The FDA’s/CDRH has become a hollowed out servicing authority stamping pieces of paper submitted by CORRUPT INDUSTRY under the 510(k).
This antiquated, toxic 1976 law has to go.
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. The upclassification to the riskiest Class III was accomplished... BUT the mesh kits are allowed IF implanted in an open abdominal procedure. This is not better. Despite decades of use in an abdominal sacral colpopexy, there is no LEVEL 1 evidence this is better or safer.
5. TODAY, 08-12-2018, The HARM CONTINUES UNABATED. THE LEADERS AT THE FDA & CDRH HAVE DONE NOTHING TO STOP THE MASSIVE INJURIES AND DEATHS CAUSED TO WOMEN AND MEN BY DANGEROUS 510(k) CLEARED "MEDICAL DEVICES".
Hundreds of thousands more men and 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 men and women.
The transvaginal mesh injuries are now the subject of the largest mass tort ever in the United States, with a STAGGERING 104,000 CASESwhich 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. BUT NO ACTION has been taken for the hundreds of thousands more injured by ALL HERNIA MESH PRODUCTS, not just the ones recalled by the FDA.
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. Patient Advocates in the Netherlands, the U.K., South Africa, and New Zealand have made significant progress with their governments to stop the sale of mesh kits. While other countries are taking actions, the FDA continues hurting women and men worldwide with its inaction.
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 hide 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 2014.
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 COMPLICIT FDA and re-market them to surgeons.
The United States Senate and the House of Representatives of the United States must pass substantive laws to protect MEN & WOMEN from being hurt by the FDA’s dangerous 510(k) medical devices.
This is not healthcare. This is harm care.
THE U.S. HOUSE OF REPRESENTATIVES & the SENATE and the TRUMP ADMINISTRATION NEED TO TAKE SPECIFIC ACTIONS TO STOP THE HARM TO LITERALLY MILLIONS OF WOMEN AND MEN.
TOTAL SYSTEM FAILURE = THOUSANDS OF MEN AND WOMEN ARE DESTROYED EVERY SINGLE DAY BY OUR SICK "HEALTH SYSTEM"!
THE HARM HAS TO STOP! NOW!
Lana C. Keeton
Lana C. Keeton, President and Founder, Truth in Medicine Incorporated
901 Pennsylvania Avenue, Suite 3-423, Miami Beach, FL 33139
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, 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 and medical device expert, presented her extensively researched, scientific, original theory on the inherent defects in the manufacturing process of all polymers used in meshes and why the manufacturing defects cause major complications when these polymers are knitted into synthetic surgical meshes are implanted in humans.
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, 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, 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, the fight to keep this from happening to other women (and to men for hernia repair) continues. May 2017 marked the beginning of Year Ten 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. 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. God bless you on your road to good health!
Don't be a Victim! Be a Victor!
Blessings, Lana Keeton, President & Founder
...and the Sword of the Spirit which is the Word of God. Ephesians 6:17
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