January 25, 2012, 08:00:00AM. By Gordon Gibb

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Miami, FL: It's been some time since the Bjork Shiley heart valve has been in the news, and with good reason—it was way back in 1986 that the Bjork Shiley Convexo-Concave heart valve was forced off the market by the US Food and Drug Administration (FDA) due to failures that led to hundreds of deaths. The problematic valve was replaced in some patients, but not in others after the risks for revision surgery was deemed too great.

For those patients, the last 25 years have been akin to living with a ticking time bomb. Nor is it inconceivable to think that someone who received a defective Bjork Shiley heart valve while they were still actively on the market would still be alive today. Anyone in need of a heart valve transplant at a fairly young age would still be going strong, provided their heart valve was functioning properly.

The issue then has been the psychological costs associated with knowing the possibility of catastrophic failure and the odds of death were that to happen: Of the Bjork Shiley Convexo-Concave valves that failed, patients died in two-thirds of the cases. Notwithstanding has been the need to remain on anti-coagulant drugs such as Warfarin, which translates to an ongoing cost for the patient.

Such patients may well want to sue for compensation.

Not all heart valves in the Bjork Shiley line were problematic. In fact, they were considered quite durable until 1979, when a design modification allegedly initiated in part to speed the manufacturing process led to problems. Failure of the welds holding the outflow strut in place would lead to catastrophic failure in more than 600 cases, and sudden cardiac death occurred in the majority of patients experiencing such failures.

The Bjork Shiley Convexo-Concave is yet another illustration of the debate currently underway in the medical community concerning the approval protocol of medical devices—and specifically, those that bear some resemblance to devices already on the market.

The FDA's 510(k) approval guidelines currently allow for a faster access to market for such devices. And here is where the great divide comes into play.

Health advocates and critics such as Public Citizen maintain that the lack of pre-market testing, even on proposed devices similar to that already being used, puts the public at risk. They advocate for abolition of the fast track protocol.

On the other side are device manufacturers who maintain the current fast track guidelines are not only sorely needed, they are way too slow. Proponents argue that device manufacturers have an easier time placing new and updated devices elsewhere in the world, and are shifting more of their focus overseas.

The Miami Herald last year profiled a retired surgeon who flew to Columbia for a procedure involving the insertion of an experimental heart valve through an artery in his leg. The surgery had to be performed there, as the heart valve used has not been approved in the US. The hospital performing the operation is affiliated with the University of Miami and many of its doctors were trained in South Florida.

Thus, the FDA is getting it from both sides: patient advocates who decry the lack of pre-market testing and say the FDA should abolish the fast-track, versus device manufacturers and some in the medical community who feel the FDA is not moving fast enough.

In the middle are patients who continue to live with the failed Bjork Shiley Convexo-Concave heart valve and who may be considering a Bjork Shiley lawsuit. They would prefer the FDA to put the brakes on the fast track entirely.

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