Failures
There have been many examples of implant failures, including rupture of silicone breast implants, hip replacement joints and artificial heart valves, such as the Bjork–Shiley valve, all of which have caused FDA intervention. The consequences of implant failure depend on the critical nature of the implant, and its position in the body. Thus heart valve failure is likely to threaten the life of the individual, while breast implant or hip joint failure is less likely to be life-threatening.
A 2011 study by Dr. Diana Zuckerman and Paul Brown of the National Research Center for Women and Families, and Dr. Steven Nissen of the Cleveland Clinic, published in the Archives of Internal Medicine, showed that most medical devices recalled in the last five years for “serious health problems or death” had been previously approved by the FDA using the less stringent, and cheaper, 510(k) process. In a few cases the devices had been deemed so low-risk that they did not need FDA regulation. Of the 113 devices recalled, 35 were for cardiovacular issues. This may lead to a reevaluation of FDA procedures and better oversight.
Read more about this topic: Implant (medicine)
Famous quotes containing the word failures:
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