What is DES?
Drug-eluting stents (also called medicated or drug-coated
stents) were invented in response to a common side effect
of balloon angioplasty surgery in which the coronary artery
became weak and prone to collapse. Stents are a metallic
metal "scaffold" or tube that is inserted into the coronary
artery in order to prevent collapse.
Further developments in stent technology led to
drug-coating in which the stent was coated with a
pharmacological agent designed to prevent reblocking
(restenosis) through the delivery of time-released drugs
into the bloodstream.
DES therapy is accompanied by antiplatelet drugs designed
to prevent clotting of the blood within the arteries for at
least six months. Common drugs include Ticlid and Plavix,
which help to ensure that restenosis does not occur during
the time in which the heart's cells are growing over the
stent and allowing it to "grow" into the anatomy of the
coronary artery.
Growing Popularity
The first stents were used in France in 1986, and the first
FDA approval for a metal stent ocurred in 1994.
Drug-eluting stents were first introduced in the 1990s and
have since grown into a multi-billion dollar business with
over six million prescriptions in America and over $5
billion in revenues per year. American manufacturers
include Medtronic, Boston Pharmaceuticals and Cordis, and
the drug is also manufactured and marketed in Europe.
Drug-Eluting Stent Side Effects
Despite their growing popularity, drug-eluting stents have
been linked with severe side effects including allergic
reactions, increased risk for cardiac-related deaths and
heart attacks, and thromobosis (blood clotting). The FDA
warned United States patients about the Cordis CYPHER stent
in 2003 after use of the CYPHER stent led to deaths in some
patients due to sub-acute thrombosis, in which blood cells
gather and clot around the stent, preventing the passage of
blood through the artery.
In addition, a 2006 study conducted in Switzerland found
that patients with drug-eluting stents are up to 40 percent
more likely to die of a cardiac event or experience a heart
attack after insertion of a DES device. In addition,
increased incidence of non-cardiac conditions such as lung
disease, cancer and stroke were found in some stent
patients. Stent thrombosis, a condition in which blood
clots in the artery and prevents blood flow, is among the
most dangerous side effects of DES treatment.
The risk also exists with non-medicated metal stents, but a
disturbing trend has appeared in coated stents in which
patients experience a linear and cumulative rate of
thrombosis over time. The release of medication from the
stent can lead to delayed healing and actually increase the
likelihood of thrombosis at the stent site. In fact, in
June 2006, Boston Scientific itself admitted that its own
studies showed a higher increase in late stent thrombosis
with its medicated stent product, implying that all
drug-eluting stents might have this effect (a claim which
was vigorously denied by its competitor companies).
Another drug-eluting stent side effect is dependence on
antiplatelet drugs over the long-term. Since patients are
usually put on Plavix and similar antithrombosis drugs
after stent insertion, they are subject to the side effects
of those drugs, which include a myriad of symptoms such as
gastrointestinal bleeding, strokes, rashes, chest pain,
flu-like symptoms, allergic reactions, and inability to
have surgery in life-threatening conditions due to the
drugs' blood-thinning and anti-clotting effects. This is in
addition to the cost of long-term Plavix use: while the
minimum antiplatelet drug therapy averages around six
months, some patients are prescribed Plavix for life.
If You've Experienced DES Side Effects
If you have experienced side effects due to medicated stent
insertion, seek medical attention immediately. Then start
looking for a lawyer who is experienced in medical device
litigation. Your drug-eluting stent attorney can help you
evaluate your potential claim and tell you whether you
qualify for benefits such as future medical care,
compensation for pain and suffering, and/or a monetary
settlement for your medical fees.
----------------------------------------------------
Visit http://www.LegalView.com for more on hernia patch
recalls, or learn about other prescription drug and
surgical drug recalls such as the Zetia and Vytorin,
Avandia, Chantix side effects as well as the Trasylol
Aprotinin recall, which can be found at
http://trasylol-aprotinin.legalview.com/ .
No comments:
Post a Comment