LANA C. KEETON
© 2005 - 2019 Lana C. Keeton All rights reserved. 09/05/2018
This material may not be published, broadcast, rewritten or redistributed.
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"THE INTERSECTION OF MEDICINE &LAW"
LANA C. KEETON MAKES 3rd PARTY SUBMISSION of 87,000 UNREPORTED SYNTHETIC SURGICAL PELVIC MESH ADVERSE EVENT REPORTS TO THE FDA/CDRH
Transvaginal Mesh Lawsuits listed against Manufacturers in Multidistrict Litigation in the U.S. District Court S.D. W.VA.:
MDL 02327 JOHNSON & JOHNSON/ETHICON 40,290 PLAINTIFFS
MDL 02326 BOSTON SCIENTIFIC 25,282 PLAINTIFFS
MDL 02325 AMERICAN MEDICAL SYSTEMS 21,251 PLAINTIFFS
MDL 02187 C.R. BARD/BARDDAVOL 15,694 PLAINTIFFS
MDL 02440 COOK MEDICAL BIOLOGIC 640 PLAINTIFFS
U.S. Federal District Courts is where ADVERSE EVENT REPORTS GO TO DIE. Hundreds of Plaintiff and Defense Attorneys do not inform the FDA of deaths and serious injuries of Hundreds of Thousands of Plaintiffs purposefully to benefit themselves financially and maintain the stock market price and profits of Big Pharma corporations. As such, Dangerous Drugs and Devices the FDA/CDRH has cleared or approved for human use remain on the market.
Today September 5, 2018, I, Lana C. Keeton, submit a 3rd party report of over 87,000 Unreported Adverse Events of severe injuries caused by pelvic synthetic surgical mesh kits which have required surgical removal of the Synthetic Surgical Mesh manufactured by these 5 companies, for both Stress Urinary Incontinence and Pelvic Organ Prolapse.
All of these adverse events reported today are verifiable through a search of the individual cases listed on Pacer.gov. Judge Joseph R. Goodwin issued Pretrial Order 293 in Ethicon / Johnson & Johnson MDL02327, S.D.W.VA. 13,000 Transvaginal Mesh Injured Plaintiffs were dismissed without prejudice April 11, 2018 specifically because there was no Mesh Removal Surgery to remove their Permanently Implanted Pelvic Mesh Medical Device(s). Deducting the 13,000 Ethicon “Non-Revision” Plaintiffs dismissed without prejudice under Pretrial Order 293 and the 4,000 Caldera Mesh Plaintiffs forced into the Federal Insurance Class Action Settlement in California from over 104.382 Mesh Plaintiffs in the Southern District of West Virginia leaves the staggering number of adverse event reports not under consideration by the FDA’s CDRH.
Based on these staggering numbers, it is imperative the FDA recall and remove all PELVIC SYNTHETIC SURGICAL MESH and MESH KITS, whether for incontinence or pelvic organ prolapse from the Market Immediately. The reclassification of Prolapse Mesh Kits to the FDA’s higher risk Class III has not, and will not, prevent the ongoing genital mutilation of hundreds of thousands of women caused by these “mesh medical devices”. Their counterpart, the dangerous Mesh Kits for bladder suspension remain in the lower risk Class II despite thousands of women becoming permanently disabled pelvic cripples from these bladder slings.
Nearly twenty (20) years after the dangerous recalled predicate device Boston Scientific’s Protegen Bladder Sling was first cleared through the FDA’s 510(k) in 1997, the FDA in January 2016, up-classified Urogynecologic Synthetic Surgical Mesh for Pelvic Organ Prolapse repair use to high risk Class III Pre Market Approval (PMA) process. Meanwhile, despite a decade of ongoing loud signals directly to the FDA of literally hundreds of thousands of women worldwide suffering death or permanent disabling injuries, dozens of the dangerous synthetic surgical pelvic mesh kits, remain on the market.
Below is the current e-mail marketing from Mass Torts Made Perfect where 500 to 1,000 Plaintiff’s Attorneys meet each April and October in Las Vegas to divvy up the
latest crop of plaintiffs harmed by a drug or device approved or cleared by the United States Food & Drug Administration or the Center for Devices & Radiological Health.
Meanwhile, the U.S. FDA/CDRH has not used its’ policing authority to protect the public health by removing these dangerous devices from the market.
“MTMP INFORMS YOU IN TIME TO GET INVOLVED” 08/21/2018
Over the past 5 years MTMP highlighted the below projects and the law firms handling them. We encouraged our attendees to get involved. We were right. Look what happened! COME TO VEGAS OCTOBER 3 – 5, 2018 TO HEAR ABOUT THE NEXT BIG MASS TORTS AND CLASS ACTIONS.
TRANSVAGINAL MESH MORE THAN $3 BILLION IN SETTLEMENTS
TALCUM POWDER MORE THAN $5 BILLION IN SETTLEMENTS
ACTOS MORE THAN $2 BILLION IN SETTLEMENTS
HIP IMPLANTS MORE THAN $8 BILLION IN SETTLEMENTS
VIOXX MORE THAN $4.5 BILLION IN SETTLEMENTS
SO THAT’S $22.5 BILLION DOLLARS PAID OUT BY MAJOR CORPORATIONS WHO PAID TO SETTLE WITH INJURED PATIENT PLAINTIFFS.
40% MINIMUM TO PLAINTIFF’S ATTORNEYS = $9 (NINE) BILLION TO ATTORNEYS.
HOW MANY HUMANS WHO DEPEND ON THE FDA/CDRH TO PROTECT THE PUBLIC HEALTH DOES $22.5 BILLION DOLLARS REPRESENT?
THE INTERSECTION OF MEDICINE AND LAW IS A DISASTER FOR DEVICE AND DRUG INJURED PATIENT/PLAINTIFFS
No demand for device companies to provide materials characterizations before they are allowed to design and run a single clinical trial for Pelvic Organ Prolapse repair has been mandated. Companies must demonstrate exactly what the reaction of the human body is to the polymers manufactured into polypropylene synthetic surgical mesh kits they sell. Companies have to test the actual medical device kit, not bench test a sample piece of mesh or implant it into a few pigs or rabbits or sheep, as is the norm for these mesh manufacturers.
Female and Male Mesh injured patients want to know why polymers manufactured into polypropylene synthetic surgical mesh cause so much injury and why the injury has not been prevented. There is a simple, complicated answer. Yes, simple/complicated. All manufacturing processes, whether for steel or polymers or any manufactured product, have tolerances and inherent manufacturing defects which create secondary quality products as a result of those inherent manufacturing defects.
Polymers have a life their own…both a shelf life and a service life. From the date of manufacture, polymers morph, degrade, decompose, react to their environment, internally and externally. Suppliers of resin to polymer manufacturers advise their customers to test the final product to validate it will perform as intended. Testing of components is unreliable and provides no guarantee their product will perform as intended in the human body.
Polymers are not stable, require additives, antioxidants, surfactants to be processed and even then the molecular structure of the polypropylene synthetic surgical mesh continues to morph internally, whether actually sitting on a shelf in a package or in the final intended use implanted in the human female pelvis. Time, temperature, moisture, heat and mechanical stress have a continuing effect on the product, even in an unused state. These same inherent manufacturing defects apply to all polypropylene synthetic surgical meshes implanted for any and all hernia meshes, whether implanted in a male or a female.
Based on their own intention, implanted mesh will not stay in place in the body without causing scarring and chronic inflammation. Johnson & Johnson, C.R. Bard, American Medical Systems, Boston Scientific, Cook Medical, Neomedic and Caldera intend for their deadly Synthetic Surgical Mesh products to cause inflammation and internal scarring. The implantation of mesh necessarily includes some relocation of internal tissue as a consequence of repairing the defect for which the mesh is implanted.
There is an exponential set of reactions/complications of injured human tissue because of the following factors and more:
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Wide variety of polymers, ie. polypropylene, polyethylene terephthalate, etc.
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Weight of the mesh, low density, high density; Pore size of the mesh; any coatings on the mesh
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Sterilization process
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Total amount of mesh implanted
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Where the mesh is placed in the body (biomechanical properties of collagen, fascia, muscle, nerves, etc. that make up the affected native tissue)
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How mesh is cut, mechanical or laser
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Wrinkle recovery, creep factor
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Host response with concomitant procedures; multiple responses of body to implantation: scarring together of tissue where removed at the same time of native tissue scarring into interstices of mesh
Chemical interaction in vivo exponentially changes the physical and chemical properties of polypropylene synthetic surgical mesh which is a degradation, decomposition process. The extracellular matrix created by these physical and chemical changes to the properties of the polypropylene synthetic surgical mesh is completely new and separate entity in the human body. The surgical procedure to implant synthetic surgical mesh causes a wound and a physical injury to the human, but the changes in the physical and chemical properties of the polypropylene synthetic surgical mesh is not the direct result of the surgical implantation “procedure” that the surgeon may follow but rather the physical, chemical interaction of the human body and the foreign body polymer and the continuing internal morphing of the foreign body polymer whether implanted in a human or in a package sitting on a shelf.
"PROTECTING THE PRODUCT, NOT THE PATIENT"
In our innate wisdom as humans we create man-made products, give them names, define their properties, give them shelf lives, describe how they will perform during service life and expect the human body and the man-made product to perform based on the words we use. Reality is the human body and the man-made product make those decisions, regardless of how we humans describe them.”
Quote by Lana C. Keeton
CONCLUSION
Doctors purposely diminish the severity of the complications to diminish the enormity of the problem. Doctors remove mesh in the office because it is so difficult to fully remove it in a surgical procedure in the hospital anyway. They hope to avoid legal liability. They are scared because even the most skilled surgeons are at risk for their careers, their reputations and their incomes when they surgically remove mesh in a hospital setting. Or they are under contract and have been paid massive amounts of money by the mesh manufacturer to protect the mesh, not the patient.
Doctors have a simplistic view of a very complicated process. The current belief in the medical community is surgical skills (or lack thereof) and the pore size, weave, strength and surgical placement in the body cause the major complications they see in their practices. Their medical view does not take into perspective the physical and chemical properties and the service/shelf life of the polymer itself. They do not study polymers in medical school. Doctors currently use the mesh classifications of a medical doctor, Parvis Amid, heavyweight, lightweight, etc. This simplistic view has to change. There is NO simplistic view. There is NO simplistic answer.
The simplistic view leads to doctors who routinely abandon their mesh injured patients because they likely do not know the truth about the mesh products they are implanting. Denial is the first line of defense to avoid legal liability. Major respected clinics and university teaching hospitals across the U.S. have joined forces protecting the mesh product, not the patient. Patient wellness and safety are last on the list. Betrayal is the norm. Ethics have been left by the wayside. God help the innocent patients who believe the health system protects their health instead of the fatally flawed “mesh medical devices”.
Hundreds of thousands of drug and device injured patients are not, and have not been, protected by BIG PHARMA CORPORATIONS, DOCTORS, HOSPITALS, THE FDA/CDRH, PLAINTIFF NOR DEFENSE ATTORNEYS. I ask the FDA/CDRH in its’ position as the pre-eminent health organization in the world to protect the public health in the face of the rampant corruption by the medical and legal cartels which routinely kill and maim hundreds of thousands of United States citizens who become patient plaintiffs.
LANA C. KEETON
© 2005 - 2019 Lana C. Keeton All rights reserved.
This material may not be published, broadcast, rewritten or redistributed.
Truth in Medicine - Med Device Expert LLC
Device Expert . Legal Consultant . Patient Advocate
"THE INTERSECTION OF MEDICINE & LAW"
