Friday, September 16, 2011
TO THE HONORABLE FDA OBGYN ADVISORY PANEL
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.
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
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!
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
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.
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!