Santa Fe, NMOne of the biggest problems with having a medical device, such as the St. Jude heart valve implanted is what to do when the implant is recalled. Back in 2000, the St. Jude Silzone mechanical heart valve was recalled due to concerns about serious problems associated with the valves. The recall only affected valves that were on the shelves; patients were not encouraged to have the device removed unless the patient suffered complications.
What that meant was patients who had the device implanted were left with a medical implant that, as far as they were concerned, could stop working at any moment, with tragic consequences. Approximately 10,500 of the heart valves were implanted in patients in the US, and those heart valves were linked to an increased risk of thrombosis, thrombus formation and stroke caused by paravalvular leak due to the Silzone coating.
A study called the Artificial Valve Endocarditis Reduction Trial (AVERT) was stopped early because it found an increased risk of paravalvular leak in valves containing Silzone compared with valves that did not contain Silzone.
So why were patients who were given a potentially faulty device—one that was no longer being used in new patients—told not to have the device removed, even if it was linked to life-threatening side effects? Because the risks associated with surgery to remove the device could be even more serious than the risks associated with leaving the device implanted, according to at least one study.
The study, published in The Journal of Thoracic and Cardiovascular Surgery (2001), examined the risks associated with having a first heart valve reoperation (that is, the valve had already been operated on once). Researchers found that patients who were having a heart valve reoperation had higher mortality rates than patients having an initial heart valve procedure. Furthermore, the mortality was even higher for patients who had reoperation on a prosthetic valve.
In other words, patients with the St. Jude Silzone heart valve implanted were more likely to suffer a life-threatening consequence if they had surgery to remove the defective valve than if they left it in and hoped nothing bad would happen.
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