Friday, Jul 4, 2008
In the brave new world of body-part implants, what happens when you get a lemon of a ticker?
Mar 2, 2001 | In the months leading up to Linda Baez's third open-heart surgery, she spent most of her days at home. Breathing was no longer easy for her; neither were simple tasks like climbing stairs. The 44-year-old mother of four constantly felt weak and exhausted. But, above all, recounts her attorney, she was worried. Two operations to replace her leaky heart valve had already failed, and even though her doctors were implanting a different artificial valve this time around, she knew that there was a good chance that she would not make it.
And she didn't. The Dedham, Mass., resident passed away quietly in her sleep one June night last year, just a few weeks after her operation.
At the time of her death, Baez had a personal injury lawsuit pending against the manufacturer of the valves, St. Jude Medical Inc., for all the pain and suffering she said she had endured due to having defective valves implanted in her not once, but twice. The whole reason she had the surgery in the first place was to correct her mitral valve prolapse, a heart condition she had had since she was a teenager. Her valve had deteriorated to the point where it was leaking blood back to the chamber from which it was just pumped. But her family believes all she received were more leaky valves. In fact, St. Jude had issued a recall of its product, the Silzone heart valve, in January 2000 because it had a higher incidence of leaking around the sewing cuff fabric (which is used to attach the device to the heart tissue) than its predecessor. Approximately 36,000 patients worldwide had received the product, 12,000 of them in the United States.
The exact cause of Baez's death will not be known until the official pathology report comes out. But Bruce Finzen, a Minneapolis attorney who is now representing the Baez estate in a wrongful death suit against St. Jude, says all evidence points to the manufacturer. "Her family holds the manufacturer responsible for her death," he says. "Her surgeon and cardiologist believe the trauma of three open-heart surgeries in a year was a substantial factor in causing her death."
What happened to Baez is a horrifying example of what can -- and, increasingly, will -- go wrong in an era in which it's become normal to trade in your own defective body parts for those manufactured, assembled and sorted by machines. In this brave new world of medical technology, surgeons can place a computerized defibrillator next to your heart, ready to shock your ticker back into action should it falter. Countless lives are saved, or prolonged, each year because of inventions like this. And as new, improved body parts come rolling off the medical assembly line, it becomes easy to take them for granted: Only a scar seems to separate the mechanically altered from the rest of us.
That is, until there's a glitch. As with anything mass-produced, not every batch is perfect. Flawed implants are rare, but sometimes they make it all the way from the factory to the surgeon's table to a carved-out place inside of you. And unlike a station wagon, which can have a faulty transmission replaced in an afternoon at the garage, the only way to retrieve a defective implant, in many cases, is to cut open a human body. And since there are no guidelines on how to proceed when there's an implant recall, whether a surgeon removes, or "ex-plants," the device is largely a judgment call.
Since 1977, there have been 571 recalls of implants, according to ECRI, a nonprofit company that assesses medical devices and tracks the number of Food and Drug Administration-reported recalls. In 1999, there were 91 reports of recalls; in 2000, 55. (In 1985, when far fewer implants were in existence, there were only 10.) In many cases, each recall involved thousands of units of the particular product. (This figure does not correspond to the number of people who received the device or had to have it taken out.)
"If you don't have implants, people will die or be crippled," says Dr. Joel J. Nobel, president of ECRI. "If the question is, are some of these implants going to become defective over time, the answer is yes. That's reality."
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