SURGICAL MESH COMPLICATIONS | INJURED BY SURGICAL MESH, TAKE ACTION!
Lorraine Evans, TVT Messed Up Mesh, Founder and Chair to Trustees & Director in the U.K. for Truth in Medicine
Following a routine TVT operation in October 2005, Lorraine Evans suffered a pulmonary embolism that sent her health into a downward spiral with ongoing health issues that continue even now.
The regular hospital visits forced Lorraine to give up her beautiful home, along with her career and social life. This did not stop Lorraine from having a hugely positive impact on so many mesh injued women.
Lorraine created TVT Messed up Mesh in 2009 to give help and support to mesh injured women in the U.K. and internationally.
At the same time, she has made tremendous inroads with governmental autorities in the U.K., most recently by being named to a very important position in the Patient and Public Voices (PPV) in the U.K.
Amazing! Applause please!!
MESSAGE FROM LORRAINE EVANS,
FOUNDER OF TVT MESHED UP MESH (TVT MUM),
and DIRECTOR for TRUTH IN MEDICINE IN THE U.K.
"In July 2014, NHS England confirmed Lorraine Evans and Hayley Martin are appointed to the working group as Patient and Public Voice (PPV) Members. We’re mesh injured, believe only a mesh sufferer understands a fellow mesh sufferer, and we will prepare and attend the meetings to represent YOU.
The working group has been established by NHS England to address concerns over surgical procedures using devices to treat stress urinary incontinence and pelvic organ prolapse. Membership will be multi-professional and include representatives from: NHS England; Department of Health; Scottish Government; Welsh Assembly Government; Medicines and Healthcare Products Regulatory Agency (MHRA); British Society of Urogynaecology (BSUG); British Association of Urological Surgeons (BAUS); and Royal College of Obstetricians and Gynaecologists (RCOG) and patient support groups. The Northern Ireland Government will be informed of progress.
ABOUT THE ROLE OF THE Patient and Public Voice (PPV) MEMBER NHS England is committed to ensuring that public and patient voices are at the centre of shaping our healthcare services. Every level of our commissioning system needs to be informed by insightful methods of listening to those who use and care about our services. Their views should inform service development. Public and patient voice will be embedded into our commissioning processes in a range of ways, including insight and feedback to shape services, voices in the governance frameworks of our programmes of work, as well as patient and public engagement in our assurance processes.
The first working group meeting took place on Wednesday 16 July at 2.30 in London. All discussions are confidential between the working group and TVT Mum will ensure our side of things is put across effectively.
In August 2014, NHS England said they are committed to ensuring that public and patient voices (PPV) are at the centre of shaping our healthcare services. We are PPV representatives and here to represent YOU we would like everyone including support group members, general public, medical professionals, legal professionals, and any other organization interested to participate by submitting any concerns you have to help bring change in practise with synthetic mesh medical devices.
In June 2014 Alex Neil health secretary in Scotland said ‘I chose to suspend mesh surgery ops because I did not trust official figures’ Do you want to see synthetic mesh surgeries suspended in the UK?
The NHS England working group need to hear what has happened to you and what you feel should be topics for discussion at future meetings. If you are interested in submitting your concerns please send via email: firstname.lastname@example.org. There’s no immediate rush to send and will allow you time for serious thought. If you are in litigation please seek legal advice before sending and also state if you wish to have your identity known or to keep it anonymous.
During the year 2014 we have worked hard providing emotional support via email, telephone and through the message board. May 2014 we had our first support group meet-up at Castle Combe, Wiltshire. We are currently organizing another meet-up on Saturday 25th October 2014 in Aldershot, Hampshire you can find the details posted on the message board. July 2014 we had our first NHS England working group meeting in London. We have also continued with our research on synthetic meshes for Stress Urinary Incontinence (SUI), Pelvic Organ Prolapse (POP) and Hernias.
Never give up, we are mesh injured, we want change, we want more help and our voices heard.
Say it as it is straight from your heart!
Thank you for all your support to our cause."
All the best Lorraine Evans
THE ABOVE ARE EXCERPTS FROM LORRAINE'S AUGUST 2014 – TVT MESSED UP MESH (TVT MUM)NEWSLETTER.
TRUTH IN MEDICINE HIGHLY RECOMMENDS SYNTHETIC SURGICAL MESH NOT BE USED IN THE FEMALE PELVIS FOR BLADDER SUSPENSION OR PELVIC ORGAN PROLAPSE.
TRUTH IN MEDICINE RECOMMENDS
SYNTHETIC SURGICAL MESH FOR THESE PURPOSES
BE REMOVED FROM THE MARKET IMMEDIATELY
BY THE FDA!
We sincerely hope you used the info that was provided here to make comments on the FDA's proposal to upclassify Synthetic Mesh used for Pelvic Organ Prolapse from Class II to Class III which ended on July 30, 2014.
Getting to the point of upclassifying transvaginal mesh to Class III has been a very long process, with thousands of adverse events filed by injured women over a period of more than 8 years. The protracted regulatory process at the FDA to date has benefited mesh manufacturing companies: Ethicon/Johnson & Johnson, Davol-Bard, American Medical Systems, Boston Scientific, Caldera and Cook Medical, NOT PATIENTS.
Sure the FDA issued warnings in 2008 and 2011, orders for 522 studies Jan 2012 and a proposal to upclassify to Class III and require clinical trials in May 2014. The result of these actions is some of the mesh companies stopped selling their prolapse mesh kits, changed the instructions for use and continue to sell mesh for use in a woman's pelvis, implanting it via abdominal sacralcolpopexy. This is not progress!
At least 60,000 lawsuits in the U.S. alone and Synthetic Surgical Mesh is still being used every day for bladder suspension and pelvic organ prolapse repair. Why is the FDA allowing this to continue? Recalls are made on a regular basis for other products.
PLEASE HELP US TO TAKE ACTION!
PLEASE SUPPORT US FINANCIALLY!
PLEASE MAKE A DONATION TO HELP US TO HELP EVERYONE!
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!