In July 2005, the FDA announced the recall of
implantable defibrillators and pacemakers manufactured by Guidant Corporation.
These devices are surgically implanted in persons who have a type of heart
disease that creates the risk of a life-threatening heart arrhythmia (abnormal
rhythm). Some of the risks associated with the defibrillators are
deterioration of the wires and its inability to deliver therapy. One of
the risks associated with pacemakers is that a sealing component used in the
devices may experience a gradual degradation, resulting in a higher than normal
moisture content with the pacemaker case.
Medtronic Heart Devices
On April 16, 2004, the FDA announced the recall of
numerous implantable defibrillators manufactured by Medtronic, Inc., which were
implanted in 1997 and 1998. These devices are considered a Class I recall,
which is the highest priority recall. In addition, another recall was
issued by the FDA on February 10, 2005 for additional Medtronic Defibrillators
where batteries were manufactured between April 2001 and December 2003.
Avandia
Avandia is widely used to treat patients with Type
II Diabetes Mellitus. Avandia has been associated with a significant
increase in the risk of myocardial infarctions and an increase in the risk of
death from cardiovascular causes. Criteria's for Avandia: Diagnosed
with Type II Diabetes; Avandia use for at least twelve weeks; fifty years old or
younger; non-smoker; death from cardiac event; Myocardial Infarction (MI)/Heart
Attack resulting in death or disability; Congestive Heart Failure (CHF)
resulting in death or disability; Cardiomyopathy.
Gadolinium
The U.S. Food and Drug Administration (FDA) recently
asked manufacturers of all Gadolinium-based contrast agents to include a new
boxed warning on the product label. These contrast agents are used to
enhance the quality of MRI images and can place patients are risk for developing
potentially fatal disease known as Nephrogenic Systemic Fibrosis (NSF) or
Nephrogenic Fibrosing Dematopathy (NFD). People may experience a
thickening of the skin and other organs, which can limit their ability to move,
extend joints and can lead to pain and even death. The FDA first warned
about NSF and NFD associated with Gadolinium in June 2006 and again in December
2006.
