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The FDA in the spotlight for failing to protect the public
It’s probably a long shot but maybe the FDA will finally be overhauled. They have been failing in their stated mission for decades.
https://www.propublica.org/article/senators-ask-gao-to-probe-fda-device-oversight-citing-cpap-recall
https://www.fda.gov/about-fda/what-we-do
“FDA Mission
The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation.”
propublica.org
Sens. Dick Durbin and Richard Blumenthal sent a letter noting how the agency missed opportunities to protect the public from faulty medical devices, citing reporting by ProPublica and the Pittsburgh Post-Gazette.
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2 Replies
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Please stop spamming with this kind of discussion, there are already enough spammers on this site
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It’s not spam Cursed. Many surgeons assume that the FDA will save them from using poor medical devices. They think that if the device is “FDA-approved” that it will be good for the patient. The evidence though, shows that the FDA is at this point in time essentially a “rubber stamp” organization, through the 510(k) process. They don’t actually do any substantial investigating, even though their own database is full of reports of harm from a variety of mesh products. They depend on the various industries to “self-police”. It’s why the surgeons that know about this are calling for registries and device tracking. It’s one of the reasons for organizations like the ACHQC. The government agencies are failing us, both surgeons and patients. Surgeons, and patients, will have to identify and call out these bad products so that they can be avoided.
The FDA only seems to get involved if very serious harm occurs. Death, or seriously debilitating effects. Mild daily suffering is not enough.
Sorry that I did not respond to your last message. Please create a Discussion on the main forum so that other people can help answer your questions. Good luck.
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