One in ten women go to hospital for mesh complications, says landmark study, amid anger that patients are not being listened to
PUBLISHED: 16:17 01 October 2017 | UPDATED: 16:40 01 October 2017
A landmark study shows one in ten women suffer problems after having the most commonly used mesh operation given to hundreds of patients every year on the NHS.
The figure means mesh is high risk, according to a table published by the British Medical Journal, and is equivalent to one woman in every small office suffering, while her nine colleagues are fine.
The study has been published amid growing anger that women were used as “window dressing” in NHS working groups that never looked at the safety of polypropylene plastic used to make the controversial devices.
The latest study by seven British medics, shows one in ten women need a hospital admission for mesh complications.
However, in reality the number suffering will be much higher say campaigners, as it does not include women going back and forth to GPs asking for help with pain or chronic urinary tract infections or women treated in private hospitals.
Kim Keltie, Newcastle University researcher and London mesh removal surgeon Suzy Elneil, led the study, which looked at more than 92,000 women over eight years.
Ms Keltie said: “We estimate 9.8 per cent undergoing mesh insertion for stress urinary incontinence experienced a complication within 30 days or five years. This is likely to be a lower estimate of the true incidence.
“Safety of these procedures is the subject of international debate and scrutiny,” Ms Keltie said, “with court actions against mesh manufacturers in countries, including Australia, Belgium, Canada, England, Israel, Italy, the Netherlands, Scotland, USA and Venezuela.
“Some manufacturers have withdrawn their products from sale.
“There is uncertainty about the rates of complications in surgery and in the longer term, concern that rates in everyday practice may be higher than previously identified.”
In Scottish Parliament this week MSP Jackson Carlaw said campaigners Elaine Holmes and Olive McIlroy were duped into thinking their voices would be heard when in fact they were used as “window dressing” in a patient safety review which left out vital evidence in the final published report, branded a whitewash.
During the petitions committee hearing, where women from around the world were invited to write to parliament, MSP Neil Findlay said the number of emails from women suffering was so overwhelming it made him want to either cry or smash his computer screen.
Surgeon Wael Agur was among clinicians involved in the mesh working groups but he resigned after an entire chapter written by him was left out of the final Scottish report.
The chapter was in an easy to understand format with tables to illustrate the figures, so that both patients and surgeons could understand the risks of mesh, he said.
However, the chapter was removed and instead the information dropped into another section of the final review, written in such a convoluted style, that even as a surgeon he struggled to understand it, he said.
In addition, mesh reviews focused on advantages like being cheaper, shorter time in theatre, shorter hospital stay, shorter anaesthetic time, shorter recovery time, he added.
They did not focus on disadvantages of a life time of chronic pain, infection and losing sex life. Average time for mesh problems to cut in was 4.5 years, he said.
“Even if the risk is small the stakes are quite high,” he said.
During the petitions committee hearing he called for:
• A public inquiry into mesh.
• A transparent MHRA database so the public can search all reports made about complications of all drugs and medical devices.
HISTORY OF THE MESH WORKING GROUPS:
Made up of clinicians and patients, they were set up in Scotland and England in 2013. But in both countries patient reps resigned because:
• Their views were dismissed.
• They could not discuss safety of the plastic mesh material.
• They were unable to discuss safety of the blind nature of the operation.
• NHS never commissioned funds to look into mesh safety in general yet the final reports say mesh is a safe and effective treatment option.
• Patients in both countries were not invited to meetings for almost a year running up to publication of the final reports in 2017.
• Scotland - a suspension of mesh was called for in 2014 by former health secretary Alex Neil who branded the mesh implant crisis a “worldwide catastrophe”. He has demanded a global summit into the growing controversy.
• England - MP Owen Smith launched an All Party Parliamentary Group into mesh. A total of 18 mesh complication specialist centres have been set up. None are in Wales, Northern Ireland or Scotland.
• Wales - A working group has been promised by the chief medical officer of Wales, Dr Frank Atherton. Prior to that women were referred back to the MHRA report which says mesh is a safe and effective treatment option.
• Northern Ireland - The Public Health Agency commissioned a workshop for surgeons to consider improved patient care and better consent. A meeting on October 9 will provide feedback. However, there is no local government in Northern Ireland as it collapsed at the start of the year so politically the situation is stagnant.
• In the UK, all surgical mesh is ear marked to become higher risk devices by 2020 under EU regulations. The Government’s health select committee has launched a working group into what will happen to regulations for all medicines and devices under BREXIT.
• In America more than 100,000 women are taking legal action. The states of Washington, Kentucky and California are taking legal action against Johnson and Johnson under consumer protection laws.
• Australia - a senate inquiry began in September 2017 and is likely to last until November. Led by senator Derryn Hinch, he says it is the biggest medical disaster since thalidomide.
• In Canada documentary makers from CTV cover the global mesh misery. Watch on You Tube
• Globally, mesh implant tapes are the most common surgery to treat women’s urinary incontinence with 3.7 million meshes sold worldwide between 2005 and 2013.
NHS ENGLAND STATISTICS:
• In the last decade 1,272 adverse mesh events have been reported to the MHRA.
• A total of 4,848 mesh tapes for incontinence have been removed in England. There are no figures for prolapse mesh removal.
• That means less than a quarter of removals have been reported as an adverse event to the MHRA.
• Of the 1,272 adverse events only 697 reports were made by surgeons.
• 12 members of the public reported organ perforation.
• 14 surgeons reported organ perforation.