The FDA (the regulator of drugs in America) received 290 reports of adverse effects, including death, suffered as a result of the Cypher Stent.
Stents are small mesh tubes which are inserted into diseased arteries. Stents are often implanted at the same time other procedures are carried out including balloon angioplasties. The balloon mechanism is inserted into the diseased artery and the balloon is inflated to push the plaque against the artery wall. The Stent is inserted to hold the plaque in place.
The Cypher Stent, manufactured by Cordis Corporation, a subsidiary of Johnson and Johnson, is coated in a drug called sirolimus. The drug is released slowly into the body and reduces the build up of plaque in the arteries.
In October 2003 the FDA issued a Public Health Alert advising that more than 60 people had died from blood clots forming around the device and causing heart attacks. In other cases the device has caused injuries requiring medical or surgical treatment. Further reports have been received from patients suffering from pain, rashes, respiratory difficulties, hives and blood pressure changes.
The Ancure Endograft Stent, produced by a subsidiary of Guidant Corporation, has been linked to 12 deaths and 57 emergency operations. On 12 June 2003 Guidant pleaded guilty to ten felony charges for covering up malfunctions with the device and was fined 92.4 million dollars. The defective device became stuck whilst it was being implanted.
The Guidant Ancure Endograft Stent, which has now been withdrawn from the market, worked differently to the Cypher Stent. The device was used to repair the aorta without open heart surgery. However, when complications during implanting the device occurred, and the device could not be dislodged for it to be removed from the patient's body, open heart surgery had to be performed.
On 18th October 2003 Guidant reached an out of court settlement in respect of nine lawsuits in what is thought to be very favourable terms.
If you or someone you know has been affected by these stents, you may be able to claim compensation for your injury and loss. Irwin Mitchell has experience in handling claims involving stents and would be happy to answer any questions you may have. You may not be alone, in which case, we will refer you to the best contact in our group action team.