Twelve thousand people in North America may be at risk due to the January 24, 2000 recall of mechanical heart valves manufactured by St. Jude Medical, Inc. The recall involves St. Jude's proprietary coating product known as Silzone. Although the prosthetic heart valve itself is not in question, it is the connective device to the heart tissue, a sewing cuff, which can cause paravalvular leak if coated with Silzone. This blood leakage might cause clotting, and if inoperable, can cause thrombosis and stroke.
The company, after consultation with the U.S Food and Drug Administration (FDA) and other regulatory agencies, voluntarily recalled all 36,000 implants they have supplied worldwide. St. Jude is not recommending wholesale removal of the devices (explants), but suggests patients undergo routine monitoring by accredited physicians.
If you have suffered injuries due to a St. Jude Medical heart valve, it may be important to contact an attorney who can help you protect your legal rights. Please keep in mind that there may be time limits within which you must commence suit.
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