For years women have complained about damage caused by the plastic mesh inserted to treat their post childbirth damage — complaints that seemed to fall on deaf ears, until now.
For it was reported yesterday that the government healthcare adviser, the National Institute for Health and Care Excellence (NICE), is going to recommend the controversial implant should no longer be routinely used because of ‘serious safety concerns’.
A NICE guidance document, due to be published on December 22nd but leaked yesterday, says using the mesh for pelvic organ prolapse (POP) operations, where the material is inserted through the vagina to support the womb, should no longer be offered as a routine op and should be available for research only.
Further guidance is due in 2019, but after pressure from MPs and Sling The Mesh, a group representing 4,400 injured women, it is expected the final guidance will be brought forward — and recommend a complete ban.
An estimated 200,000 women across the UK have had the implants since they were introduced in the late Nineties to treat incontinence, or repair damage where ligaments supporting the womb have collapsed.
A large proportion of women given the mesh have not had problems, but as Good Health has highlighted, in some women it has fragmented and ‘migrated,’ cutting through tissue and causing nerve damage, chronic pain and infection, leaving them unable to walk properly, work or have sex.
The safety admission has opened the floodgates to one of the biggest compensation claims in NHS history. David Golten, a London lawyer representing more than 500 women, believes hundreds more will come forward and the damages ‘could run into billions’.
‘It is the first time any of the medical authorities have admitted this procedure is dangerous,’ he told Good Health.
For the women affected it’s a vindication — of sorts, says Kath Sansom, who set up Sling The Mesh, and has suffered permanent damage to her coccyx as a result of the procedure. ‘Doctors tried to make us feel we were making a fuss about nothing.
‘The latest publication in a scientific journal in September, using the NHS’s data, showed at least 10 per cent of women implanted with this mesh suffer complications requiring overnight hospital treatment, and we know the real figure is much higher.’
Grandmother Jemima Williams, 57, from Barry, South Wales, has had 18 operations to remove fragments of the mesh since 2002, when it was implanted in her to treat post-childbirth incontinence. Jemima, who is married to a GP, suffers chronic pain, walks with a stick and has been told she will need a colostomy bag because of permanent nerve damage.
‘There are many of us who have been told we can’t take legal action because it is too long after surgery,’ she says. ‘We are going to start pressuring the Government to lift the ten-year bar on litigation.’
The claims will centre on whether women were warned of the risks and therefore gave informed consent to the operation, whether the surgeons botched the implants, and, most importantly, whether the mesh was suitable for use in the first place.
Although the mesh starts off flexible it appears to become brittle once implanted. Once it has broken up and begun to ‘migrate’, removal becomes almost impossible without causing further damage.
Jemima has been on a long waiting list to see Sohier Elneil, a consultant urogynaecologist at University College Hospital in London, who has developed a rare expertise in treating women whose meshes have disintegrated.
‘Removing this material is a real problem and has now become a major part of my clinical practice,’ Miss Elneil says. ‘These women are suffering terribly.’
Carl Heneghan, a professor of evidence-based medicine at Oxford University and a campaigner for better regulation for medical devices, says the use of the tape for pelvic prolapse was accepted by the Medicines and Healthcare Products Regulatory Agency (MHRA) in 2005, after what he says was minimal testing of one year.
‘Why in the first place didn’t they say the mesh should only be used in the context of research?’ he told Good Health. ‘Why has the MHRA spent 12 years ignoring the evidence this mesh is dangerous?
‘We apparently allowed a device on to the market even though we didn’t know what happened to it beyond one year in the human body. It should have been tested for a minimum of five years.’
Kath Sansom says there has been no guidance on what women who already have the mesh should now do. ‘Should they be demanding to have it removed or what,’ she says. ‘We know it can break up more than ten years after it’s been implanted. Lots of women, including those who don’t have problems, must now be very worried.’
Meanwhile, women with incontinence or prolapse are in the dark about whether or not they should accept a mesh implant, or insist on being referred to a consultant with the skills to do a ‘native tissue’ repair. This procedure, which involves complex internal stitching, has fallen out of favour since the introduction of the mesh, which seemed to offer a quicker, cheaper alternative.
Wael Agur, a urogynaecologist surgeon from the university of Glasgow, said this week that there has been a resurgence of interest in the traditional repair technique since the problems of mesh have become widely known.
So far the MHRA and NHS England, which jointly approved the use of the mesh, have declined to comment. Both said they would not make a statement on the leaked draft of the NICE guidance because they have not seen it.
A spokesman for the Royal College of Obstetricians and Gynaecologists (RCOG) told us: ‘We are aware that some women experience complications following mesh surgery many years after the procedure.
‘We are pleased that a learning resource for GPs has been created so that women with mesh complications receive the appropriate support and can be swiftly referred to specialist centres that have a multi-disciplinary team of professionals who can listen, advise and support them.’
The RCOG website has a special section to help worried patients. Go to rcog.org.uk and search for ‘mesh information for the public’.