Could It Happen Again?

Most readers of “Twenty-Five–Year Experience With the Bjork-Shiley Convexoconcave Heart Valve: A Continuing Clinical Concern” in this issue of Circulation have not heard of the valve.1 Many elements of its story parallel those of cerivastatin2,3⇓ and rofecoxib,4 but with a twist: Recalling a heart valve may entail greater risks than leaving a possible “time bomb” in place. The Bjork-Shiley story raises many questions about balancing the benefits of drugs and devices with their risks to public safety. For example:See p 2850 My personal involvement began when a lawyer for Shiley, Inc, with a biostatistical degree read our account of the Braunwald-Cutter heart valve and wanted to understand why the University of Alabama at Birmingham and the Mayo Clinic decided to prophylactically remove every one.5 Subsequently, I served on scientific panels, spearheaded a multi-institutional effort to quantify the risks of prosthesis explant,6 and suggested ways to use this information for the tough decision making ahead.7The Bjork-Shiley heart valve, developed by Shiley, Inc, in collaboration with Dr Viking Bjork of Sweden, was …