The FDA & Mesh - Failed Policy

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The Food and Drug Administration site links can help you sometimes, but they are often riddled with hidden policy euphemisms and are not consumer friendly.

Let's start with what I will say are the most helpful pages. 

 

  • CLICK HERE FOR THE FDA'S HOME PAGE FOR UROGYNECOLOGIC SURGICAL MESH IMPLANTS/PROCEDURES:

http://tinyurl.com/k9p5gz9

  

  • FDA'S "ADVERSE EVENT" MEDICAL REPORTING SYSTEM. YOU MUST USE THE FDA MEDWATCH SYSTEM BELOW TO DESCRIBE YOUR DEVICE:
        • INCLUDE ANY DEVICE PRODUCT NUMBERS OR INFORMATION YOU CAN GLEAN FROM YOUR HOSPITAL RECORDS.
        • THE UNOFFICIAL RULE IS: MORE IS BETTER
        • DATES OF ONSET OF INJURY, DURATION OF INJURY
        • PAIN LEVELS: SEVERITY, FREQUENCY AND DURATION AND LOCATION
        • EVEN PICTURES OF YOUR SYMPTOMS, AND ANY OTHER HARM, INCLUDING PSYCHOLOGICAL, PSYCHOSOCIAL, SOCIOLOGICAL - ANYTHING OF A MEDICAL NATURE.

 

Report ANY and ALL Adverse Events (negative side effects/symptoms) to the FDA.

 

 


 

NOW, FOR THE NOT-SO-GOOD NEWS. . . EVER HEARD OF THE FDA'S 510k Clearance Process?

Often also referred to by manufacturers mostly as the Pre-Market Approval Process?

THE POLICY IS ENTIRELY LEGAL. IT'S ALSO SIMULTANEOUSLY ENTIRELY UNETHICAL.

 

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I didn't know either until my mom became immediately, gravely sick after her "pre-market" cleared mesh device was put into the hands of thousands and thousands of doctors through the Mesh Manufactures unholy alliance with the FDA and marketing reps for both.

 

  • FDA APPROVAL MEANS SOMETHING ENTIRELY different than FDA CLEARANCE (slight-of hand already?)

I'm not really sure if either is any good at all. I just know, from personal experience that CLEARANCE is WORSE because it doesn't require testing.

In the case of mesh; POLYPROPYLENE MESH FOR SUI AND POP WAS NEVER TESTED ON A SINGLE LIVING HUMAN, YET IT WAS CLEARED BY THE FDA.

 

FDA APPROVED vs. FDA CLEARED

*Credit: The Princess Bride (1989) i-do-not-think-that-word-means-what-you-think-it-means-gif.jpg

 

 

START READING, FOR THERE'S PLENTY OF IT! (Make sure you sit down with a good cup of coffee or tea and dictionary.com as well as a business and medical dictionary - very useful for more quickly learning!)

 

FDA APPROVAL FOR DRUGS:

http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194949.htm

 

FDA APPROVAL FOR MEDICAL DEVICES

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/default.htm

 

FDA CLEARANCE FOR MEDICAL DEVICES

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/default.htm 

 

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