1. Plaintiff Attorneys used an anemic trial strategy despite significant scientific expert evidence and knowledge to the contrary. Ambiguity remains. Hundreds of thousands of women are at risk from unsafe surgical procedures using synthetic surgical mesh in the female pelvis and reproductive system that cause serious permanent disabling injuries.
2. Plaintiff Attorneys did not integrate all the causes of the harm from transvaginal mesh procedures in their strategy. The procedure, synthetic surgical mesh and trocar combined in the female pelvis and reproductive system are catastrophic along with comorbidities, age, concomitant procedures, again catastrophic.
3. The DUMBED DOWN Trial Strategy used was a limited concept of pore size which is difficult to prove and does not integrate the myriad physical and chemical properties of polypropylene synthetic surgical mesh and wound healing, critical to the understanding of mesh injury. Most important physical property: the polypropylene synthetic surgical mesh shrinks itself due to inherent manufacturing defects.
Synthetic Surgical Mesh remains on the market. Why?
1. Plaintiff Attorneys,
2. the American Urogynecological Society (AUGS)
3. the American College of Obstetrics and Gynecology (ACOG)
4. Doctors such as Dr. John Miklos and Dr. G. Willy Davila
5. Hospitals such as Cleveland Clinic and the Mayo Clinic
6. the United States Food and Drug Administration’s Center for Devices and Radiological Health (FDA’s CDRH)
7. the director of the CDRH, Dr. Jeffrey Shuren, and David Krause, and other top officials at the FDA and
8. Johnson & Johnson’s Ethicon
Kept mesh on the market by a series of events.
The events listed below culminated in plaintiff’s attorneys proving abdominal sacral colpopexy was a better, safer alternative procedure to Pleivc Organ Prolapse repair through the vagina in bellwether trials in the U.S. District Court for the Southern District of West Virginia. IT IS NOT SAFER!
January 2012: The FDA’s CDRH issues 522 orders to 33 companies for 99 products they must begin clinical trials testing their synthetic surgical mesh products for safety and efficacy.
April 2012: Dr. John Miklos and Dr. Robert Moore hold doctor conference in Atlanta.
April 12, 2012 Mass Torts Made Perfect Panel
April 12, 2012 Mass Torts Made Perfect Panel
Abdominal Sacral Colpopexy recommended
Pelvic Mesh: How to Represent the Victims
Robert Price, Levin Papantonio Thomas Mitchell Rafferty & Proctor
Amy Eskin, Hersh & Hersh
Lana Keeton, Truth in Medicine
April 27, 2012 Lana Keeton sends letter to all Plaintiff’s Attorneys in the MultiDistrict Litigation warning of the significant dangers of Abdominal Sacral Colpopexy including clinical trials
May 2012 Johnson and Johnson’s Ethicon will stop selling 5 of their transvaginal mesh products. Only the TVT Secur was removed and the rest of the TVT bladder sling meshes remained on the market.
GYNECARE ProliftTM Pelvic Floor Repair System
GYNECARE Prolift +MTM Pelvic Floor Repair System
GYNECARE ProsimaTM Pelvic Floor Repair System
GYNECARE GYNEMESH MTM Partially Absorbable Mesh
GYNECARE TVT SecurTM System (not all TVT products)
Ethicon also notified FDA's Office of Surveillance and Biometrics of their intention to make a labeling change to the Indication for Use for GYNECARE GYNEMESH PS Nonabsorbable PROLENE Soft Mesh indicating it for abdominal (open or laparoscopic) use only.
(ABDOMINAL SACRAL COLPOPEXY!)
With approval of the labeling change by the FDA, the 522 orders for their products were placed on hold and eventually terminated since the orders were applicable to vaginally placed POP mesh products only. Sales continued in the US and globally under the then current indication until regulatory approval of the labeling change was obtained in each country.
June 2012: Johnson and Johnson’s Ethicon send letter to Judge Joseph Goodwin they are removing 5 products from market
September 2012: The applied for approval of label changes for indication for use to Abdominal Sacral Colpopexy was eventually signed by Dr. Ben Fisher at the FDA’s CDRH
This Very neat package NEVER publicized Kept Mesh on the Market for use in the Female Pelvis and Reproductive System. This, in my opinion, is a crime against women. It PRESERVES:
a. Use of mesh for abdominal sacral colpopexy by doctors
b. The mesh profits for Johnson & Johnson’s Ethicon Gynemesh
c. Injury to hundreds of thousands of women patients
There is NO LEVEL ONE (1) EVIDENCE of success
of abdominal sacral colpopexy despite decades of use.
COLLUSION OR COINCIDENCE?