Defective Drug-Coated Stents

The Food and Drug Administration (FDA) has assembled a panel of specialists to look into serious medical issues associated with drug-coated stents. Although the panel was initially convened with the intent to discuss defective heart devices, the recent clotting issues associated with drug-coated stents has prompted the FDA to include outside experts familiar with the subject. Since being introduced to the medical community in 2003, drug-coated stents have become far more popular than their bare-metal mesh predecessors.

Stents are typically used to dilate narrowed blood vessels preventing normal levels of blood flow to the heart. Stents are implanted in order to prop open arteries to avoid blood clotting following procedures like angioplasties. Although traditional bare-metal mesh stents were effective in propping open arteries, they have occasionally had problems related to improper closure, leading to clot recurrence. In effort to combat such problems, drug-coated stents were developed.

Drug-Coated Stents

Drug-coated stents were engineered with the intent of preventing scar tissue development that could potentially re-result in blood clotting. The 2003 release of drug-coated stents was highly-anticipated after which certain hospitals were reportedly implanting drug-coated stents in an estimated 90% of patients. The device was considered to be a far better alternative than traditional bare-metal mesh stents; however, recent studies conducted by The Cleveland Clinic have shown an increased risk of blood clotting associated with drug-coated stents than with bare-metal mesh stents. According to the study, drug-coated stent patients are four-to five-times more likely to suffer blood clots. In response to this study, many of the hospitals that were using drug-coated stents have resorted back to using stents of the traditional bare-metal variety. It has been estimated that use of drug-coated stents has decreased between 10 and 20% as a result of the Cleveland Clinics data.

While the report is viewed as problematic for drug-coated stent manufacturers, there are many medical professionals who believe that the newly-discovered risk is not enough to justify a recall of the product or a return to use of the older bare-metal stents.

Drug-Coated Stent Manufacturers

There are two drug-coated stent manufacturers servicing the United States: Boston Scientific Corp.’s Taxus and Johnson & Johnson’s Cypher. Abbott Laboratories recently purchased Guidant Corp.’s vascular business for more than $4 Billion and are in the process of developing a new drug-coated stent model. The Xience model is expected to be unveiled sometime in 2008, with Abbott representatives claiming it will be safer alternative than current models. The drug-coated stent market is estimated as a $6 Billion a year business, suggesting that a major defect affecting the devices could generate a great deal of personal injury litigation aiming to curb profitability for a product that has proven capable of causing serious harm.

Drug-Coated Stent Lawsuits

Patients implanted with drug-coated stents have been found at risk of suffering blood clotting issues as a result of certain device defects. If you or a loved one has been injured as a result of a defective product, you may be entitled to receive personal injury compensation from the device manufacturer. The Pensacola personal injury attorneys of Aylstock, Witkin Kreis & Overholtz handle national litigation across the United States for victims injured by defective pharmaceuticals and medical devices. Contact their offices at (844) 794-7402 to get additional information on your rights as a drug-coated stent injury victim.