The US FDA Testing and APproval Process is not as Rigorous as You might Believe

The Institute of Medicine, part of the National Academy of Sciences, has called on the US FDA to improve its testing and approval process for medical devices before letting them go out onto the market where they might end up in your body. The Institute of Medicine is tasked with advising the federal government on science policy. The Institute has concluded that current FDA testing and approval processes do not allow the FDA to be sure that medical devices are safe or effective prior to their use on patients.

The Institute of Medicine's recommendation did not specify desired changes. But the US FDA has already rejected the Institute's central finding. And medical device makers are pressuring the FDA to streamline and expedite the medical device approval process.

The Institute's recommendation follows on the heels of updated US FDA warnings about the dangers of transvaginal surgical mesh repairs for the problem of pelvic prolapse. The updated 2011 FDA warning overrides the agency's previous statement in 2008 that pronounced the risks of complications from the medical surgical mesh device to be rare.

Your body and your health are the real battlefield in this contest. The outcomes and decisions regarding the US FDA testing and approval process for medical devices will ultimately have their effects on your health and well-being. Stay tuned. It's your body, and your health.




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