Ethical issues in biomedical engineering: the Bjork-Shiley heart valve

The ethical issues surrounding the failure of one type of Bjork-Shiley heart valve (due to fracture of the outflow strut), and Shiley Inc.'s handling of the problem are examined. withholding of information on the part of Shiley is discussed. The consequences of this behavior (as many as 765 fractures and 480 deaths have been estimated) are described. Regulatory changes that could prevent future problems of this nature are outlined.<
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