Cleveland, OHWhen it comes to analyzing the catastrophe that was the Bjork Shiley Heart Valve situation, it took some analysts a while to give in-depth analysis of the situation. The Bjork Shiley valve was removed from the market in 1986, but even in 2005 experts were asking if the problems experienced with the Bjork Shiley heart valves could happen again.
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 and "Once marketed, why was the device not withdrawn when catastrophic failures continued to occur?"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.
Although the device was pulled from the market, it was not removed from patients who had it implanted because of risks associated with the removal surgery. This means that there are still patients who have the valve implanted and could be at risk of valve fracture. As recently as 2005, according to a study in Circulation (Blot, W. et al, 2005) there were still patients experiencing valve fractures, although the risk was low at less than 0.1 percent per year. Researchers concluded, "Twenty-five years after the initial BSCC valve implants, fractures continue to occur. Continued monitoring of BSCC patients is needed to track and quantify risks and enable periodic updating of guidelines for patients and their physicians."
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.
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