Sling The Mesh in the news: 2019

Vladimir Iakovlev issues a report on plastic mesh degradation and its devastating effects on human health. Read the report

The Royal College of Obstetricians and Gynaecologists issue a report on action plans for women’s health and omit mesh issues. Medical Plastics News

New Zealand publishes a Mesh Restorative Justice report after talking to 600 patients irreversibly harmed by surgical mesh implants used to treat incontinence, prolapse or hernia.

The BMJ launches a global campaign to stamp out conflicts of interest in medicine on the back of the pelvic mesh scandal. The Sydney Morning Herald

Elsewhere in November…

Suzanne Baxter spends mot of her days in bed from the crippling pain of a vaginal mesh implant. Kent Online

Two women from Ireland call for an audit of mesh to work out the scale of suffering. The Irish Times

Two women were given rectopexy mesh for a rectal prolapse – but didn’t even need surgery. Their lvies have been shattered by the complications. Daily Mail

Medical specialist Ranee Thakker says lessons must be learned from the pelvic mesh disaster, otherwise the profession will be dead. Croakey Health Media

Health minister Simon Harris says the Government has ruled out a redress scheme for women injured after vaginal mesh implants. Irish Examiner

A woman who lives in daily crippling pain says mesh is like living with a ticking time bomb. Irish Examiner

The results of around 500 clinical trials run by NHS Trusts remain unreported, costing over £250 million in research waste. TranspariMED

The Queen’s Speech heralds Brexit as an opportunity for Britain to become a world leader in innovation (In other words, drugs and devices that have not ben tested in humans. Innovative or new does not mean good! It simply means new. And The Guardian reported that US wants access to NHS in post-Brexit deal…)

The Labour Party pledge support for mesh-injured woman in a campaign of profits before safety. Spalding Today

Dr George Angus gives evidence at a panel discussion in Australia:

The International Federation of Gynecology and Obstetrics releases a position statement describing the use of mesh as like “a fast-moving train with few stops”. Read the full statement

The time has come to subject medial devices to the same rigorous scrutiny as medicines, which require three stages of clincial trials. Upsalla Monitoring

A member of Johnson & Johnson staff said she she saw a pattern of problems emerging for women after having a mesh sling for incontinence as long ago as 2007. While J&J tried to say these were temporary problems, she made it clear they were not. Northern California Record

A Johnson & Johnson doctor says a 20% erosion rate is okay. Northern California Record

A snapshot survey of 16 hospitals found that 2 defied the suspension and carried on using mesh. BJOG (see Abstract 1207; page 228)

A research paper shows that women who are given fully informed consent on risks versus benefits would never choose mesh surgery. International Urogynecology Journal

Taiwan calls for a ban on vaginal mesh. Taipei Times

Women have not been listened to, yet they have been suffering devastating effects after being implanted with a product made of polypropylene plastic that has never been properly tested. Women’s Health

The plastic used to make surgical mesh gets fewer checks than washing machines. It is emerging that the polypropylene is not fit to be inserted into human bodies as it is not biocompatible. Sky News

Sky News analysis: The vaginal mesh scandal affects us all. The plastic material is also used for hernia repairs, plus it highlights the appalling state of regulation for medical devices globally.

The family of a young New Zealand woman who died after suffering mesh pain and complications for two years say a Government review of mesh implants could be a waste of time. Dave Collis’ wife, Sarah, died in 2015, aged 27. Stuff.co.nz

Women were guinea pigs for mesh insertions and now they are guinea pigs for lucrative robotic assisted mesh removal. New Zealand Listener

A thesis discussed the scandal of vaginal mesh. The degree of loss of self and loss of hope comes across loud and clear in the mesh implant scandal, where research focuses on the fix and not new life-shattering complications. Qualitative data is missing. Read the thesis

The Healthcare Quality Improvement Partnership announces plans for a database to log complications when mesh is used again. It is still not robust enough to capture the data on suffering. Read the report

The former commissioner of the US Food and Drug Administration joins global drug giant Pfizer to help it get approval for its products, just two months after leaving his job of regulating medicines and devices. Business Insider (and so the revolving door continues…)

Women complain of severe delays in getting treatment for complications. The Journel Eire

BMJ EBM editor in chief Carl Heneghan talks about the confusion surrounding mesh implants and the lack of long-term good quality evidence to support its use.

Christopher Walker has been arrested and charged with luring women into pelvic mesh removal surgeries that may not have been necessary after contracting with a middleman. His defenders say this is ridiculous. Dr Walker is one of the few urogynecologists who recognises mesh injuries and has been an expert testifying on behalf of the mesh-injured community. Mesh Medical Device Newsdesk

Vagina glue is being researched at The University of Texas at Arlington to fix prolapse in its early stages. EurekAlert! (I doubt there will be robust evidence to prove this is safe and effective… research in mice and chicken embryos…)

New Zealand campaigners are told a mesh register to track complications is too expensive. RNZ

Mesh Lives Matter rally coverage:

• The UK is in the grip of a pelvic mesh crisis. Thompsons
• Manchester Evening News covers the Manchester rally outside the NICE conference.
• Hysterical Women blog: University College London Hospital, which closed a pelvic mesh removal service without warning, had claimed the decision only affected 13 women. However, it admitted in a meeting with campaigners that in reality it affected 247.
• Dorset Eye covers the protest.
• Hysterical Women publishes a guest blog by Beverley Burrows: “Living with a chronic condition can be debilitating; both physically and mentally. I can feel worthless and a burden to my family, and I have a myriad of intense and long-lasting feelings – everything from exhaustion to fear to guilt because of the demands made on my family.”
• Norfolk women join protest rallies over pelvic mesh. Eastern Daily Press

Elsewhere in May…

The hernia mesh complication risk is as high as 37%, according to a paper published in the journal Hernia.

Dr Phil Hammond covers the mesh scandal in Private Eye.

Medicines and Healthcare products Regulatory Agency chief resigns amid vaginal mesh scandal. Woman and Home

Beverley Burrows shares her mesh journey. Say It Forward

New York Times editorial on the mess that has led to scandals such as vaginal mesh, breast implants and Essure. Regulations need tightening and equivalence approval needs to go. Post-market surveillance needs to be monitored. All countries need a Sunshine Payment Act.

Mesh has been used in the UK during the suspension – a total of 16 mesh slings and 164 suprapubic slings, which could be either mesh or non mesh. Read the report

The US Food and Drug Administration closes a secret filing system that for 20 years allowed medical giants to hide reports of patient harm. KHN

The National Institute for Health and Care Excellence (NICE) published new guidelines that lifted a previously imposed ban on mesh products for stress urinary incontinence and pelvic organ prolapse, and allowed implants to be used as long as the patient was fully aware of the risks. In response:

• NICE clears the way for mesh to be used again. BBC Victoria Derbyshire programme
• How can surgeons give fully informed consent when NICE admit they don’t know the complications? ITV News
• Outrage as NICE issue new guidelines. The Telegraph
• NICE guidelines pave the way to harm future generations of women. The Guardian
• Guidelines appear to unban the banned vaginal prolapse mesh. BMJ
• MP Owen Smith says he thinks NICE has been got at by medical societies to keep mesh. Cambs Times
• BMJ EBM editor in chief Carl Heneghan writes: “Twenty years after mesh was first introduced there are still considerable shortcomings in the evidence base: the quality of evidence for complication is weak and mostly lacking. NICE guidance neglects the serious risks associated with the use of mesh in surgery. Campaigners fear the evidence is untrustworthy, biased and too low quality to inform decision-making.”
• ‘We’re absolutely appalled’, say campaigners over NICE decision. ITV News
• Why has NICE published its guidelines before Baroness Cumberlege announces her review outcome? Medical Plastics News
• Hysterical Women covers the NICE guidelines among its sexism in health care magazine. Read the post
• “So weak” mesh guidelines are not much different to what was written 16 years ago. New Scientist
• Four women tell how mesh has destroyed their life and for some, left them feeling suicidal. Daily Mail
• Sling The Mesh and Thompsons Solicitors write to all NHS Trusts warning against the use of mesh again until Baroness Cumberlege has reported her findings, following outrage from campaigners on new NICE guidelines. Read more
• Medical Plastics News reports on Sling The Mesh’s stark warning issued to the NHS alongside Thompsons lawyers.
• Campaigning journalist appalled at NICE decision. HoldtheFrontPage
• Jackie Cheetham says of the new NICE guidelines: “Every day on our support group, we see women suffering severe pain, some losing their bowels and bladders, all thanks to mesh surgery. Surgeons who take their guidance from NICE need to be more honest with women in the first instance and they need to stop covering up the true risks.” Yorkshire Gazette and Herald
• Women warn hospital trusts that if they implant mesh now, before six safety checks are ticked off, they will be acting unlawfully. Oxford Mail
• Margie Maguire suffered a prolapse after the birth of her daughter, but the mesh fix has left her relying on a mobility scooter and she fears was the cause of two miscarriages. She hit out at the practice as the NICE guidelines caused outrage. Oxford Mail
• One in 20 women are suicidal after having a mesh implant. Huffington Post
• Sling The Mesh to rally outside the annual NICE Conference and University College London Hospital (UCLH) on May 9, 2019. The protest is against NICE guidelines that pave the way for women of tomorrow to be harmed, and against UCLH stopping Suzy Elneil’s mesh removal service for no good reason. Medical Plastics News
• Julie Gilsennan tells Sky News how vaginal mesh has ruined her life and new guidelines ignore ‘thousands’ of women:

Meanwhile, The US Food and Drug Administration orders a ban on vaginal prolapse mesh. In response:

• Linda Millband, lead lawyer for clinical negligence at Thompsons Solicitors, questions whether regulators will continue to look the other way. Read her post
• Sales of pelvic mesh could be stopped in India after the US Food and Drug Administration vaginal prolapse mesh ban. The Print
• CBS 60 Minutes covers the mesh scandal, which, it says, is bigger than thalidomide. Removed meshes have shrunk – some up to 50% – and are covered in scar tissue.

Elsewhere in April…

An 83-year-old is suffering in extreme pain, but been told her case is not urgent. Margaret Keers had her mesh implant in 2003. Belfast Telegraph

Shelley Wills’ mum Sue killed herself after suffering prolapse mesh pain for years, but was told she had mental health problems. Metro

Indian Government asks Johnson & Johnson to reveal how many mesh kits were imported to the country in the past three years. The Print

Photographer Caroline Briggs releases a powerful photographic documentary into the suffering of women harmed by mesh. BBC

Woman given rectopexy mesh from Anthony Dixon when she didn’t even need surgery is given £185,000 in compensation. Fletchers Solicitors

Mesh implants scandal or standard of care? An interesting article where surgeons who have taken industry funding say mesh is good, while one who has taken no funding says no studies exist where the focus is safety. Journal of the American Medical Association

Finland news outlet YLE covers story of Johanna Zalagh, who runs a support forum for women affected by mesh.

Johnson & Johnson is ordered to pay a fine of $9.9 million or face trial for failing to warn of serious risk in its instructions for mesh kits. The fine was issued by the Washington Attorney General. Watch the announcement:

Bard (BD) withdraws its mesh from the UK market voluntarily:

• MP Owen Smith says it sends a clear message to the world that people are losing faith in mesh products. Sky News
• Bard takes its urogynae mesh off the UK market. Medical Plastics News
• Bard field corrective action notification letter
• BMJ EBM editor in chief Carl Heneghan reacts to the withdrawal:

Elsewhere in March…

The scientific community accepts for the first time that the plastic of mesh implants can act as an adjuvant for autoimmune disease and allergies. Best Practice and Research Clinical Rheumatology

French Candian Radio Canada runs mesh story for first time. Women are not given fully informed consent on mesh implants.

One in 20 women with mesh injuries contemplate suicide, survey reveals. Daily Mail

British Hernia Centre viewpoint by Andrew de Beaux. Read his viewpoint – sadly, it blames media hype. That old favourite. It doesn’t tally with our experience.

Toughen up guidelines or the mesh scandal will repeat itself, warn campaigners, whose survey shows one in 20 women have attempted suicide. Cambs Times

The Norfolk and Suffolk mesh group that meets regularly for friendship and support with the only other people who understand their suffering. Eastern Daily Press

The US Food and Drug Administration issues a press statement saying implant materials can cause autoimmune reactions.

US Food and Drug Administration tightening regulatory requirements for some medical devices. NPR:

The House of Lords debates steps being taken in the UK to improve the safety of medicines and devices. House of Lords Library

The Government is planing to draw up compulsory implant registry so patients can be tracked for their lifetime. International Consortium of Investigative Journalists

Regulators have failed patients and historically there is a lack of transparency around medical devices. Med-Tech News

MP Owen Smith writes a blog for PoliticsHome about his debate on medical device licensing:

The Government encourages women to sue surgeons for suffering mesh complications – yet it is a treatment that until last year the NHS recommended! The Guardian

Should vaginal mesh be pulled off the US market? Women who suffered serious harm and scientists who conducted research for industry offered conflicting testimony to an expert panel convened by the US Food and Drug Administration to review mesh safety. International Consortium of Investigative Journalists

Eight out of 10 European universities don’t publish outcomes of trials into health care treatments. It means badly performing products can be quietly brushed under the carpet. The European Medicines Agency is urged to force trial authors to publish outcomes. TranspariMed

Ahead of a debate in the House of Commons, MP Owen Smith says 1,004 patients died in three years while thousands are hurt every year in the UK from complications with medical devices. Cambs Times

MP Owen Smith leads a Commons debate on toughening up medical implant regulations. Hansard

A 15-year-old girl was given a biological rectopexy mesh implant to fix a rectal prolapse and is still suffering five years later. Chloe Thurston is thought to be the youngest UK patient to have had the procedure. BBC

Grandmother Anne Cook says all pelvic mesh needs to be banned as it is heartbreaking seeing the suffering of way too many. Cambridgeshire Live

The transobturator sling, by its design, places the pudendal nerve in peril while the retropubic sling does not. MENAFN

The cost of medical marketing has gone from $17.7 billion in 1997 to almost $30 billion. BMJ EBM

Aberdeen University professor Mohammed Abdel-fatteh forgets to declare £100,000 of funding from mesh maker Coloplast while running a study into their mesh. Abdel-Fatteh had spoken at a conference in December 2018 where he said journalists and MPs lead the mesh debate based on emotions. BBC

Norfolk woman Michelle Randall, who had a mesh implant fitted in 2005, wishes she could give some of her pain away so people understand the hell of living with hidden illness. Eastern Daily Press

BMJ look into organisations that pose as patient organisations – and found eight in 10 take industry funding on the very treatments they critique for the UK’s NICE guidelines.

Vaginal mesh is a monster – and once affected, women can never be fully fixed. Washington Post

A Canadian study of 57,000 women shows those who need mesh removal are at increased risk of depression, self-harm and suicidal thoughts. CTV News

Surgeons need to take time to listen to patient concerns and talk to them about the state of the evidence for hernia mesh, said B. Todd Heniford – the chief of gastrointestinal and minimally invasive surgery at Carolinas Medical Center in Charlotte, North Carolina – at the American College of Surgeons 2018 Clinical Congress. General Surgery News