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Bjork Shiley Heart Valve

   Hundreds of people have had to have their Bjork Shiley Heart Valve's replaced because of strut fractures and other safety issues. Defective Bjork Shiley Heart Valves were implanted in more than 40,000 Americans.

   Shiley manufactured and sold the BSCC valve between 1979 and 1986 until it was removed from the market. Approximately 86,000 BSCC valves are believed to have been implanted worldwide. Worldwide, 619 valve fractures have been reported to Shiley. In approximately two-thirds of the cases, it is reported the patient died following the valve fracture.

   The FDA forced the Bjork-Shiley Convexo-Concave heart valve off the market in 1986. Pfizer purchased Shiley in 1979 at the onset of its Convexo-Concave valve ordeal. In 1992, after years of litigation, Pfizer sold Shiley's businesses to Italy's Sorin Biomedical. Sorin opted not to purchase rights to the C/C valve. Recently, a firm by the name of Alliance Medical Technologies, comprised of former Shiley and Pfizer employees, purchased the rights to Shiley's Monostrut heart valve line from Sorin.

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