Heart patients victims of failed pacemakers and defribillators
First Guidant recalled several models of defribillators. That itself is not a major problem since companies often need to recall defective products when they are simply not aware of product problems unless they are used for a while. But the main problem was that Guidant continued to sell these defective products even when it knew they were failing.
Then one would expect that the FDA would let the American public know as soon as possible about any problems with the products that it monitors. On the other hand, FDA had reports of malfunctioning pacemakers and other heart devices but it never bothered to make the information public.
In the meantime, Americans were dying. From 1990 to 2002, there were approximately 2.25 million pacemakers (PMs) and 416,000 implantable cardioverter defibrillators (ICDs) implanted in the United States. During the same time period, 17,323 devices (8834 PMs and 8489 ICDs) were removed from patients due to confirmed device malfunction. The annual ICD malfunction replacement rate of 20.7 per 1,000 implants was significantly higher than the PM malfunction replacement rate of 4.6 replacements per 1000 implants. The PM malfunction replacement rate decreased significantly during the study. In contrast, the ICD malfunction replacement rate trended down during the first half of the 1990's but increased during the latter half of the study. In addition, more than 50% of the ICD malfunctions occurred during the last three years of the study.
PM or ICD malfunctions were directly responsible for 61 confirmed deaths out of the nearly three million devices implanted during this time period. However, the vast majority of reported malfunctions did not lead to death or serious injury, and were detected in time to ensure that patients would continue to receive therapy when it was needed, according to information released by the Agency after a long delay.
Unlike Guidant, which acted in a very irresponsible manner - more or less how Merck and Pfizer handled problems with Vioxx, Bextra, and Celebrex, Metronic, another maker of heart devices, is going to release the same data to doctors and patients that it provides the FDA.
What does it mean for you?
If you are a user of any heart device, you have enough reason to get worried. You may actually have a defective device and your doctor may not know about it and the manufacturer may be hiding that information from you.
Then one would expect that the FDA would let the American public know as soon as possible about any problems with the products that it monitors. On the other hand, FDA had reports of malfunctioning pacemakers and other heart devices but it never bothered to make the information public.
In the meantime, Americans were dying. From 1990 to 2002, there were approximately 2.25 million pacemakers (PMs) and 416,000 implantable cardioverter defibrillators (ICDs) implanted in the United States. During the same time period, 17,323 devices (8834 PMs and 8489 ICDs) were removed from patients due to confirmed device malfunction. The annual ICD malfunction replacement rate of 20.7 per 1,000 implants was significantly higher than the PM malfunction replacement rate of 4.6 replacements per 1000 implants. The PM malfunction replacement rate decreased significantly during the study. In contrast, the ICD malfunction replacement rate trended down during the first half of the 1990's but increased during the latter half of the study. In addition, more than 50% of the ICD malfunctions occurred during the last three years of the study.
PM or ICD malfunctions were directly responsible for 61 confirmed deaths out of the nearly three million devices implanted during this time period. However, the vast majority of reported malfunctions did not lead to death or serious injury, and were detected in time to ensure that patients would continue to receive therapy when it was needed, according to information released by the Agency after a long delay.
Unlike Guidant, which acted in a very irresponsible manner - more or less how Merck and Pfizer handled problems with Vioxx, Bextra, and Celebrex, Metronic, another maker of heart devices, is going to release the same data to doctors and patients that it provides the FDA.
What does it mean for you?
If you are a user of any heart device, you have enough reason to get worried. You may actually have a defective device and your doctor may not know about it and the manufacturer may be hiding that information from you.
posted by eCreativa Media | 7:11 PM
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