Between 1990 and 2000, the rate of recalls and safety alerts relating to popular heart rhythm devices, pacemakers, and defibrillators, dramatically increased. During the period, the Food & Drug Administration issued over 50 advisories, approximately 3 each month. Furthermore, since 1990, use of various
heart devices has increased 49%.
The economic costs associated with device recalls totaled nearly $1 billion over the past decade. These costs include
hospital stays, device replacement, and
physicians' fees. The cost of unneccessary pain, suffering, and
loss of life is inexcusable.
Generally, the advisory rate for implantable cardioverter-defibrillators (ICDs) is higher than that of pacemakers. ICDs are more complex devices. In addition, they are considered life-sustaining, as such, authorities are not hesitant to issue alerts when there is a potential problem.
In addition to mechanical problems with heart devices, a recent study linked Staphylococcus aureus bacteremia (staph infection) with implanted heart devices. Staph
infections are dangerous and can be deadly. The findings were reported in the Journal of the American Heart Association.
If you have experienced serious health problems due to a cardiovascular device, it may be important to
contact an attorney who can help you protect your legal rights. Please keep in mind that there may be
time limits within which you must commence suit.
See Also
- Heart Devices: Overview
- Medtronic Defibrillators
- Heart Problems
- Infections