April 7, 2009
Pulling a medical device off the market is one thing. Removing it from the bodies of thousands of patients is a lot more complicated and dangerous.
Consider the Sprint Fidelis, a heart defibrillator cable. In 2007 its maker, Medtronic, stopped selling it after five patients who had the cables died.
But only now is the full scope of the public health problem becoming clear for the Sprint Fidelis, which is still used by 150,000 people in this country.
In the next few years, thousands of those patients may face risky surgical procedures to remove and replace the electrical cable, which connects a defibrillator to a chamber of the heart.
Medtronic estimates that the cable has failed in a little more than 5 percent of patients after 45 months of being implanted. But as a preventive measure, some patients with working cables are having them removed.
Already, four patients have died during extractions. Experts fear that the toll could quickly rise if such procedures are not performed by skilled doctors at medical centers that have performed many of the operations.
“I think we are just seeing the tip of the iceberg,” said Dr. Charles J. Love, a cardiologist at Ohio State University Medical Center in Columbus, who specializes in cable extractions.
For many of the patients around the country who may need the procedure, finding the right medical center will not be easy.