Multi-Link Vision Stents
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>> Guidant Multi-Link Vision Stents (recalled in 2003)
On October 8, 2003 Guidant announced that it initiated a recall of certain lots of the MULTI-LINK VISION Coronary Stent.
New data indicate that medicated or drug-eluting stents may cause 4,500 heart attacks every year, up to 2,000 of them fatal. This increased risk, moreover, could persist for a lifetime, requiring patients to take blood thinners for the rest of their lives, thereby facing the sometimes fatal side effects of those drugs.
Update: Schmidt & Clark is no longer accepting Heart Stent cases.
The Guidant Multi-Link Vision stent is a small, lattice-shaped, metal tube that is inserted permanently into an artery. The heart stent helps to hold open an artery so that blood can flow through it.
The Guidant Multi-Link Vision stent contains drugs that can potentially reduce the chance of arteries becoming blocked again.
1. The Alarming "NEW" Truth About Medicated Stents - "There's so much evidence" of the new danger regarding medicated or drug-eluting heart stents, says Spencer King, the Piedmont Hospital cardiologist who in 1987 implanted the first stent in North America.
2. FDA Approved - Medical Device Manufacturer Loophole - FDA 510(k) - It's appalling that the manufacturers of heart/cardiac stents brought a product to market that has been implanted into more than 4 million people without ever performing proper clinical trials.
3. Why Were These Devices Approved By The FDA In The First Place? - A device can be approved with few or no clinical trials if it is deemed "substantially equivalent" to a gadget that existed before 1976.