St Jude Medical Silzone heart valves

Three years after its introduction in 1997, St Jude Medical Silzone heart valves were found as the main cause of making people sick due to defective coating. St. Jude Medical, Inc., manufacturers of these valves, recalled devices with Silzone coating on January 21, 2000. During that period, about 2,300 Canadians were implanted with defective valves.

St Jude Medical Silzone heart valves were coated in silver to reduce the rate of infection, but the first class action lawsuits were filled in 2000 alleged that St Jude Medical was negligent in researching and developing the valve, marketing the product without proper testing. This manufacturer company sells and distributes mechanical heart valves and annuloplasty rings to hospitals around the world.

The silver-based coating St. Jude Medical used is known as "Silzone", applied to the sewing rings of the mechanical devices to reduce the risk of bacterial infection. It was estimated that only during January 2000, more than 36,000 Silzone heart valves were sold and implanted in patients around the world.

After that, St. Jude Medical announced a voluntary worldwide recall on all field inventory including repair products using Silzone coating on the sewing cuff fabric, such as the heart valve replacement, and made available information on its website and printed literature, meant to reach people suffering injury from implanted defective valves.

St. Jude Medical is no longer distributing any product with Silzone coating, and there is a Medical Expense Reimbursement Program instituted for patients who received this implant, although expressly remarking that reimbursement covers reasonable medical expenses that insurance are not reimbursing, being "medically necessary to detect, diagnose and treat paravalvular leak" as the company stated.

Although, the recall did not include Silzone products implanted in patients before January 21, 2000, the letter was made available for both physicians and general public information, and is still available at this address: http://www.sjm.com/documents/devices/2000recallnotification.pdf.

Silzone products issued safety warning in many countries before the recall, facing refused permission for hospitals and surgeons to use these products, while in those nations were St Jude Medical Silzone heart valves were approved, not all hospitals accepted these products and stopped implanting such devices, concerned about their patients safety.

Research began to find increasing incidence of paravalvular leak (PVL) that eventually led to St. Jude Medicals recall. Paravalvular leak (PVL) is a flow of blood around the mechanical device, usually between the heart tissue and the attached valve sewing ring, making it necessary to remove the valve due to complications.

Actually, there are lawsuits against the company throughout Europe, as well as in Canada and the United States, where pre-trial discovery issues for Silzone cases have been handled by lawyers in the District of Minnesota.

As of August 2006, trial dates for cases in litigation between March 14, 2006 and June 13, 2006, had not been determined yet. Even when not all people have received a Silzone heart valve implant, the large number of injured persons makes a significant number of claims for damages to file the lawsuit.