SURGICAL MESH COMPLICATIONS | INJURED BY SURGICAL MESH, TAKE ACTION!
THE LETTER BELOW WAS HAND DELIVERED TO THESE U.S. SENATORS OFFICES DEC 4, 2014 by LANA KEETON: CHARLES E. GRASSLEY, Iowa, SUSAN COLLINS, Maine, ROBERT P. CASEY, JR, Pennsylvania, ELIZABETH WARREN, Massachusetts, TOM HARKIN (retiring), Iowa, EDWARD JOHN MARKEY, Massachusetts, MARCO RUBIO, Florida, BILL NELSON, Florida, RICHARD BLUMENTHAL, Connecticut, LAMAR ALEXANDER, Tennessee, MIKE LEE, Utah
WOMEN NEED TO BE PROTECTED BY THE FDA!! COLONIAL MILITIA MAN at MICHELLE BACHMANN NO AMNESTY RALLY in D.C. 12-03-2014
THE FDA IS HURTING WOMEN
Dangerous 510(k) Medical Devices:
Synthetic Surgical Mesh, Morcellators and the Essure Device
CONGRESSIONAL HEARING URGENT
CONGRESS must mandate the FDA protect the public health, not just be a servicing authority stamping pieces of paper submitted by industry under the 510(k). This antiquated 1976 law must be brought into the 21st century. Affordable Care Act has nothing to do with actual healthcare but is an insurance reform act. Better care is NOT PROVIDED.
The COLLECTIVE HARM caused by the implantation of 510(k) cleared synthetic surgical mesh kits with metal trocars has reached epidemic proportions.
1. Thousands of adverse events have been filed with the FDA since 2007.
2. The FDA issued warnings of serious harm of mesh implanted for pelvic organ prolapse, in 2008 and 2011.
3. The FDA mandated 522 studies in January 2012 for 99 mesh products made by 33 companies. Ethicon Inc/Johnson & Johnson removed their Prolift mesh kits, C.R. Bard Inc. removed their Avaulta mesh kits and Boston Scientific removed their Pinnacle mesh kits from the market the same year.
4. 2014 the FDA issued a notification of its intent to up-classify these pelvic organ prolapse mesh kits to Class III for premarket approval. No decision has been published by the FDA as of December 4, 2014.
In the meantime, hundreds of thousands more women have been injured by these so-called “medical devices”. They are nothing more than a petroleum waste by-product costing about $13.00 for the raw material to the companies causing permanent disability (inability to sit, to walk, to have sex, to work, to urinate, to defecate, to even leave their homes) and financial ruin to thousands and thousands of women.
These injuries are now the subject of the largest mass tort ever in the United States, 69,893 are currently in one court alone, the U.S. District Court for the Southern District of West Virginia under one judge, the Honorable Joseph R. Goodwin. Thousands more are filed in state courts across the U.S.
This epidemic is international. Surgical mesh kits are the subject of the largest mass tort ever in Australia. The health minister in Scotland has halted the sale of mesh kits till proven safe. The Netherlands, the U.K., South Africa, and New Zealand have patient advocates petitioning their governments to stop the sale of mesh kits. The FDA is hurting women worldwide.
These products have been implanted in women worldwide without clinical trials using polymer resins which specifically state in their material safety data sheets (MSDS) they are NEVER to be used for human implantation. This has been proven in trials on both the state and federal levels.
Worse the companies have lied to the doctors who implant the mesh, hiding the true nature of the severity and frequency of the complications. Again this has been proven in trials in both state and federal courts. A jury in Texas awarded the plaintiff $73.5 million dollars ($50 million in punitive damages) Salazar v. Boston Scientific in September.
November 13, 2014 a jury in Miami, Florida awarded each of the 4 plaintiffs over $6 million dollars, Amal Eghnayem, Margarita Dotres, Mania Nunez and Juana Betancourt v. Boston Scientific.
Christine Scott v. C. R. Bard was awarded $5.5 million dollars in a California Court in 2012. Jo Ann Huskey v. Ethicon Inc/Johnson & Johnson was awarded $3.27 million dollars in West Virginia in September 2014. The list goes on and on.
These women all went to their doctors to be well, not to be injured and file a lawsuit. But NOTHING has stopped these companies from continuing to sell these mesh kits. They simply change the instructions for use (IFU), get new 510(k) clearance from the FDA and re-market them to surgeons.
Synthetic Surgical Mesh kits are not the only culprits. Morcellator devices are spitting lethal cancer from fibroid tumors into women’s bodies killing them within months. The black box warning on morcellators will not prevent the use of these devices as industry sends its paid minions out to declare the “safety” of the product, never mind the deaths. The metal Essure device implanted in women for birth control is cutting its way into other organs, leaving them permanently injured. All of these women need to be heard and protected.
The United States Senate and the House of Representatives of the United States must pass substantive laws to protect women from being hurt by the FDA’s dangerous 510(k) medical devices.
This is not healthcare. This is harm care.
Please hold a Congressional Hearing to determine the actions necessary to stop the brutalization and mutilation of women in the operating room.
PLEASE STOP THE HARM TO WOMEN.
We at Truth in Medicine look forward to hearing from you with your positive response to our request. Thank you.
Lana C. Keeton
Lana C. Keeton, President and Founder, Truth in Medicine Incorporated
cc: The Board of Directors of Truth in Medicine Incorporated
Lorraine Evans, International Director, U.K. & Europe
Kelly Villoch, Creative Director
Barbara B. Smith, Secretary
Janet Holt, patient advocate
LANA KEETON, HART SENATE OFFICE BLDG, calling on SENATORS TO HOLD A CONGRESSIONAL HEARING, 12-04-2014
LANA KEETON, SPIRIT OF JUSTICE STATUE in front of Sam Rayburn House Office Building 12-03-2014
LANA KEETON at MICHELLE BACHMANN'S NO AMNESTY RALLY, seeking Congressional Support, 12-03-2014
BACK AT THE FDA!!
Friday, August 22, 2014 Lana Keeton, President and Founder of Truth in Medicine, and Janet Holt, former Regulatory Affairs Director of Truth in Medicine, met with key personnel at the FDA/CDRH. See list below. Truth in Medicine continues to work toward recall of synthetic surgical mesh for pelvic organ prolapse repair, bladder suspension and hernia repair. Mesh is not okay unless there is no human tissue available to repair the fascial defect.
Heavily marketed by mesh manufacturers C.R. Bard, Ethicon/J&J, Boston Scientific, American Medical Systems as "the gold standard", polymers, such as polypropylene, are nothing more than petroleum waste byproducts. Their propaganda is not backed up by scientific evidence or studies, just millions and millions of dollars of adverstising. And hundreds and hundreds of paid medical consultants worldwide masquerading as YOUR friendly surgeon, also paid millions and millions.
Ms. Keeton, a steel broker for over 30 years, now a legal consultant, presented her extensively researched, scientific, original theory on the inherent defects in the manufacturing process of all polymers used in meshes and why the defects cause complications when polymers are implanted in humans. Mrs. Holt, a successful Texas cattle rancher and restaurateur, and not one to mince words, let the attendees know in no uncertain terms multiple surgeries to remove a 510(k) cleared medical device is absolutely untenable.
Benjamin Fisher, PhD, Toxicologist, Director, Office of Device Evaluation (ODE), Division of Reproductive, Gastro-renal, and Urological Devices (DRGUD)
Honggang Wang, PhD, Toxicologist, ODE/DRGUD/OGDB
Irada Isayeva, PhD, Materials Engineer, Office of Science and Engineering Laboratories (OSEL)
It's not over! We will be back at the FDA, again and again, as long as it takes to get this medical mutilation device off the market.
Jane Pennington, Janet Holt, Lana Keeton, Denise Jacobs in Washington, D.C. April 2011 for Congressional Hearing on Medical Devices
Denise Jacobs, Dianne Kelley, Lana Keeton, Kelly Villoch Lead Truth in Medicine Oct 1, 2010 Get the Mesh Out Rally in Washington, D.C.!
Jane Pennington, Sarah McFarland, Wendy Bradley, Janet Holt, Lana Keeton at FDA/CDRH Town Hall Meeting Dallas, TX March 2011
Gynecare TVT Mesh Complications Lana Keeton Dec 23, 2001
Gynecare TVT Mesh Complications - Necrotizing Fasciitis - Lana Keeton Dec 25, 2001
Gynecare TVT Mesh Removal Surgery Pics of Lana Keeton 06-21-2010
Explanted Gynecare TVT Mesh Lana Keeton 06-21-2010 1st Implanted Dec 21, 2001
Here at Truth in Medicine, we are fighting to keep this from happening to other women (and to men for hernia repair). May 2014 marked the beginning of Year Seven for Truth in Medicine's mission to get Synthetic Surgical Mesh off the market, though individual efforts started at the FDA in 2007. Those of us mesh injured patients who are able have been traveling to Washington speaking before Congress, the Institute of Medicine (IOM) and the FDA starting in early 2010.
A milestone came when our testimony from June 2010 was included in the IOM report on the flawed 510 (k) Premarket Notification (PMN) clearance process, which came out in August 2011. Add to that the July 13, 2011 FDA warning of the significant harm from transvaginal mesh for pelvic organ prolapse, and the floodgates of awareness of this medical disaster opened up. As a result, synthetic surgical mesh has become the "poster child" for bad medical devices on Capitol Hill.
We won some battles but this is not over. The fight continues. Still, hundreds of thousands of patients have mesh implanted every year for hernia repair, bladder suspension and pelvic organ prolapse, leading to horrific complications and a lifetime of pain and suffering. Despite the warnings, thousands of lawsuits and mandated 522 studies by the FDA people continue to be harmed every day.
We have to step up our efforts as patients educating patients! Please participate. Please take action. Please join our cause! We need your support, your donations and most of all, action on your part.
Tell everyone you know not to listen to claims “Minimally Invasive, Outpatient Procedure”. “Oh, it’s a new mesh and it’s better.” Please tell everyone you know the truth about mesh and the harm it causes. Don't let someone you know, someone you love be harmed!
ALL MESHES are capable of causing significant harm and even death. They shrink, they harden and they move within the body AFTER they are permanently surgically implanted. Having them surgically removed when they cause complications is like removing gum from hair.
The doctor has to surgically cut and remove your own tissue to get the mesh out. And most doctors who implant meshes do not have the surgical skills to remove them. Or how to locate them in your body with an MRI or CT Scan or Ultrasound.
Life altering catastrophic complications happen every day to patients from the surgical implantation of Synthetic Surgical Mesh for hernia repair, pelvic organ prolapse and bladder suspension, both male and female.
When this happens, doctors frequently have no idea how to deal with the complications. Or to avoid liability, they deny mesh is the root of the complications and/or frequently blame the patient.
Truth in Medicine is fighting the sale of mesh by greed driven pharmaceutical companies and medical device manufacturers. The 510(k) Premarket Notification “clearance” process at the FDA does not adequately protect patients! Truth in Medicine has a presence in Washington and is determined to stop the atrocity of mesh implantation.
Many “outpatient procedures” are life threatening! Are they worth risking your life? Do you really need surgery? Is your doctor implanting a medical device? Is your doctor really telling you everything he or she knows?
If it sounds too good to be true, it probably is. There are no magic buttons. Doctors do not heal you. Doctors only have the ability to help your body heal itself.
If you already have mesh implanted, you can not change what happened to you. You can prevent it from happening to other people!! Your participation in our cause will make a difference! Please make a difference! Please register on the Worldwide Registry of Complications of Synthetic Surgical Mesh so we will be able to show the FDA and its’ CDRH the true number of people harmed by mesh!
REMEMBER…if you need surgery and do not have Synthetic Surgical Mesh already implanted in you, ask your doctor to repair your hernia, improve your incontinence symptoms or treat pelvic organ prolapse with an alternative procedure! If they don’t know an alternative procedure, find another doctor who does. You will be saving yourself lifelong heartache and pain.
We really need you to help us to help others. Please donate to support our cause!