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!"

Thursday, March 30, 2017

LANA KEETON ON CAPITOL HILL...JEFF SHUREN, MD, JD, DIRECTOR OF THE CDRH...YOU'RE FIRED!




LANA KEETON AT WORK ON CAPITOL HILL

JEFF SHUREN....YOU'RE FIRED!

JEFF SHUREN, MD, JD, DIRECTOR OF THE FDA'S CENTER FOR DEVICES & RADIOLOGICAL (CDRH) HEALTH, OBAMA APPOINTEE IN 2009

SHUREN PROTECTS UNSAFE MEDICAL DEVICES, 
NOT PATIENTS!

NO. 1
GE HEALTHCARE'S UNSAFE MRI  
(JEFFREY IMELT, CEO OF GE, WAS OBAMA'S JOBS CZAR)

NO. 2
SYNTHETIC SURGICAL MESHES FOR HERNIA REPAIR, BLADDER SUSPENSION & 
PELVIC ORGAN PROLAPSE
ETHICON/J&J
BOSTON SCIENTIFIC
C.R. BARD
AMERICAN MEDICAL SYSTEMS
COOK MEDICAL
CALDERA
COLOPLAST

NO. 3
ESSURE STERILIZATION DEVICE
MANUFACTURED BY BAYER

NO. 4 
MORCELLATOR DEVICES FOR FIBROID TUMORS
WOMEN DIE WITHIN MONTHS FROM OCCULT CANCER IN THE FIBROIDS JOHNSON & JOHNSON & OTHER MANUFACTURERS

PRESIDENT DONALD J. TRUMP  

HUNDREDS OF THOUSANDS OF INJURED PATIENTS ARE ASKING YOU
TO TELL JEFF SHUREN, MD, JD, DIRECTOR OF THE CDRH...YOU'RE FIRED!

FDA CLEARED (NOT CLINICALLY TESTED FOR SAFETY AND EFFECTIVENESS) MEDICAL DEVICES ARE KILLING AND INJURING HUNDREDS OF THOUSANDS EVERY YEAR, EXPONENTIALLY INCREASING THE COST OF HEALTH CARE AND BURDENING THE COURT SYSTEM, MAKING PLAINTIFF'S ATTORNEYS MULTI MILLIONAIRES WHILE COMPLETELY DESTROYING THE LIVES OF UNSUSPECTING PATIENTS!

PLEASE, PLEASE HELP US!






Tuesday, March 28, 2017

LANA KEETON, WEEK TWO ON CAPITOL HILL!

Great meeting yesterday at Judicial Watch with a lead investigative counsel on the issue of fraud and corruption at the FDA/CDRH. He gave me direction and I will be meeting with him again very soon. He was an amazing source of information and I am very grateful to him for the 2 hours he spent with me. I want to expose the fraud in clearing mesh at the FDA.CDRH in hopes President Trump will look at it and make HUUUGGGEE CHANGES THERE! PRAY!!

Pics below


Thursday, March 23, 2017

LANA KEETON, A DAY ON CAPITOL HILL MARCH 22, 2017

A DAY ON CAPITOL HILL....

Yesterday I met with the House Judiciary Committee, headed by Representative Bob Goodlatte, who is currently seeking information from RELION, a lead generator for Plaintiff Attorneys for Mass Torts. Having worked with Mass Tort Plaintiffs Attorneys as a Legal Consultant, Medical Device Expert and having been a Patient Advocate through the patient advocacy organization I founded, Truth in Medicine since 2007, I have very valuable input to the House Judiciary Committee to protect Mesh Injured Patient Plaintiffs.

I also met with the House Oversight and Government Reform headed by Representative Jason Chaffetz and had the good fortune to actually meet and introduce myself to Representative Chaffetz. It was quite an honor.

MESH INJURED PATIENTS ARE FIRST INJURED BY SYNTHETIC SURGICAL MESH, POLYPROPYLENE, AND A MYRIAD OF OTHERS.....

THEN THEY ARE FURTHER INJURED BY THE COURT SYSTEM,  A TRAVESTY BEYOND WORDS FOR THOSE WHO HAVE LOST NOT ONLY THEIR HEALTH, BUT THEIR FAMILIES, THEIR HOMES, THEIR JOBS, THEIR INCOME AND THE RESPECT AND DIGNITY NORMALLY AFFORDED US.

THE SYSTEM WINS!

TIME FOR THIS TO STOP. TIME FOR LEGISLATORS TO PROTECT US FROM THE MEDICAL HARMCARE SYSTEM DESTROYING SO MANY LIVES!




Tuesday, February 28, 2017

THE FEDERAL GOVERNMENT V. WOMEN: FUNDING AND FEEDING THE UNIVERSITIES WITH YOUR PELVIS! by LANA C. KEETON written on MAY 21, 2013



THE FEDERAL GOVERNMENT VS. WOMEN:
FUNDING AND FEEDING THE UNIVERSITIES WITH YOUR PELVIS!
By LANA C. KEETON - MAY 21, 2013

            Women are being maimed and tortured every single day because the federal government is feeding and funding the universities with our beautiful, precious bodies.
For almost 12 years now, I believed I was horribly injured because of corporate greed and the evil humans who ran them. The revelation I had today belongs in the headlines along with the IRS scandal, the DOJ attack on our 1st amendment rights at the AP and the State Department failings in Benghazi that killed 4 brave Americans serving their country in Libya.

The ultimate betrayal: the government that is supposed to protect you is preying on you.

            The U.S. Food and Drug Administration (FDA), the Center for Devices and Radiologic Health (CDRH) The Pelvic Floor Disorders Network (PFDN), created and funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), and its Gynecologic Health and Disease Branch (GHDB) work together to keep a steady flow of humans moving through the healthcare system by funding clinical trials at universities and hospitals (with your hard earned tax dollars). And, of course, device and drug companies are their willing accomplices.

God forbid you should be healthy. They would all be out of their jobs. They do not want you to be well. (We’re in trouble.)  


WHERE IS THE FUNDING FOR THE PATIENT HARM CAUSED BY GOVERNMENT HUMAN EXPERIMENTATION?

            It does not exist. Walk out of a hospital harmed by the “healthcare” provided and you are on your own. Sorry. You are not only permanently injured and out of a job, you are out of a life. There is no cavalry coming to the rescue.

            It’s not the lack of health insurance that hobbles Americans harmed by the system. It is the physical harm itself that ruins lives. Healthy people can work, support their families, care for themselves and participate in society.

            You are the by-product of a system run amuck. Government makes the laws which protect the doctors, hospitals, corporations and health insurance companies. What they do not protect is YOU, the patient.

So now look at this.

                  Pelvic Organ Prolapse

            Pelvic organ prolapse occurs when pelvic muscles and tissues can no longer support one or more of the pelvic organs, causing them to protrude or bulge through the vaginal canal. This protrusion may be uncomfortable, making physical activity difficult and interfering with sexual activity.

            Recent research suggests that 3.3 million women in the United States have had pelvic organ prolapse. Because of a possible association with aging, this number is expected to rise to 4.9 million by 2050. This increase highlights a public health        need for safe and effective treatments for pelvic organ prolapse. NICHD-     supported research on surgical approaches aims to better understand the long- term risks and benefits of these treatments for the condition.

            What will it matter? When these trials are done the women will all be dead.

            Pelvic organ prolapse is a key area of study for the NICHD-supported  Pelvic Floor Disorders Network (PFDN), supported through the NICHD’s Gynecological Health and Disease Branch (GHDB), within the Division of Extramural Research. Through its eight clinical centers and a Data Coordinating Center, the PFDN carries out important studies to help advance clinical care and improve our understanding of pelvic organ prolapse and other        PFDs, including their causes, their mechanisms, their treatments, and ways to possibly prevent them. Since the Network launched in 2001, more than 200 doctors, nurses, and researchers have joined with more than 4,000 women in    studies on PFDs. This ongoing partnership between researchers and patients is     critical to the PFDN’s success.
           

IS THIS SEXUAL ABUSE OF, AND SEXUAL DISCRIMINATION AGAINST, WOMEN? Not exactly sure but it certainly seems like it to me.
For me personally, I have an answer to a question I have been asking myself for almost 12 years.
How could any surgeon EVER violate a woman’s pelvis with trocars that look like meat hooks and then insert synthetic surgical mesh, a petroleum waste byproduct, through the most private, precious, life-giving part of a woman’s body?

Answer: Group think, crowd mentality, compliments of your government funded clinical trials at prominent hospitals and universities. They have to feed the system or they are all out of a job.

So each and every one of us mesh injured patients no longer has a life, at least not the beautiful one we had before a surgeon implanted the evil that is mesh.


GHDB…..Does that stand for GOD HELP the DAMN BASTARDS? Cause for sure they are all going to hell.