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