Thursday, August 27, 2009


"In a stunning turn of events on what could be one of the largest Qui Tam cases in US history, the First Circuit Federal Appeals Court released it's opinion today reinstating a part of the whistleblower claim against Ortho Biotech, the Johnson & Johnson subsidiary, regarding the alleged kick back scheme for it's drug Procrit"....photo at right of Attorney Jan Schlichtmann, attorneys for the plaintiffs! (read full article below)

Thank God Johnson & Johnson is being held accountable!

Just like Ethisphere Magazine a couple of years ago, I ask "What's Ailing Johnson & Johnson?"

My opinion: A complete lack of ethics and the pursuit of profit legally or illegally. They are a major part of the health care crisis because of their disease mongering, creating a "disease" and then providing the drug or device which will "maintain", never cure the disease, all the while making literally billions of dollars in profit.

The J&J Credo clearly states their first responsibility is to their stockholders, not to the patients whom they profess to "cure".



Funny this Whistleblower case over their Procrit drug GOT NO PRESS! Unbelievable...J&J gets everything swept under the carpet...broken sterilizers in San Angelo, Texas that pumped out over 3.4 million unsterilized Vicry sutures in the early 90's, deaths from the Ortho Evra patch in the last couple of years, deaths and horrific complications from their trademark Prolene polypropylene mesh tape used for hernia repairs, bladder suspension for both men and women and pelvic organ prolapse.


My thoughts: Think Revelations 21:8..."But the fearful, and unbelieving, and the abominable, and murderers, and whoremongers, and sorcerers, and idolaters, and all liars, shall have their part in the lake which burneth with fire and brimstone: which is the second death."


QUOTED FROM: http://thesettlementchannel.squarespace.com/

Procrit whistleblower case revived by First District appeals court decision
Thursday, August 13, 2009 at 07:37AM


In a stunning turn of events on what could be one of the largest Qui Tam cases in US history, the First Circuit Federal Appeals Court released it's opinion today reinstating a part of the whistleblower claim against Ortho Biotech, the Johnson & Johnson subsidiary, regarding the alleged kick back scheme for it's drug Procrit



You may read the entire opinion by clicking the link here, The case number is 08-1409 and the name is United States, ex rel. Mark Eugene Duxbury and Dean McClellan, Plaintiffs vs Ortho Bio Products.


This case was spearheaded by Attorney Jan Schlichtmann on behalf of the relators Duxbury and MacClellan and when the trial court dismissed the claim, the appeal was filed and argued in mid 2008 and today's decision affirmed part of the decision but cleared the way for the Duxbury claim on kick backs and rebating tied to the off label marketing and use of Procrit in oncology clinics and hospitals.


We will be having Attorney Jan Schlichtmann on Speaking of Justice today to discuss the courts ruling, his thoughts on the elements that were affirmed as well as the next steps in this long dormant but now front page Whistle Blower case regarding Procrit and the marketing of it's off label use. As long time readers of this page will recall this was also featured in a Wall Street Journal profile on the case at about the time of the original trial in 2007 and while many had given the case up for dead, the Appeals Court has done a comprehensive analysis of what the bar is to filing a Whistle Blower claim and brought in a real stunner on what could be a massive potential claim against Ortho Biotech.


Of interest to structured settlement and claims professionals is the fact that this case is also potentially one of the largest non-qualifed structured settlement cases in US history due to the early and comprehensive use of a 468B trust to handle any and all claims attached to this Qui Tam case and subsequent litigation. This will be an intriguing case to follow so don't miss this broadcast!


Johnson & Johnson Procrit whistleblower case discussed on video


Thursday, August 13, 2009 at 07:44PM


In this video earlier today with Attorney Jan Schlichtmann, attorneys for the plaintiffs in the Ortho Biotech Qui Tam case, joins Speaking of Justice to discuss how this case will proceed given the stunning decision by the US Appeals Court to certify Mark Duxbury as a whistleblower.


As mentioned in my earlier post, this case if it is joined by the US Attorney and Attorney General has the potential to be a multi-billion dollar recovery according to AP reports in todays news.


The question becomes, will Attorney General's prior work as counsel for Johnson & Johnson in any way influence the decision by the US Attorney's office to join the case and attempt to recover billions of dollars of taxpayer money at a time when Health Care is utterly dominating the political news and debate.


Why in the world, given the ruling of the US Appeals Court, which appears to be totally consistent with the Rockwell ruling by the Supreme Court in 2007, wouldn't the US Attorney proceed to go get these funds? I guess we will find out shortly if this Justice Department is going to be a true departure from the Bush DOJ very shortly.

QUOTED FROM: www.drugrecalllawyerblog.com
Posted On: August 24, 2009 by
John J. Cord


Johnson & Johnson Warned by FDA

Last week, the FDA sent a warning letter to Johnson & Johnson over trials of its antibiotic drug, ceftobiprole. J&J hopes that Ceftobiprole will be approved for treatment of skin infections, including MRSA (which is frequently a hospital-acquired infection).


The FDA reports that J&J has been violating its own study protocols, including:
Failure to ensure that patients properly store the drug
Failure to perform appropriate patient examinations
Failure to document some doses given to patients
Hiring unqualified investigators
Enrolling patients who do not meet J&J’s own eligibility criteria


These types of problems are systemic in the whole system. Many blame the FDA for allowing bad drugs to reach the market, but the primary failure is with the drug companies who fail to conduct adequate studies (or worse, hide the results of their otherwise-adequate studies). The FDA does not do independent studies of the drugs—that is not something taxpayers should have to pay for. Drugmakers have responsibility to perform studies of their own drugs to ensure they meet safety and efficacy requirements. Unfortunately, this is sometimes like the wolf guarding the hen house.

Saturday, August 8, 2009

HEALTHCARE NIGHTMARE: SYNTHETIC SURGICAL MESH COMPLICATIONS!

DON'T WANT TO TAKE A CHANCE ON LOOKING
LIKE THIS PICTURE...
DON'T ALLOW A DOCTOR TO USE MESH FOR HERNIA REPAIR, BLADDER SUSPENSION OR PELVIC ORGAN PROLAPSE

Death by bleedout, death from strangulation of the bowels, perforation of the bladder, male infertility, necrotizing fasciitis, inability to urinate, hernias, colostomies...just a few of the complications of the surgical implantation of Synthetic Surgical Mesh.

Synthetic Surgical Mesh is a very dangerous product being surgically implanted in millions of people every year. The manufacturers of these products know they cause serious permanent injury to patients, but continue to sell them as safe and effective.

The complications put patients permanently in the health care system, cost insurance companies millions and millions of dollars and create thousands of medical malpractice lawsuits.

What you won't see are thousands of product liability lawsuits. Why?It is an extremely complicated product most attorneys don't understand.

The First Annual Conference of Truth in Medicine, a patients advocacy organization, will clear up the confusion.

Truth in Medicine Incorporated has already had success by having the FDA issue a Public Health Notification warning of complications from the use of synthetic surgical mesh.
Our First Annual Conference in Sept 25-27, 2009 in Ft Lauderdale brings together an important group of health care decision makers, prominent doctors from major health care facilities, who are participating in the Conference and who support our cause.

Please attend the Conference.

An alliance between yourself and Truth in Medicine will have a major impact bringing about better health care, reducing health care insurance premiums and filing the right product liability lawsuit for the real CULPRIT...SYNTHETIC SURGICAL MESH.

The conference agenda is posted prominently at http://www.truthinmedicine.us.com/. See 1st Annual Conference 2009 menu tab for all the details. Scroll to the bottom to use PayPal to register.

There is a special session on Sunday morning, September 27, 2009:

Meet the Attorneys!

8:00 – 11:30AM at the Renaissance Ft Lauderdale, FL

Attorneys will be given a "Mesh Education". What it is. What it does. What harm it causes. Why it is inherently defective. How "Mesh" facts can be applied to the law. Why Federal Pre-Emption does not apply to Mesh. Who the experts are. How to get a jump on discovery and save thousands and thousands of dollars...what are the "right" interrogatories...what are the "right" requests for production of documents. How to make Synthetic Surgical Mesh the next mass tort.

Medical Device Manufacturers make billions and billions of dollars of profit annually. They profit while patients suffer debilitating, lifelong complications, doctors careers, reputations and livelihoods are put at serious risk, insurance companies pay out huge sums on medical claims and millions and millions of Americans then are forced to pay higher premiums for health insurance. "Surviving the Complications of Synthetic Surgical Mesh" is a must for any firm seeking the tools to win big when representing their "Mesh" Clients!! A very small investment for huge returns.

The "Meet the Attorney" session is free to Mesh Sufferers.

See you at the Conference!!

CONFERENCE REGISTRATION FEE:

$99.00 for Truth in Medicine Members Includes
Continental Breakfast Friday & Saturday and Luncheon Friday

$99.00 for Early Registration by September 10, 2009 – $119.00 September 11 and after

$495.00 for Sunday Session only for Attorney Firms by September 10- Includes 2 members of the firm - $594.00 September 11 and afterAdditional $99.00 for each additional member of the firm -regardless of date of registrationPlease use multiple quantities on the PayPal button to register your firm.

CONFERENCE QUESTIONS CONTACT:

Lana C. Keeton
Truth in Medicine Incorporated
Miami Beach, FL 33139
786-566-7780

CONFERENCE LOCATION:
RENAISSANCE FORT LAUDERDALE HOTEL
1617 SE 17th Street, Ft Lauderdale, FL 33316
954-626-1700 phone 954-626-1752 fax

HOTEL TELEPHONE REGISTRATION:
Mention Truth in Medicine Room Block for
$89.00 special group rate [normally $159.00]
$139.00 upgrade to a Junior Suite [normally $219.00]
800-228-9290 in the U.S. and Canada (or any of the worldwide reservation
numbers for Renaissance Hotels)

HOTEL ONLINE REGISTRATION:

HOTEL QUESTIONS CONTACT:
Margaret Luppino
Convention Services Manager
954-626-1706 direct line

Friday, July 3, 2009


Jury Awards $5.75 Million in Medical Malpractice Suit
December, 2003
Miami-Dade Circuit CourtCase No.: 00-14725-CA-30

Salvador Plasencia v. Jorge Echenique, M.D. and Miami Urological Surgical Consultants

Plaintiff attorneys:
Partner Marvin Kurzban and Associate Jed Kurzban at
Kurzban Kurzban Weinger & Tetzeli in Miami.
Defense Attorneys:
Partner David Dittmar and Senior Associate Patricia Murray at
Dittmar & Hauser in Miami, representing Echenique;
Peter Restani, a Partner at Restani McAllister & Cassetty in Coral Gables, representing Miami Urological

In 2003, justice was finally served for 37-year-old Mr. Plasencia, the victim of severe medical malpractice. Suffering from end-stage kidney failure - unnoticed and untreated by three different physicians - Mr. Plasencia and his two minor children brought suit in 2000, recovered a verdict for a total of $5.75 million in damages from the jury.
In February of 1996 and in response to various complaints, Mr. Plasencia's general practitioner, Ms. Teresa Cardoso, performed a urinalysis and found clear warning signs of serious kidney disease. In spite of the presence of both blood and protein, Dr. Cardoso failed to recognize the presence and significance of the protein. Dr. Cardoso referred Mr. Plasencia to a urologist, Dr. Jorge Echenique, where two more urinalyses were conducted again showing the combined presence of blood and protein. Not unlike Dr. Cardoso, Dr. Echenique too failed to recognize the significance of the results and so did not order any follow-up tests.
After a year of continued suffering, Mr. Plasencia again visited Dr. Cardoso who referred him to a second urologist, Dr. Arthur Lim of Miami Urological and Surgical Consultants. Again, the urologist failed to interpret the available data or to gather new data in a useful manner and Mr. Plasencia was sent home. Untreated and still suffering, Mr. Plasencia checked himself in to a hospital where was diagnosed with end-stage kidney failure - the result of untreated inflammation of kidney tissue.

Defendants Echenique and Miami Urological Surgical Consultants argued that the type of kidney disease from which Plasencia was suffering was untreatable and early detection would not have substantially changed the need for a kidney transplant. Defense counsel David Dittmar argued that a directed verdict should have been entered for the defendants.

Prior to trial, physician Cardoso settled for an undisclosed amount. On May 9, following a 10-day trial and 5-hour jury deliberations, Mr. Plasencia was awarded $5.75 million in damages. The jury awarded $3 million in past pain and suffering; $1.5 million for future medical costs; $500,000 for Plasencia's two minor daughters' lost services and comfort and anxiety; $443,000 in future lost earnings capability; $228,000 in past medical costs; and $78,000 for past lost earnings. The jury also determined that while Mr. Plasencia was 1 percent at fault, Dr. Cardoso was 19 percent at fault, Dr. Echenique 53 percent at fault, and Dr. Lim and Miami Urological were 27 percent at fault. [or $1,552,500.00]

SEEMS TO BE A PATTERN HERE...SEND THE PATIENT HOME UNTREATED AND STILL SUFFERING!! BEEN THERE, DONE THAT!

THINK DR. BERNARD CANTOR AND MT SINAI MEDICAL CENTER MIAMI BEACH...

http://www.kkwtlaw.com/CM/Articles/medical_malpractice_suit.asp

ABOVE ARTICLE FROM THE WEBSITE OF KURZBAN, KURZBAN, WEINGER & TETZELI...

Monday, June 29, 2009

MESHIE FRIENDS MEET! CHARLOTTE, LANA & DEBORAH
* * * * * * * * * * *
TRUTH IN MEDICINE INCORPORATED
FIRST ANNUAL CONFERENCE
"SURVIVING THE COMPLICATIONS OF
SYNTHETIC SURGICAL MESH"
FRIDAY & SATURDAY, SEPTEMBER 25-26, 2009

CONFERENCE REGISTRATION
FEE: $100.00 for Truth in Medicine Members
Includes Continental Breakfast Friday &
Saturday and Luncheon Friday
$100.00 for Early Registration by September 1, 2009
$120.00 September 1 and after

INSTRUCTIONS FOR CONFERENCE REGISTRATION TO BE POSTED
HERE BY THURSDAY, JULY 2, 2009.....PLEASE CHECK BACK!!

HERE IS THE HOTEL RESERVATION INFORMATION.......
RENAISSANCE FORT LAUDERDALE HOTEL
1617 SE 17th Street, Ft Lauderdale, FL 33316
954-626-1700 phone 954-626-1752 fax

HOTEL TELEPHONE REGISTRATION:
Mention Truth in Medicine Room Block for
$89.00 special group rate [normally $159.00]
$139.00 upgrade to a Junior Suite [normally $219.00]
800-228-9290 in the U.S. and Canada
(or any of the worldwide reservation numbers for Renaissance Hotels)

HOTEL ONLINE REGISTRATION: www.renaissancehotels.com/fllbr
ENTER GROUP CODE: TIMTIMA

HOTEL QUESTIONS CONTACT:
Margaret Luppino
Convention Services Manager
954-626-1706 direct line
m.luppino@renaissancefortlauderdale.com

CONFERENCE QUESTIONS CONTACT:
Lana C. Keeton
Founder/President
Truth in Medicine Incorporated
1521 Alton Road, #198
Miami Beach, FL 33139

e-mail: truthinmedicine@bellsouth.net
websites:
http://www.truthinmedicine.us.com/
http://www.truthinmedicine.co.uk/

>>>>INITIAL CONFERENCE AGENDA <<<

THURSDAY, SEPTEMBER 24, 2009:
MEET & GREET COCKTAIL PARTY 6:00 – 8:00 p.m.
Patio at the Bimini Boatyard
across the parking lot from the Renaissance Hotel
Cash Bar - Free Hors d'oeuvres

FRIDAY, SEPTEMBER 25, 2009:
> CONTINENTAL BREAKFAST 9:00 – 10:30 AM
> LUNCHEON MEETING 11:30 AM – 5:00 PM

SPEAKERS:
Dr. Diana Zuckerman, President
National Research Center for Women & Families
www.center4research.org
Nancy Muller, Executive Director
National Association for Continence
www.nafc.org

Dr. G. Willy Davila, Chairman, Dept of Gynecology
Head of Urogynecology & Reconstructive Pelvic Surgery
Cleveland Clinic Weston, Weston, FL
Kenneth W. Goodman, PhD
Professor and Director, Bioethics Program
Co-Director, Ethics Programs
University of Miami
Miami, FL

> COCKTAIL PARTY 6:00 – 8:00 PM

SATURDAY SEPTEMBER 26, 2009:
> CONTINENTAL BREAKFAST 8:00 – 11:30 AM
>DOCTORS ROUNDTABLE 4:00 - 6:00 P.M.

>SATURDAY AFTERNOON & EVENING - FREE TIME!!
ENJOY ALL THAT FT LAUDERDALE OFFERS ON YOUR OWN!
RENAISSANCE HOTEL PERFECTLY LOCATED FOR FUN!!
$1.00 TROLLEY TO ANYWHERE IN FT LAUDERDALE,
the BEACH, RESTAURANTS, SIGHTSEEING!

SUNDAY, SEPTEMBER 27, 2009:
> CONTINENTAL BREAKFAST - 8:00 AM – 11:30AM

***Events subject to change without notice

Monday, May 11, 2009

SYNTHETIC SURGICAL MESH CONFERENCE...

HOW TO SURVIVE A BAD OUTCOME FROM SURGICAL MESH IMPLANTATION!

SAVE THE DATE!!
MORE DETAILS COMING SOON!!

TRUTH IN MEDICINE
FIRST ANNUAL CONFERENCE
FRIDAY AND SATURDAY,

SEPTEMBER 25-26, 2009
FT. LAUDERDALE, FL USA

OUR WORK AS PATIENTS ADVOCATES CONTINUES!
A PUBLIC HEALTH WARNING WAS ISSUED OCTOBER 2008 BY THE FDA/CDRH FOR SYNTHETIC SURGICAL MESH USED FOR STRESS URINARY INCONTINENCE AND PELVIC ORGAN PROLAPSE!

A GIANT STEP TOWARD THE REMOVAL OF SYNTHETIC SURGICAL MESH FROM THE MARKETPLACE! MORE TO COME!!

EQUALLY AS IMPORTANT AS THE WARNING IS HELPING PEOPLE TO SURVIVE A BAD OUTCOME FROM SURGICAL MESH IMPLANTATION....WE'RE HERE TO HELP!!
OUR FABULOUS SPEAKERS:

DR. DIANA ZUCKERMAN, PRESIDENT
NATIONAL RESEARCH CENTER FOR WOMEN & FAMILIES
www.center4research.org

NANCY MULLER, EXECUTIVE DIRECTOR
NATIONAL ASSOCIATION FOR CONTINENCE
www.nafc.org

DR. RICHARD MILLER, PROF OF SURGERY, MEDICAL DIR
TRAUMA INTENSIVE CARE UNIT,
DIV OF TRAUMA AND SURGICAL CRITICAL CARE
VANDERBILT UNIVESITY MEDCIAL CENTER
NASHVILLE, TENNESSEE

Unofficial Events for the Conference:

A MEET AND GREET COCKTAIL PARTY on Thursday, September 24, 2009

WORSHIP SERVICE followed by BRUNCH ON SUNDAY, September 27, 2009!

HOPE YOU WILL BE ABLE TO ATTEND ALL THE EVENTS!!!

I REALLY LOOK FORWARD TO MEETING EVERYONE, ESPECIALLY ALL MY WONDERFUL MESHIE FRIENDS!! :) :)

GOD BLESS, LANA

LANA KEETON
FOUNDER and PRESIDENT
TRUTH IN MEDICINE INCORPORATED
1521 ALTON ROAD,#198
MIAMI BEACH, FL 33139

www.truthinmedicine.us.com

Tuesday, May 5, 2009

KICKING FARMACEUTICAL FANNY!



All Meshed Up?

HELP ME AND THOUSANDS OF OTHERS WHOSE LIVES HAVE BEEN DESTROYED BY THE COMPLICATIONS OF SYNTHETIC SURGICAL MESH.....

KICK SOME FARMACEUTICAL FANNY!

Go to http://www.truthinmedicine.us.com/

REGISTER ON THE WORLDWIDE REGISTRY OF COMPLICATIONS OF SYNTHETIC SURGICAL MESH!!

SOMEBODY'S GOTTA DO IT!

IT'S FOR SURE GOVERNMENT AND THE HEALTH SYSTEM ARE NOT GOING TO DO IT!!

THEY LIVE IN THE ANTIQUATED WORLD OF THE MAUDE DATA BASE....

MANUFACTURER AND USER DATA BASE EXPERIENCE ?

@#!&?^>!@#!&%$#@

THAT'S WHAT I THOUGHT YOU WOULD SAY...

ARE YOU KIDDING ME? WHAT IS THAT? HEAR ANYBODY TALKING ABOUT IT AT THE WATER COOLER? I DON'T THINK SO!

THE TRICK HERE IS THE MANUFACTURER WANTS TO MAKE SURE YOU NEVER HEAR OF IT. WHY IS THAT?

EASY...YOU DON'T REPORT YOUR NEAR DEATH EXPERIENCE, OR HORRIFIC COMPLICATION, FROM THEIR NIFTY ? ? LIFE-SAVING ? ? MEDICAL DEVICE....THEIR DEFECTIVE MEDICAL DEVICES ARE NOT RECALLED.

THEY GO ON TO DESTROY MORE LIVES.....PHYSICALLY, MENTALLY, EMOTIONALLY, FINANCIALLY...

LET'S STOP THAT CYCLE!

LET'S STEP OUTSIDE THE BOX!

REGISTER YOUR COMPLICATIONS AT

WWW.TRUTHINMEDICINE.US.COM!!!

LET'S SHOW EVERYONE THE TRUTH!

JOIN THE TEAM AT TRUTH IN MEDICINE!

LET'S STOP THE USE OF PETROLEUM-BASED SYNTHETIC SURGICAL MESH IN HUMAN BEINGS!!!

LET'S KICK SOME FARMACEUTICAL FANNY!!!

HAVE QUESTIONS? NEED ANSWERS? WE'RE HERE TO HELP!!!

truthinmedicine@bellsouth.net

Sunday, November 23, 2008

GYNECARE TVT COMPLICATIONS & DEATHS CONTINUE TO RISE!

ETHICON'S PROLENE POLYPROPYLENE SYNTHETIC SURGICAL MESH USED IN GYNECARE TVT DEVICE INTERNALLY MUTILATES HUMAN BEINGS!

EVERY DAY MORE & MORE PEOPLE WITH MESH COMPLICATIONS FROM HERNIA REPAIR, PELVIC FLOOR DISORDER AND BLADDER SUSPENSION, BOTH MALE AND FEMALE, CONTACT ME SEARCHING FOR HELP!
Every morning the FDA, the CDRH and the Pharmaceutical Companies have blood on their hands. Every day new victims of synthetic surgical mesh complications are internally mutilated and begin a slow horrifying death…of their life as they knew it, of their hopes and dreams, of their physical abilities.

Americans go to doctors, whom they trust, who perform surgery on them in accredited hospitals using FDA approved products. They believe in the system. Americans don’t ask questions. They trust a system that actually betrays them.

The FDA facilitates the pharmaceutical industry’s betrayal of Americans and the health system because of the flawed 510 (k) Premarket Notification Approval Process.

There is greater interest in profitability for industry than in assuring patient safety. Speed of approval is more important than safety. As for the efficacy of thousands of medical devices implanted in Americans, that is an unknown.

The FDA’s 510 (k) Pre-market Notification submission process only establishes that medical devices are “substantially equivalent” to a product already approved for sale. There is no proof of the safety and efficacy of these medical devices. No human clinical trials are required.

All Americans need to be well advised of the difference between the FDA’s Pre-Market Approval and the FDA’s 510 (k) Pre-Market Notification submission processes.

Pre-Market Approval means that there have been human clinical trials. Safety and efficacy of the medical device has been established. Risks and complications of the device are relatively well known.

Pre-Market Notification means that the pharmaceutical companies have followed the FDA’s criteria for establishing “substantial equivalence”. The medical device is approved for sale. No human clinical trials are necessary.

For Pre-Market Notification, the safety and efficacy[that it actually works] of the device does not have to be established. Risks and complications will be learned as physicians perform surgery on the general public. Each and every surgical patient is unknowingly a part of a human clinical trial, a guinea pig.

Steps to educate the American public about these very important differences have to be enacted by Congress. The following actions would enable all Americans to make informed decisions about their healthcare.

a. Provide a written statement to every patient entering the hospital for implantation of a medical device clearly explaining the difference between Pre-Market Approval and Pre-Market Notification. The patient should be notified at that time what the approval process was with the FDA for the medical device and/or foreign body being implanted in them.

b. Provide an Adverse Event Report to each and every patient with his/her discharge papers following any procedure involving any foreign body that is implanted in them.

The Adverse Event Report should include the name of the manufacturer, name of the product, model/catalog #, FDA approval number whether Pre-Market Approval or 510 (k) Pre-Market Notification, name of doctor performing implantation, user facility, date of surgery, original diagnosis for procedure, surgical procedure followed for the implantation of the foreign body, traceability label, etc.

For future medical care, patients will be able to fully advise their doctors of anything and everything that is in their bodies

Inadequate, substandard physician training in the implantation of synthetic surgical mesh significantly increases the percentage of complications.

Each new mesh product and/or delivery method has a learning curve for each doctor. There is a much greater incidence of complications in the first 20 implantation procedures of medical devices that any doctor performs.

If there are 20,000 doctors performing procedures on their first 20 patients using only one medical device through one method of implantation, that would be 400,000 patients that are at greater risk for complications from that one product alone.

As there are over 10,000 new medical devices approved by the FDA each year used by 20,000 doctors on 20 patients, the figure would be in the multi millions.

This learning curve is devastating to the American public. This does not factor in bad doctors and bad medical care, only the normal percentages of a new procedure with a good doctor.

Human tissue is powerless against implanted synthetic surgical mesh. The mesh moves at will within the human body.

Movement of the mesh within the body, erosion, as it is so benignly described, is an irreversible complication. Removing the mesh from the human body when it causes complications is an Irreversible Complication. It is like removing gum from hair. No package insert for mesh from any pharmaceutical company states this.

Once the complication occurs, physicians do not know how to remove the mesh. Or it is physically impossible to remove because of where it is within the body. Explantation of surgical mesh has not been addressed on the package inserts or in the limited training of doctors who implant surgical mesh.

Very frequently mesh victims are substantially more harmed during the removal of the mesh, the explantation process, than from the irreversible complications of erosion. Daily torment from the complications of surgical mesh becomes a way of life for its victims.

The long term impact of these Synthetic Surgical Meshes on the lives of the victims, the load placed on the health care system, the load placed on the court system and on all Americans through increased premiums to major medical insurance companies who pay for the continuing care of Surgical Mesh Victims is staggering. This is a major medical catastrophe. The use of surgical meshes has to be completely stopped.

The FDA, the CDRH and HHS depend on an extremely flawed system to make determinations about recalling these dangerous medical devices and drugs. Who knows about the MAUDE database?

Certainly not me, until I nearly died from the surgical implantation of the Gynecare TVT System and its TVT device, Prolene polypropylene mesh.

Most people don’t unless they become seriously injured by a defective medical device or a dangerous medication.

Please do your part to remove Petroleum Based Synthetic Surgical Mesh from the marketplace completely.

Go to
www.truthinmedicine.us.com and fill out the Worldwide Registry of Complications of Surgical Mesh.

The information will be compiled and given to Congress to force the FDA/CDRH to recall all Synthetic Surgical Mesh from the marketplace.

The site is secure and encrypted. No one will have your name or identifying information. The only one to see all the information will be me.

Your privacy will be protected by assigning a number to your submission to the Registry when used in the presentation to Congress.

Take the steps to stop this from happening to one more human being. Go to
www.truthinmedicine.us.com right now. You can not change what happened to you. You can stop it from happening to another human being!!

God bless, Lana Keeton