St. Jude Silzone Leakage May Still Arise

Newport Beach, CADespite having been recalled more than 10 years ago, the St. Jude Medical Silzone mechanical heart valve could still cause problems for some prosthetic patients. According to James T. Capretz, attorney in Newport Beach, California, even though the manufacturer of the St. Jude heart valve initially claimed paravalvular leakage of the valves would not occur beyond a few months after implantation, patients have reportedly had problems with their allegedly defective heart valve through recent times.

"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.

"These late examples of leakage show us that patient problems still exist and people may have late leakage notwithstanding continuing leakage reassurances by the company," Capretz says. "This is not surprising considering manufacturers commonly attempt to publicly minimize their problems." Symptoms of paravalvular leakage reportedly include fluid retention, swelling of the ankles and a return of cardiac symptoms.

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.