FDA's Approval Process Allowed NexGen's Defects to Get Through

FDA's Approval Process Allowed NexGen's Defects to Get Through

Recently, many have been questioning the use of the Section 510(k) approval process employed by the U.S. Food and Drug Administration (FDA), allowing some medical devices to be sold on the open market without requiring pre-market testing. The argument against the Section 510(k) approval process is that it allows too many harmful and defective medical devices to reach the market. Others point out the benefits of less regulation, such as promoting innovation and creating an incentive for companies to develop creative solutions to health problems. Still, any flaws in the process cannot excuse the companies manufacturing these devices from conducting their due diligence to ensure that consumers in whom these devices are implanted will be safe.

Zimmer first marketed the NexGen knee replacement system almost 20 years ago and for the most part, it has been a success. Things have not gone quite so smoothly recently as there are reports that recipients of the NexGen CR-Flex are experiencing high rates of failure in the device. Though such failure is often limited to pain and loosening, in some of the more serious cases the patient must go back in for revision surgery. The supposed issue with the NexGen CR-Flex stems from the way the device bonds itself to the thigh bone through natural growth rather than through the use of a cement like many other similar devices.

Dr. Richard Berger worked with Zimmer as a consultant for over a decade and knows the ins and outs of the NexGen CR-Flex as well as anyone. In a study conducted at the Rush University Medical Center in Chicago, Dr. Berger similarly found that the failure rate of the NexGen CR-Flex in his patients was far too high by industry standards. After presenting the study to the annual conference of the American Academy of Orthopaedic surgeons, the researchers involved all agreed that surgeons should cease using the NexGen CR-Flex in knee replacement surgeries.

An industry giant like Zimmer undoubtedly has the resources to conduct the appropriate level of testing in order to keep customers safe, and its duty as a company that makes billions of dollars of profit in the public health industry dictates that it do so. Even though there has not been a Zimmer NexGen knee recall as of yet, Dr. Berger's findings indicate that there could be a convincing case for recall in the future. If you were the recipient of a NexGen CR-Flex and have experienced pain, loosening, or required revision surgery, now is the time for you to be informed of your rights.

The attorneys at the Rottenstein Law Group have over 25 years of experience effectively representing the rights of their clients against big companies like Zimmer.

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