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:
“When we can begin to take our failures nonseriously, it means we are ceasing to be afraid of them. It is of immense importance to learn to laugh at ourselves.”
—Katherine Mansfield (1888–1923)
“The failures of the press have contributed immensely to the emergence of a talk-show nation, in which public discourse is reduced to ranting and raving and posturing. We now have a mainstream press whose news agenda is increasingly influenced by this netherworld.”
—Carl Bernstein (b. 1944)
“If there is a special Hell for writers it would be in the forced contemplation of their own works, with all the misconceptions, the omissions, the failures that any finished work of art implies.”
—John Dos Passos (1896–1970)