Bjork Shiley Heart Valve Plagued by Deception: Report

Washington, DCNearly ten years after the Bjork Shiley Convexo-Concave heart valve was withdrawn from the market, Professor John H. Fielder authored an exhaustive analysis of the troubles associated with the allegedly problematic medical device, and what the market withdrawal might have really meant.

The heart valve was introduced in 1980 (some reports say 1979) and underwent a number of design changes during six troubled years before Bjork Shiley—with the blessing of the US Food and Drug Administration (FDA)—finally relented to growing concerns and pulled the plug. Ironically, Professor Fielder notes in 'Defects and Deceptions: The Bjork-Shiley Heart Valve,' the most recent revision of the device prior to the recall may have finally been the magic bullet. Unfortunately, that doesn't help the scores of patients who may have received the defective heart valve prior to the final revision.

When the Bjork Shiley Convexo-Concave (BSCC) heart valve was withdrawn, advocates of the product cited a failure rate of about half of one percent, given the tens of thousands of individuals having received the mechanical heart valve. By 1993, Professor Fielder noted, there were 386 reported deaths. Since then that number has escalated to over 600—still a small percentage. However Professor Fielder, in his essay, referenced an estimate by public advocacy group Public Citizen, which placed the number of actual deaths at 50 percent higher than the number of reported deaths.

Studies anchored in the Netherlands added to the controversy, according to Professor Fielder, writing in IEEE Technology and Society Magazine (1995: 17-22). The studies were based on the explanation (removal) of Bjork Shiley heart valves from 22 patients for reasons of age, size of valve, opening angle and / or valve position. Two of the patients each had two valves replaced, making a total of 24 BSCC valves explanted for closer examination outside the body.

Professor Fielder noted that strut weaknesses cannot be seen with the naked eye, but rather require the use of a scanning electron microscope to detect abnormalities. What these scans found, writes Professor Fielder "is breathtaking." Of the 24 valves removed and thoroughly studied, 37.5 percent were in various stages of strut fracture. The finding, writes Professor Fielder, reinforces the position of those who believe the actual number of fractures from strut failure "is far higher than what is reported."

The actual study authors put it this way: "This finding supports our hypothesis that, owing to the legal character of the failing aortic valve strut, fractures remain under-reported; few such patients reach hospital and necropsy [autopsy] is rarely done."

Was the Bjork Shiley Convexo-Concave heart valve defective, asks Professor Fielder in his paper? "Yes, but not simply because a small percentage fractured. What made the valve defective were the unethical practices that surrounded its marketing and development."

Professor Fielder noted that when a Bjork Shiley Convexo-Concave fails, a patient needs immediate attention, with an expectation to survive one, to two hours following a failure. Were that failure to occur in association with an aortic valve—that patient may have but a few minutes to live. About two-thirds of Bjork Shiley Convexo-Concave patients who encounter a valve failure, do not survive. Those who do can have serious complications.

Any patient continuing to survive with a Bjork Shiley valve and living in fear, may wish to consider legal action. The families of those who may have died due to a Bjork Shiley BSCC heart valve may be well served to investigate the potential for a Bjork Shiley lawsuit.