What government allows over 100,000 women to be injured by a "Medical Device", Synthetic Surgical Mesh, for pelvic organ prolapse and bladder suspenson?
SURPRISE!! The good ole U.S. of A!
Yes, your government works in collusion with the major medical device manufacturers allowing "Medical Devices" to be sold to all hospitals and doctors in the United States of America that ARE NOT SAFE!
The Prolift pelvic mesh kit was placed on the market by Ethicon, Inc. a subsidiary of Johnson & Johnson, in 2005 based on a letter the employees wrote to themselves and placed in their own file that NO CLEARANCE WAS REQUIRED BY THE FDA!
However, when they did file for clearance through the 510(k) Premarket Notification Clearance process of the Prolift +M in 2007, there was a HICCUP!
It took Johnson & Johnson/Ethicon a year but finally after many back and forth revisions to the Prolift+M, both the original Prolift and the Prolift+M were cleared under a 510(k) by the FDA's CDRH with a little help from their "special friend", Dr. David Krause, a Branch Chief at the CDRH.
More to come on the "special friend" as the RICO Civil Claim, 1:15-cv-20442 in the United States District Court for the Southern District of Florida unfolds.
As to the DEAD WOMEN, no lawsuit will bring them back to life. Just ask Robert Fish about his Mother committing suicide in the back yard, slitting her wrists and then shooting herself in the heart, to be sure she did not survive her own suicide. Or ask the family of Joy Poteet and the many others who we will never know their names because JOHNSON & JOHNSON/ETHICON redacted their names from the Med Watch Reports they filed with the FDA.
How long is our government going to facilitate the ongoing slaughter of innocent women who go to their doctor to be well but wind up dead?
At this rate, for many years to come.