. They were used to replace mitral or aortic valves but were taken off the market due to a risk of a component on the valve fracturing. That fracture could cause uncontrolled blood flow and could also result in releasing a portion of the valve into the blood stream, potentially cutting off blood flow to other parts of the body.
Because of the risks associated with surgery to remove the valve—the rate of death associated with the surgery was around five percent—not all patients were given surgery to remove the valve. Instead, they were put on anticoagulant medications such as Warfarin to prevent blood clots. But they spend each day knowing they have a valve that could potentially fail or fracture at any moment, putting their lives at risk.
According to The New York Times (1/25/92), the valves were implicated in approximately 300 deaths, and two-thirds of patients whose valves fracture die as a result.
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In 1992, the FDA issued its warning about the Shiley valves, noting that the risk of fracture could be five times higher than previously thought and warning that valve fracture is often fatal.