A high-profile campaigner who has called for the permanent banning of controversial implants used to treat complications after childbirth says she is ‘appalled’ by recommendations to allow their use again before the findings of an independent review are revealed.
Yvette Greenway, founder of the ‘Mashed Up By Mesh’ campaign group, says she is just one of thousands of women left ‘living at the mercy of the mesh’, having had the vaginal implant fitted in 2009.
She welcomed a ban on their use last summer after Baroness Cumberlege CBE, Chair of the Independent Medicines and Medical Devices Safety Review, said an immediate halt on their use was needed given the ‘life-changing’ and ‘life-threatening injuries’ many women had described.
At the time Baroness Cumberlege said a number of conditions must be met before the use of vaginal mesh could again be considered safe – conditions she today said had not been met and would not be for ‘some considerable time’.
Ms Greenway has campaigned for the temporary ban, which was introduced last July, to be made permanent.
Now she says she feels the publication of new guidelines by the National Institute of Health and Care Excellence (NICE), which pave the way for the implants to be used again, show ‘arrogance beyond belief’ and ‘a complete disregard for the investigations being conducted by the Review Team.’
The health watchdog, which decides what drugs and procedures must be offered by NHS doctors, said the ‘true prevalence of long-term complications following surgery with mesh is unknown and there is limited evidence over harm caused’.
Ms Greenway had a hysterectomy and a mesh implant in 2009 after suffering from continued bleeding, infections and a uterine prolapse.
She says she has since suffered physically and psychologically, experiencing worsening bleeding, infections, urinary incontinence and constant pain.
“I am absolutely appalled by what I have heard and I can’t believe that, in the middle of an ongoing review in which hundreds more women have come forward to speak about how their lives have been ruined, guidelines are suddenly issued saying mesh implants can be used again. It shows arrogance beyond belief,” she said.
“NICE should use the review process to educate themselves by engaging with all those involved, rather than taking decisions independently.
“The review team have been travelling up and down the country speaking to women to hear how it has impacted on their lives yet NICE haven’t even had the decency to wait until the review is concluded and its findings and recommendations published.
“It is so disrespectful to woman and again and shows complete disregard for their well-being.
“Given that NICE say ‘limited evidence’ means ‘the true prevalence of long-term complications following surgery with mesh is unknown’, how can they possibly endorse any use, for whatever purpose, of an unstable product?”
Ms Greenway is currently being represented by medical negligence specialists Hudgell Solicitors with regards to the treatment she received and the impact it has had on her life.
The firm, which has offices in London, Leeds, Manchester and Hull, says it has ‘considerable supportive evidence’ from independent experts that Ms Greenway was not fully informed of the ‘potential life-changing and life-limiting’ consequences of having the mesh implant fitted, and was not informed of other options available to her.
Hudgell Solicitors is also representing other clients with regard to long term complications due to the alleged ‘negligent fitting’ of mesh implants.
It has been estimated that almost 10 per cent of around 92,000 women who had a vaginal mesh implant in England in the eight years up to March 2015 experienced problems.
Designed to be permanent, the mesh implants are used to solve stress urinary incontinence or prolapse and become embedded in the surrounding tissue in the first few weeks after fitting to provide better pelvic support.
Full removal can require hours of surgery and doctors have to weigh up the risk of damage to nerves and nearby organs, including the bladder and bowel.
Mesh was presented as a ‘solution to solve all problems’
Ms Greenway says she was ‘given no option’ other than to have the mesh implanted, something she feels happened to many others as they were given the impression it was an accepted and trusted method of ‘solving all problems’.
Now, despite NICE saying that surgery should only be offered to women for whom non-surgical approaches have failed or been rejected, that women must be counselled about the possible complications and that both short and long-term outcomes must be recorded in a national registry,
Ms Greenway she feels the U-turn will lead to more suffering.
“I will not stop campaigning until there is a complete ban on an implant that is designed to be permanent and has shown, in far too many cases, that it is unstable with severe flaws that can cause life-changing conditions to those affected, and their families,” she added.
“It’s not enough to say that women will be given information about the risks – people need full and complete information. They need to read, and listen to, the stories of people who have suffered and the extent of their suffering; they need to read all published material about mesh implants.
“It can’t just be a passing mention and women given the impression there is little risk of harm.
“How can it be said that women will be given all information when NICE can’t even be bothered to wait for the full findings of an independent review to be published?
“For many years until last July the health service took the quickest, most cost effective option – putting money over quality of life. I thought the ban last year was a turning point but now we have gone back.
“When I had mine fitted I had no idea how little means testing had been done on mesh implants and how little the medical profession knew about the possible complications and side effects.
“The suspension on their use last year came nine years after I had my implant fitted and was because so many women were suffering.
“There is no evidence to suggest for a minute that they are safe to use. Thousands of women were lambs to the slaughter before the suspension last summer, and more will suffer now.”
Ms Greenway says for some, including herself, removal is an option, but will not necessarily lead to a cessation of all mesh related symptoms.
“Some women cannot have their meshes fully removed, as the surgery is simply too difficult and carries huge risks. They are designed to be permanent and many specialists are not willing to remove them, they either can’t, or won’t. Also, there is no guarantee that removal equates to cure,” she added.
“What we know now is that mesh is a very nasty characteristic. It can become brittle and erode, which has happened in my case
“It is sharp and exposed edges can slice through nearby organs. You are left living with something inside you which can cause major damage left in, and if you try and take it out.
“Living with this brings not only physical suffering but psychological suffering too, whilst also having a massive impact on relationships. Penetrative sex is not an option and there have been reports circulated of men being cut by mesh.
“I’m suffering but I consider myself one of the lucky ones. There are people who have been left with severe life-changing and life-limiting injuries, left struggling to walk or in wheelchairs. Many people are condemned to life on painkillers, but these can never fully take away the pain.
“It is a constant drain on life. I am in constant pain, suffer repeated bleeding and infections and some days I can’t get out of bed. You feel dirty and unable to live life – you are damaged in every possible way you can think of.
“When the worst pain comes it feels like I have been hit between the legs by a block of concrete. I have to sit on a special cushion to lessen the pain.”
Medical negligence solicitors worried by sudden change in guidelines
Senior medical negligence lawyer Josie Robinson, of Hudgell Solicitors, is representing Ms Greenway and said: “It is clear from Yvette’s experience that she, like so many women, was given very little information about the implants and went ahead without a clear understanding of the possible long term risks and complications.
“Thousands of other women no doubt had the same experience and we are also representing women where there are serious concerns over the standard of procedure when the implants were fitted.
“We feel it is too soon to reverse the decision to stop mesh implants being used and are very surprised to see these new guidelines published before the end of the independent review.
“By saying that a record is now going to be kept of the impact on women who do have this surgery from now on is effectively admitting that they are leading them into the unknown. That cannot be right.
Baroness Cumberlege CBE, Chair of the Independent Medicines and Medical Devices Safety Review, says they are ‘in the midst’ of the ongoing review with recommendations expected to be published ‘later this year’.