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Bjork Shiley Heart Valve
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.
If you or a loved one suffered injuries from a Bjork Shiley heart valve, please fill out the form at the right for a free case evaluation by a qualified defective medical device attorney.
Bjork Shiley Heart ValveRSS Feed
Sheily Inc of Irvine, CA, to Notify Patients of Heart Valve
Mar 12, 1992 | ww.fda.gov
The Food and Drug Administration has asked Shiley Inc. of Irvine, Calif., the maker of Bjork-Shiley heart valves, to notify patients and physicians that risk of fracture for some sizes of these valves may be higher than previously thought.The fracture rate for the large sizes of the 60-degree Shiley (C-C) valve is now thought to be as much as five times higher than previously estimated. Valve fracture is often fatal. FDA believes that the risk of fracture of these large valves, over...
Bjork Shiley Heart Valve
Quick Facts
Bjork Shiley Heart Valve Reference Guide
Date Approved
1979
Manufacturer
Bjork-Shiley Approved Uses
Heart valve replacement
Complications
Strut fracture
Valve fracture
Sudden cardiac death
Related Topics
Defective Medical Devices
1979
Manufacturer
Bjork-Shiley Approved Uses
Heart valve replacement
Complications
Strut fracture
Valve fracture
Sudden cardiac death
Related Topics
Defective Medical Devices
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