St. Jude Heart Valve Recall

On January 21, 2000, St. Jude recalled all products with the Silzone coating.

Approximately 12,000 patients have the silizone coated heart valves, according to St. Jude's own clinical study, at least two percent of these patients may experience the paravalvular leakage associated with the valves.

The valves

The St. Jude Silzone valve is a St. Jude conventional mechanical heart valve. The valve sewing ring is coated with elemental silver-Silzone, which St. Jude believed would reduce valve infections (endocarditis)-because of its antibacterial qualities.

After St. Jude distributed the valves with Silzone in March 1998, they conducted a clinical follow-up to determine the effect of the Silzone coating on the incidence of valve endocarditis. The study examined a one group consisting of patients implanted with the standard St. Jude heart valve, and a second group implanted with the new Silzone coated valves.

The study indicated a higher incidence of paravalvular leakage with the Silzone valve. Of 800 patients studied: only one out of 400 implanted with the standard St. Jude valve had a paravalvular leak, the 400 with the silizone valve had eight cases of paravalvular leak.

Lawyers believe St. Jude Medical was negligent in designing, manufacturing and marketing a defective heart valve that was not adequately tested and that the risks of serious bodily injury exceeded the benefits associated with the silizone coating and design.

More information at St Jude Heart Valve Recall

If you have been injured by a St Jude Heart Valve contact a lawyer here.