Outpatient Procedure?

2011-09-16T06:02:00.000-07:00

TO THE HONORABLE FDA OBGYN ADVISORY PANEL
GAITHERSBURG, MD
SEPTEMBER 9, 2011

Synthetic Surgical Mesh is a flawed concept. It depends on a misuse of the body’s inflammatory process. The purpose of inflammation is to protect the body. Purposely creating inflammation with the flawed “tension free” synthetic surgical mesh concept starts an irreversible disease process. The body is in a constant state of heightened immune response.

The primary focus of yesterday’s meeting was a doctor’s ability, or lack of ability, to implant synthetic surgical mesh. Does a doctor’s skill change the chemical and physical properties of synthetic mesh? No. Does a doctor’s skill stop the inherent degradation and decomposition of polymers? No. Do doctors prevent shrinking and hardening of mesh? No. The conversation has to change to the cause of the problem, the device itself.

In the last 10 years, I personally have treated with over 20 of the best doctors across America, literally, from South Florida to California. I have had 17 surgeries and/or procedures to “manage” erosion. Dr. G. Willy Davila at the Cleveland Clinic Weston treated me for 7 years and did not stop the chronic pain. Finally in 2010 Dr. Philippe Zimmern at UTSW in Dallas, removed 4 “ of mesh in a 3 hour surgery. Finally the pain stopped. Women do not want their complications to be managed. They do not want the complications associated with mesh. Thank God, I will not suffer anymore in-office trimmings, a barbaric practice which hides the real number of adverse events.

Surgical mesh does not treat causation. Hernia, incontinence and pelvic organ prolapse are symptoms of a condition, torn or weakened tissue. Rather than address the weakened tissue, doctors are treating symptoms of the condition. These are not life threatening conditions. Treatment with the medical device, synthetic surgical mesh, is life threatening.

If, as presented here by so many medical doctors, the cause of the complications is due to limited surgical skills, the design is bad. This is not a practice of medicine issue. This is medical device safety issue. It is not usable because the design is flawed. It is a petroleum waste byproduct, in effect garbage. It should recalled by the FDA, except in rare cases, for all uses including hernia repair, bladder suspension and pelvic organ prolapse.

Here are a few key points.
1. The literature is rife with publications that mesh is not inert. There are too many variables for mesh to be used in a human. It is impossible to standardize.

2. Based on my understanding of mesh, as a medical device expert with 30 years experience and thousands of hours of research, load transfer is impossible to achieve. The biomechanical properties of living tissue are measured by strain. Human tissue is not measured in same context as textiles which are measured by tensile.

3. Textile manufacturing process
The use of chemical additives for the processing itself, along with antimicrobials, adhesion preventatives, physical mishandling by humans, surfactants like nonylphenol which are known endocrine disruptors, cross contamination by bacteria in the manufacturing facilities, uncontrolled chemical reactions between the polymer, the various additi ves and the human body is impossible to quantify. The in vivo degradation process sets up chronic inflammation and a cascade of autoimmune diseases.

The Alternatives
1. Treat the cause of the condition; strengthen all the tissue, not just bridge or scaffold with mesh
2. Base treatment on quality of life and the needs of the individual patient, not on the one size fits all mentality created by commercialized mesh kits
3. Use incontinence products
4. Implant non-cross linked biological meshes which constructively remodel inside the body
5. Prescribe pessaries and other non-surgical removable inserts.
6. Diet, exercise and a wellness mentality to protect and strengthen weakened tissue.

All of this is well documented. All of this is in the known literature. Please stop considering the flawed medical device, synthetic surgical mesh, through the solitary lens of doctor skills. This is a very complex issue and there is no magic button. Stop the use of synthetic surgical mesh except in the rare cases where there is no tissue available. Thank you!

Lana C. Keeton
President & Founder
Truth in Medicine Incorporated
1521 Alton Road, #198 Miami Beach, FL 33139
305.671.9332 phone 800.509.9917 fax 786.566.7780 cell

2011-09-16T05:57:00.000-07:00

INSTITUTE OF MEDICINE - PUBLIC MEETING - TESTIMONY
by LANA C. KEETON, PRESIDENT & FOUNDER
TRUTH IN MEDICINE INCORPORATED
SEPTEMBER 16, 2011
My name is Lana Keeton. I am the President and Founder of Truth in Medicine Incorporated, a patient advocacy organization. I personally wish I never heard of the 510(k) but it came slamming into my life back in December 2001. I woke up from surgery with a flesh eating bacteria and spent the next 3 months struggling to survive as the giant abscess on my stomach very slowly closed.
Based on my personal experience, the FDA’s 510 (k) clearance process just doesn’t work. The system is seriously failing the American public.
It has to be replaced. Meant as a bridge when the FDA first started regulating devices in 1976, it has long since become obsolete.
My near death from implantation of synthetic surgical mesh brings me here today. What happened to me should happen to no one. Following surgery for hysterectomy and mesh bladder suspension, I was in the hospital for almost 3 weeks, in bed for 3 months and did not work for 6 months. I lost my health, my home, my business and wound up in bankruptcy. Despite being a long time highly successful steel broker, I was at one time homeless and hungry from a highly touted “minimally invasive” outpatient procedure. I have been to over 20 doctors since 2001 trying to get well and have had multiple mesh removal surgeries. I still require one more surgery.
My bladder became a cottage industry for doctors, hospitals, attorneys and the court system and by now probably has a value of over a million dollars. The cost has been paid by me, my health insurance carrier, when I had health insurance, and the American taxpayer. This is in stark contrast to the original cost of the small piece of implanted Prolene mesh, $1,320.00. $1,320.00 billed to my health insurance company and over a million dollars to deal with the consequences is ludicrous.

Very, very sadly, I am not the only one with a million dollar bladder from the FDA’s 510 (k) 974098 for the Gynecare TVT System. It has been implanted in hundreds of thousands of women with staggering personal and financial costs….permanently disabled patients, broken families and relationships, millions of dollars in cost to the insurance companies, increased premiums to all Americans and court systems overburdened with mass torts where the tab is picked up by the American taxpayer.

My experience and thousands of others is a glaring example of the flawed 510(k) clearance process. The Protegen Sling, was taken off the market as misbranded and adulterated, only 3 months after the Gynecare TVT sling was cleared for sale by the FDA’s 510(k) in October 1998.

Ethicon’s Gynecare TVT sling was cleared by the FDA as being “substantially equivalent” to the recalled predicate device, the Protegen Sling. The TVT sling remains on the market almost 13 years later. Based on Medical Device Reports from Ethicon, at least 10 women have died from the Gynecare TVT sling.

Synthetic Surgical Mesh, a Class II medical device is responsible overall for the deaths of at least 17 women and who knows how many men. Over 6,000 adverse events have been reported to the FDA’s MAUDE database for mesh used for hernia repair, bladder suspension and pelvic organ prolapse since 2005.

But the FDA does not have the regulatory power to recall these 510(k) cleared dangerous devices.

Last week there was a meeting of the FDA’s ObGyn Advisory Panel which recommended re-classifying surgical mesh for pelvic organ prolapse to Class III. Re-classification will take up to 3 years and will only apply to new applications for new mesh devices.

Does anything change for patients? Yes, hundreds of attorney ads warn them of the dangers of mesh and validate them if they are already harmed.

Are the real issues recognized? No. Real experts on the mesh polymers themselves are not consulted.

The panel discussion at the meeting never turned to the real cause of the problem, the medical device itself, a petroleum based waste by product purported to be bio-compatible. Doctors on the panel and in the audience blamed other doctors lack of surgical skills for the high rate of complications caused by a bad medical device. ACOG and AUGS and industry and others called for better doctor training, better patient selection and better informed consent.

If mesh were a baby stroller that had killed 17 babies and injured over 6,000 b, it would be off the market. The manufacturer would never suggest better training of moms on how to push the stroller. But that is exactly what happened last week at the FDA Ob-Gyn panel meeting. This process is fundamentally flawed.

Does a doctor’s skill change the chemical and physical properties of synthetic mesh? No. Does a doctor’s skill stop the inherent degradation and decomposition of polymers? No. Do doctors prevent shrinking and hardening of mesh? No.

Even with the panel recommendation, all synthetic meshes for all uses currently cleared for sale by the FDA’s 510(k) will remain on the market. Patients continue to be harmed.

Today, this morning, patients across America are being put at risk by life-threatening

medical devices implanted for a non-life threatening condition, weakened or torn tissue. You don’t usually hear of someone dying of a hernia or incontinence or pelvic organ prolapse. But patients do die at alarming rates from the 510 (k) cleared medical device, synthetic surgical mesh.
The FDA has the duty and the obligation to protect the public health and to put patient safety first, before all other stakeholders. Please stop the great concern voiced by doctors, the FDA and industry about the burden placed on industry. Those who profit mightily should shoulder all the associated costs.
Please end the practice of patients paying the price of bad medical devices forcing them to live the consequences of decisions beyond their control and without their knowledge.

Safe and effective devices tested and proven by a different and better FDA regulatory framework will change the medical ecosystem, taking the grievous burden off individual patients, lawsuits out of American courts and significantly reduce the cost of healthcare to all Americans. The FDA’s 510(k) simply does not work anymore! Please replace it with a better regulatory process that truly protects patients!

Respectfully,
Lana C. Keeton
Founder and President
Truth in Medicine Incorporated
1521 Alton Road, #198
Miami Beach, FL 33139

phone: 305-671-9332 cell phone: 786-566-7780
e-mail: lanakeeton@truthinmedicine.us.com
website: www.truthinmedicine.us.com
Regardless of the decisions relating to the 510(k), please implement the following now.
1) Educate the American public about the difference between Pre Market Approval and Pre Market Notification Clearance Process.
2) Make patient labeling mandatory for all medical devices.
3) Make reporting mandatory with clear consequences for silence by doctors, hospitals and medical device makers.
4) Create a very specific guide for the FDA/CDRH to make better use of their regulatory authority. The decision making process for when and how to use FDA’s regulatory authority should not be left to the discretion of FDA/CDRH employees.
5) Include a mechanism which stops medical device makers from paying doctors to misuse their legal authority to sell products off label to increase the sales of their products.

Let's Get The Mesh Out!

2011-09-16T05:51:00.001-07:00

Good morning. My name is Lana Keeton. I am the President and Founder of Truth in Medicine, a patient advocacy organization. I am a medical device expert, with over 5000 hours of research into synthetic surgical mesh used for hernia repair, bladder suspension and pelvic organ prolapse. My experience as a steel broker for over 30 years fueled my research into the physical and chemical properties of polymers used for synthetic mesh and I have a unique perspective.

It’s really hard for me to stand here today in front of a room where many are hell bent on implanting garbage into humans. While the rest of the world is going green, doctors and device makers are going dark. Doctors and Device Makers should follow the example of the well known company, Waste Management, and dump Synthetic Surgical Mesh, a petroleum waste by product, a recycled garbage into the city dump.

Medical advisors & consultants, very well compensated, rally around surgical mesh like they are saving mankind. Mesh is not a polio vaccine. Mesh is not a cure for whooping cough. Mesh does not cure anything. It is a petroleum based waste by product from the gasoline refining process. I ask you, if they won’t put it in a car, why are surgeons implanting it into humans? I ask the FDA, the CDRH, this panel to make a wise decision.

There is group of pelvic organ prolapse surgeons, who are outraged their “toolkit” has been raided. They submitted a paper to the FDA, calling for the FDA to involve itself in practice of medicine issues only they, the surgeons themselves, have the power to change. These surgeons now take the position their “unskilled” counterparts do not properly implant synthetic mesh, causing the large number of complications. I strongly feel these surgeons should take a closer look at the bad tool. Have they taken in to consideration perhaps the usability of the design is flawed? Guess not since they are defending the tools in their toolkit as opposed to the thousands and thousands of injured patients…and let’s not forget the dead ones, either.

We probably would not be having this meeting today if doctors who implant mesh actually researched polymers themselves, instead of depending on the company who makes it and the sales rep. Or if they actually had mesh implanted in them.

Doctors look at the inflammatory reaction of the body to synthetic meshes and the ensuing disease process based on their medical training. They do not look at the chemicals causing the disease process.

So instead of better patient selection, better physician training or better informed consent recommended by this group of surgeons, let’s stop placing ticking time bombs of petroleum waste byproducts into women for POP and SUI and into men and women for hernias.

Respectfully, the FDA’s Ob-Gyn Advisory Panel Meeting scheduled to make recommendations here at this meeting on the use of synthetic surgical meshes is unqualified for its intended purpose, much like the synthetic meshes widely implanted in humans. Without a chemical textile engineer, a microbiologist, a human tissue engineer and other experts on synthetic polymers [polypropylene, polyethylene terephathlate, etc….] used in the manufacture of medical textiles, no valid conclusions will be drawn.

I am calling for all synthetic meshes to become controlled substances requiring the surgeon to write a prescription. Implanting surgeons should manage and/or pay for all mesh complications such as surgical mesh removal, pain management or other therapies necessary to manage the complications for at least 5 years. All synthetic meshes should be considered a drug under the FDA’s Pre-Market Approval Process. The chemical reaction of these drugs in concert with the chemical make-up of synthetic mesh implanted in the body is a biological disaster.

Synthetic Meshes have to be recalled, reclassified and tested as a drug for all chemical additives used in the textile manufacturing process, including antimicrobials, surfactants, dyes and other chemicals hazardous to human health. Thank you!

Institute of Medicine Public Health Effectiveness of the FDA 510 (k) Clearance Process

2010-06-25T10:23:00.000-07:00

The Institute of Medicine has a Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process. The Committee held a public workshop on June 14-15, 2010 in Washington, DC. The purpose of the workshop was for the committee to gather information related to the statement of task.

I attended the workshop and testified along with 5 members of the organization I founded, Truth in Medicine Incorporated. My written testimony follows. If you go to the following link, you will be able to see my actual testimony on video. When you get to the web page, scroll down to Public Comment Section and go to the timeline 11:00 minutes:

http://www.tvworldwide.com/events/iom/100614/default.cfm?id=12479&type=flv&test=0&live=0

My name is Lana Keeton. I am the President and Founder of Truth in Medicine Incorporated, a patient advocacy organization. I am here despite my near death from the implantation of a medical device, Synthetic Surgical Mesh, in December 2001. I was in the hospital for almost 3 weeks, in bed for 3 months and did not work for 6 months. I lost my health, my home, my business and wound up in bankruptcy. I have been homeless and hungry in the last 8 years and I live in chronic pain. I have been to over 20 doctors since 2001 trying to get well and have had multiple mesh removal surgeries. In fact, I have another surgery scheduled for next Tuesday.

My bladder has become a cottage industry for doctors, hospitals, attorneys and the court system and by now probably has a value of over a million dollars. That cost has been paid by me, my health insurance carrier, when I had health insurance, and the American taxpayer. This is in stark contrast to the original cost of this small piece of Prolene mesh about $1,200.00. $1,200.00 to create it and over a million dollars to deal with the consequences is insane. Johnson & Johnson may have made a $1,000.00 profit and myself and the American public is still paying for it 8 years later.

Clearance of the Gynecare TVT Prolene Mesh System sold by Ethicon & its parent company Johnson & Johnson was a medical marketing decision. I was not included in the decision made by Gynecare, by Ethicon, by Johnson & Johnson to put an unproven, unsafe dangerous petroleum based permanently placed medical device into the stream of commerce. The FDA cleared the device for sale through the 510(k). No patient should ever, ever, ever have to travel the journey I have traveled because of an unproven medical device.

The 510(k) clearance process is the Fox guarding the Hen House. It does not protect patients. The choice to make an informed decision of whether to take the risk of serious harm or death vs. the benefits is not an option for patients. Medical Marketing trumps patient safety.

The FDA does not educate the public, or even its own employees, medical devices are cleared through a process not requiring proof of safety or efficacy for Class I or Class II devices. An uninformed, unaware public is daily endangered by unsafe, unproven medical devices.

The battle cry of industry is innovation. They say innovation will be thwarted without this fast, easy money access to selling products. My question is: what innovation? How long has it been since polio was cured? When was the small pox vaccine created? A very long time ago. Is there a cure for cancer? No. Has AIDS been eradicated? No.

What pharmaceutical company is leading the charge to find these cures? Who knows? Do pharmaceutical companies sell sickness to the worried well? Yes. Is there an epidemic of disease mongering in the U.S.? Yes.

The 510 (k) clearance process is highly flawed. You as a committee have the duty and the obligation to put patient safety first and foremost for any and all clearance/approval processes at the FDA/CDRH.

Please stop the Conspiracy of Silence leaving patients in the dark. I recommend you make the following changes to the 510(k) clearance process:

1)Educate the American public about the difference between Pre Market Approval and Pre Market Notification Clearance Process.

2)Make patient labeling mandatory for all medical devices.

3)Make reporting mandatory with clear consequences for silence by doctors, hospitals and medical device makers.

4)Create a very specific guide for the FDA/CDRH to make better use of their regulatory authority. The decision making process for when and how to use FDA’s regulatory authority should not be left to the discretion of FDA/CDRH employees.

5)Include a mechanism which stops medical device makers from paying doctors to misuse their legal authority to sell products off label to increase the sales of their products.

I am not the only one with a million dollar bladder. 510 (k) #974098 for the Gynecare TVT system alone has astounding financial costs associated with it….disabled patients who are no longer functioning members of society, broken families and relationships, millions of dollars in cost to the insurance companies for the multiple surgeries each disabled patient requires, increased premiums to all Americans as the insurance companies pass along these costs, the court systems became overburdened with thousands of lawsuits, the cost of which is again passed along to all Americans through the taxes they pay to support the court systems.

And the result…catastrophic devastation to unsuspecting Americans who believed any product used in a hospital had been proven safe and effective by the FDA. That is simply not the truth. You can change it so none of you or your loved ones becomes one of those unsuspecting Americans.

Please end the practice of patients paying the price of bad medical devices forcing them to live the consequences of industry’s decisions without their knowledge.

Respectfully,
Lana C. Keeton
Founder and President
Truth in Medicine Incorporated
1521 Alton Road, #198
Miami Beach, FL 33139

phone: 305-671-9332
e-mail: lanakeeton@truthinmedicine.us.com
website: www.truthinmedicine.us.com
blog: www.theladyisachamp.blogspot.com

Lana Keeton Wins Medical Negligence Verdict Against Dr. Bernard Cantor

2010-06-05T07:31:00.000-07:00

Dateline: Miami, Florida Patients Advocate Lana Keeton, Founder and President of Truth in Medicine, scored a victory in court. Ms. Keeton won a verdict against defendant, Dr. Bernard Cantor, a Miami doctor, for medical negligence. The victory is a first in a lawsuit involving the Johnson & Johnson Gynecare TVT Prolene synthetic surgical mesh. Ms. Keeton underwent a hysterectomy and bladder suspension in December 2001 that almost ended her life.

Successfully treated for a necrotizing soft tissue infection at Jackson Memorial Hospital, following the initial surgery performed at Mt Sinai Medical Center on Miami Beach by Dr. Bernard Cantor, Ms. Keeton spent several months recuperating. Her experience has made her a formidable force in advocating for other injured patients.

Testifying at trial, Ms. Keeton stated she was not given proper informed consent for the implantation of the mesh. Dr. Cantor’s description to Ms. Keeton of the Prolene synthetic surgical mesh was simply “It’s a new tape. You will really like it.” No mention was made of the fact that the “tape” was a permanently placed medical device which cannot be removed without significant damage to tissue once implanted in the body. Nor did Dr. Cantor tell Ms. Keeton the product could be improperly implanted during the procedure or could erode (move by itself within the body) to cause permanent irreversible complications which she suffers. Dr. Cantor also omitted his lack of experience in the performing the procedure and complications in patients he had operated on prior to Ms. Keeton which required re-operation of the patient.

Ms. Keeton and Mr. James Shull, the Vice President of Truth in Medicine, were instrumental in getting the FDA to issue a Public Health Notification warning doctors and patients of the serious risks and complications of trans-vaginal placement of synthetic surgical mesh in October 2008. Based on their work, many law firms began filing lawsuits on behalf of other patients permanently harmed by synthetic mesh.

In an e-mail to a Truth in Medicine member in September 2009, Dr. Bobby Shull, Professor of Obstetrics and Gynecology, Dept Obstetrics and Gynecology, Texas A&M’s Scott & White Clinic in Temple, Texas says:

“Personally, I am pleased there is a patient advocacy group who is involved in helping us learn more about these products. My feeling is we will look back on this time with a sense of ‘why did anyone ever convince women to be subjected to these treatments?’ when little real information existed on the risks to be assumed.

There are other examples in gynecology; the Dalkon Shield for example or earlier sub-urethral slings…Protegen is one. Other products have been removed from the market only after a number of women were found to have been harmed.

It is unfortunate that women are and have been harmed. Perhaps with your group's influence the current situation can be changed for the sake of all the other women who are yet to be treated.”

Truth in Medicine’s primary initiative to achieve its’ mission is an Informed Consent Project with the University of Miami’s Bioethics Department headed by Kenneth W. Goodman, PhD. The focus is to create a comprehensive Informed Consent Tool Kit website for medical devices, the first being for synthetic surgical mesh. This would significantly lower the cost and increase the quality of healthcare.

Ms. Keeton notes the proliferation of synthetic surgical mesh “kits” have emboldened surgeons lacking the requisite surgical skills to do operations that have bad outcomes for the patients because, among other things, they do not know how to deal with the complications.

Ms. Keeton says, “The victory over Dr. Bernard Cantor signifies a big step forward in stopping future harm of other patients.”

Corporate Criminals? Ongoing Investigations of Johnson & Johnson Will Give Us The Answer!!

2009-11-10T21:11:00.001-08:00

The wanton disregard for humanity in the quest for profits is disgusting. J&J is no different than street corner drug dealers, except they operate under the cover of a "corporation". Just take a look at the picture above...

I DO NOT UNDERSTAND WHY THERE IS NO CRIMINAL INVESTIGATION INTO THE PATTERN OF REALLY BAD CORPORATE BEHAVIOR OF J&J. MAYBE THERE IS AND WE DON'T KNOW IT.

They certainly offer no relief of any kind to "externalities", those they know they are going to harm. They just do not know the names or the faces of those they know they will harm. Those nifty little package inserts sealed in the sterile packaging of their medical devices with all those disclaimers protect them legally in almost all instances.

Of course, their billions of dollars of profit also protect them, as it is virtually impossible to win in a lawsuit for the harm they cause.

See excerpts from the RPM Report below which may be the beginnings of those investigations, we can only hope:

Monday, November 09 2009 - Omnicare Settles Long Term Care Kickback Case; Is J&J the Real Target? By Michael McCaughan

"In an era of billion dollar fraud settlements, a $98 million settlement with Omnicare and an even smaller agreement with Ivax may seem like small potatoes. But prosecutors still have some big fish on the hook, including Johnson & Johnson....Here is what J&J says specifically about the Omnicare investigation:

In September 2005, the Company received a subpoena from the U.S. Attorney's Office, District of Massachusetts, seeking documents related to sales and marketing of eight drugs to Omnicare, Inc., a manager of pharmaceutical benefits for long-term care facilities. The Johnson & Johnson subsidiaries involved responded to the subpoena. Several employees of the Company's pharmaceutical subsidiaries have been subpoenaed to testify before a grand jury in connection with this investigation.

In April 2009, the Company was served with the complaints in two civil qui tam cases relating to marketing of prescription drugs to Omnicare, Inc. The complaints assert claims under the federal False Claims Act and related state statutes in connection with the marketing of several drugs to Omnicare. The government has not yet announced whether it will intervene in these cases."

"But that is not the only investigation involving Risperdal disclosed by J&J. The company's 10-Q filing cites at least 8 other subpoenas received by the company involving promotions of the product:

(1) a January 2004 subpoena seeking information about "sales and marketing of, and clinical trials for" from the Office of Personnel Management (which runs the Federal Employee Health Benefit Program);

(2) a November 2005 subpoena seeking information about "marketing of and adverse reactions to" Risperdal from the Philadelphia US Attorney (which brought the Zyprexa case);

(3) grand jury "subpoenas" related to that investigation;

(4-6) three separate subpoenas from the feds in Boston, Philadelphia and San Francisco "concerning, respectively, sales and marketing of Risperdal by Janssen (now OMJPI), Topamax by Ortho-McNeil (now OMJPI) and Natrecor by Scios" seeking "information regarding the Company's corporate supervision and oversight of these three subsidiaries, including their sales and marketing of these drugs";

(7) grand jury "subpoenas" in Boston related to those investigations; and

(8) a "HIPPA Subpoena" from Boston a "seeking information regarding the Company's financial relationship with several psychiatrists."
That tally does not include product liability cases (including some filed by state and federal government payors) involving Risperdal, nor does it include numerous pricing cases that presumably involve Risperdal as well.

We have no idea when or if any of those cases will result in prosecutions or settlements. But if they do, we're betting there will be some big numbers on the table."

MEANWHILE…..FROM PHARMALOT.COM …

Weldon Pays $8.5M For Florida Lots As J&J Cuts Jobs
By Ed Silverman November 3rd, 2009 // 3:07 pm

Just a week before announcing that Johnson & Johnson will cut some 8,000 jobs, J&J chair and chief executive Bill Weldon plunked down $8.45 million for two adjacent vacant waterfront lots in North Palm Beach, Fl., and he bought them from former General Electric chair and chief executive Jack Welch, according to The Palm Beach Daily News and brought to our attention by Bnet.

The properties are listed as 1264 Lake Worth Lane in Lost Tree Village with 113 feet of water frontage for $2.975 million and 1284 Lake Worth Lane, with 111 feet of frontage, for $5 million, according to the Property Appraiser’s Office records, the paper writes. Several realtors advertise exclusive properties in the enclave.
One of the realtors has this to say: “Lost Tree…is known for its Ocean, intracoastal, golf course, and lake views…There are homes on Lake Worth with wide water views and deep water ocean access, golf cottages located near the private golf course, and homes on interior lakes in this beautiful community. Lost Tree offers a private 18 hole golf course, 8 tennis courts, private beach…a beautiful beach club with a private restaurant open 2 days a week for dinner and for lunches most of the year.”

As for J&J employees? Some will be canvassing severance packages, COBRA health plans and, possibly, unemployment benefits. “These types of changes are difficult under any circumstances, and will have a very personal impact on people who have been dedicated to the mission of Johnson & Johnson,” Weldon says in today’s statement about the reorganization. Well, if nothing else, he’s stimulating the economy, albeit a well-to-do pocket.

MY THOUGHTS ON CEO WELDON’S PURCHASES….

For what it’s worth, all those $8.5 million after tax dollars Weldon is spending is on the backs of thousands and thousands of injured patients.
Johnson & Johnson spends millions and millions of dollars paying legions of attorneys to continue to make their billions of dollars in profit. Don’t believe me check out the Pacer System and do a search on J&J…literally hundreds of cases at any given time.

Think…Panacryl sutures, Ortho Evra patches, Prolene mesh, Intergel adhesion preventive…they will put anything on the market…deadly or not.

Just ask their Dr. Joel Lippman, their ex-Chief Medical Oficer, who tried to stop some of these products from going on the market.

If they were spending ANY of that money on the “externalities”, as they call injured patients, God bless Weldon.

As that is not the case, I am not sending any blessings Weldon’s way.

2009-09-19T20:47:00.000-07:00

FOR IMMEDIATE RELEASE
September 19, 2009

Contact: Lana Keeton

Truth in Medicine Incorporated

786-566-7780

FIRST ANNUAL TRUTH IN MEDICINE CONFERENCE

“SURVIVING THE COMPLICATIONS OF SYNTHETIC SURGICAL MESH”

Conference to Address Synthetic Meshes impact on more than 13 million Baby Boomers causing increased health care costs with 30-40% Complication Rate

CONTACT: truthinmedicine@bellsouth.net

WEBSITE: http://www.truthinmedicine.us.com/

FORT LAUDERDALE, Fla., Sept 19, 2009 –For the first time, a group of injured patients representing millions who have received synthetic surgical mesh for the common problems of hernia repair and urinary incontinence, will meet, one-on-one with patient advocates and surgeons to address the high complication rates of synthetic meshes at the first annual Truth in Medicine, conference at the Renaissance Ft Lauderdale Renaissance Fort Lauderdale Hotel, September 25-26, 2009.

“While medical device makers and some doctors advertise a 1-2% complication rate, thousands of injured patients have contacted Truth in Medicine, to tell their stories of ruined lives from irreversible complications indicating a rate of closer to 30 to 40 %,” says patient advocate and founder of Truth in Medicine, Lana Keeton.

Keeton, herself a synthetic mesh sufferer, helps to educate and support injured patients through Truth in Medicine showing them how to find medical treatment and making them realize they are not suffering alone. “These are very serious complications,” says Keeton.

“Millions of people may have synthetic surgical mesh of one kind or another implanted in their bodies which can shrink, migrate, perforate bowels, the vaginal wall, the urethra and/or the bladder and in some cases lead to death.”

Truth in Medicine patient advocates were the driving force behind the FDA issuing its first Public Health Notification in October 2008, on “Serious complications associated with Trans-vaginal Placement of Surgical Mesh…” and FDA's Information on Surgical Mesh for Hernia Repairs http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm142636.htm. Their focus now is to have the same Public Health Notification warning of complications of placement of synthetic hernia mesh.

Also, Truth in Medicine is pushing the FDA to re-open their Synthetic Surgical Mesh Investigation, following the “resignation” of Dr. Daniel Schultz, head of the CDRH who approved Regen for marketing against the recommendations of internal agency scientists and to re-review synthetic mesh according to the GAO’s recommendations earlier this year to re-review 25 other medical devices approved without assurances of safety or efficacy, says Keeton.

Presentations will be made Friday & Saturday, September 25-26, at the Renaissance Fort Lauderdale Hotel, 1617 SE 17th Street, Ft. Lauderdale, FL 33316 and include featured speakers:
Dr. Diana Zuckerman, President of the National Research Center for Women & Families; Nancy Muller, Executive Director of the national Association for Continence; and Ken W. Goodman, PhD, Director, Bioethics Program and Co-Director, Ethics Programs, University of Miami.

Doctors Roundtable will include members of the American Urogynecological Society (AUGS), representatives from AUGS' Board of Directors, Dr. Zuckerman and Dr. Goodman.

MEDIA: Will have access to patients from around the country to tell their stories, as well as surgeons and urogynecologists.

BACKGROUND RESOURCES: - Truth in Medicine was recently highlighted on the consumer Web site, InjuryBoard.com in a four part series, which generated more consumer responses than any other single story, and by WPLG TV 10 http://www.local10.com/video/17492050/index.html in Miami. #

ADDITIONAL HYPERLINKS:

FDA's Public Health Notification for Transvaginal Placement of Mesh:

http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm061976.htm
FDA on Surgical Mesh for Hernia Repairs:

http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm142636.htm

Injury Board four part series: http://www.injuryboard.com/national-news/suffering-in-silence-from-a-medical-device---surgical-mesh-part-4.aspx?googleid=262334

WPLG TV 10 Miami: http://www.local10.com/video/17492050/index.html

FDA “APPROVED” SAFE AND EFFECTIVE? THAT IS NOT WHAT IT MEANS!

2009-09-03T23:07:00.000-07:00

DON'T DIE AN EARLY DEATH

FROM SYNTHETIC SURGICAL MESH!

FDA “APPROVED” SAFE AND EFFECTIVE?

THAT IS NOT WHAT IT MEANS!

“MINIMALLY INVASIVE OUTPATIENT PROCEDURES”

ARE DANGEROUS!

Synthetic Surgical Mesh is a very dangerous product being surgically implanted in millions of people every year. Doctors implant surgical mesh for hernia repair, pelvic organ prolapse and bladder suspension, both male and female. Doctors are even using it now when women have Caesarean section delivery of their babies.

The manufacturers of these products know they cause serious permanent injury to patients, but continue to sell them as safe and effective, “approved” by the FDA.

Major pharmaceutical companies sell small pieces of polypropylene mesh [looks like window screen with raw edges] for thousands of dollars and call them “medical devices”.
The same polypropylene is also used to make pots and pans, roofing membrane, road paving materials, silt fences, carpeting...lots of things.

Polypropylene implanted in humans through “minimally invasive outpatient procedures” can cause severe permanent debilitating pain, death, perforation of the bladder, strangulation of the bowel, inability to sit, stand, walk, urinate or have sex and male infertility. These complications can appear immediately after surgery or many years later.

Patients wind up permanently in the health care system, cost insurance companies millions and millions of dollars and create thousands of medical malpractice lawsuits. This affects all Americans by causing higher health insurance premiums and weighing down the court system, not to mention the devastation to the patient.

Someone YOU know has synthetic surgical mesh implanted in them. They may not even know it. They just know they are sick and in pain. Learn about this serious silent health crisis. Come to the First Annual Conference of Truth in Medicine Friday & Saturday, September 25-26, 2009 in Ft Lauderdale, FL at the Renaissance Ft Lauderdale, “Surviving the Complications of Synthetic Surgical Mesh”.

Please go to www.truthinmedicine.us.com for more information, to become a member or register for the conference. We are patients helping patients to get well and stopping this from happening to others. Join us in making a difference for others!

Your friendly steel salesman, turned patients advocate, p.s. I still sell steel!!
Lana Keeton, Founder & President
Truth in Medicine Incorporated
1521 Alton Road, #198
Miami Beach, FL 33139
truthinmedicine@bellsouth.net
www.truthinmedicine.us.com
www.lanakeeton.com

2009-08-27T18:05:00.000-07:00

"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.

HEALTHCARE NIGHTMARE: SYNTHETIC SURGICAL MESH COMPLICATIONS!

2009-08-07T22:09:00.000-07:00

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

truthinmedicine@bellsouth.net

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:

www.renaissancehotels.com/fllbr GROUP CODE: TIMTIMA

HOTEL QUESTIONS CONTACT:

Margaret Luppino

Convention Services Manager

954-626-1706 direct line

m.luppino@renaissancefortlauderdale.com

2009-07-02T21:31:00.000-07:00

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...

2009-06-29T19:43:00.000-07:00

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

2009-05-10T22:38:00.000-07:00

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

KICKING FARMACEUTICAL FANNY!

2009-05-05T16:48:00.000-07:00

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

2008-11-23T10:51:00.000-08:00

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

With Great Pride, in Honor of My Amazing Incredible Father, Private 1st Class Kenneth Harold Keeton who served our country in World War II

2008-11-11T19:05:00.000-08:00

KENNETH HAROLD KEETON

MARCH 4, 1923 - JULY 18, 1962

Yesterday I received copies of letters that my Father wrote to his Mother and younger sisters in 1943, 1944 and 1945 while he was serving in World War II in the Phillippines. Monday November 10, 2008...one day before Veteran's Day I get those letters! That's the best. A window into the world my Father lived while he was serving our country.

One letter he wrote his Mom while he was in basic training at Camp Mackall in Hoffman, North Carolina in March 1944 was signed "Love and good night again to all, "Pvt." Kenneth Harold Keeton....out to the left in the margin by "Pvt." he wrote "I'm proud of this." with an arrow pointing to it. Wow, that made me feel good.

That's the man who loved me and raised me to be who I am. A man who was proud to serve the in the armed forces of the United States of America and make it safe and free.

My Dad died of a heart attack at 39 one hot summer day in July 1962. Worst day of my life. But every single day of my life I know how much he loved me. That love has carried me through some unbelievably tough stuff in my life, but nothing that could ever compare to the time he proudly served our country, the United States of America in the 188th Glider Infantry in the United States Army during World War II.

I pray for every person that reads these words the kind of amazing love that I had from my Father.

God bless my wonderful loving Father and God bless America!

I'll see you in heaven Daddy! God, I miss you with all my heart. Give Mom a kiss for me. I know you are there together. In love and honor, your daughter, Lana

The Gold Standard of Medical Care Now!

2008-09-16T10:52:00.000-07:00

THE ANSWER IS TRUTH IN MEDICINE!

The Human Body is powerless against synthetic surgical meshes used for hernia repair, pelvic floor dysfunction and bladder suspension, both male and female. Unfortunately, the ability to sue in state courts is not the answer.

The answer is TRUTH IN MEDICINE.

Petroleum Based Synthetic Surgical Meshes do not belong in the Human Body.

Surgical Meshes are foreign bodies and the body tries to expel this foreign body in any way that it can. The human body can not expel synthetic surgical mesh.

Despite extensive, well known published studies of the horrific complications of synthetic surgical meshes, the use proliferates daily. Commercialization of surgical mesh by multi-billion dollar pharmaceutical giants has substituted “surgical mesh kits” for good surgical skills.

Doctors, who would never consider doing a procedure knowing they do not have the requisite skills, are emboldened by the “mesh kits” that tout “minimally invasive, outpatient procedure”. “Local anesthesia, short recovery time, back to work in a few days.….just use this handy piece of polypropylene attached to this needle or ring or implantation mechanism and you can start your own assembly line. Line up those gurneys around your office, like the cars lined up at the McDonald’s drive thru.”

And a little “business enhancement program”, offered as an incentive by the pharmaceutical giants, builds the reputations and the practices of these unskilled doctors cum “skilled surgeons”. They become known throughout the community as innovators, leaders in this new and exciting world of petroleum based synthetic meshes as replacement parts for humans.

Never mind that human tissue is powerless against mesh. Never mind that this unskilled surgeon is incapable of removing the mesh once you have complications. Never mind that lack of skill of the surgeon is not the only reason mesh can not be removed. The worst of it is, removing the mesh is frequently a greater danger than leaving it in the body.

Human tissue has grown into the interstices of the mesh. Nerves have become entrapped in the mesh. Unskilled surgeons will send you to pain management. Uneducated surgeons will cut your nerves. Irresponsible surgeons will remove muscles and other parts…ovaries, uteruses, testicles, spermatic cords.

Doctors will remove pieces and parts of the human body, all the while denying mesh is the cause of the complications. Why will they deny mesh is the cause of the problem? They will be reciting the script given to them by the multi billion dollar pharmaceutical companies and medical device makers to keep the doctors and the pharmaceutical companies from being sued.

So here we are again.

The Doctor believes you will sue him for destroying your life as you knew it. All you want is a doctor who will treat you and make you whole again. Suing a doctor is not the answer to your horrific medical complications.

Truth in Medicine is the answer.

All you want is TRUTH.

All you want is MEDICAL CARE.

All you want is not to have to go to another doctor, not to have another infection, not to have another procedure, not to lose your job, to be able to pick up your grand baby, to be able to make love again, for the pain to stop.

That does not happen because Truth in Medicine no longer exists.

Today’s world of “confidentiality” protects doctors, hospitals, pharmaceutical companies, medical device makers, and the FDA. Nothing protects patients anymore. Patients have been dropped into the black hole of confidentiality so they will not know the truth.

How did this happen? What happened to Truth in Medicine? What happened to “First do no Harm”?

Looking back, Baby boomers have driven cultural changes in the U.S. for decades. In the 50’s there was a tremendous expansion of schools to serve boomers who were passing through the nations’ school systems. The list of changes driven by 80 million baby boomers passing through our society goes on and on.

McDonalds started serving hamburgers to millions and millions of Baby Boomers. Fast food created a fast food mentality about life in general. Nowadays, anytime one has to wait for something more than 15 seconds, 30 seconds, everyone is complaining.

This has translated into medicine…fast food medicine and disease mongering. While disease mongering made the uterus, ovaries and fallopian tubes diseases to be treated, Doctors found the hysterectomy to be very lucrative. Open surgical procedures were replaced by laparoscopic, faster recovery procedures. Hernia repair with surgical mesh became the norm, because doctors no longer have surgical skills to perform a traditional hernia repair.

First came synthetic mesh for hernia repair. Next came the Vaginal Prolift, Anterior and Posterior Lifts, and Bladder Suspension with surgical mesh kits.
Men’s and Women’s bodies are now enslaved to chronic pain and irreversible complications because the commercialization of mesh kits has replaced good surgical skills.

Let’s work together to stop the use of petroleum based synthetic surgical meshes in humans.

Let’s stop the commercialization of surgical mesh and mesh kits.

Let’s return to the answer: Truth in Medicine!

Want to discover more?

Stop, look and listen to Truth In Medicine! See my video clip as televised on WPLG Channel 10 News in Miami, Florida at http://local10.com/video/17492050/index.html

PREPARE FOR THE FIGHT OF YOUR LIFE!

2007-10-26T06:17:00.000-07:00

DOCTORS AND PHARMACEUTICAL COMPANIES HAVE STRUCK A DEAL!

DOCTORS DON’T ASK….PHARMACEUTICAL COMPANIES DON’T TELL!!

Sweet Deal for the Doctors and Pharmaceutical Companies…a NIGHTMARE FOR

YOU. You are the patient, who has a problem from mesh, Doctor says it’s not so.

You become invisible…doctor after doctor after doctor denies it’s the mesh, saying

they never had a problem with mesh. “All my mesh surgeries are perfect. Must be

something wrong with you…or your mind. Here take this prescription for Morphine.”

It must be a script…the answer is always the same no matter who your doctor is, or

more likely, was. You know you are never going back to that quack.

You are Eve and have just eaten Satan’s apple. You have just eaten the forbidden

fruit, “medical mesh.” Except the tree of knowledge of mesh is only evil…there’s no

good side to it! You’re done….forget your life as you knew it! You become invisible.

You become the victim of Frankenstein doctors who remove parts of you, cut your

nerves, disfigure and mutilate you inside, all the while telling you they will stop the pain.

Yeah right!! You become the walking wounded. AND INVISIBLE!

AND THE DEAL WORKS….THEY DON’T GET SUED!

DON’T ASK! DON’T TELL!

WORKS FOR THE DOCTORS AND THE PHARMACEUTICAL COMPANIES…

BUT FORGET YOU!

LIGHTS, CAMERA . . . ACTION!

2007-08-02T12:24:00.000-07:00

WOMEN UNITE!

Now is your chance to stand up and shine like a star!

Has your life and body been irrevocably changed (and not in a good way) by the Gynecare TVT System?

Tell it to the judge!

Stand up in a court of law and tell it like it is. I'm calling on all women who have been injured by this product and procedure to speak their piece.

Stand up and be counted! Let's unite to make certain no other innocent person has to suffer in pain for the rest of their lives because of a product and procedure that should not even be in the marketplace.

My lawsuit is the ideal platform from which to strike a blow at the company that manufactures and distributes the Gynecare TVT System.

I have filed a product liability lawsuit against Ethicon, Inc, Gynecare and Johnson & Johnson in the United States District Court for the Southern District of Florida.

Lana C. Keeton, Plaintiff Pro Se vs. Ethicon, Inc. (d/b/a Gynecare Worldwide) and Johnson & Johnson.

It is set for trial for October 1, 2007.

I need your help. Will you, and anyone else reading this with problems from the Gynecare TVT tape, please testify at trial? We have to help each other to stop this from happening to other women.

Please send me your contact info: name, e-mail address and phone number to:

Lana Keeton
Miami, Florida

lana@lanakeeton.com

August 17, 2007 is the deadline for my witness list, so please contact me now, or I will not be able to put you on the witness stand to tell your story.

A huge issue for all women, this procedure, if done at all, should only be done by an experienced urogynecologist. The procedure is blind. The doctor sticks a needle into your vagina and brings it out through the abdominal skin. They then look through a cystoscopy to make sure it is not in your bladder. The only thing they know from this, is that it is (problably) not in your bladder. No one knows where that tape is once it is inside of you.

That is, unless you have problems from it, of course. Problems that includes cutting into your bladder, your vagina, your urethra. Then, believe me, you definitely know where it is. You can feel it hurting you. At the same time, however, your doctor still does not know where the tape is for sure.

The Gynecare TVT System and its TVT Device (Prolene mesh tape) are inherently defective for more than one reason.

1. The tape itself has abrasive edges that cut human tissue. Sensitive, living tissue in organs like the bladder, the vagina, the urethra. It is a process that will not stop unless your doctor surgically intervenes in some manner.

I have reports from an expert witness that the edges of the tape are defective. Please contact me at miamiblog@bellsouth.net if you would like me to send you the information.

2. The plastic sheaths that cover the tape for the purpose of implanting it in your body have to be pulled out after the tape is put inside you. Any movement of that tape after implantation is undesirable.

3. There is much more....

This has been a long arduous painful process for me. I hope I will be able to help other women not to suffer as I have. Please contact me.

Peace and Blessings,

Lana

CAUGHT BETWEEN A ROCK AND A HARD PLACE

2007-08-02T05:12:00.000-07:00

I was an experiment.

I was research.

I am one of Johnson and Johnson's guinea pigs.

No amount of money will ever pay for the damage Johnson and Johnson intentionally perpetrated on me.

They knew when they put the Gynecare TVT Sling into the marketplace, it would harm me! They fully intended to harm me and thousands more in the name of the almighty dollar.

Johnson and Johnson has not taken the Hippocratic Oath. Doctors have taken the Hippocratic Oath which states: "First do no harm . . ."

Johnson and Johnson deliberately put a medical device into the stream of commerce that they knew without a doubt would harm someone. Their attitude?

“Oh, you’re just part of a very low percentage…less than 1% will be harmed.”

Guess again! Did you know that 1% of a million consumers is ten thousand consumers? That's an unacceptable number of women. Are they kidding? For each and every one of those ten thousand consumers, it is 100%.

I repeat, it is 100%....one hundred percent! That’s 10,000 families of those 10,000 consumers whose lives will be impacted.

Not to mention the 10,000 doctors whose careers and personal lives are also put at risk. All because doctors took the Hippocratic Oath while Johnson and Johnson did not!

In their rush to the marketplace without clinical trials on medical devices, Johnson and Johnson is physically harming people, destroying their lives, and flooding the court system with lawsuits. They can afford it. They have lawyers who can afford to wait it out in court with countless delays for years while the injured struggle to survive the damage. There is a law regarding truth in lending. There needs to be a law regarding truth in medical devices.

Johnson and Johnson needs to change their credo which says, “Research must be carried on, innovative programs developed and mistakes paid for.”

OUR CREDO
by Johnson and Johnson

We believe our first responsibility is to the doctors, nurses and patients, to the mothers and fathers and all others who use our products and services. In meeting their needs, everything we do must be of high quality. We must constantly strive to reduce our costs in order to maintain reasonable prices. Customers' orders must be serviced promptly and accurately. Our suppliers and distributors must have an opportunity to make a fair profit.

We are responsible to our employees, the men and women who work with us throughout the world. Everyone must be considered as an individual. We must respect their dignity and recognize their merit. They must have a sense of security in their jobs. Compensation must be fair and adequate, and working conditions clean, orderly and safe. We must be mindful of ways to help our employees fulfill their family responsibilities. Employees must feel free to make suggestions and complaints. There must be equal opportunity for employment, development and advancement for those qualified. We must provide competent management, and their actions must be just and ethical.

We are responsible to the communities in which we live and work and to the world community as well. We must be good citizens – support good works and charities and bear our fair share of taxes. We must encourage civic improvements and better health and education. We must maintain in good order the property we are privileged to use, protecting the environment and natural resources.

Our final responsibility is to our stockholders. Business must make a sound profit. We must experiment with new ideas. Research must be carried on, innovative programs developed and mistakes paid for. New equipment must be purchased, new facilities provided and new products launched. Reserves must be created to provide for adverse times. When we operate according to these principles, the stockholders should realize a fair return.

In other words, harm the consumer as long as the stockholders realize their fair return!

I WAS BUTCHERED BY A PRODUCT APPROVED BY THE FDA!

2007-07-03T18:55:00.001-07:00

“THE CHOICE TO MAKE AN INFORMED DECISION ABOUT MY OWN HEALTH CARE WAS TAKEN AWAY FROM ME.

I WOULD RATHER BE INCONTINENT AND HAVE MY LIFE BACK.

WHAT HAPPENED TO ME IS NOT GOING TO HAPPEN TO OTHER WOMEN.”

- LANA C. KEETON, JUNE 27, 2007

MY NARRATIVE OF THE EVENTS OR

WHY I'M SUING THEIR ASSES OFF!

A GYNECARE TVT System was used to surgically implant a GYNECARE TVT Device, a non-absorbable PROLENE MESH TAPE , 1.1cm x 45 cm, Catalog/Model #810041 into me, Lana C. Keeton, on or about December 21, 2001. The surgery was performed on me at the Mt Sinai Hospital Gumenick Ambulatory Surgery Center, located at 4300 Alton Road, Miami Beach, FL 33140. A life threatening infection was caused by the TVT Device itself, and by the procedure to implant the TVT Device, using the TVT System’s TVT Introducer and TVT Rigid Catheter Guide.

I underwent a second emergency surgery to remove the life threatening infection known as necrotizing fasciitis, a flesh eating bacteria. A large portion of the flesh and underlying tissue of the left side of the my stomach was removed to prevent certain death from the infection. The wound was not surgically closed. The wound was left open to be debrided and cleaned daily for weeks by health care professionals.

Following emergency surgery, I remained in the hospital in the burn unit of Ryder Trauma Center of Jackson Memorial Hospital in Miami, Florida. While in Jackson Memorial, a million units of a broad spectrum of antibiotics was administered intravenously every two hours for at least four days following emergency surgery. The infection was not controlled.

A few days later, intravenous antibiotics were started again and administered for approximately another 8 days. Following discharge from Jackson Memorial Hospital, I returned to clinic every 3 to 5 days until early March to be treated. At the clinic, Doctors continued to cut infected tissue from the wound in my stomach. This cutting was done without anesthesia and it hurt, bad!On days I did not go to clinic, home health care nurses cleaned the wound twice daily for weeks. At the same time, gauze soaked with a bleach solution, called Dakins solution, was applied directly to and left in the open wound. Nasty! This was an extremely painful process.

The scar left by the wound has attached itself directly to the fascia below. As a result, the skin will not move where the scar is. The scar is not flat. It has crevices and is not straight. My stomach looks like a road map from the scars of the two surgeries and the multiple debridements (cutting and removing of infected tissue).

I lived with the ever present fear of death. In constant pain, I was in danger daily of death for almost three months. Re-hospitalization was required at the end of January 2002 because the infection was not controlled. During this entire time I was highly infectious and was in danger of being infected in other parts of my body. Infection of other parts of the body would have required removal of any site that the flesh eating bacteria moved to. Such a thing is so horrifying to live with that I remain traumatized and frightened of it all to this day.

I was a danger to others during this entire time. Anyone else contaminated with liquid from the wound would have required the same treatment as me, aggressive debridement of the infected area. A portion of the TVT Device (Prolene Mesh Tape) cut into my bladder following the two surgeries. That portion of the TVT Device has remained inside the bladder instead of supporting it as it was purportedly designed to do.

The portion of the TVT Device that remains inside my bladder has required continuing monitoring and multiple surgical procedures to remove it.

The TVT Device has cut and/or moved into my bladder for over 5 years. It continues now to cut and/or move into my bladder. I can feel that as I type this and it is an awful feeling, believe me! As if that isn’t bad enough, the cutting of the tissue by the TVT device causes ongoing bladder problems for me. I have become urge incontinent, have difficulty emptying my bladder and who knows, I may be unable to void in the future. I’ve discovered this is a progressive symptom caused by the movement of the TVT device within my body. My monitoring and surgical procedures will continue indefinitely.

Subsequently, my life became very complicated and unstable as a direct result of this surgery touted by doctors as a simple, outpatient procedure.

The whirlwind of activity included but was not limited to:

1) seeing doctors and going through procedures, not to mention the worry and anxiety of not knowing what was wrong with me.

2) medical malpractice lawsuit – providing documentation, consulting with attorneys, doing depositions.

3) product liability lawsuit – prosecuting the complaint, doing research, writing and filing motions, driving downtown to the courthouse, serving subpoenas, doing depositions, being humiliated, harassed and badgered by the counsel for the defendants at deposition.

Additionally, I was furthered injured by the malfunctioning of a medical device called the Harmonic Scalpel used during the surgical procedure to implant the TVT Device. The Harmonic Scalpel is manufactured, marketed, sold and distributed by the defendants in my lawsuit.

In addition, I lost approximately 700 cc’s of blood during the surgical procedure from the malfunctioning Harmonic Scalpel complicating the surgical procedure. This significant loss of blood compromised my ability to fight the infection, necrotizing fasciitis, a flesh eating bacteria.

Now, all that's not what I expected to happen from a little outpatient procedure!

Read On and Get Righteously Indignant!

www.investor.jnj.com

In the United States, attention has been focused on drug prices and profits and programs that encourage doctors to write prescriptions for particular drugs or recommend particular medical devices.

www.investor.jnj.com/governance/EdgarDetail.cfm?CompanyID=JNJ&amp;amp;amp;amp;amp;amp;amp;amp;CIK=200406&FID=950123-00-313...

NO LAUGHING MATTER

2007-06-15T06:15:00.000-07:00

Dr. Alan Garely of Mineola, NY, laughed when process server, Amir Levy, handed him the subpoena at his office on Friday afternoon, June 15, 2007.

My attorney will take care of this, he said, or words to that effect.

Sure enough, Garely's attorney, Catherine Mirabel, Fagler & Amsler, L.L.P. of East Meadow, NY did just that. In a conversation with me (I'm the Plaintiff Pro Se, Lana C. Keeton) on Monday, June 18, 2007, Ms. Mirabel told me personally that Dr. Garely had no information. Ms. Mirabel also stated that Dr. Garely had ended his relationship with Ethicon, Inc's, Gynecare Worldwide, a Johnson and Johnson Company.

Strange that Dr. Garely has no information about that relationship. Rather convenient as a matter of fact. Also of interest is that Ms. Mirabel faxed a copy of Dr. Garely's subpoenas to the office of the firm representing the defendants in the case before she made that phone call to Ms. Keeton.

In sworn testimony at a deposition on June 8, 2005, Dr. Bernard Cantor of Weston, Florida, stated "I believe I submitted a copy of the letter from Dr. Garely stating that I had taken his course [in the procedure to implant Gynecare TVT Prolene mesh tape] and was capable of performing the procedure."

For me, this is no laughing matter. Surgery performed in December 2001 by Dr. Bernard Cantor at Mt. Sinai Hospital in Miami Beach, Florida left me with necrotizing fasciitis, the "flesh eating bacteria." A Gynecare TVT device was implanted in my bladder during that surgery.

For the record, Plaintiff Pro Se Lana C. Keeton of Miami, Florida sued Ethicon, Inc, d/b/a Gynecare Worldwide and Johnson and Johnson in December 2005. The product liability lawsuit alleges that the Gynecare TVT System and its' Gynecare TVT Device are inherently defective. The lawsuit is currently pending before the United States District Court for the Southern Disctrict of Florida.

The images below are not for the faint-of-heart. Be forewarned. They are gruesome and the immediate results of my surgery. For additional information about what happened to me, keep your eyes peeled to this blog spot. Any interested parties may contact me at miamiblog@bellsouth.net.