For years women have complained of damage caused by the plastic mesh inserted to treat post-childbirth injuries - complaints that seemed to fall on deaf ears, until now.
This is because it was recently reported that the UK government health-care adviser, the National Institute for Health and Care Excellence (Nice), is going to recommend that the controversial implant should no longer be routinely used due to “serious safety concerns”.
A guidance document from the institute, to be published on December 22 but which has been leaked, 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 routinely offered 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 4400 injured women - it is expected the final guidance will be brought forward and a complete ban recommended.
An estimated 200 000 women across the UK have had the implants since they were introduced in the late 1990s 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 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 damages “could run into billions”.
“It is the first time 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% 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, has had 18 operations to remove fragments of the mesh since 2002, when it was implanted to treat her post-childbirth incontinence. Williams, 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 10-year bar on litigation.”
The claims will centre on whether women were warned of the risks and so gave informed consent for the operation, whether 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 seems to become brittle after implanting. Once it has broken up and begun to “migrate”, removal becomes near impossible without causing further damage.
Williams 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,” Elneil says.
Carl Heneghan, a professor of evidence-based medicine at Oxford University and a campaigner for better regulation of medical devices, says these women were suffering terribly.
Heneghan 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?”
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 asks. “We know it can break up more than 10 years after it’s 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 and cheaper alternative.