Written by GuestPoster on January 24, 2012 – 12:58 am
When you visit a medical professional, you expect the best care possible—from the doctor and from the equipment he uses. After all, medical help is not cheap these days.
One of the reasons the price tag for certain procedures and the use of particular devices is so high is that the vetting process these products must go through is a rigorous, long-term affair. It could take years for certain equipment to make it from the drawing board to a hospital.
The U.S. Food and Drug Administration (FDA) monitors all phases of a products development: design, manufacturing and even marketing. But even with that intense process in place, defective—and sometimes dangerous—products make it through.
What kind of products? Defective implants, surgical instruments, pacemakers or prosthetics. All these can be the cause of a product liability claim when someone is injured or dies during a surgery or exposure to a medical device.
The following two devices, however, because of their commonplace use, are the most prone to being defective.
Stents
A stent is nothing more than a small tube made out of metal and plastic that’s inserted into an artery or blood vessel that’s become too narrow due to atherosclerosis. Sometimes these stents are coated in a slow-releasing drug that is thought to prevent scarring of the arteries. However, some speculate that these stents are causing blood clotting. The FDA is watching drug-coated stents closely to determine if there is a connection.
Pacemaker
A pacemaker is a device that’s surgically implanted in people who suffer from a certain type of heart disease that causes a life-threatening condition known as arrhythmia or abnormal rhythm. The pacemaker delivers an electrical shock to the heart to restore the normal rhythm.
Pacemakers are pretty common and almost seem beyond causing harm, but a major recall in 2005 changed all that.
The Guidant defibrillators are known to be subject to failures, which could result in the the product’s inability to deliver an electrical shock when the patient needs it the most: during episodes of arrhythmia. Two deaths have been reported to the FDA connected to a failure of a device like this. This is obviously a life-threatening concern for anyone with a Guidant defibrillator implant.
The other pacemaker that was involved with a massive recall was the Medtronic defibrillator. Medtronic warned patients and health care providers on October 15, 2007 that one of the wires that links the defibrillator to the heart could break. It was the electrical wire called the “lead.”
This recall affected some 268,000 patients. Medtronic reported five deaths that may have been linked to this defective wire.
What to Do If You’ve Been Injured by a Defective Medical Device
If you or a loved one has been injured by a defective medical device, contact the Philadelphia wrongful death attorneys at The Killino Firm today. We believe that medical device manufacturers have a responsibility to American consumers to test their devices thoroughly before presenting them to the Food and Drug Administration (FDA) for approval and to give the FDA information about the device’s possible defects.
