When a product is recalled because it is defective, the recall generally involves having consumers stop using the product and pulling it from shelves. However, in the case of a recalled medical device that has been implanted inside of a person’s body, what choices does the patient have?
This is the question currently being faced by more than 75,000 patients who have a flawed medical device implanted in their chests. The U.S. Food and Drug Administration (FDA) recently recalled a defibrillator manufactured by St. Jude Medical. The concern was over potential risks of personal injury and wrongful death because its wires have broken free from the outer insulation. If this happens, the patient is at risk of receiving an unnecessary shock to the heart, or of not receiving the necessary jolt when there is an irregular heartbeat.
For now, these patients must be monitored by their doctors to ensure that the defective leads to the defibrillator do not become broken. To make matters challenging, in some cases it can be impossible to detect if there has been a breach in the wires even with the help of an x-ray.
There is definitely a serious need for more information concerning this defective medical product as right now there appears to be very little data on who may be at risk of injury. Since the medical device was recalled, it will also be difficult to give patients advice as to their safest course of action.
So this means that patients are left with three options:
•1. Leave the faulty lead connected to the defibrillator
•2. Disconnect the flawed wires and insert new wires
•3. Take the device out of the patient’s body
Surgery is certainly not easy option, and may even be dangerous to the patient. In fact, it could cause damage to the heart itself. Unfortunately, all of these options are less than ideal, posing uncertainty for patients who now must decide how to proceed.
Source: Star Tribune, “A flawed device brings a tough choice for Riata patients,” James Walsh, March 10, 2012
