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Ethicon Media Monitoring 5/7/2018
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Revealed: Devon hospitals are STILL using controversial mesh
May 4, 2018 | Devon Live
By Anita Merritt
After hospitals in Devon claimed they were no longer using vaginal mesh implants, it has emerged that the controversial material is still being used for the treatment of incontinence. -
Vaginal mesh op 'should be last resort' in Wales
May 4, 2018 | BBC News
A woman who has suffered chronic pain since having vaginal mesh implants wants them banned, as experts say they should only be used as a "last resort". -
Make mesh implants last resort says Welsh NHS report
May 4, 2018 | iTV
An expert group asked to recommend how the Welsh NHS should respond to cases of women left in chronic pain from vaginal mesh operations has called for a totally new approach, avoiding surgery whenever possible.
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Revealed: Devon hospitals are STILL using controversial mesh
May 4, 2018 | Devon Live
By Anita Merritt
After hospitals in Devon claimed they were no longer using vaginal mesh implants, it has emerged that the controversial material is still being used for the treatment of incontinence.
An investigation by DevonLive.com has revealed that as the mesh is being labelled as tension free vaginal tape (TVT), patients may not be aware it is the same mesh that has been linked to serious complications including chronic pain, discomfort and difficulty walking or having sex following vaginal mesh implants.
Hundreds of women every year are having the mesh, which is intended to be permanent, removed. It has been offered in cases of pelvic organ prolapse and incontinence after childbirth.
All four of Devon’s acute hospitals have confirmed they use tension free vaginal tape (TVT) and that they consider it to be “safe and effective”.
Derriford Hospital went as far as to state there was a “difference” between the two, but failed to acknowledge it as being mesh.
However, a surgeon - regarded as a mesh expert - has revealed the mesh and the tape are ‘exactly the same thing’.
Dr Wael Agur, a consultant urogynecologist and head of the urogynaecology service in NHS Ayrshire & Arran, West of Scotland, said: “The polypropylene mesh tape for stress urinary incontinence is a smaller implant is the same as used in prolapse surgery. It is only 1cm wide by about 40cms where as the prolapse mesh is much wider but it's the same synthetic material and it can cause the same horrible complications.
"For example it can still cause nerve injury.
“As you can imagine the complications in prolapse appear earlier on and are more severe as the mesh is larger. That’s why many hospitals have stopped using prolpase mesh - but they are still using the tape.
“A benefit of the tape for incontinence surgery is that operations can be done as day surgery, which saves a lot of money for the NHS.
“Latest figures show a drop of 48 per cent in the numbers of mesh tapes. In Scotland, all hospitals stopped using it for both procedures in 2014 after it was officially suspended by the Scottish government.
“We have been using an alternative which is just as, or even more effective. Patients may stay in hospital for a bit longer, however, there are fewer complications.”
Concerned by whether Devon patients are being presented with the full facts before treatment for incontinence, he said: “From my experience hospitals do play silly buggers which asked about mesh implants and give an answer just based on prolapse.
“If they doing that to journalists what are they doing to patients?”
Last month DevonLive.com asked all acute hospitals in Devon whether they still used vaginal mesh implants and if not, how long it had been for.
Torbay Hospital, Mount Stuart Hospital in Torquay, the Royal Devon & Exeter Hospital and North Devon District Hospital all confirmed the implants were not being used. University Hospitals Plymouth NHS Trust failed to respond but has today confirmed it hasn’t.
The hospitals have since been asked to verify if all mesh for both prolapse and incontinence is no longer used.
Dr Phil Hughes, medical director from University Hospitals Plymouth NHS Trust, said: “Providing safe and high quality care to our patients is extremely important to us. We recognise the use of vaginal mesh in surgery is a concern for some women and we would like to provide assurance that we do not use vaginal mesh in surgical procedures at Derriford Hospital.
“It is important we do point out that there is a difference between vaginal mesh, which we do not use, and the tension free vaginal tape (TVT) that we do use. TVT is a narrow tape that lifts the bladder neck and is a very effective safe treatment for stress urinary incontinence.
“In consultation with our patients, members of the gynaecological team will talk through the various options available for treatment, which hopefully helps to alleviate any concerns women might have. Staff from our colorectal, urological and gynaecological teams also host regular Bladder and Bowel Events (BABE), which are open to all and aimed at supporting people with bladder and bowel problems.”
For the Royal Devon & Exeter Hospital, North Devon and Torbay NHS Trusts, a joint statement was provided.
A spokesperson said: “All procedures carried out at the three NHS Trusts are done so in accordance with NICE guidelines.
“In line with these guidelines we do offer vaginal tape for the treatment of female stress urinary incontinence (SUI), but again reiterate that we do not use vaginal mesh in any surgery related to vaginal prolapse.
“The sling that is used in cases of SUI is made of a polypropylene mesh material.
“There are several different treatments for stress urinary incontinence, which include non-surgical options such as physiotherapy, and surgical procedures that involve the use of Tension-free Vaginal Tape (TVT).
“With each patient we fully discuss the variety of treatment options available to them and follow up with patients after undergoing any treatment. The TVT procedure is offered as one option in the management of SUI.
“All trusts have considered the use of mesh within this procedure following the recent concerns raised and still believe this to be a safe and effective treatment for women with SUI where conservative treatment has not been successful.
“The trusts will, of course, review this in light of further national guidance expected this autumn.
“There can be complications with any type of surgery and we strongly encourage anyone experiencing discomfort after their procedure to visit their GP.”
Data from the Medicines and Healthcare Products Regulatory Agency (MHRA) has showed there have 1,279 adverse incidents in the past 10 years relating to both stress urinary incontinence (SUI) and pelvic organ prolapse (POP), a study by a surgeon called Jonathan Duckett claims less than 27 per cent of surgeons report all of their mesh removal to the MHRA so the figure is believed to be under reported.
Also, a study of NHS figures by Professor Carl Heneghan of Oxford University, has revealed the cost in outpatient appointments alone for women going back suffering prolapse and incontinence mesh problems in the last nine years is £245m.
Guidance from England’s National Institute for Health and Care Excellence in December said that following “serious, but well-recognised safety concerns” vaginal mesh should only be used for research purposes in future.
Campaign group Sling the Mesh, which has seen its member numbers more than double to 1,500 in a year, is calling for the implants to be suspended UK wide until a Government review into risk is completed. It is also calling for NICE guidelines due out in 2019, to be brought forward.
Kath Sansom, of Sling The Mesh, said: "It is time for surgeons to be transparent. In this case they have pulled the wool over everyone’s eyes. Enough is enough.
“They know exactly what women are talking about when they present with concerns about the mesh in the media.
"In hospital coding the most commonly used sling to treat incontinence is called a Tension Free Vaginal Tape (TVT), which is a tape, so surgeons think that gives them the right to say they do not use 'the mesh in the media'
"However, those TVT tape kits come with instructions for use and in those it says more than 30 times that this tape is made of mesh.
"We say this breaks serious codes of ethics and certainly breaks the Montgomery Ruling, which says surgeons must give information on all of the risks and benefits of an operation."
Disappointed that Devon’s hospital’s haven’t until now said they still use the controversial mesh, she added: “SUI slings are made of polypropylene mesh which is inserted vaginally so they should have made that clear when they were first asked if the use vaginal mesh implants.
“I hope they are making it very clear to women going to hospital consultations in the region that the implant they are intending to use is a plastic polypropylene mesh material and the same mesh material that is being warned about in the media.”
https://www.devonlive.com/news/devon-news/revealed-devon-hospitals-still-using-1532709
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Vaginal mesh op 'should be last resort' in Wales
May 4, 2018 | BBC News
A woman who has suffered chronic pain since having vaginal mesh implants wants them banned, as experts say they should only be used as a "last resort".
A group set up by the Welsh Government has recommended different ways of treating patients with incontinence or prolapsed pelvic organs.
Some mesh implants have caused painful and debilitating complications for patients.
Jemima Williams has been in constant pain since having the surgery.
The grandmother from Vale of Glamorgan, who first had the implants in 2002 after a pelvic organ prolapse, said: "I never sleep... I wake up in excruciating pain, which is burning, rectal pain, vaginal pain.
"A sort of grating, stabbing, burning and then I have bone pain in my spine, my hip and all down my left leg in particular."
Ms Williams, who often struggles to get out of bed due to complications following mesh implant surgery, has endured countless operations and procedures since her initial surgery.
She said surgeons have told her it is too dangerous to remove any mesh which is still causing her problems.
On Friday, a report by a group of experts on behalf of the Welsh Government said preventative measures should be promoted more.
They include services for continence, chronic pain and physiotherapy.
Better information for patients and a "more robust" process of consent are also needed, the group said.
But Ms Williams said recommendations that they should only be used as a last resort, do not go far enough.
She said: "What is a last resort and who are these perfect patients who are going to be [good] candidates to undergo that operation successfully?
"I want to see a ban. I and many, many people would like to see a suspension of the use of mesh globally."
Ms Williams wants the Welsh Government to carry out audit looking into the number of complications patients have suffered since having mesh surgery.
Mesh implants, which include different types of plastic tape and slings, are used to ease incontinence and to support organs such as the vagina, uterus, bowel, bladder or urethra which have prolapsed after childbirth.
Hundreds of women in the UK are launching a legal action against the NHS after suffering complications.
The polypropylene meshes have been prescribed on the NHS across the UK but reviews in England and Scotland have said they should not be routinely used for pelvic organ prolapse.
The UK government has conducted an audit to determine the extent of the problems caused by mesh.
Welsh Health Secretary Vaughan Gething will make a statement on the report on Tuesday.
http://www.bbc.com/news/uk-wales-44001471
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Make mesh implants last resort says Welsh NHS report
May 4, 2018 | iTV
An expert group asked to recommend how the Welsh NHS should respond to cases of women left in chronic pain from vaginal mesh operations has called for a totally new approach, avoiding surgery whenever possible. It suggests that the operation became routine, at one time performed on 1,000 Welsh women a year, because for too long no-one spoke up -or was listened to- about the disastrous possible side effects.
Unusually for a medical report, it begins with a quote from the civil rights campaigner Martin Luther King, "our lives begin to end the day we become silent about things that matter”. It highlights what the report's authors heard when women did speak out about what had happened to them.
Many Mesh Survivors have developed auto-immune disease brought on by the serious complications of a failed mesh implant. People are dealing with the effects of horrific internal injuries, disability, loss of relationships, they are suffering from infection – some are now resistant to antibiotics, systemic disease and chronic pain on a daily basis– EVIDENCE TO WELSH NHS INVESTIGATION
The surgery was carried out to treat urinary incontinence, vaginal prolapse and birth related injuries. The report accepts that women satisfied with a good outcome of their synthetic mesh operation have not been have heard and "might represent the vast majority". However, it does list a series of what it calls "adverse experiences".
Not being informed correctly of the potential risks involved or the potential side effects and how severe and life changing these could be.
Not being warned of the potential devastating, life changing complications that could be experienced.
An inadequate consent process with one patient reporting that ‘the only written information provided was the manufacturer’s leaflet’.
A surgeons denying that pain due to the transvaginal tape he had inserted.
”Medical staff disregarding a mesh complication as post operative symptoms, and not initially attributing symptoms to mesh and insisting on looking for other causes.
Women being made to feel like they were ‘making a fuss’, when it later became evident that their symptoms were due to mesh.
Consultants being patronising of their ill and vulnerable patients, often reducing them to tears.’
Instead of surgery, the report recommends what it calls a "pelvic health and wellbeing care pathway" designed to avoid wherever possible an operation which is still performed on nearly 200 Welsh women a year. It would aim to offer better continence care, physiotherapy and pain management.
http://www.itv.com/news/wales/2018-05-04/make-mesh-implants-last-resort-says-welsh-nhs-report/
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