Pacemakers, Implantable Defibrillators Frequently Recalled
Maisel says that his study, which is published in this week's issue of The Journal of the American Medical Association, represents the first compilation of all reported device malfunction advisories.
Eric N. Prystowsky, MD, president of the North American Society of Pacing and Electrophysiology, which represents doctors who specialize in the use of pacemakers and ICDs, says his group welcomes Maisel's study because "it is the first attempt ... to track all these reports."
But Prystowsky says the study has to be assessed realistically. As a specialist working at St. Vincent's Hospital in Indianapolis, home of the Indiana Heart Institute, Prystowsky says he oversees the implantation of 400 pacemakers and 200 ICDs each year. He says that he is well aware of the frequency of safety alerts, yet he says, "even with all these alerts it is exceedingly uncommon to bring back patients to replace a device."
Prystowsky says that it is, therefore, unlikely that device alerts cost anywhere near $870 million, because "that figure is based on the assumption that all devices are replaced."
Most alerts require little more than more frequent office visits to better monitor the patient, says Prystowsky, who is a consultant to Guidant, a manufacturer of both ICDs and pacemakers.
Although Maisel's paper tracks the number of FDA-issued alerts, it doesn't provide any data on the health effects of those alerts and Maisel admits that he can only estimate the costs involved with the alerts. He explains that the FDA warnings are the only official records available. When an alert is issued a notice goes out to the doctor who implanted the device and the patient in whom it was implanted. It is then up to the doctor and patient to decide how to respond, says Maisel.
A better approach, according to one expert, would be some uniform recommendations -- not generated by the device industry or the FDA -- about how to handle and track potential malfunctions.
In an editorial that accompanies the study, Kim A. Eagle, MD, chief of clinical cardiology at the University of Michigan Medical Center in Ann Arbor, tells WebMD that tracking devices after they are implanted is actually "a lot more complicated than tracking side-effects of pills. It is much more challenging because the devices are more complex."