Friday, April 21, 2017

SURGICAL MESH STILL ON THE MARKET. WHY? @ETHICON - @$JNJ MDL02327 PROTECTED BY PLAINTIFF ATTORNEYS? COLLUSION OR COINCIDENCE? MESH INJURED PATIENT....YOU DECIDE!


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. Henry Garrard III is only attorney speaker on the agenda. 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
Henry Garrard, Blasingame Burch Garrard Ashley
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?

Tuesday, April 18, 2017

WHITEHOUSE.GOV WE THE PEOPLE PETITION SENT TO WEST VIRGINIA MDL PLAINTIFF'S ATTORNEYS TO HELP MESH INJURED WOMEN GET MESH OFF THE MARKET!

Dear MDL Litigators,
Over 100,000 lawsuits have not gotten pelvic mesh off the market.
SO I HAVE CREATED A PETITION…..and the injured patients and the friends and families of the dead worldwide are going to do just that. GET MESH OFF THE MARKET!
Please join us by signing the Petition at WhiteHouse.gov. There will still be thousands and thousands of lawsuits as mesh is phased out of medical practice…so please, please sign.
WE'RE LIVE!! 324 SIGNATURES so far on www.WHITEHOUSE.gov.
GOD is GOOD!
LET'S DO THIS!! EVERYBODY "SIGN ONE...GET ONE"... We have 24 days to get another 99,676 signatures to reach 100,000!
PROTECT PATIENTS from DANGEROUS MEDICAL DEVICES, INVESTIGATE and END FDA CORRUPTION, FIRE FDA/CDRH DIRECTOR JEFF SHUREN.
Truth in Medicine Incorporated calls for an end to fraud and corruption at the FDA, the root of International Medical Carnage. In the U.S. alone, over 100,000 women are internally mutilated by pelvic mesh devices, over 33,067 women horribly injured by the essure sterilization device and hundreds of women dead from occult cancer set free in their bodies by a morcellator device used to remove fibroid tumors. Other countries follow the lead of the US FDA.
Hundreds of thousands more are injured worldwide. None of these women knew a surgery performed by their doctor would permanently disable, injure or kill them.
Under FDA/CDRH Director Jeff Shuren, ALL REMAIN ON THE MARKET. Remove these dangerous devices from the market now. Investigate and end FDA corruption.
Director Shuren "You're Fired!"
Lana C. Keeton
© 2005 - 2017 Lana C. Keeton All rights reserved. Peace be with You.
This material may not be published, broadcast, rewritten or redistributed.
Med Device Expert LLC
Device Expert . Legal Consultant . Patient Advocate
1602 Alton Road, #423, Miami Beach, FL 33139

305-671-9331 phone . 800-509-9917 fax

786-566-7780 . 305-342-8002 cell phones

Monday, April 10, 2017

PRESIDENT TRUMP, WHITE HOUSE PETITION ASKS PLEASE PROTECT PATIENTS from DANGEROUS MEDICAL DEVICES, INVESTIGATE and END FDA CORRUPTION, FIRE FDA/CDRH DIRECTOR JEFF SHUREN.


I just started a petition on the White House petitions site, We the People.

Please sign it now!

We the people ask the federal government to Propose a new Administration policy:

PROTECT PATIENTS from DANGEROUS MEDICAL DEVICES, INVESTIGATE and END FDA CORRUPTION,
FIRE FDA/CDRH DIRECTOR JEFF SHUREN.

Created by L.K. on April 10, 2017

LET'S DO THIS! WORLDWIDE! 

SIGN WHITE HOUSE PETITION!

SEND THE MESSAGE...WOMEN RULE!

GET MESH, ESSURE AND MORCELLATORS OFF THE MARKET.

FIRE FDA/CDRH DIRECTOR JEFF SHUREN.


HERE'S THE LINK TO SIGN THE PETITION:

https://petitions.whitehouse.gov/petition/protect-patients-dangerous-medical-devices-investigate-and-end-fda-corruption-fire-fdacdrh-director-jeff-shuren


Truth in Medicine Incorporated calls for an end to fraud and corruption at the FDA, the root of International Medical Carnage. 

In the U.S. alone, over 100,000 women are internally mutilated by pelvic mesh devices, over 33,067 women horribly injured by the essure sterilization device and hundreds of women dead from occult cancer set free in their bodies by a morcellator device used to remove fibroid tumors. 

Other countries follow the lead of the US FDA. Hundreds of thousands more are injured worldwide.

None of these women knew a surgery performed by their doctor would permanently disable, injure or kill them. 

Under FDA/CDRH Director Jeff Shuren, ALL REMAIN ON THE MARKET. 

Remove these dangerous devices from the market now. Investigate and end FDA corruption. 

Director Shuren "You're Fired!"