Defective Medical Devices: An Overview

 Posted on November 14, 2013 in Defective Medical Devices

Every year, defective medical devices affect thousands of Americans and the problem only seems to be growing, according to Consumer Reports. Medical devices that are implanted into bodies (including but not limited to defibrillators, surgical mesh, and artificial joints) often go untested. “For most implants and other high-risk devices brought to the market,” Consumer Reports claims, “manufacturers do nothing more than file some paperwork and pay the Food and Drug Administration a user fee of roughly $4,000 to start selling a product that can rack up many millions of dollars in revenue.” Sometimes the only testing that occurs, according to Consumer Reports, is in the bodies of patients who undergo treatments or surgeries thinking that the product has already undergone an extensive testing phase.

Some meta organizations have called on the FDA to change, or at least tighten, their approval process in an effort to curb the number of cases of people dealing with the effects of a defective medical device. In 2011, according to Consumer Reports, “a panel from the prestigious Institute of Medicine said the FDA should overhaul its device regulatory system because it fails to ensure patient safety before and after products go on the market.” This is not only because many medical devices end up in the market without having undergone testing, it's also because “there's no systematic way for the government, researchers, or patients to spot or learn about problems with devices.” This is because medical devices don't often have serial numbers the way even common appliances, such as toasters, do. According to the FDA, the Center for Devices and Radiological Health “is responsible for regulating firms who manufacture, repackage, re-label, and/or import medical devices sold in the United States.” Medical devices are classified into three categories, and regulatory control increases with the level of classification. In 2012, Congress passed legislation that helped to loosen controls of regulation through the FDA Safety and Innovation Act, which included Medical Device User Fee Amendments.

If you or someone you know has been affected by a defective medical device, the most important step is to contact an experienced defective medical device lawyer today.