ASHAMED as I am to admit it, when I was told I needed a medical implant my immediate thoughts were not about its safety or reliability, but about its size.
My device 鈥� an implantable defibrillator designed to shock the heart into beating properly 鈥� was to sit under the pectoral muscle in my chest. I am rather skinny and didn鈥檛 want to look like I had a single, very conspicuous man-breast. The fact that the device was no bigger than a pack of playing cards was no comfort. Only after it was inside me and the swelling had subsided was I able to breathe a sigh of relief.
As it turned out, man-breasts were the least of my worries. In June this year, more than three years after I received my implant, I was sent a letter by my cardiologist informing me that the manufacturer of my defibrillator, the Indianapolis-based company Guidant, had issued a product recall. A number of defibrillators of the same model as mine had malfunctioned. In March this year Joshua Oukrop, a 21-year-old student collapsed and died while out mountain-biking in Utah after his defib failed.
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So what was going wrong? The failure of the device appeared to be caused by two components carrying a high voltage being mounted too close to each other. This allowed a current to arc between them, causing a short circuit when the device was supposed to be delivering a therapeutic shock to the heart when it stopped beating correctly. It turns out that Guidant has known about this fault since February 2002, when it received the first reports of malfunctions, and in April that year it redesigned the device. All this was outlined in its letters to doctors this year.
I had my defib implanted in March 2002, after Guidant had spotted the problem, but I ended up with one from the dodgy batch because Guidant kept quiet about the potential problem and decided not to inform clinicians, patients or regulatory bodies, even though several reports of malfunctions continued to come in. And it continued to sell off its old unmodified defibs knowing they could malfunction.
Guidant only alerted doctors about the full extent of the problem in May this year, when it got wind of an investigation into the issue by The New York Times. Guidant now faces class-action lawsuits and is under investigation by the US Food and Drug Administration and the UK鈥檚 Medicines and Healthcare Products Regulatory Agency, which regulate medical devices.
Meanwhile, many patients are now stuck with these devices inside them. Guidant has discouraged cardiologists from replacing them on the grounds that the risk of doing so may outweigh the risks posed by this malfunction. With the cost to Guidant of replacing each device running to $50,000 or more, it is difficult not to be cynical about why it is giving this advice. Guidant does recommend that patients increase the frequency of visits to their cardiologist, who can check to ensure that the device is still functioning. But given the sporadic nature of the fault, no amount of monitoring will tell you if the device is about to fail.
Of course, no device is perfect, and there is always a small chance of a random failure. Guidant鈥檚 defence in this fiasco is that the chances of failure due to the malfunction were less than the chances of random failure. Replacing the devices might pose greater risks, the company said.
鈥淭his year, manufacturers have issued safety alerts on over 130,000 defibrillators鈥�
But random and unpredictable failures are one thing; failures that are preventable and systemic are quite another. What鈥檚 more, medical decisions about what is best for a patient should be made by cardiologists, not by manufacturers of the medical technology, and to do that they need to have all the relevant information made available to them. If this process is sidestepped, patients are denied an informed choice. For one 21-year-old man, this may have cost him his life. It didn鈥檛 take me long to choose: I decided to have my defibrillator replaced. At 36 I am relatively young, and fairly fit, so I am willing to take my chances and risk infection and the other complications that can occur during a replacement procedure. But this presents me with another difficult choice: what do I replace it with?
This year, manufacturers across the industry have issued safety alerts on more than 130,000 defibrillators, mainly relating to electrical problems. Given that only 200,000 defibrillators are implanted worldwide each year, this doesn鈥檛 do much for my already battered faith in the industry. Of course, my existing device may be perfectly OK, and I could go another five or six years before a low battery causes that bulge in my chest to start beeping, telling me that it鈥檚 time for a replacement.
But what Guidant appears not to understand is that from the patient鈥檚 perspective, all 26,000 of its potentially faulty defibs are as good as useless, because you can never know if yours will save your life. The only way of telling if it isn鈥檛 a dud is by crossing your fingers and waiting to see what happens after your next attack.
