Heart Stents

 

In the United States, coronary artery disease is a leading cause of death among men and women. The American Heart Association reports that about every 29 seconds, someone in the U.S. suffers from a coronary artery disease-related event, and about every minute someone dies from such an event. One way to fix clogged arteries-- that can cause chest pains, sudden heart attacks and strokes-- is the use of heart stents. Every year, when hundreds of thousands of people need procedures to open up their arteries, this procedure is usually performed with heart stents.

Drug coated heart stents may cause clotting.Once a heart stent has been implanted into the heart arteries, it becomes part of the artery itself and remains there permanently. In November 2004, a Duke University Medical Center study-- presented at the American Heart Association’s scientific sessions-- showed heart stents do not improve the long-term survival rates of heart patients, even when drug-coated heart stents are used.

In April 2003, Cordis Corporation, a subsidiary of Johnson & Johnson, received FDA approval to market there Cypher drug-coated heart stents. Within six months several hundred people had suffered life-threatening injuries and 60 heart stent related side effects had been reported.. The FDA issued two major warnings about this product in 2003, yet the heart stents remained on the market.

These serious injuries and deaths suffered by patients with Cypher heart stents were largely caused by blood clots. These Cordis-Johnson and Johnson heart stents pose a high risk of causing blood clots around the stent. Stent thrombosis has a high risk of causing a heart attack. In addition to these serious risks, Cyper heart stents have also been linked to severe allergic reactions, of which the FDA received at least 50 adverse drug reaction reports in 2003 alone.

In March 2004, competitor Boston Scientific received FDA approval to market Taxus drug-coated heart stents. Less than six months later, the company announced a partial recall of the Taxus heart stents due to safety concerns, eventually climbing to over 100,000 recalled devices. At least three patients are reported to have died as a result, and many others have been seriously injured as a result of the Taxus defects.

 

 









Ashkin Law Firm
Roberta Ashkin, Esq.
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