“All medical devices have benefits and risks,” warns the U.S. Food and Drug Administration (FDA), the government agency responsible for monitoring reports of adverse events and other problems with medical devices. Risks indeed: in October alone, the FDA listed 37 recalls of medical device recalls for defects or malfunctioning.
An unusual FDA recall in August was that of recall of 465,000 pacemakers “after security vulnerabilities were discovered that could let hackers reprogram the devices, potentially putting patient lives at risk,” reported Fortune magazine. Fortunately, the vulnerability can be easily fixed with a software upgrade that takes only a few minutes to complete.
Consumer Reports investigated four of the most commonly use surgically implanted medical devices—surgical mesh, lap-bands, metal hip replacements, and cardiac devices—and found that most medical implants have never been tested for safety. “Tens of millions of Americans [one in five American adults] live with medical devices implanted in their bodies … Most of them assume that someone, somewhere, tested the devices for safety and effectiveness,” the report stated.
It turns out the implanted patients are the guinea pigs: “For most implants and other high-risk devices brought to market, manufacturers do nothing more than file some paperwork and pay the Food and Drug Administration a user fee … to start selling a product.” The FDA explains, “At the time a medical device is approved or cleared, it has a benefit-risk profile that health care providers, patients, and consumers use to make patient management decisions. Once a medical device is on the market, new information, including unanticipated problems, may change the benefit-risk profile of a device.” Hence the many recalls of medical devices.
Why does this happen? One undoubted reason is haste. Medical device manufacturers want to get their products on the market as soon as possible, so that the potential millions of dollars in revenues can start pouring in. Advocates for consumers, like Consumer Reports, have been asking for more careful review and testing of a device before it is sold. Early this year, the FDA’s Center for Devices and Radiological Health (CDRH) issued new guidelines for reporting potential medical device problems in the future. Part of its new guidelines change the way it tracks “emerging signals” of a problem with a medical device that can endanger patients.
It’s important that you consult an experience attorney if you have been implanted with a medical device that was later shown to be defective or dangerous.
Richard Manger, principal of Manger Law Firm, has extensive experience in litigation and settlements, with a focus on personal injury and workers’ compensation law. We are proud of the strong relationships of loyalty and trust we develop with our clients. We go above and beyond to achieve the best possible outcome in your case. You can contact Richard Manger via email at firstname.lastname@example.org, or by calling (336) 882-2000.