Important News from Your Texas Accident Lawyer
FDA Medical Device Testing & Approval Process Called into Question
Posted on Aug 28, 2011
The Institute of Medicine, part of the National Academy of Sciences, is calling on the FDA to beef up its scrutiny of medical devices before letting them go onto the market where they might end up in your body. The Institute of Medicine advises our federal government on science policy, and it has concluded that the current FDA testing & approval process does 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 detail potential changes. But the FDA has already rejected the Institute's central finding. And medical device makers simultaneously are pressuring the FDA to streamline and expedite the medical device approval process. The Institute's recommendation follows upon the heels of an updated FDA warning about the dangers of transvaginal surgical mesh in pelvic prolapse repairs. This July 2011 FDA warning updates the agency's previous statement in 2008 which pronounced the risks of complications from the medical device to be rare.
Your body and your health are the real battlefield in this contest. The outcomes and decisions regarding the FDA testing & approval process for medical devices will ultimately have their effects on your health and well being. This conflict between science, government, and medical device marketers occurs within the larger environment of ongoing contention over the "Obamacare" mandates. Chances are that a decision in one of these matters will have some influence upon the decision in the other. Stay tuned. It's your body, and your health.
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