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Who Actually Pulled Bjork Shiley BSCC Heart Valve Off the Market?

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Washington, DCDeep in the bowels of an archive maintained by the New York Times is a compelling investigative piece that aims to shed light on the Bjork Shiley Heart Valve, a mechanical device removed from the market in 1986 after too many patients experienced problems with the device. Many, numbering in the hundreds, died.

The problem is what to do about the patients who may still have functioning Bjork Shiley heart valves pumping away in their chests. The estimate was 55,000 in 1990. There are likely fewer today. But anyone still with one of those heart valves beating in their chests will forever wonder if, and when it might fail.

A failure of the Bjork Shiley BSCC can be catastrophic—especially if the device fractures at one of the welds. The unrestricted blood flow can cause death in under an hour, if not minutes if left untreated.

The Times article, first published April 17, 1990 referenced 389 fractures of the Bjork-Shiley convexo-concave heart valve since 1979. Of those fractures suffered by patients worldwide, death resulted in two out of every three cases.

It's one of the reasons why the problematic valve was removed from the market in 1986. Critics are quick to blame Shiley Inc., the company that developed and marketed the valve, for an inferior product. But there are other factors at play, including a regulator that, it has always been assumed, took action to pull the valve from the market.

According to the Times article, the US Food and Drug Administration (FDA) did no such thing. Various officials within the FDA, it has been reported, urged the agency to order the valve off the market. But the FDA deferred. In reality, the FDA is reported to have taken no official action until 1986—the year the Bjork Shiley Convexo-Concave valve disappeared from the market—and that was only to announce a review of the troubled valve in light of growing problems.

In reality, the Bjork Shiley valve was voluntarily removed from the market by the manufacturer itself citing, according to the New York Times, negative publicity. Regulators, it was reported at the time, acknowledged to Congressional officials that their response was found to be lacking, and that the FDA should have acted sooner.

Any would-be plaintiff thinking of filing a Bjork Shiley lawsuit due to problems with an original heart valve might be well served to look beyond the manufacturer in seeking a smoking gun.

Bjork Shiley heart valves were originally developed by noted Swedish surgeon and scientist Dr. Viking O. Bjork, and engineer Donald P. Shiley, who founded Shiley Inc., the manufacturer and marketer of the heart valves. Both men have since passed away, and the widow of Donald Shiley, Darlene, now spends her time as a philanthropist donating millions of dollars to worthy causes.

Shiley Inc. was purchased by Pfizer Inc. in 1979.

The manufacturer eventually moved to a one-piece valve strut that did away with the problematic welds that plagued the original design of the defective Bjork Shiley Heart Valves. The original welds proved unreliable—and while the percentage of patients whose heart valves failed when compared to the number of total valve insertions was low, the concern lay with the high risk of rapid death faced by patients whose valve (s) suddenly failed.

Bjork Shiley lawsuits allege that proponents of the manufacturer were negligent in not communicating emerging problems with the device to the medical community, or the general public. A class-action lawsuit against Pfizer Inc. was settled in early 1992, with the defendant facing millions of dollars in settlement claims. For any patient who may have survived a Bjork Shiley BSCC strut fracture and required revision surgery to have the valve replaced, it may not be too late to pursue a damage claim.

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READER COMMENTS

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I have recently undertook to search for the Bjork-Shiley Heart Valve that disappeared from the market, as I had been an engineer at Shiley -1974-75. I recall that the very first recall of the CCBS design was in the summer of 1975, when we were informed that three male patients had their valves fail, all of the same size and from the same lot number; two died and the third was hanging onto life, unaware of his condition. The FDA showed up at Shiley Labs, unannounced, to inform the President of Shiley Labs that FDA was going to announce its recall that evening on Channel 7, Los Angeles. When the President asked why the public announcement over TV, he got this answer: "There are no secret recalls.

I was briefly contacted by an attorney (1991) from the firm handling the class action suit against Pfizer/Shiley as he found that I had worked there in the early seventies. He informed me of the particulars of the lawsuit, then asked if I had ever worked on the design of the heart valve, I told him. "Yes, and I had made a study of the strut welding to determine if a superior welding technique was available".
We talked a bit about who was my supervisor, etc. Then he asked me the nature of my study and if I had presented it formally to the VP Of Engineering. "Yes", I said and told him the specifics of my work. I had come to Shiley following the relocation of my former employer/company- Electron Beam Research (Union Carbide) nearby Shiley Labs.

I had designed and supervised fabrication of electron beam welding systems for the company, and learned quite a lot about the superiority of EB welding of metals, and participated in numerous EB projects, the largest being for Arvin Industries in Indiana which had a contract to EB weld the first Ford exhaust convertors for their 1974 vehicles.

EB welding is generally performed in a high vacuum chamber, has precise position control in three dimensions and precise control of the energy directed to the work piece.
It was completely logical to me to EB weld the valve struts to the valve ring, first fixturing them in a circular holder with the struts properly positioned within respective holes in the ring. the protruding portion of the strut facing outward and thusly targeted by the electron beam. The time and energy transferred would be controlled so as to melt the end of the wire struts, and then a brief motion around the perimeter of the hole so as to have the two metals fuse with a shiny finish with no manual finishing required.
My approach was sound, and would have been a perfect application for EB welding. Also, a whole lot of labor was eliminated be not requiring all those former dental techs to grind, file the weld beads. And, quality control was a nightmare with all of the manual arc welding.

The most important gain by EB welding the struts to the valve ring was achieved by eliminating chill lines in the strut
that were created by manual arc welding heat rising up the strut wire. Chill lines form with two crystalline species on opposing side of the chill line. When this is the condition on exotic metals, it invites fatigue at this chill line and failure after the millions of cycles of the pyrolytic carbon disk cradled in the struts- exactly what had occurred with a number of implanted valves.

The attorney who was calling me, asked if I had kept a copy of my report, to which I replied, "No, it was proper when leaving an employer to turn in all files and materials to the company".

So, If this is of any value after all these years since I worked at Shiley Labs, chalk it up to the fact that FDA had only a few years earlier become the regulatory agency for the new and expanding field of artificial implants, and perhaps never hired any product engineers to assist in these recall cases. Today, I could use the work!

Have a nice day!

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