Cardiac stents became widely utilized in the 1990s. Still, in recent years drug-coated stents have become increasingly common, making up around 90% of all heart stents used in procedures across the United States.
One of two commercially available medicated cardiac stents is the Cypher stent. The Boston Scientific Taxus stent is the alternative.
Since the Cypher medicated stent was authorized for sale in the US three years ago, it has surged to the top of the sales charts. There are roughly 6 million Taxus or Cypher stents users who have drug-coated devices. These medicated stents sell for more than $5 billion annually.
The FDA authorized the Johnson & Johnson subsidiary Cordis’ Cypher stent for use in angioplasty operations in April 2005. Five months later, the FDA warned doctors to keep an eye on their patient’s symptoms in relation to the device.
Drug-releasing stents, such as Cordis’ Cypher, are inserted into previously untreated arteries as an alternative to the bare metal stents first developed in the mid-1990s. The surgeon inserts the device to keep the cleansed artery open, to provide heart disease patients with it, or to utilize it to stop the area from collapsing. By preventing endothelial cell proliferation in the vessels, the Cypher stent, in turn, permits adequate blood flow to other organs.
Cypher stents were developed as an alternative to conventional metal implants to allegedly lower the risk of arterial occlusion in the future and avoid the formation of scar tissue in the vicinity. It also has a thin polymer coating that carries the medication sirolimus. The substance has now been injected into the bile duct, colon, esophagus, big bronchi or trachea, urethra, and ureters for similar goals. It has also been added to peripheral and central veins and arteries.
Eighty percent of all implanted stents in the US have a medication coating, such as the Cypher.
After the angioplasty, the stent is left in the artery or other body area to keep it open. The rate of re-blockage decreases as the medication is released gradually.
What Are the Complications?
A Cleveland Clinic Study found that drug-coated stents are four to five times more likely than conventional medical models to be linked to blood clotting and thrombosis. The findings were presented at the Transcatheter Cardiovascular Therapeutics Conference in 2006.
3,500 patients received the Cypher, whereas 1,800 patients received Boston Scientific’s Taxus Stent.
According to research, the risk of blood clotting was determined to be 0.4 percent in Taxus patients and 0.6 percent in Cypher patients. According to medical experts, sirolimus prevents the blood vessels’ internal coating that prevents clots from forming.
Late thrombosis, however, can trigger a series of additional health hazards for the receiver, including heart attacks, strokes, and even death.
According to the FDA’s warning, hundreds of patients have experienced blood clots since the medical device’s introduction—up to 390 incidents in all. Seventy stories involve fatalities or further operations and medical treatment.
From this group, several patients developed hypersensitive allergic reactions that included discomfort, a rash, breathing difficulties, hives, itching, a fever, or changes in blood pressure.
Although cardiologists have questioned Cypher stents’ safety, Johnson & Johnson has persisted in defending their product to Wall Street analysts. They have adopted the stance that there is no distinction between the danger associated with medication-infused stents and older bare metal stents.
Many have, however, hypothesized that this is merely an attempt to prevent revenue loss while FDA officials assess the safety of these gadgets.
Boston Scientific, the maker of the other brand of medicated stents, has acknowledged that there is an elevated risk of blood clots with their own Taxus stent. They went back and looked at their own data comparing patients who had bare metal stents to those who received drug-coated stents several years after the bare metal stents were implanted.
Another study that was presented at a cardiologists’ conference in September 2006 verified that the Cypher stent’s clotting risk is comparable to that of the Boston Scientific Taxus stent.
Johnson and Johnson Cypher Stents
A thin layer of polymer that contains sirolimus is deposited on the Cypher stent. The sirolimus works as it is gradually delivered in an effort to slow down restenosis and reclosure. The stent is either a flexible wire or a perforated tube and is put into blocked coronary arteries. The stent is utilized to improve blood flow to the body’s other organs.
The stent is mostly utilized for coronary arteries, although it has lately been transplanted to other tubular body parts, such as the urethra, ureters, colon, esophagus, big bronchi or trachea, and peripheral and central veins and arteries.
The FDA authorized the use of the Cypher stent in 2003 for patients undergoing angioplasty to clear blocked coronary arteries. The Johnson and Johnson-produced stent is a metal mesh tube that keeps the arteries from being blocked. To reduce the likelihood of artery blockage, sirolimus is administered into the patient’s veins. In the United States, drug-coated stents have been used in around 80% of all implantations.
Studies have been commissioned to assess the efficacy and safety of the stents in the patients who have received them due to potential risks. According to these findings, up to 290 people who had the device implanted experienced clotting or thrombosis. A month after the stent has been placed, there is a chance of clotting, and more than 60 cases of thrombosis have resulted in fatalities.
Patients have been reporting bad reactions to the gadget in more than 50 cases, including mortality incidents. Rashes, aches, hives, fever, respiratory system alterations, blood pressure alterations, and itching are signs of hypersensitivity reactions. A patient’s risk of developing heart failure, a heart attack, or a stroke may rise if there is a chance of clotting.
The sirolimus trials recommended that patients take an anticoagulant for a few months, although other studies recommended using it for anything between six months and a year.
Another important issue with drug-coated stents is that some medical professionals are doubtful as to whether an artery can effectively repair itself and form a new lining subsequently. This is in addition to dangerous clotting. The fact that clots will almost certainly form without the lining or an anticoagulant raises concerns since they could potentially adhere to the already-placed stents. If a patient stops taking their anticoagulant medication, such as Plavix, the health risks keep rising.
An angioplasty procedure alone is stressful enough. More worry just makes everyone involved more emotionally and mentally exhausted. It is terrible to discover the potential health problems that a life-saving medical technology may bring about after it has been installed in your body.
Do I Need a Lawyer?
You and your family are certainly coping with the recovery process at this time, and medical expenses can add up rapidly. Making contact with a lawyer with knowledge of medical device malfunction can put your mind at ease because the lawyer will handle the legal aspects of the damages that you are entitled to.
There is a good chance that a member of your family who had the Cypher stent inserted is having negative side effects from the device. Additional doctor appointments, costs, lost pay, and discomfort are associated with removing the stent. You will be led through the legal procedure by your attorney.
If you or a loved one has been injured from using the Cypher Coronary Stent, you should see your doctor immediately. If you have suffered injuries, you should contact a class action attorney who can help you recover damages for your injury.