1

The Voices Today on Messed up Mesh

Telephone: (+44) 01454 772803 · Mobile: 07754 499280 Email: contact@tvt-messed-up-mesh.org.uk Website: www.tvt-messed-up-mesh.org.uk

Date: 26th April 2019 Edition: 1

The Independent Medicines and Medical Devices Safety review (IMMDSR) TVT MUM submitted their evidence November 2018 for the review team, due to unforeseen circumstances our evidence submission was thankfully accepted. We declined to have the document published on the IMMDSR website as we only had a short timescale and also contains sensitive content, we’re happy the evidence is in the right hands. Lorraine Evans Founder, The Voices Today on Messed up Mesh (TVT MUM) and Hayley Martin MBACP FdA Counsellor/Psychotherapist and two accompanying people will attend IMMDS review with Baroness Cumberlege, CBE, DSG, DL and the review team Oral Hearing on 21st May 2019. Information for the IMMDSR review team

1. If you would like to share a small statement on your mesh experience or to see changes within the health system or any other concern’s you may have; we can give the information to Baroness Cumberlege and review team

2. The Petition, we’re sending shortly before 21st May 2019 the up-to-date official download petition version with all signatories. Please see page 6 for more information.

3. Government Compensation? (bullet points in brief, not fully inclusive concerns) • For many years people suffered in constant long-term pain, no one to help us • Medical professionals were and some still are dismissive • Experiments for implanting the mesh implant medical devices • Experiments for complex surgical procedures for excision/removal of mesh implants,

in some cases multiple meshes implanted by multiple manufacturers • Through surgical experimenting patients are left with permanent injuries, crippled

and quality of life destroyed • Most surgeons had one day/weekend video training, attendance of sales rep’s, plus

concerns on synthetic mesh implanted/fixed incorrectly • Patients suffer with thoughts of suicide and sadly some have committed suicide • Currently there’s a medical health crisis, not enough experienced surgeons

4. Requested by IMMDSR - if you would like to be a case study about any difficulties you have claiming Personal Independent Payments (PIP) or any other benefits.

Can you help on any of the item’s above? Please email: lorraine@tvt-messed-up-mesh.org.uk

Please visit the link below to view written and oral evidence http://www.immdsreview.org.uk/Evidence.html

2

NICE Guidelines Published April 2019 IMMDSR statement on the use of surgical mesh following publication of the NICE guideline 02/04/19 - Baroness Cumberlege CBE, Chair of the Independent Medicines and Medical Devices Safety Review said: Our position is very clear. Last July, we recommended, and NHS England and the Department of Health & Social Care agreed to, an immediate pause in the use of mesh for stress urinary incontinence. To read the full statement please visit this link: http://immdsreview.org.uk/news.html

Multi-Disciplinary Teams (MDT’s) UK Today surgeons recognise there’s a critical status to have more experienced synthetic mesh removal surgeons to help with mesh complications for SUI, POP, Hernia and Rectopexy. Campaigners and support groups fought hard throughout the years for Multi-Disciplinary Teams (MDT) centres, if we didn’t do this at the beginning where would we be now?

1. 2005, Lorraine is at the beginning of her dreadful mesh journey, TVT surgery was performed by an obstetrician, next day nearly died, Pulmonary Embolism, suffered ongoing ill health plus other complications. It was not known publicly about mesh complications.

2. 2008, discovered something not right, appointment with GP, could see mesh poking through, didn’t know who to contact, was asked to research, couldn’t find anyone in the UK. Found in the USA Dr. Shlomo Raz, Professor of Urology and Philippe E. Zimmern, MD Professor of Urology https://www.tvt-messed-up-mesh.org.uk/pdfs/Dr-Zimmern.pdf

3. During 2008, found a USA support group (Lana Keeton) shared difficult times with the members, extremely helpful, there was no support group in the UK at the time. The members increased in the UK and around the world.

4. During 2008, emailed Dr Raz and Prof Zimmern, asked who can help me in the UK, was given contact details for Professor Christopher Reginald Chapple BSc, MD, FRCS (Urol), FEBU, made a private consultation appointment, travelled in severe pain, was a 4 hour journey there and back. Confirmed mesh has gone through the vaginal wall.

5. 2008-2009, Professor Chapple could not help further, not in his NHS catchment area, gave two more surgeons (UK) to contact the first surgeon was very dismissive, then contacted Professor Marcus Drake BM, BCh, MA(Cantab.), DM (Oxon.), FRCS(Urol) an experienced and highly respected surgeon, he helped me over the years and saved my life.

6. 2009, the mesh journey begins for the UK, The Voices Today on Messed up Mesh (TVT MUM) website is published with a message board for all the members, it was during this time we all helped each other, shared experiences, shared valuable information, increased support groups, and found more surgeons, for years it was and still is difficult to find an experienced mesh removal surgeon.

To find an MDT centre please ask your GP to refer you, the centres are for patients with mesh complications. All centres state – ‘If surgery to treat mesh complications is advised by the MDT, and this surgery is felt to be beyond the remit of the unit, onward referral will be made to an appropriately experienced centre’

Please view this link with the map and press the red icon for centre information: https://www.baus.org.uk/patients/sui_mesh_complications.aspx

3

Do you want to see an effective care pathway for all the mesh injured? NHS England - Clinical Reference Group Stakeholder Registration – April 2019-December 2020 Thank you Christopher Harding MA MB BChir MD FRCS Urol and Keri Lewis NHS Communications & Engagement Lead, ‘an opportunity for all the mesh injured to participate shaping the framework for mesh complication and removal services,’ Travelling expenses paid attending meetings or if unable to travel you can join the webinar. Stakeholder registration is open for all stakeholders, including patients, carers, service users, members of the public, clinical staff, provider organisations working in specialised services and voluntary sector partners. When filling out the stakeholder registration form, the CRG Selection - Item 6 will ask – ‘Please select at least one Clinical Reference Group, from the Programmes of Care, you wish to register as a stakeholder’ Select: ‘Specialised Women’s Services’.

To register please view this link:

https://www.engage.england.nhs.uk/application/crg-stakeholder-reg-april-2019/ Informed Consent in the UK The Montgomery case in 2015 was a landmark for informed consent in the UK Published May 2017 - The Montgomery v Lanarkshire case of March 2015 drew fresh attention to informed consent. Nadine Montgomery, …….

To read the full article please visit this link: https://www.bmj.com/content/357/bmj.j2224

4

Worldwide Campaigners and Support Groups Mesh injured patients and people seeking advice should know there are numerous campaigners, support groups and individual support available, the press/media appears to only show one or maybe a couple of groups available. Some mesh injured want different kinds of support, some don’t have access to the internet, not internet savvy, also some would like to join/attend/meet up in a local group, and others want complete privacy and confidentiality support by telephone. Would you like to see a consolidated list of available campaigners, support groups plus also some individuals prefer to work alone to give support? We can publish a webpage, ie: Name of Group, Country, About/Purpose, Contact details (can include telephone, email, website/social media link, or what you feel is relevant) If this interests you please contact Lorraine for more information, feedback is very much appreciated. Contact email: lorraine@tvt-messed-up-mesh.org.uk Australia Sean is the husband of a mesh injured woman. He provides a different perspective into a mesh injured person's life and the effect on the family.

YouTube Video: https://youtu.be/jSgQXgKVr48

Worldwide Consultant Surgeon’s Genuine Quotes UK, Urogynaecology, research, public understanding of evidence, surgical training, pelvic mesh, native tissue alternatives. ‘Shocking story - many hallmarks of the current suffering by many. Chronic pain, not believed, use of dustbin terms (in this case - Somatisation Disorder), impact on job / relationship / social life, desperation and depression. Any one feeling the same must seek help. and persist.’ UK, Year 2011 – Consultant Gynaecologist ‘There needs to be pressure form the medical profession about the dangers of these synthetic implants. There is considerable under-reporting of side effects because surgeons may be reluctant to admit such problems occur in their practice, especially with private patients.’ USA, Reconstructive Urology Fellow. Specializing in urethroplasty, prosthetic surgery, urinary diversion, and robotic recon. ‘I think we need to be honest as a community in determining if surgeon case volume is adequate to maintain credentials for mesh sling placement.’ USA, Urologist specializing in male, female and transgender surgery. Associate Prof. & Director of Reconstructive Urology. ‘Great point. Too often mesh slings are used by inexperienced surgeons who took a weekend course and would otherwise feel uncomfortable doing an autologous sling.’

We’re seeing loads more surgeon quotes too!

5

Worldwide News

USA US Food and Drugs Administration - FDA On April 16, 2019, the FDA ordered all manufacturers of surgical mesh intended for transvaginal repair of anterior compartment prolapse (cystocele) to stop selling and distributing their products immediately. The FDA has determined that the manufacturers, Boston Scientific and Coloplast, have not demonstrated reasonable assurance of safety and effectiveness for these devices, …. To read more: https://www.fda.gov/medicaldevices/productsandmedicalprocedures/implantsandprosthetics/urogynsurgicalmesh/

USA Johnson & Johnson pays $9.9M to settle Washington state pelvic mesh lawsuit April 22, 2019 at 10:58 am Updated April 22, 2019 at 4:22 pm https://www.seattletimes.com/seattle-news/johnson-johnson-settles-washington-pelvic-mesh-lawsuit-for-nearly-10-million/ Washington Attorney General Bob Ferguson settles Johnson & Johnson surgical mesh lawsuit 4-22-2019

YouTube Video: https://youtu.be/FmJt2xsU_4s

India Sales of pelvic surgical mesh for women could be stopped in India after US ban The US FDA stopped the sale of the surgical mesh, used to treat the abnormal descent of the pelvis in women, due to a rise in adverse complaints. HIMANI CHANDNA Updated: 20 April, 2019 3:13 pm IST - To read full article please view the link below: https://theprint.in/india/governance/sales-of-pelvic-surgical-mesh-for-women-could-be-stopped-in-india-after-us-ban/223548/

India After J&J implant row, govt plans to hire 750 officers to regulate medical devices Plan is to hire these officers, who will exclusively regulate sale of medical devices such as coronary stents & hip implants, through a written exam conducted by UPSC. HIMANI CHANDNA Updated: 17 April, 2019 1:32 pm IST - To read full article please view the link below: https://theprint.in/india/governance/after-jj-implant-row-govt-plans-to-hire-750-officers-to-regulate-medical-devices/222442/

6

The World Petition The World petition is for all countries it's about surgical synthetic mesh implant medical device complications affecting people who had this surgical procedure for Stress Urinary Incontinence (SUI), Pelvic Organ Prolapse (POP), Hernia (common types) Rectopexy (Bowel). Copying and pasting the petition is prohibited and not recognised as the TVT MUM official petition. Signatories have given consent when they sign, Governments and relevant official organisations can request a download copy of the petition and is treated as strictly confidential. At the bottom of the petition you can view all signatories please click on ‘load more’, thank you for signing and to all signatories who have kindly shared their mesh experiences. To protect privacy - No email addresses are shared with us or any third parties.

If the full petition does not show/load correctly on your screen, please click on ‘Read Petition’ located as per red circle on above image.

Please share and sign the online world petition

https://www.thepetitionsite.com/1/an-urgent-review-is-required-on-the-medical-devices-tvt-tvto-tot-and-the-use-of-mesh-graft-for/

To view more updates please visit our Twitter feed

https://twitter.com/TVTMum

Do you have any news, or something you would like to share for the May 2019 Edition? Full credit is given to all contributors

We would love to hear from you! Email: contact@tvt-messed-up-mesh.org.uk

“Be kind, for everyone you meet is fighting a hard battle.”

Socrates (469-399 B.C.)