Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
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Showing posts with label NICE. Show all posts
Showing posts with label NICE. Show all posts

Friday, January 12, 2018

A Ban on Hernia Mesh? NICE !


10 January 2018  FiDA highlight


Experts are currently looking at the use of vaginal mesh implants in Wales, but the impact on hernia patients is not being considered in the study.
Last month the National Institute for Health and Care Excellence (NICE) recommended mesh operations should be banned from treating organ prolapse.
The Welsh Government said it was outside the scope of its review.

Richard, 67, from Penarth, said the exclusion of hernia patients has been "pretty upsetting".
He has had to give up work as an actor because of the pain, and can no longer stand for too long after several mesh implants for hernias.
"It feels at times like a knife sticking into the wound," he said. "I had hoped to be doing an awful lot more with my time.
What is a hernia?
A hernia occurs when an internal part of the body pushes through a weakness in the muscle or surrounding tissue wall.
In many cases, it causes no or very few symptoms, although people may notice a swelling or lump in their abdomen or groin.
The Royal College of Surgeons said mesh can be the "most effective" way to treat a hernia.
"There's always a small risk with any type of surgery but hernia mesh implants have a lower risk of infection than those used to treat prolapse," it added.
But one former surgeon based in Kent said there needed to be more awareness about any potential complications.
Peter Jones said patients were becoming more aware but "in the main, no they are not warned about the risks".
Plastic mesh implants were also used to ease incontinence and to support organs which have prolapsed after childbirth, but some have caused painful and debilitating complications for patients.
Last month, NICE recommended vaginal mesh operations should be banned for treating organ prolapse in England.
The Welsh Government said the review group has focused on the "use of vaginal mesh and tape for pelvic stress urinary incontinence and vaginal pelvic organ prolapse".

It added all NHS Wales organisations were expected to follow the NICE guidelines. It said the group's work will be completed by the end of the month.
http://www.bbc.com/news/uk-wales-42641633#

Monday, November 27, 2017

Vaginal Mesh Implants: Experimental! NICE



By Anna Collinson
Reporter, Victoria Derbyshire programme
  • 27 November 2017  FiDA highlight
Draft guidelines from NICE say the implants should only be used for research - and not routine operations.
Some implants can cut into the vagina and women have been left in permanent pain, unable to walk, work or have sex.
One expert said it is highly likely the NHS will take up the recommendation.
However, the organisation is not compelled to act on findings it receives from NICE.
Both NHS England and NICE declined to comment.

'Life-changing consequences'
In the documents - to be published after consultation in December - NICE said there were "serious but well-recognised safety concerns" and that "evidence of long-term efficacy [for implants treating organ prolapse] is inadequate in quality and quantity".
It added that "when complications occur, these can be serious and have life-changing consequences", but said "most commentaries received from patients reported satisfaction with the procedure".
One woman, Margie Maguire, 41 - told the Victoria Derbyshire programme she cannot have any more children or walk unaided because of the damage caused by the mesh.
"I have chronic pelvic pain on a daily basis and I'm on nine different medications when I have a pain attack.
"These can last from two to six hours at a time and is like having a heart attack," she said.
Kate Langley told the programme in April she had been admitted to hospital 53 times to try to end the pain, but - like many women - the mesh was so near the nerve it could not be fully removed.
She has been left with nerve damage and in permanent pain by the implants, giving up her business as a childminder because the pain was so intense.
The surgeon who first examined her, she explained, "could see the [mesh] tape had come through my vagina - protruding through"
The plastic meshes are made of polypropylene - the same material used to make certain drinks bottles - and manufactured by many different companies.
They are used to support organs such as the vagina, uterus, bowel, bladder or urethra which have prolapsed after childbirth.
The University of Oxford's Prof Carl Heneghan, an expert in the subject, said the draft guidelines were an admission that health services had "got this wrong" - calling the use of mesh a "catastrophe".
He described the draft guidelines as a "backdoor ban" on implants that would effectively end their use.
But he said it had come too late.

"Seven years I have been watching this emerge - it is absolutely farcical how bad it is. Either they're burying their heads in the sand or they don't know what they're doing."
He called for a registry to be created for everyone who had been treated with the implants so that their effects could be fully understood.
In April, the BBC learned more than 800 UK women are taking legal action against the NHS and the makers of vaginal mesh implants.
The NICE documents suggest "randomised controlled trial data showed no added benefit of using mesh compared with native tissue repair".

Between April 2007 and March 2015, more than 92,000 women had vaginal mesh implants in England, according to NHS data from the Hospital Episodes Statistics.
About one in 11 women has experienced problems, the data suggests.
The use of vaginal mesh to treat urinary incontinence is not mentioned in the draft NICE guidelines.
In Scotland, former Scottish Health Secretary Alex Neil requested a suspension of mesh implants by the NHS in 2014, but figures obtained by the BBC in December 2016 showed hundreds of operations have been performed since.
A number of Scottish health boards have stopped using mesh implants altogether.
The mesh is also used routinely in hernia repair despite concerns it is leaving many patients in chronic pain.
The Department of Health declined to comment.

Watch the Victoria Derbyshire programme on weekdays between 09:00 and 11:00 on BBC Two and the BBC News Channel.
http://www.bbc.com/news/health-42110076