By Lana C. Keeton, Legal Consultant/Research Analyst
1602 Alton Road, #423, Miami Beach, FL 33130
Synthetic Surgical Mesh is toxic, over-engineered and degrades during manufacture, shelf life and in the human body following surgical implantation.
It is a misuse of the body’s inflammatory process. Tension free concept is for human tissue to scar into the interstices of the mesh to hold it in place following surgical implantation. The concept is flawed as the final result of implantation is never known as there is no clinical data to support this.
Despite processes used during manufacturing process, polypropylene leaches nonylphenol. Nonylphenol is an endocrine disruptor and has an estrogen effect. It causes thymocyte apoptosis resulting in auto-immune disease. (1,2,3)
“In its second recently released action plan, EPA targets nonylphenol and nonylphenol ethoxylates (NPEs). Nonylphenol is a raw material for making NPEs, which are nonionic surfactants that can break down into nonylphenol in the environment. Nonylphenol is toxic to aquatic organisms, according to the agency, and it biodegrades slowly….Under its plan, EPA will add nonylphenol and NPEs to the Toxics Release Inventory, requiring companies to report their discharges of these substances into water and air or onto land. …EPA also intends to propose a new regulation in 2011 that would require any company that wants to use NPEs or nonylphenol in new applications to notify the agency before doing so. Plus, federal regulators will consider adding nonylphenol and NPEs to the list of chemicals of concern that might present an unreasonable risk to human health or the environment.” (4)
Synthetic mesh degrades continually starting with the thermal knitting during manufacture, in the package on the shelf and inside the human body. (5,6,7) Dr. Bruce Ramshaw has presented his findings on hernia mesh explants to the CDRH/FDA demonstrating mesh hardens, shrinks and deforms while implanted. This is in addition to scar contracture caused by the actual surgical procedures to implant the mesh. Mesh/tissue integration is ill defined in the literature and in clinical trials.
“We propose that while evidence-based medicine is a noble ideal, marketing-based medicine is the current reality…Although many internal industry documents are legally available on the internet, there are as yet few publications in the biomedical literature based primarily on internal industry sources. These internal documents, as well as material drawn from other sources, provide insight into the intersection between marketing and science within the pharmaceutical industry.” (8)
Millions of TVT slings have been implanted based on a 1995 study of 75 women in a university setting, outpatient only, with no concomitant surgery and no previous surgeries used in 510 (k) 974098 for the Gynecare TVT System. “Minimally Invasive, outpatient procedure” belies the inherent danger of the procedure to implant mesh and the ensuing complications. (9,10,11)
Patient Abandonment is rampant. No protocol exists to address complications and explant the mesh. No protocol [mri, ct scan, ultrasound] to see the mesh in the body is currently recommended by manufacturers and/or doctors. Unskilled surgeons emboldened by commercialization of mesh kits are unable to perform delicate dangerous surgeries to explant the mesh. Patient Labeling must be mandated by the FDA so patients are able to get future medical care when complications arise.
Regulation and oversight:
March 12, 1999 FDA Guidance for preparing a 510 (k) specifies the medical device maker [MDM] test mesh for strengths, etc. No such specification is recommended for tests for human tissue to allow for load transfer.
The conversation has to change. Instead of the search for the “perfect mesh”, focus on doctors surgical skills to repair individual patient needs. A one size fits all approach has become the “gold standard” due to marketing based medicine.
No one is looking at the entire picture. Every aspect of mesh must be evaluated, in particular the chemical toxicity and physical degradation of the implanted synthetic mesh over the lifetime of the patient. In vivo performance is currently an unknown.
FDA/CDRH has input through the indications for use, intended use, implantation procedure. Important role in assuring safety by assuring the doctor is informed as medical device makers hide behind the “Learned Intermediary” statutes in litigation and the patient is left in a regulatory black hole.
Conclusion and next steps:
CDRH must take immediate action to warn patients of the risks and complications mesh used for hernia repair, through public education, not just advising doctors.
The CDRH controls the doorway to hospitals and doctors across America. As a patient advocate and an American citizen, I ask the FDA/CDRH take the following actions:
- Stop all clearances of all synthetic surgical meshes until there has been a complete review of all surgical meshes currently on the market.
- Predicate device for mesh is sutures. There is a special guidance document for sutures. Create a special guidance document for mesh.
- Revise the current Guidance for Premarket Notification for Surgical Meshes (March 12, 1999) to include proper testing procedures for human tissue strength, load transfer and autoimmune disease.
- Mandate all Instructions for Use for Synthetic and/or Biologic Surgical Meshes Include a protocol for mesh removal and testing procedures for location of mesh after implantation.
- Package the instructions for use in a separate non-sterile package from the sterile medical device and include patient labeling.
- Make patient labeling mandatory for all synthetic and/or biologic surgical meshes.
1 Chairman: Dr. Tsuguyoshi Suzuki, professor emeritus of the University of Tokyo Advisory Committee on Environmental Endocrine Disrupters (1999) Draft Report on the Test Results of Endocrine Disrupting Effects of Nonylphenol on Fish. October 1999
2 Prof P.P. Mathur Pondicherry University Dr Oli Sarkar Pondicherry University (2009) How do Endocrine disruptors affect male fertility? Environmental Contaminants and Male Reproduction 4 January 2009;
3 Juan P. Hernandez,* Wendong Huang,† Laura M. Chapman,* Steven Chua,‡ David D. Moore,‡ and William S. Baldwin*,1 (2007) The Environmental Estrogen, Nonylphenol, Activates the Constitutive Androstane Receptor. Toxicological Sciences 98(2), 416–426
(2007) doi:10.1093/toxsci/kfm107 Advance Access publication May 5, 2007
*Biological Sciences, The University of Texas at El Paso, El Paso, Texas 79968; †Gene Regulation and Drug Discovery, City of Hope National Medical Center, Duarte, California 91010; and ‡Molecular and Cellular Biology, Baylor College of Medicine, Houston, Texas 77030
4 Cheryl Hogue (2010) Blueprints For Chemical Control (directed by Lisa Jackson, Administrator, EPA). Government and Policy Chemical and Engineering News ISSN 0009-2347 American Chemical Society October 4, 2010 Volume 88, Number 40, pp. 30 – 31, DOI:10.1021/CEN092810164754
5 J. S. Afonso & P. A. L. S. Martins & M. J. B. C. Girao & R. M. Natal Jorge & A. J. M. Ferreira & T. Mascarenhas & A. A. Fernandes & J. Bernardes & E. C. Baracat & G. Rodrigues de Lima & B. Patricio (2008) Mechanical properties of polypropylene mesh used in pelvic floor repair. Int Urogynecol J (2008) 19:375–380, DOI 10.1007/s00192-007-0446-1
6 JOSE S. AFONSO1,*, RENATO M. N. JORGE2, PEDRO S. MARTINS2, MARLY DA S. SOLDI4, OSWALDO L. ALVES5, BELMIRO PATRICIO3, TERESA MASCARENHAS3, MARAIR G.F. SARTORI1, MANOEL J. B. C. GIRAO1 (2009) Structural and thermal properties of polypropylene mesh used in treatment of stress urinary incontinence Acta of Bioengineering and Biomechanics Vol. 11, No. 3, 2009 Original Paper
1 Department of Gynecology, Federal University of São Paulo, Brazil.
2 Institute of Mechanical Engineering, University of Porto, Porto, Portugal.
3 Department of Gynecology, University of Porto, Porto, Portugal
4 Faculty of Chemistry, Federal University of Santa Catarina (UFSC), Trindade, Florianópolis, Brazil.
5 Institute of Chemistry, State University of Campinas (UNICAMP), Campinas, Brazil
7 H.P. DIETZ ET AL (2003) Mechanical properties of urogynecologic implant materials. Int Urogynecol J (2003) 14: 239–243 DOI 10.1007/s00192-003-1041-8
8 Glen I. Spielmans & Peter I. Parry (2009) From Evidence-based Medicine to Marketing-based Medicine: Evidence from Internal Industry Documents. Bioethical Inquiry DOI 10.1007/s11673-010-9208-8 Received: 2 October 2009 / Accepted: 15 December 2009 # Springer Science+Business Media B.V. 2010
9 Tristi W. Muir, MD, Paul K. Tulikangas, MD, Marie Fidela Paraiso, MD, and Mark D. Walters, MD (2003) The Relationship of Tension-Free Vaginal Tape Insertion and the Vascular Anatomy. VOL. 101, NO. 5, PART 1, MAY 2003 0029-7844/03 © 2003 by The American College of Obstetricians and Gynecologists. Published by Elsevier doi:10.1016/S0029-7844(03)00011-5
10 Peter J. Schmitt, President, Textile Development Associates, Inc. (2007) Comparison of the Gynecare TVT Sling to the Boston Scientific Protegen Sling. Re: Lana C. Keeton, Plaintiff Pro Se, Case 06-21116-Civ-Ungaro-Benages
11 Peter J. Schmitt, President, Textile Development Associates, Inc. (2007) The Characteristics of the TVT Sling Material. Expert Witness Report Re: Lana C. Keeton, Plaintiff Pro Se, Keeton vs. Gynecare Worldwide, #06-21116
|The research article above, “Synthetic Surgical Mesh: Evidence Based Medicine or Marketing Based Medicine?” is original research by Lana Keeton and is copyrighted to the Library of Congress.It was presented to the following Senior Personnel at the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) at the FDA White Oak Campus in Silver Springs, MD on November 3, 2010.More orignal research by Lana Keeton on the physical danger and chemical toxicity of synthetic mesh will soon be published.Dr. Jeff Shuren: CDRH Center DirectorDiane Mitchell: CDRH Assistant Director for Science, Office of the Center DirectorGeetha Jayan: Network Leader, Office of the Center Director
James Saviola: Network Leader, Office of the Center Director
Bakul Patel: Policy Advisor, Office of the Center Director
Patricia Dillon: Staff Fellow, Office of the Center Director
Nilsa Loyo-Berrios: Branch Chief, Office of Surveillance and Biometrics
Nasrin Mirsaidi: MDR Specialist, Office of Surveillance and Biometrics
Cara Krulewitch: Lead Epidemiologist, Office of Surveillance and Biometrics
Nancy Pressly: Acting Associate Division Director, Office of Surveillance and Biometrics
Douglas Wood: Acting Division Director, Office of Surveillance and Biometrics
Thomas Knott: Branch Chief, Office of Compliance
Charles Anamelechi: Commissioners Fellow, Office of Compliance
Murray Malin: Medical Officer, Office of Compliance
Dora Vega: Medical Officer, Office of Compliance
Xin Xie: Commissioners Fellow, Office of Compliance
Wayne Miller: Consumer Safety Officer, Office of Compliance
Paula Silberberg: Public Health Advisor, Office of Communications Education and Radiation Programs
David Krause: Branch Chief, Office of Device Evaluation
Colin Pollard: Branch Chief, Office of Device Evaluation
Julia Corrado: Medical Officer, Office of Device Evaluation
Jill Brown: Medical Officer, Office of Device Evaluation Martin
Martin McDermott: Biomedical Engineer, Office of Science and Engineering Laboratories