September 8, 2011...Day One!
FDA ObGyn Advisory Panel Meeting on Synthetic Surgical Mesh implanted in the pelvis of women. Transvaginal mesh it is now called...no matter where placed, no matter the brand. All lumped into one...
Guess that's okay in a sense because ALL of them cause immeasurable harm.
When will the FDA take action to stop the harm to millions of mesh injured patients, MEN AND WOMEN ALIKE?
The medical device companies have a seemingly unending amount of time to continue the harm while Patients NEVER get a second chance. Once the mesh is in, it is permanent.
So while the mesh makers get a do over, Patients become permanently disabled pelvic cripples.
An FDA warning October 2008.
Another more serious FDA warning July 13, 2011.
The FDA mandates 522 studies to 33 companies for 99 mesh products January 2012.
The FDA puts forth the possiblity of upclassifying mesh kits manufactured for pelvic organ prolapse May 2014. Comments are accepted through July 2014.
September 8, 2014...patients are still harmed every single day while mesh companies still getting a do over.
What really needs a do over is the FDA's 510(k) Premarket Notification clearance process which allowed these products ever to be sold in the first place.
Write your Congressman. Write the FDA. Write your State authorities.
LET'S GET SYNTHETIC SURGICAL MESH OFF THE MARKET...PERMANENTLY!
NO MORE DO OVERS!