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Dangerous Medical Devices and the Food and Drug Administration

Medical devices and medical products such as replacement hips, heart stents, surgical mesh — and other implantable devices we rely on for our health — are supposed to be safe. However, no one is perfect and mistakes can be made during the design and manufacture of these medical products. As soon as a dangerous product is discovered, it’s vital that governments, hospitals, medical service providers and doctors warn consumers, remove the items from the market and take immediate action to curb the potential for injury and death.

The U.S. Food and Drug Administration (FDA) plays a vital role in keeping American consumers safe from dangerous medical products and devices. Every year, the FDA gets hundreds of thousands of complaints about suspected dangerous medical devices that may have caused death and serious injuries in patients. The FDA surveils the medical device market via its Medical Device Reporting (MDR) wing, which fulfills the role of monitoring device performance and detecting those that could be dangerous.

Medical device importers, user facilities and manufacturers are classified as “mandatory reporters” by the MDR, which means that they must supply the FDA with special reports concerning product problems and adverse events. The FDA also asks that patients, caregivers, health care professionals and consumers send voluntary information concerning adverse events related to medical devices.

Although the FDA does a lot to ensure consumers stay safe from dangerous medical devices, it’s common for many people to get hurt before the true dangers of a particular medical device get revealed. If you’ve been hurt — or suspect that you or a loved one has been killed — as a result of a faulty medical implement, a personal injury lawyer may be able to help you pursue justice and restitution in court.

Source: FDA, “Medical Device Reporting (MDR),” accessed Oct. 05, 2017