25 million Americans rely on implanted medical devices. Warning: If a defective model is recalled, no one is required to tell you. Here’s how to help fix this problem.
Some 25 million Americans rely on implanted medical devices. They help us live longer, more active lives. But this high-tech gadgetry can mean high potential for trouble. Between 1990 and 2001, 689 recall notices, affecting more than two million implants, were issued for malfunctions or labeling or manufacturing errors.
In case of an implant recall, firms remove a product from the market, while a safety alert warns hospitals and surgeons to monitor any of the recalled implants that may pose a substantial risk. But a notice does not go to the patients who are walking around with a possibly faulty device.
Some experts say there is a way to alert future medical-implant patients to problems: a national registry. Robert E. Baier, Ph.D., director of the biomaterials graduate program at the State University of New York at Buffalo, envisions a state-run implant registry, similar to the automotive industry’s registry.
All that’s needed, says Baier, are bar code stickers for each implant one for the medical chart, another scanned in with the code on the patient’s wristband.
That way, any future safety alerts about the implant would be attached to the patient’s contact information
That way, any future safety alerts about the implant would be attached to the patient’s contact information and could be mailed directly to his or her home. What’s more, if patients were tracked nationally, doctors might know sooner when a problem is emerging.
Until then, how to protect yourself? If surgery isn’t an emergency, research the pros and cons of similar medical products made by different manufacturers and get recommendations from more than one doctor. Once you have an implant, take these steps to minimize potential problems:
Know your device. Find out exactly what the implant is and what it’s supposed to do. Don’t leave the hospital until you’ve written down the company and product name, model and serial number. Ask that this information be put in your medical chart; surprisingly, such record keeping isn’t routine.
Be sure every doctor who treats you knows you have an implant. Even if a device is functioning well, patients may need to avoid certain machines, like an MRI scanner.
Keep yourself (and others) informed. Check out the manufacturer’s Website if you have a question. And to find out whether there’s ever been a recall for your product or model, visit the FDA’s site at www.recalls.gov. You can also report your own problems to the FDA at this site.
Stay in touch with your surgeon. Your follow-up care may be handled by another doctor, but your surgeon or his or her hospital would be the most likely to hear of a recall or safety alert. Let that office know if you’ve moved or changed your phone number.
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