Eugene Blackstone, writing an editorial for the journal Circulation (2005), examined the issues surrounding the Bjork Shiley valve. Among the questions he raised were "Why was the device approved by the Food and Drug Administration (FDA) when catastrophic failure occurred in premarket trials?" and "Once marketed, why was the device not withdrawn when catastrophic failures continued to occur?"
Those catastrophic failures, according to Blackstone, occurred during premarket trials, before the device was ever approved for use. When the Bjork Shiley valve was removed from the market in 1986, it was done so because of concerns that the outlet strut on the BSCC heart valve could fracture, allowing an uncontrollable blood flow while at the same time releasing a mechanical disc into the patient's blood stream. According to reports, approximately two-thirds of patients who had their BSCC heart valve fracture suffered cardiac arrest and died.
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Blackstone argues that despite catastrophic failures during premarket testing, the FDA allowed the valve to go to market because of Shiley Inc's assertion that the first valve failure was a fluke. If they had not approved the device for sale on the market, the catastrophe would not have occurred.