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St. Jude Silzone Heart Valve
St. Jude Medical, on January 24, 2000 Inc. announced that
it had initiated a worldwide voluntary recall of all field
inventory of heart valve replacement and repair products incorporating
its proprietary Silzone coating on the sewing cuff fabric.
St. Jude indicated that while it will no longer distribute
products with Silzone, it was not recommending explants of
these products unless individual patient monitoring detected
complications.
St. Jude Medical reported that approximately 12,000 patients
have the Silzone coated heart valves and at least two percent
of these patients may experience the paravalvular leakage
associated with the Silzone coated valves. This condition
makes the heart a less effective pump and can result in heart
failure.
About St. Jude Heart Valve with Silzone Coating
The St. Jude heart valve with Silzone coating was introduced
in 1997 and purportedly had the potential to reduce the incidence
of endocarditis in valve procedures. St. Jude has claimed
that the reported complication does not involve the valve
mechanism itself, but appears to be associated with the Silzone-coated
sewing cuff fabric.
St. Jude Heart Valve Clinical Trial
Shortly after St. Jude began distributing the Silzone valve
in the United States in March 1998, it began a long-term,
clinical follow-up trial designed to determine the effect
of the Silzone coating on the incidence of valve endocarditis.
The study was divided into two groups, the first group consisting
of patients implanted with the standard St. Jude heart valve,
and the second group implanted with the new Silzone valve.
Early results found an increase in the incidence of explants
due to paravalvular leak with the Silzone valve. In the first
800 patients, the 400 implanted with the standard St. Jude
valve had one case of explant due to paravalvular leak, compared
to eight cases of explant due to paravalvular leak with the
Silzone valve.
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