"The company originally said the leakage, if it would happen, would have happened within months of the time of implant," Capretz says. "As cases turned up showing that leakage could happen years after implant, the company now acknowledges the leakage could occur some time after implant."
The problem with the Silzone valve is that the sewing cuff was coated in a product called Silzone, which combined silver and two other metals. Those metals could cause a heart valve leak in some patients (a condition known as paravalvular leakage), which could result in heart failure if the valve is not timely replaced. It is also believed that the coated cuffs could cause adverse thromboembolic events. The valves were taken off the market in January 2000.
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Patients should consult with their cardiologist if they are wearing one of these valves and are suffering from any current heart issues. Patients who are not sure if they have a St. Jude Silzone heart valve implanted can contact the company or go on the company website to find out if they are wearing a Silzone valve. Capretz warns, however, that communications with medical device companies are often recorded.