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product_liability heart_stentCardiac heart stents have made news after the FDA issued its second warning about blood clots occurring in the latest drug coated cardiac heart stents to enter the market. Cordis Corp. received FDA approval for in April 2003 for its Cypher cardiac heart stents. Since then, the cardiac heart stents have been popular. The new cardiac heart stents emits a drug that can prevent the artery from becoming clogged again.
What were unforeseen with the cardiac heart stents were the reports of blood clots. In July 2003, the FDA announced a cardiac heart stents warning after receiving reports of blood clots from 34 cardiac heart stents recipients, including 5 deaths. Many patients were left questioning the safety of the cardiac heart stents in October 2003 when the FDA issued yet another warning.
The number of adverse events reports among cardiac heart stents users appeared to have significantly increased from July. By October 20, 2003, the FDA had received reports that over 290 cardiac heart stents patients suffered blood clots, with over 60 deaths resulting. Patients are now questioning the safety of cardiac heart stents, and so far, there have been up to 300,000 cardiac heart stents implanted in the U.S. Cardiologists are being advised of the importance of choosing the right size cardiac heart stents for patients and for proper implantation while scientists continue to study if the cardiac heart stents do have an increased risk for blood clotting.
Over 2,000 patients every year are suffering avoidable injury and death as a result of stents, small metal devices used to hold open heart arteries, according to two doctors who wrote an editorial published in a leading medical journal.
The ar...
Despite reports of more injuries related to Boston Scientific Corp.’s heart stents, the FDA said they did not plan on taking any further action against the company. Last year, Boston Scientific recalled more than 99,000 Taxus heart stents following re...