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On January 22, 2000 all St. Jude heart valve replacement and repair products with Silzone were voluntarily recalled by their manufacturer, St. Jude Medical, Inc. The St. Jude heart valve recall was prompted by a clinical study indicating an unacceptable risk of valve leaks requiring re-operation to remove and repair Silzone St. Jude heart valves.
The self-sponsored St. Jude heart valve clinical study, known as AVERT (Artificial Valve Endocarditis Reduction trial) is considered the largest and most rigorous clinical study ever designed to measure the safety and efficacy of a prosthetic heart valve. In this St. Jude heart valve study, 4,400 participants were studied over many years in order to measure the efficacy of the Silzone coating on the valve sewing cuff to reduce infection risk after surgery.
The study was cut short in January 2000 after researchers discovered that eight of the 398 trial participants with a Silzone St. Jude heart valve suffered paravalvular leakage that required re-operation and explantation. This was eight times the frequency of paravalvular leakage in patients with non-Silzone St. Jude heart valve devices.
St. Jude states that the defect is directly related to the Silzone fabric coating and is not related to the quality of the heart valve itself. The Silzone St. Jude heart valve was first introduced on the worldwide medical market in 1997 with the hopes that this proprietary material would reduce the risk of endocarditis in patients. The manufacturer estimates that there have been 36,000 implants of St. Jude heart valve repair and replacement products since they were first made available worldwide.
While St. Jude Medical will no longer produce or distribute heart valves with Silzone due to serious safety concerns, the company does not recommend re-operation and St. Jude heart valve explantation unless that patient has experienced complications.
There are, however, serious risks associated with St. Jude heart valve leakage. When a leakage occurs it is typically between the valve sewing ring (where the Silzone is located) and the heat tissue area of prosthetic valve attachment. When this leak occurs, a patient may develop an infection, called endocarditis, which can lead to reduced heart functioning, heart failure, and death if not promptly and properly addressed and treated. The St. Jude heart valve was supposed to lower the risk of infection when, in fact, this product actually increases the risk of life threatening complications.
One lawsuit has already been filed against the manufacturers of the St. Jude heart valve. After having open heart surgery in 1999, one woman experienced a St. Jude heart valve leakage which caused injury and infection and required two additional surgeries. Medical device manufacturers have a responsibility to protect consumers from unacceptable risks associated with product defects. When a person is injured by a medical device, they may be eligible to seek compensation for their losses and suffering. If you would like to learn more about the St. Jude heart valve recall, please contact us to speak with a qualified and experienced attorney who can help protect your legal interests.
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