Rising pacemaker and defibrillator recalls raise concerns, journal says, but firms say report is
misleading
Terry Fiedler
Star Tribune
Wednesday, August 15, 2001
More than 500,000 patients were affected by pacemaker and defibrillator recalls and safety alerts from 1990 to 2000, according to the latest issue of the Journal of the
American Medical Association. And an editorial in the journal concludes that the growing number of incidents might be "a significant issue for cardiovascular
health care in the United States."
Minnesota is home to the world's three largest manufacturers of implanted pacemakers and defibrillators -- Fridley-based Medtronic Inc., Little Canada-based St.
Jude Medical Inc., and the cardiac rhythm management group of Guidant Corp., headquartered in Arden Hills.
"The numbers are alarming in a way they shouldn't be," said Dr. Marshall Stanton, Medtronic's medical director. "They are misleading."
"Terminology is everything," said Prudential Securities analyst Sandra Hollenhorst, who noted that most advisories involve small noninvasive reprogramming of the
devices or recall of field inventory, rather than requiring surgical replacement of devices.
In an article in the journal's Aug. 15 issue, five doctors analyzed recalls and safety alerts for pacemakers -- implanted devices that use electrical shocks to prompt
hearts that are beating too slowly -- and implanted defibrillators that shock hearts that are beating too quickly.
After praising the devices as "two of the most remarkable medical and technological advances in the 20th century," the authors segued into a review of federal data.
From 1990 to 2000, 52 advisories involving 408,500 pacemaker and 114,645 defibrillators were issued by the U.S. Food and Drug Administration (FDA), they wrote.
They concluded from their research that the rate of advisories increased slightly between 1995 and 2000 for both devices and that, with the growing number of
implant patients, the number of patients affected by the advisories would continue to increase.
About 900,000 people had pacemakers or defibrillators at end of 2000. Pacemakers generated worldwide revenue of $2.8 billion last year; defibrillators, $1.7 billion.
The authors estimated that medical costs related to the advisories were $870 million during the decade, and summed up the situation by writing: "Hopefully, the
intense efforts, which have resulted in remarkable technological advances ... will be accompanied by equally intense efforts from the manufacturers and the FDA to
improve the overall safety of these devices and reduce the number and rate of recall."
Jeff Sims, vice president of reliability and quality assurance for Guidant's cardiac rhythm management group, called the study "one-sided."
"The authors are quantifying risk without benefits," Sims said. "[These devices] are saving hundreds of billions in medical costs a year."
He added that authors also didn't make clear that most of the safety advisories resulted in minor adjustments, such as a noninvasive software programming change.
About 1 percent of the recalls and safety advisories result in replacement of an implanted device, Hollenhorst said.
In most cases of a safety advisory or recall, "We're not saying the car is broken and you're stranded," Sims said. "We're saying we can fix that component on your
dashboard and do it noninvasively."
St. Jude spokesman Peter Gove gave the example of one of the company's pacemaker advisories to 150,000 patients, although the failure rate of devices in that group
was less than one-tenth of one percent. He also emphasized that it's the companies that aggressively are reporting any problems to the FDA, which in turn, issues
warnings.
Hollenhorst of Prudential Securities doesn't expect the report to have a big impact on the companies that make the devices.
"You'd like these products to be perfect, but you could show this kind of thing for almost any medical product," she said.
-- Terry Fiedler is at tfiedler@startribune.com .
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