Hidden FDA Reports Detail Harm Caused by Medical Devices


The FDA keeps suppressed lists of medical device failures.  You can read about it on Medscape:

FDA spokeswoman Deborah Kotz confirmed that the “registry exemption” was created without any public notice or regulations. “Any device manufacturer can request an exemption from its reporting requirements,” she said in an email.

I don’t want to sound overdramatic here, but it seemed like a cover-up. Dr. Douglas Kwazneski, surgeon

Agency records provided to KHN show that more than 480,000 injuries or malfunctions were reported through the alternative summary reporting program in 2017 alone.

There’s no mention of how many devices harmed patients despite ISO certifications.

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