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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.


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St. Jude Heart Valve Recall

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.

St. Jude Silzone Heart Valve Trial

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.

St. Jude Silzone Heart Valve Lawsuit

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.
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St. Jude Silzone Side Effects Lawsuits
St. Jude Silzone Side Effects Lawsuits
January 12, 2013
Even though more than 12 years have passed since the St. Jude Silzone heart valve was pulled from the market, lawsuits were still making their way through the courts the past two years, including one lawsuit in Canada. The lawsuits alleged St. Jude manufactured a defective heart valve that developed a valve leak in some patients, resulting in their having surgery to remove the defective St. Jude heart valve. READ MORE

Problems for Defective St. Jude Heart Valve Patient Lay in Waiting Beyond Surgery
Problems for Defective St. Jude Heart Valve Patient Lay in Waiting Beyond Surgery
December 9, 2012
Problems encountered by patients with regard to the allegedly defective St. Jude heart valve, often wind up with more trouble than they bargained for even after the allegedly defective heart valve is replaced. READ MORE

Studies Suggest St. Jude Device Not Effective
Studies Suggest St. Jude Device Not Effective
October 27, 2012
Two studies suggest a St. Jude Medical device may not be as effective as thought. The device, known as the St. Jude Amplatzer PFO Occluder was designed to close holes in the patient's heart following a stroke, but two studies suggest the device is no better at preventing repeat strokes in patients than non-surgical treatments. In 2000, certain St. Jude heart valves were recalled after concerns about heart problems linked to the silzone mechanical heart valve. Included in concerns about the reportedly defective heart valve were an increased risk of heart failure, thrombosis and stroke. READ MORE


Posted by

Hi, I had a st jude silzone coating mitral valve replacement at 33yrs of age, in 1999, Due to a genetic problem. After 15 months I had endocarditis and had to have the valve replaced. I was in hospital for 10 weeks having treatment, this destroyed my family at the time. I recovered well and worked hard to return to work approximately a year later.
However, I now have heart failure and find it hard to work.
Yours Faithfully
Dean Blainey

United Kingdom

Posted by

My husband had aortic valve replacement on June 3rd and died on June 6th.

Posted by

December 1998 was the first time my husband went to the doctor concerned about the flu like symptoms he was having. It was found he had a large heart and was therefore sent to a cardiologist who suggested surgery mechanical valve in plant since he was a young 58 year old. Surgery was done was no more than 3 weeks later and he was feeling terrible. We continue to go to the doctors to find out what the problem could be they were adamant that it could not possibly be his heart, they had just fixed the problem.they tbought infection, pneumonia even Dressliers syndrome. They had him in the hospital and finally had a team of cardiologists look at him. They did an esophageal test to look at his heart. They were horrified to findhis heart had leaked from 12 o'clock to 5 o'clock. This was in July 1999.His surgery was set for Aug 7 . I was blessed that he survived but not until 3 more surgeries were done. It left his heart very badly damaged. He lived another 10 years and had a cardiac arrest which resulted in brain damage because we were once again lucky to have a AED close by. The damage was to great and a year and he later his organization s failed and he died peacefully. You could say it was a success cess husband was a fighter and had a great will to survive. But as far as I am concerned he was taken far to soon because of the damage done because St Jude decided to change their product without fully testing it.


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