Boston Scientific and Johnson & Johnson 'Coated Stents': More Harm Than Good?
DRUG COATED HEART STENTS IMPLANTED IN MILLIONS OF PATIENTS COULD BE TICKING TIME BOMBS - AND THEY ARE PERMANENT
Recently published reports of studies by the New England Journal of Medicine have shown that drug-eluting stents were associated with an increased rate of death, as compared with bare-metal stents. (March 8, 2007).
Stents are tiny pieces of wire used to prevent heart attacks by keeping arteries open. Drug-eluting stents contain drugs that potentially reduce the chance the arteries will become blocked again. The downfall - they create a place where potentially deadly blood clots can form and cause heart attacks.
The American College of Cardiology announced this week (March 27, 2007) that implanting drug-coated stents in addition to traditional drug therapy alone provided no lasting benefit. The news comes as a surprise to many in the cardiac community, and perhaps another blow to the makers of drug coated stents.
Stents generate nearly $5 billion a year in U.S. sales for Boston Scientific and Johnson & Johnson, the two companies that dominate the market. Both corporations admit the increased risk of blood clots but claim the benefits still outweigh these risks.
The Taxus stent from Boston Scientific, first used in 2004, achieved more sales in its first year than any health care product in history. (Source: NY Times)
However, The FDA issued a Class I Recall on the Taxus Express in July of 2004, because "characteristics in the design resulted in failure of the balloon to deflate and impeded removal of the balloon after stent placement," which lead to significant patient complications, including emergency coronary artery bypass graft surgery and death.
Class I recalls (according to the FDA) are the most serious type of recall and involve situations where there is a reasonable probability that use of the product will cause serious injury or death.
If you or someone you love has had a drug-eluding stent implanted, please contact our attorneys immediately.
More Information on Drug-Coated Stents
- Questions and Answers on Coronary Drug-Eluting Stents (FDA)
- FDA Statement on Coronary Drug-Eluting Stents
- "Stent"
-
MedlinePlus Medical Encyclopedia
