The Times article reports that as of 1992, approximately 500 of the valves implanted worldwide had failed. Not a high number compared to the number that were implanted, but of the 500 failures, two-thirds of the patients died. That means that having the valve fail put patients at a greatly increased risk of death. Approximately 25,000 of the devices were implanted by 1986, when the FDA issued its recall.
The valves were recalled after concerns about the failure rate and the risk of death when the valves failed. According to the Times article, some Bjork Shiley valves were cracked before they were ever implanted, and those valves may not have been properly fixed. The article alleges that rather than properly welding cracked valves, the valves were simply polished over, and paperwork was forged to make it appear the valves had been properly repaired. Employee 2832, the employee who was said to have re-welded the valves, reportedly did not exist.
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Even decades after the settlements were announced, the FDA still looks to the Bjork Shiley ordeal. In a presentation on percutaneous aortic valves and drug eluting stents, Dr. Steven Greer noted, "The Bjork-Shiley fiasco taught us that a failed heart valve leads to rapid death."