In April 2005, the FDA approved the Cyper stent, manufactured by Johnson & Johnson subsidiary Cordis, for angioplasty procedures. Five months later, the FDA issued a warning to physicians concerning the device, advising them to monitor patients’ symptoms.
An alternative to the bare metal stents introduced in the mid-1990s, drug-releasing stents like Cordis’ Cypher are added to previously-untreated arteries. Surgeons insert the device to keep the cleaned artery open, give it to patients with heart disease, or use it to prevent the area from collapsing. The Cypher stent, in turn, allows for proper blood flow to other organs by inhibiting the growth of endothelial cells in the vessels.
Compared to the standard metal devices, Cypher stents were introduced to supposedly reduce chances of future artery clogging and prevent scar tissue growth around the area. As well, it features a thin layer of polymer that contains drug sirolimus. Over time, the product has since been added to peripheral and central veins and arteries, the bile duct, colon, esophagus, large bronchi or trachea, urethra, and ureters for similar purposes. In the United States, 80 percent of all implanted stents are drug coated like the Cypher.
The stent, then, is left in the artery or other part of the body to keep it open after the angioplasty. The drug being released gradually reduces the re-blockage rate.
According to a Cleveland Clinic Study, with data revealed at the Transcatheter Cardiovasular Therapeutics conference in 2006, drug-coated stents are four to five times as likely to be associated with blood clotting and thrombosis compared to the standard medical models.
The data presented at the time observed 1,800 patients given Boston Scientific’s Taxus Stent and 3,500 with the Cypher. Researchers found that patients with the Taxus had a 0.4 percent risk of blood clotting, while the degree was slightly higher – 0.6 percent – for the Cypher. Healthcare professionals believe the sirolimus stops the protective coating inside the blood vessels that protects against clots.
However, late thrombosis can start off a chain of further health risks for the recipient: heart attacks, a stroke, or possibly death.
Since the medical device’s introduction, hundreds of recipients reported blood clots – up to 390 cases, according to the FDA’s warning. 70 reports involve deaths or additional surgeries and medical intervention.
Out of this group, certain patients experienced hypersensitive allergic reactions, including pain, a rash, respiratory changes, hives, itching, a fever, or blood pressure changes.
Filing a Lawsuit
Because of the costs associated with stents ($6.5 billion annually with an 80-percent profit margin, to be exact), manufacturers strongly contest the negative findings.
Nevertheless, for a recipient who experienced instances of blood clotting or an allergic reaction, the aftermath is extremely frightening and costly, especially if additional surgeries are needed. If you or a family member has found yourself in this precipitous, life-threatening situation or have since gone through corrective procedures after receiving a Cypher stent, Trantolo & Trantolo is here to help. Bring your defective medical device claim to our experienced trial attorneys today.