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 for 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 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.
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. Topic of speech, how doctors can avoid
legal liability when implanting mesh
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?
