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Consumer Reports: Most Medical Implants Never Tested For Safety

If you are one of the tens of millions of Americans living with a medical implant such as an artificial joint or surgical mesh, you probably assumed the device was well-tested for safety. In most cases, you’d be wrong.

According to Consumer Reports, most medical implants and other high-risk devices aren’t safety tested before hitting the market. Manufacturers file some paperwork, pay a fee to the Food and Drug Administration (usually about $4,000) then start selling products that often rack up millions of dollars.

For the small number of products that do require advance safety studies, the government regulations mandate smaller and less rigorous studies than what is required for prescription drugs.

A Consumer Reports investigation that included interviews with doctors and patients, as well as an analysis of medical research and the FDA’s device-safety database, showed several areas of concern:

* Medical devices/implants often aren’t tested before entering the market.
* There is no structure in place to allow the government, researchers, medical practitioners or patients about issues with such devices.
*Without changes to the system, patients have little recourse to protect themselves.

Personal injury attorneys agree with a 2011 finding from the Institute of Medicine said the FDA should overhaul the system by which devices are regulated and approved. Instead, a law currently under debate in Congress would keep the current system virtually intact and ratify an agreement between the regulatory agency and industry for quicker device approval.

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