“THE INTERSECTION OF MEDICINE AND LAW”Presentation made by LANA C. KEETON on 09/05/2018 to the FDA’S CDRH of 87,000 UNREPORTED SYNTHETIC SURGICAL PELVIC MESH ADVERSE EVENT REPORTS from the U.S. DISTRICT COURT OF WEST VIRGINIA

LANA C. KEETON

© 2005 - 2018 Lana C. Keeton All rights reserved. 09/05/2018

This material may not be published, broadcast, rewritten or redistributed.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 AND LAW”

Presentation made by LANA C. KEETON on 09/05/2018 

to the FDA’S CDRH of  87,000 UNREPORTED 

SYNTHETIC SURGICAL PELVIC MESH ADVERSE EVENT REPORTS

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 3^rd 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:

1.     1.  Wide variety of polymers, ie. polypropylene, polyethylene terephthalate, etc.

2.      -2,  Weight of the mesh, low density, high density; Pore size of the mesh; any coatings on the mesh

3.     3.  Sterilization process

4.      -4. Total amount of mesh implanted

5.      5. Where the mesh is placed in the body (biomechanical properties of collagen, fascia, muscle,         nerves,etc. that make up the affected native tissue)

6.    6.   How mesh is cut, mechanical or laser

7.      7. Wrinkle recovery, creep factor

8.      8.  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 - 2018 Lana C. Keeton All rights reserved. 09/05/2018

This material may not be published, broadcast, rewritten or redistributed.

Truth in Medicine  -  Med Device Expert LLC

Device Expert . Legal Consultant . Patient Advocate

901 Pennsylvania Avenue, Suite 3-423, Miami Beach, FL 33139

305-671-9331 phone . 800-509-9917 fax 786-566-7780 . 305-342-8002 cell phones

www.LanaKeeton.com  www.MedDeviceExpertLLC.com  www.TruthinMedicine.us.com

“THE INTERSECTION OF MEDICINE AND LAW”

Presentation made by LANA C. KEETON on 09/05/2018 

to the FDA’S CDRH of 

87,000 UNREPORTED SYNTHETIC SURGICAL PELVIC MESH

ADVERSE EVENT REPORTS

SYNTHETIC SURGICAL MESH FATALLY FLAWED: MUST BE RECALLED by LANA C. KEETON (c) all rights reserved 03/02/2012

SYNTHETIC SURGICAL MESH FATALLY FLAWED:

MUST BE RECALLED

By LANA C. KEETON

© all rights reserved Lana C. Keeton 03/02/2012

This material may not be published, broadcast, rewritten or redistributed.

Med Device Expert LLC

Device Expert . Legal Consultant . Patient Advocate

901 Pennsylvania Avenue, Suite 3-423, Miami Beach, FL 33139

305-671-9331 phone . 800-509-9917 fax 786-566-7780 . 305-342-8002 cell phones

www.LanaKeeton.com   www.MedDeviceExpertLLC.com   www.TruthinMedicine.us.com

IT’S THE DEVICE, NOT THE DOCTOR!

            There is a raging debate between and among the FDA, surgeons, the medical device industry, patients and patient advocates. Why the debate? On July 13, 2011 the FDA issued a Safety Communication Update: “The FDA is issuing this update to inform you that serious complications associated with surgical mesh for transvaginal repair of POP are not rare. This is a change from what the FDA previously reported on Oct. 20, 2008. Furthermore, it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk.”

           

            Proclaiming the FDA has no “denominator”, a group of pelvic organ prolapse surgeons issued “Time to Rethink: an Evidence-Based Response” stating their “concerns regarding the message the FDA Safety Communication is sending to our patients, the healthcare community and ‘unfortunately’ to the legal community as well.” These surgeons are clinging to their mesh as though there are no alternatives.

            Public Citizen then called for a ban on the marketing of all currently available non-absorbable surgical mesh products specifically designed and labeled for trans-vaginal repair of pelvic organ prolapse (POP), a recall of all surgical mesh products currently available for POP and all proposed future POP products be classified as a class III device only approved through the premarket approval process.

            Profit driven entities selling and implanting synthetic surgical mesh, protecting their financial interests, created a straw man argument: “Surgical procedures are more difficult to compare than pharmaceuticals because they are dependent on the judgment and skills of the operator.”

            “Time to Rethink” is a moot argument, and under its current regulatory authority, should be completely disregarded by the FDA. The FDA does not regulate the practice of medicine, nor have authority over, doctors or surgeons.  The FDA regulates medical devices, not surgical procedure.

            Even if the FDA had the authority to regulate the practice of medicine, the POP surgeons have no basis to take the position the FDA’s MAUDE database adverse events reported for POP repair were caused by bad surgeons for the following reasons: 

1.      Surgical report not available through adverse event reports on MAUDE database.

2.      Injured patient not available for examination by the POP surgeons.

3.      If the premise were correct and the adverse events are caused by bad surgeons and the average doctor is unable to use mesh/mesh kits per instructions for use provided in the package insert, the mesh and/or mesh kit is defective. It is a flaw in the usability of the design and consequently, a flaw in the medical device itself.

            Other professional medical societies recommend educating the patient of the harm, but take no actions to stop the harm. The American Congress of Obstetricians and Gynecologists (ACOG) responded to the FDA’s 2011 warning with its Practice Bulletin #85, “Pelvic Organ Prolapse” (reaffirmed in 2009): “…patients should consent to surgery with an understanding of the postoperative risks and complications and lack of long-term outcomes data.” ACOG’s response to new data in the FDA’s 2011 warning is its’ outdated 2009 Practice Bulletin?

            ACOG further states: “Fellows should follow the emerging literature closely to remain knowledgeable about which techniques and products should be avoided and which are ultimately proved to be of benefit to patients.” Exactly when and how are Fellows supposed to know techniques and products have been proved to be of benefit to patients? What guidelines does ACOG offer? This in no way informs the debate. These products and procedures are ever evolving because they cause significant harm and do not provide better outcomes.    

            Following the October 2008 FDA warning, the American Urogynecologic Society (AUGS) presented a January 2009 webinar pointing out to their members how to avoid legal liability from surgical mesh implantation by informing women of the complications of mesh. Perhaps if they had put down their scalpels then, there would not have been another 2,874 seriously injured women reporting adverse event reports on the MAUDE database and the July 2011 Patient Safety Communication would not have been issued by the FDA.

            Still today, patient consumers are not adequately informed of potential prolonged, delayed and irreversible disorders from the implantation of synthetic surgical mesh. Daily thousands of women continue to be put at risk for serious harm, and even death, from synthetic surgical mesh implantation while POP surgeons protect their “important tool in our surgical armamentarium” while professing  “This large segment of highly dedicated

surgeons,…could suffer unjustified and arbitrary medical-legal exposure.” POP surgeons have the power not to pick up the scalpel to implant surgical mesh in women, protecting themselves from medical-legal exposure and women from debilitating, life altering permanent complications. There are other options available.

 “TENSION-FREE” CONCEPT FLAWED

            Surgically implanting mesh without sutures purposely unleashes the body’s natural inflammatory response. The body attempts to encapsulate or reject the implanted foreign body polymer. Acute inflammation is not followed by healing. Chronic inflammation sets in creating a cascade of life threatening inflammatory responses.  

            Mesh is not tension free once human tissue scars into the interstices of the mesh. Inflammation from scar tissue growing into the interstices creates a scar plate with greater strength than the surrounding tissue. Tension is placed on surrounding muscle, tissues or organs. This process stops normal body function.

            In pelvic floor repair, the tissue-mesh scar plate can create more serious problems than the original prolapse. Achieving anatomically correct pelvic floor is virtually impossible as the mesh-tissue scar plate displaces other organs, tissue and muscles, again stopping normal body functions.

CONCLUSION

            Synthetic Surgical Mesh fails to meet the FDA’s 510(k) “Intended Use/Indications Statement” for pelvic organ prolapse repair. It fails to bridge and/or support fascial defects in the vagina because it is incapable of following the direction of the fascia, particularly in the pelvis. It actually stops normal body function because it creates an amorphous matrix. Long term, failure of Synthetic Surgical Mesh is highly probable, no matter who the surgeon, what the surgical procedure, who the manufacturer of the device or where the placement of the mesh in the pelvis.

What is not being debated:

1.      Risk Evaluation and Mitigation Strategy for potential irreversible complications.

2.      The root cause of the irreversible complications

3.      No established protocol for the visualization of the mesh in the body through MRI, CT Scan or Ultrasound.

4.      No established mesh removal protocol. What surgical procedure addresses the complications? Are there surgical procedures to address the complications? Do these procedures account for the in vivo shrinking, hardening and/or degradation of synthetic surgical meshes used for hernia repair, bladder suspension and pelvic organ prolapse repair? 

5.      The “skilled” surgeons blaming the “unskilled” surgeons hypothesis is a straw man argument. Even the “skilled” surgeons are frequently incapable of removing mesh.

6.      Hundreds of studies, research papers and abstracts only recite the facts as seen by medical professionals from their individual perspective as doctors, not evaluations of the overall flawed concept of the use of synthetic surgical mesh.

7.      There is no comprehensive analysis of the physical and chemical properties of the petroleum based polymers used in the manufacture of synthetic surgical mesh in relation to the human body or how mesh physically and chemically breaks down in the body resulting in life threatening chronic inflammation (which may lead to autoimmune disease).

8.      Who, what, where, when and why are missing from the narrative.

                        Despite the debate, still no clear path exists for patients suffering symptoms of weakened or torn tissue evidenced as hernias, incontinence or pelvic organ prolapse. All the current market conditions which precipitated the FDA’s July 13, 2011 warning of trans-vaginal mesh implantation, are the same today, except there is a national dialogue and huge awareness of the serious complications of synthetic surgical mesh implantation.

            There is a tremendous amount of discussion without real solutions. Patient harm continues unabated. Hernias, incontinence and pelvic organ prolapse are not diseases. They are conditions. The symptoms of these non-life threatening conditions are routinely treated with life threatening, life altering devices. This is not a surgical procedure issue. This is a dangerous medical device issue. As Public Citizen has called for, the solution is a complete recall of these very harmful devices.

            Truth in Medicine supports the petition of Public Citizen  pursuant to the Medical Device Amendments to the federal Food, Drug, and Cosmetic Act, 21 U.S.C. 360f and 360h, and 21 C.F.R. 10.30, 810, and 895 to immediately 1) ban the marketing of all currently available non-absorbable surgical mesh products specifically designed and labeled for trans-vaginal repair of pelvic organ prolapse (POP) 2) recall  all surgical mesh products currently on the market available for POP and 3) that all proposed future POP products be classified as a class III device only approved through the premarket approval process.

Respectfully,

Truth in Medicine Incorporated

Lana C. Keeton

Lana C. Keeton

President & Founder

901 Pennsylvania Avenue, Suite 3-423

Miami Beach, FL 33139

lanakeeton@truthinmedicine.us.com

 www.truthinmedicine.us.com