Bjork Shiley Heart Valve

The Bjork-Shiley valve is a mechanical heart valve prosthesis. Since 1971, it has been used to replace the aortic or mitral valves. It marks the first example of a successfully used tilting-disk valve. It was manufactured first by Shiley Inc., then later by Pfizer. One model of the Bjork-Shiley valve became the subject of a famous lawsuit and recall after it was shown to malfunction, usually fatally, in a number of cases.

Beginning in 1979, Bjork-Shiley valves with the convexo-concave design displayed a tendency to develop fractures in the outflow strut which could result in catastrophic valve failure and potential cardiac death. Eventually, 619 of the 80,000 convexo-concave valves implanted fractured in this way, with the patient dying in two thirds of those cases. The convexo-concave valve was forced off the market by the FDA in 1986. Valves welded by specific welders were at greater risk of fracture. The Convexo-Concave valve was withdrawn from the market and multiple lawsuits were filed on behalf of affected patients.

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