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product_liability heart_stentRestenosis occurs in about 1/3 rd of angioplasties within six months, meaning the artery has become blocked again. Experts believe restenosis is the body''s immune system response to the angioplasty. By using a stent to prop open the coronary arteries, the occurrence of restenosis has been reduced. Coronary artery diseases are the leading cause of death for both men and women in the U.S. and Europe, so the frequency of restenosis has affected a great number of people.
In April 2003, a new drug-coated stent was approved for Johnson and Johnson''s Cypher stent. Instead of just propping open the artery like the metal stent did, the new Cypher stent was coated with a drug called Sirolimus to reduce the likelihood of restenosis from occurring from scarring. When the greatly anticipated Cypher stent entered the market in April 2003, it took just three months for it to be used in 50,000 patients.
Then in July 2003, the FDA issued a warning after receiving reports that blood clots had occurred in 34 Cypher recipients, including five who died. By October 2003, the agency had to issue its second warning when the reports of blood clots in Cypher recipients exceeded 290, including more than 60 cases associated to the patient''s death. While the FDA later issued a statement in November concluding the Cypher stent was a safe and effective device, there are three kinds of drug-coated stents being made. There are still no definitive studies indicating if one stent may have a lower incidence of restenosis.
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...