In January 2000, St. Jude Medical, Inc. announced a worldwide recall of its heart valve products, tissue valves, and annuloplasty rings incorporating its proprietary Silzone coating. St. Jude's Silzone Heart valves are one of the most popular heart valves and St. Jude's estimates there are approximately 36,000 implants worldwide of St. Jude Medical heart valve replacement and repair products with Silzone coating.
The recall was initiated following reports that the valves may cause paravalvular leaking leading to blood clots, thrombosis, or stroke. A paravalvular leak is a flow of blood around the artificial valve usually between the valve sewing ring and the heart tissue to which the valve is attached. A clinical trial conducted by St. Jude revealed an unacceptable level of product re-operation to remove and repair Silzone® valves due to paravalvular leakage.
Although St. Jude indicated that while it will no longer distribute products with Silzone® coating, it was not recommending removal of these products unless patient monitoring detected complications. People who have received Silzone implants should see a doctor immediately. |
