Cardiac Devices May Need Replacing
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As many as 28,000 people with implanted heart pacemakers made by Guidant Corp. may need to have them replaced because of recently discovered defects, the company said yesterday. It was the second major safety alert from the medical device maker in the past month. The announcement that thousands of people could face unexpected surgery to replace their pacemakers came on the same day that the Institute of Medicine issued a stinging report that criticized the Food and Drug Administration’s monitoring of medical device safety as inadequate and in need of significant congressional reform. The report found that the agency lacks the authority to demand that manufacturers do follow-up studies of widely used devices and has no way of determining whether promised safety studies are actually done or of informing consumers of the results. “We were asked to take a look at the system . . . and we found that such a system needs to be built,” said committee Chairman Hugh Tilson, a professor and senior adviser to the dean of the University of North Carolina School of Public Health. “We found numerous areas where substantial improvement could be made.” The Guidant alert for its pacemakers underscored the message of the study by the institute, a branch of the National Academies. The problems reported yesterday were in pacemakers implanted between 1997 and 2000 and followed by one month a safety warning involving another Guidant product — about 109,000 implanted defibrillators. But unlike that recall, yesterday’s announcement explicitly warned doctors that the pacemakers might need to be replaced. The company said that it had reports of 69 failures in nine models of its pacemakers and that several patients lost consciousness or developed possible heart failure. One person, the Guidant statement said, might have died as a result, but the device was not returned for testing and the company could not confirm that the pacemaker was responsible. Guidant said the problem resulted from gradual degrading of a seal in the pacemakers, which allowed a higher than normal amount of moisture to enter. The company said that about 28,000 of the 78,000 questionable implanted pacemakers are still in use and that about 18,000 are in the United States. Sales of the nine models were discontinued in 2000. Since the arthritis painkiller Vioxx was abruptly removed from the market last fall because of evidence of potentially deadly cardiovascular side effects, the FDA has been sharply criticized for its safety monitoring and has faced pressure to upgrade its efforts. The agency has implemented a number of internal changes to try to improve its safety record, and last fall it asked the Institute of Medicine to do a full review of its drug safety policies. More : washingtonpost.com |