St. Jude Silzone Mechanical Heart Valves

St. Jude Silzone mechanical heart valves were recalled in 2000 after concerns arose about the risk of serious heart problems linked to the St. Jude heart valves. Among the concerns are an increased risk of Silzone heart failure, thrombosis and stroke. Although the valves were recalled, they were not removed from everyone who received one, so some patients could still be at an increased risk of heart problems.

In January 2000, St. Jude Silzone mechanical heart valves were recalled, following evidence that silver coating on the valves was prone to leaking. The condition, which is known as paravalvular leakage, can lead to heart failure. Approximately 36,000 valves were implanted worldwide, with around 10,500 implanted in the US. At the time, St. Jude said it was no longer distributing the Silzone mechanical heart valve but recommended implanted devices be removed only if the patient suffered complications.

Furthermore, there was concern that the Silzone heart valve could be linked to an increased risk of thrombosis, thrombus formation and stroke, all of which can be serious.

The St. Jude mechanical heart valve, introduced in 1997, was similar to the company's other heart valves but had a Silzone coating. That coating was made of silver to reduce the risk of infection, but lawsuits allege the Silzone coating was developed and marketed without proper testing.

According to the product recall, there was a "statistically significant higher rate of paravalvular leak leading to valve explants in patients implanted with St. Jude Medical mechanical heart valves with Silzone coated sewing cuffs."

Among the products affected by the recall were silzone-coated mechanical heart valves, silzone-coated tissue heart valves and silzone-coated annuloplasty rings.

A trial called the Artificial Valve Endocarditis Reduction Trial (AVERT) was halted early—on January 21, 2000—because of the increased risk of paravalvular leak in the Silzone valve compared with the standard valve. Researchers found a 2.76 percent incidence of paravalvar leakage in patients with the Silzone valve as compared with a 1.02 percent incidence in patients without the Silzone valve.

The trial also showed an increased risk of stroke, reversible ischaemic neurological deficits and valve thrombosis in patients with Silzone valves, although the increase was not considered significant.

A class action lawsuit was filed in Minneapolis against St. Jude Medical involving the Silzone heart valve. Lawsuits allege the device was defectively designed and was not adequately tested to ensure its safety before being released on the market.

Silzone Mechanical Heart Valve Complaint

If you or a loved one has suffered from a defective St. Jude Silzone mechanical heart valve and the Silzone heart valve was or must be replaced, you may qualify for damages. Please click the link below to submit your complaint to a St. Jude Silzone lawyer.
Last updated on Mar-2-12