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:
- 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.
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.
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)
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:
FDA APPROVAL FOR MEDICAL DEVICES
FDA CLEARANCE FOR MEDICAL DEVICES