St. Jude Has Recalled All Silzone Heart Valves
A lawsuit was recently filed against St. Jude Medical Alleging Defective Heart Valves caused injuries to a Massachusetts woman.
The woman had open heart surgery in April of 1999, she soon experienced leakage around the heart valve stemming from an infection (endocarditis). This condition called paravalvular leakage, makes the heart a less effective pump and can result in heart failure.
In November 1999, the failing Silzone valve was replaced with another
St. Jude Silzone valve. The second valve also leaked requiring a third surgery
in May 2000.
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.
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 paravalvular leakage.
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.
Contact a lawyer via our Massachusetts-Lawyers.com
Submission form here.