Study Reveals FDA Let Massive Number of Unsafe Medical Products on Market


May 05, 2014

Recalled medical devices from the years 2005-2009 were reviewed recently by researchers who published their results in the Annals of Internal Medicine (AIM). Based on the findings of the study, the AIM researchers concluded that the FDA has allowed the sale and use of tens of millions of unsafe medical devices which were not properly tested before being placed on the market.

The products that were allowed to be marketed to consumers were determined to be high-risk, dangerous and defective for use by patients. According to the researchers, the reason these products were marketed to consumers was because the FDA did not employ the pre-market approval (PMA) test that is used for high-risk products. There is another method that the FDA uses to test products that it used primarily for low-risk devices.

The process used for low-risk products is called the 510(k) test. There is less testing and inspection undertaken when this test method is employed. As it turns out, most of the devices that have since been recalled were only subjected to this more lax 510(k) method of testing. Only nineteen percent of the recalled products were actually put through the proper PMA method of testing before they reached the market. The FDA has since come under scrutiny for having flawed approval processes in place for dangerous medical devices.

Patients are placed in a precarious position in these cases because they make decisions based upon their physician's medical advice. They do not see information about the device that is going to be implanted in their body nor do they usually get to read research reports about the device. A number of these defective medical devices being implanted or used by patients are cardiovascular devices. A problem or defect with these types of devices can cost a patient their life.

Quality testing should be a given when bringing such high-risk products to the market. There is no room for cutting corners or being lax about quality control and safety testing. If you or a loved one has been the victim of a defective medical device or drug, we invite you to contact our Atlanta Defective Medical Device attorneys at Montlick and Associates. We believe that medical devices should be safe, or they should not be on the market at all.

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Category: Personal Injury

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