Sling The Mesh in the news: 2023

The FDA issues a warning that it is aware of increased use of surgical mesh products in breast surgery. However, the safety and effectiveness, including in augmentation or mastectomy reconstruction, has not been determined FDA

$500K is offered to a man whose hernia mesh stuck to his tissue in a giant ball. Levin Papantonio Rafferty

Wife of high profile barrister Michael Mansfield, left faecally incontinent and in pain from mesh, wins £1million compensation Daily Mail

Kath Sansom, founder of Sling The Mesh, told Good Health the legal route for mesh compensation is strewn with difficulties. “Lawyers and judges want expert medical witnesses to give opinions on the women’s injuries. But these experts are either mesh surgeons or their colleagues, who vigorously deny there is any evidence of damage or disability. Many women are too stressed or ill to pursue legal claims. Those who get to court are often horrendously discredited by lawyers, who say their pain is only due to anxiety or mental-health problems. In one case, a woman who was sexually abused as a child was told the abuse, rather than the plastic mesh, was the reason for her vaginal pain. The embarrassment made her drop the case.” Daily Mail

Patient Experience Library magazine covers our call for people to complete the Sunshine Consultation for one Central Registry where industry, by law, must declare money it has given to the health sector. See p3

Scots man in chronic pain and unable to have children after hernia mesh implant in groin. Daily Record

A surgeon patted the bottom of a female patient in a hospital lift and later told her husband to “go home and fill her up”, a medical tribunal has heard. Consultant Tony Dixon is said to have behaved inappropriately more than a week after he performed colorectal surgery on the woman. He appeared at a Medical Practitioners Tribunal Service hearing in Manchester earlier, where he is accused of misconduct in relation to six patients. BBC

Bristol consultant failed to gain surgery consent and then dismissed the female patient as a “drama queen,” a medical tribunal has heard. Consultant Anthony Dixon is said to have told his patient “it can’t be all that bad” when she returned to him following her surgery. She was allegedly in “severe pain” after earlier undergoing a revision of a procedure known as LVMR (laparoscopic ventral mesh rectopexy). ITV West

Woman enduring painful hell is among hundreds operated on by Bristol surgeon Tony Dixon who is facing a misconduct hearing. The Independent

Dixon vs North Bristol Trust Judgement papers from 2022

The Ring of Fire investigative series covers the dangers of bio mesh on their You Tube channel. Bio mesh is used from animal products. Ini this episode they talk of an American man who died of sepsis and organ failure due to infection from biological mesh.

Sunshine Payment Act consultation announced by Government. Prof Carl Heneghan said: “It’s really important that the public trust how we deliver medicines and no one really has an understanding of who is being paid what. There is evidence that conflict of interest distorts results and clinical practice because there is so much money in healthcare – there’s a real incentive for industry to get their product out there.” Trust The Evidence

Disclosure of industry payments to the healthcare sector will seek views on the possible introduction of new secondary legislation to place a duty on manufacturers and commercial suppliers of medicines, devices and borderline substances to report details of the payments and other benefits they provide to healthcare professionals and organisations. Government consultation on Sunshine Payment Act

A costs judge has slashed the 62 hours claimed by a firm for work on mesh claims which had “striking similarities” and where their values were wildly over-inflated. Costs Judge James said: “I do not find the schedules to have been drafted systematically or with the care and attention to be expected of a boutique clin neg firm specialising in vaginal mesh claims, frankly the six I have seen are all over the place.” Law Gazette

One in four researchers are withholding information about money they’ve taken from the pharmaceutical industry. Numerous studies show commercial money significantly influences researchers to sway clinical trial results in favour of the drug or device they are testing – which means potentially harmful drugs and devices are on the market. Kath Sansom, who runs Sling The Mesh and has led campaigning for a Sunshine Act, said: ‘The lack of progress makes us worry that ministers are just parking the reforms in the long grass. The current situation means that too often we are effectively being told a meaningless pack of lies rather than a reputable scientific study.” Daily Mail

Mesh is suspended in New Zealand. The Director-General of Health, Dr Diana Sarfati, has supported, a time-limited pause on the use of surgical mesh for stress urinary incontinence. An assessment found that the balance of benefit and harm from the procedure will be improved by the series of additional measures already planned such as a registry, and it recommends a pause until those measures are substantively in place. NZ Government press release

Hollow claim by the Royal Australasian College of Surgeons (RACS) who say it is a win for patient safety. Its spokesperson Dr Sharon English says : “We have been calling for improvements that need to be made regarding the implantation, assessment and reporting of stress urinary incontinence surgery. These include the credentialling of surgeons, creation of a pelvic floor registry, development of a structured informed consent process and establishment of regional multidisciplinary meetings.” However ,she added: “We see this as a win for patient safety and look forward to a resumption of the use of mesh sling to treat SUI within a solid safety system as soon as possible.” New Zealand Doctor

Slings for incontinence are suspended in New Zealand due to safety concerns. This follows a similar move in the United Kingdom. It is being celebrated by a woman who spearheaded a campaign to highlight the harrowing mesh injuries suffered by her and many other Kiwi women. “It is an acknowledgement that their concerns were not just in their heads,” Sally Walker told the Herald. “It will give us some hope.” New Zealand Herald

Women who underwent mesh surgery were not given accurate information before the life-altering procedure, a case review has found. The study also said poor communication between patients and doctors led, in some cases, to mistrust. Medical notes were often misleading or did not detail the surgery that had occurred or its outcomes. The Scottish review spent two years looking at the cases of 18 women who received transvaginal mesh implants. BBC Online

• Among those sharing the BBC’s report was Harry Potter author JK Rowling:

Mesh surgery women not given accurate advice, says report. https://t.co/NB8eibRdnQ

— J.K. Rowling (@jk_rowling) June 20, 2023

Women whose lives have been ruined by mesh surgery often did not even need it. An independent panel of ­specialists discovered some were suffering from conditions that should not have been treated with controversial plastic mesh devices, but they were given them anyway, with catastrophic consequences. The major review into the worst medical disaster of modern times by professor of healthcare and medical law at Glasgow Caledonian University Alison Britton also uncovered evidence women were repeatedly “misled” – told they had undergone full mesh removal when, in fact, just tiny amounts of plastic had been surgically excised. Sunday Post

How have the Cumberlege recommendations on mesh progressed in the past three years? Nuala McGovern discussed this on BBC Radio 4’s Woman’s Hour with Georgina Jones, professor of health psychology at Leeds Beckett University; and Hannah Devlin, science correspondent of The Guardian. Listen from 49:22

❓How have the Cumberlege recommendations on mesh progressed in the last three years?

🏥 @BBCNuala discusses with @Profgljones and @hannahdev from @guardian

🎧 Listen here ⬇

— BBC Woman's Hour (@BBCWomansHour) June 5, 2023

One in 12 patients who had hernia mesh have been readmitted to hospital for complications, prompting a Scottish politician to call for ban on its use. MSP Katy Clark said: “I fear we face yet another significant public health scandal relating to mesh implants – those used to treat patients with hernias in our NHS. Just as the women affected by transvaginal mesh were initially ignored, hernia patients experiencing real pain and suffering because of surgical mesh implants find themselves in a similar position now.” Irvine Times

News that the Solicitors Regulation Authority is intervening into a practitioner who represents women over mesh implants claims has highlighted shortcomings in a redress system where obtaining compensation ‘feels like a battle’. Within hours of it emerging that Darren Hanison, owner of Fortitude Law, had been intervened into by the SRA, mesh support groups saw women in despair. Dozens of women who received disastrous pelvic mesh implants were suddenly unrepresented and unsure if their claim was ever going to be completed. ‘I’ve not slept, I am still shocked and numb,’ said one member of the support group Sling the Mesh. ‘Never been so gutted in my life,’ added another. Law Society Gazette

A report from Medi-Tech Insights estimates the global hernia repair devices market will grow by between 5% and 7% by 2027. It also shows that the latest hernia mesh has been approved in the US using what is known as the 510K route. That means it’s virtually automatically approved with no clinical trials as its “equivalent” to products already on the market. Yahoo! Sports

The Health Select Committee in New Zealand hears evidence on suspending mesh implants for incontinence, which have been suspended in the UK since 2018:

Wael Agur gave evidence at that Health Select Committee hearing, and his written statement highlighted that chronic pain occurs in at least 18% of women – yet the Government said for years the risk was as low as 1%…
He also wrote: “The significant underreporting of mesh-related complications has been acknowledged by most, if not all, medical device regulators.” Read the full statement

Health Secretary Steve Barclay has been warned that Government plans to speed up approval for healthcare treatments allowing them to be fast tracked to the UK is a huge concern for patient safety. We might as well park an ambulance at the bottom of a cliff and wait for harmed patients to fall in. Cambs Times

The long-term consequences of lax approval and the failure to heed the early warnings led to hundreds of thousands of women being irreversibly harmed. In 1996, the US FDA approved the ProtoGen sling, agreeing that the product was “substantially equivalent” to the Mersilene Mesh used to treat hernias. Boston Scientific relied on a 90-day study in rats and its use in cardiovascular implants for approval. At the time, clinical data for its use in the vaginal area wasn’t required for approval. By November 1997, the company started its first long-term study,  despite already knowing of at least 125 harmful events. By 1999, a small study of 34 women who had the Protogen removed for complications showed that half the meshes had eroded through the vaginal wall. At the end of 1999, Boston Scientific voluntarily recalled 20,000 of its implants because of the mounting problems related to its use. Carl Heneghan Deadly Devices Blog

Scottish women say their trust is depleted in the Specialist Mesh Centre. Holyrood’s health committee gathered the views of 75 women on the Complex Mesh Surgical Service (CMSS). The report said the women’s long-term negative experiences had coloured their views of the current service. BBC Online

Mesh campaigners living in agony blast Scottish Government for repeatedly ignoring them. Mesh campaigners have criticised the Scottish Government for ignoring their concerns – only weeks after new First Minister Humza Yousaf said he would be “open” to meeting them. Patients blame surgical mesh products for leaving them disabled and in chronic pain, and want an independent review into the use of the products. Daily Record

“The first Easter without my beautiful girl”: Alison Sharrock speaks to Best magazine about her daughter Sara Baines, who took her own life after being left in chronic pain from a mesh implant:

A woman whose daughter took her own life after being left in chronic pain from a mesh implant spoke of her family’s heartbreak. An inquest heard Sara Baines, 34, suffered from chronic pain due to complications from surgical mesh that was implanted after she gave birth in 2011. Her mother, Alison Sharrock is now raising Sara’s only daughter, Mischa, 11 and says Sara was failed by the health system on multiple occasions. Alison said Sara couldn’t take the pain any more. Daily Mail

Sara Baines took her life when she could no longer cope with the pain caused by a mesh implant. Her mum said: “We couldn’t work out why her health was spiralling. Then Sara began researching mesh. She found a support group called: ‘Sling The Mesh’ and discovered there were thousands of women like her, in agony.” The Mirror

A Winnipeg woman is suing Johnson & Johnson after more than a decade of pain which she says was caused by one of the medical giant’s surgical mesh products splitting apart and becoming embedded in her organs and tissues. CBC News

The family of a Flintshire mum who took her own life said she was “fobbed off” and “gaslighted” by the health service about her chronic pain. Sara Baines, 34, died after an act of self-harm in September 2022. An inquest was told she suffered from chronic pain due to complications resulting from surgical mesh that was implanted after she gave birth in 2011. The Leader

Bioengineers have found that lipid/fatty deposits on the surfaces of implants can play a mediating role between the body and implants – with some lipids acting as peacekeepers while others stir up conflict. This could help scientists develop coatings for implants that deflect host immune system aggression, reducing malfunction rates for devices like pacemakers, coronary stents and surgical mesh. Rice University New, Houston

Sam Hindle has 23cm of polypropylene mesh in her body and lives in constant fear that it will become unstable and cause irreversible damage. “You are in your own Battle Royale, strapped to a time bomb, and thinking when is it going to go off. I’ve had it in for 18 years so I have got to be pushing my luck. You don’t know when it is going to go off and what damage it is going to do.” BBC News

A US judge found that Ethicon’s marketing materials about pelvic mesh devices, and its instructions for use, deceived doctors and patients by failing to disclose serious risks – violating California’s unfair competition and false advertising laws. Reuters

A new antimicrobial suture material that glows in medical imaging could provide a promising alternative for mesh implants and internal stitches. Science Daily

The Scottish Government has spent more than £3.6million on hernia mesh products that campaigners claim have devastating effects on their health and bodies. Patients want an independent review into the products and procedures but Health Secretary Humza Yousaf has ruled it out. Daily Record

Mesh campaigners claim Health Secretary Humza Yousaf refused to meet them to hear their concerns. Patients blame surgical mesh products for leaving them disabled and in chronic pain and want the Scottish Government to hold an independent review into the use of the products. Daily Record

A US lawsuit alleges Covidien Symbotex mesh used during an umbilical hernia mesh repair caused painful complications, after a collagen film degraded over time, increasing the risk of adhesions and recurrent hernias. AboutLawsuits.com

A Scottish mum who had a controversial mesh implant at an Edinburgh hospital says she has been left “disabled and in excruciating pain” from the procedure. Mhairi Foley, 42, had a hernia operation in August 2019 to repair protruding abdominal tissue left at the site of surgical scars from a Caesarean section. The operation involved a sheet of prolene mesh being implanted into her abdomen to reconstruct the abdominal wall. Edinburgh Live

Vaginal mesh lawsuits accuse companies of a variety of misconduct, including negligence, warranty breaches, design and manufacturing defects and deceptive marketing, for how surgical meshes were promoted to the public. Forbes