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Medical Devices Approved By The FDA Can Still Be Harmful

Before doctors and hospitals implant or use medical devices for patients, the Food and Drug Administration (FDA) must review the devices. The review process is called pre-market approval and involves clinical testing to ensure safety.

However, device manufacturers can expedite pre-market approval if they can show that a product is “substantially similar” to one already approved and on the market. In those cases, the product can be vetted through the less stringent 510(k) approval process, which requires no human testing.

Not surprisingly, the Government Accountability Office (GAO) reported in 2009 that many high-risk medical devices were improperly tested and approved under the lower 510(k) standard. In 2010, the FDA tightened its 510(k) regulations, but recently published study in the Archives of Internal Medicine suggests the updated regulations are inadequate.

According to the study, of the medical devices recalled between 2005 and 2009, 21 had passed the standard FDA testing procedure while 80 had passed only under the lower 510(k) testing requirements. A 2011 GAO report sheds further light on the problem, revealing that the FDA approved at least 67 high-risk medical devices under the 510(k) process in the same four-year period.

Risky Medical Products Put Patients at Greater Risk

The sad truth is that the less stringent 510(k) standards are negatively affecting real people. For example, a Colorado woman recently testified before a Special Senate Committee on Aging about how her four-year-old artificial hip was recalled and had to be removed because it was releasing cobalt and chromium metals into her bloodstream. The product had been tested and passed under the 510(k) process.

Fortunately, the FDA is currently reviewing high-risk products approved under 510(k) to determine if additional testing should be completed. The FDA also provides public access to its online databases so those interested can check to see if a specific medical device was approved under the pre-market procedure or the 501(k) system.

Hopefully the FDA review with lead to stronger testing requirements for medical devices before allowing potentially dangerous products to be used by doctors and hospitals on unsuspecting patients. Critics who bemoan the fact that the United States is slower than other countries to approve medical devices should note that longer approval times are a trade-off for discovering long-term effects of defective medical devices before they are used on trusting patients.

If you or a loved one has suffered because of a defective medical device, contact an experienced attorney to discuss your situation and your options. Our medical malpractice attorneys serve clients throughout northern California including Santa Clara County, San Mateo County, Alameda County and Monterey County.

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