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 Kath Sansom. Show all posts
Showing posts with label Kath Sansom. Show all posts

Friday, August 4, 2017

UK Parliament Hearing About Implant Device FAILURE


Deborah, left, with Owen Smith and Sling the Mesh - Kath Sansom 
Published: 09:34 Friday 04 August 2017  FiDA highlight

A woman who lives her life in excruciating pain after a medical operation four years ago, joined other women at Parliament last month in a campaign to get the surgical procedure banned in the UK. The Sling the Mesh Campaign is calling for an operation using pelvic mesh implants to be banned after thousands of women suffered serious health complications. Deborah Wood, of Bexhill, underwent an operation in 2013 but after experiencing numerous negative side-effects, including extensive bleeding and extremely painful sexual intercourse, she began the process of having the mesh removed. She said: “I have had five operations to remove the tape and I still have a small amount of tape and arms left in. I don’t think I can go through anymore operations. “For the past four years, I have been in chronic pain 24/7. I have nerve damage in my legs – the pain in my legs is constant, they feel like someone is driving red hot glass into my legs. I get a lot of pain in my vagina and my pubic bone. I don’t have any sensation in my bladder so I can’t tell when it is full or empty, I have to use catheters. “I am now left permanently disabled. I cannot walk very far, I need to use crutches, a wheelchair and mobility scooter. I have just been diagnosed with PTSD and I am now on antidepressants. “Before all of this happened I was at university getting a degree in photography and had a photography studio. I had to give that all up. “I am 49 years old and the thought I have to live the rest of my life in pain scares me.” Deborah travelled to London on July 18 with other members of the Sling the Mesh Campaign to meet with Labour MP Owen Smith, who has set up an All Party Parliamentary Group into mesh surgery. The mesh patch or vaginal tape, also known as TVT, TVTO and TOT, are used to treat incontinence and prolapse, often caused by childbirth. Politicians called for mesh operations to be suspended in Scotland in June 2014 and in May 2017, Scottish health secretary Shona Robison called for an independent expert to review a mesh safety report. The English mesh review was due out at the end of July 2017. Deborah added: “The TVT/TOT must stop in the UK. We need to get the public aware to prevent more horrific injuries. This mesh has ruined my life.” Visit https://slingthemesh.wordpress.com/ for details.


Read more at: http://www.bexhillobserver.net/news/health/woman-who-lives-in-constant-pain-calls-for-op-to-be-banned-1-8087506

Tuesday, June 6, 2017

The Biggest Global Health Disaster of Our Time: Surgical Mesh


PUBLISHED: 20:06 06 June 2017  FiDA highlight


One in three women could be suffering in silence with mesh implant problems in a women’s health scandal that has been called the biggest disaster of our time.

One of the risks of pelvic mesh implants is loss of sex life due to chronic burning and cutting pains or chronic infec tion. This has led to marriages breaking down. The risks are unacceptable say campaigners globally. PHOTO: Pexels.
The shocking figures come as a Scottish surgeon this week told BBC Radio that mesh has a: “Whopping 15 per cent of women who develop serious complications.”
Speaking on the Kaye Adams show, Dr Wael Agur said: “No woman should get a life long disability just because of a surgical treatment of urinary incontinence.
“One life ruined is one too many and it’s absolutely unacceptable that a patient will take pain killers for the rest of her life.”
Instead, he said surgeons should move back to two alternative, time honoured surgical fixes, with risks which are acceptable.
The mesh implant scandal was featured on the BBC Victoria Derbyshire show in April. Seen here interviewing reporter Kath Sansom, Claire Cooper and Kate Langley.
Campaigners globally say pelvic mesh risk, quoted in all countries as one to three per cent, is vastly under estimated and based on studies which are either short term, run by medics with conflicts of interest or on animals who cannot speak of the pain or lost sex lives due to intense burning and cheese wire pains in their vaginas.
As the scandal unravels women are calling on governments worldwide to ban mesh implants, used to fix incontinence and prolapse, often caused by pregnancy and childbirth.
Campaigners, Elaine Holmes and Olive McIlroy fought for a suspension on mesh in Scotland in June 2014 but it was re-instated in March 2017 amid claims of a whitewash independent review - now being scrutinised by an independent expert.
Scottish MPs Neil Findlay and Jackson Carlaw have called this a disaster on asbestos proportions.
Leaked document of the English Group Working Party into mesh implants - group members agreed to try to reduce media impact of mesh relating to Yellow Card reporting. Patient reps have not been invited to any meetings for more than a year. PHOTO: Contributed
Welsh MP Owen Smith has called it the worst health scandal he has seen in his time as a politician.
Australian senator Derryn Hinch has said this is the biggest women’s health issue since the morning sickness drug thalidomide.
American lawyer Ben Anderson said: “This is the greatest women’s health crisis of our generation.”
New Zealand politician, Christine Rankin, who suffered agonising mesh implant pain and was told by her surgeon to get used to living with it, said: “Mesh is dangerous and it should be used with caution and the truth needs to be told about it.”
The MHRA commissioned a study into mesh complications. The result is the York Report from 2012.
Problems reported by women globally include leg pain making it difficult to walk far, pain in buttocks and groin making it painful to sit for long, the sharp-edged mesh cutting into tissues, nerves or even busting through vaginal walls, chronic infections and allergic reactions to the plastic material.
Some women are left disabled in wheelchairs and others have to use sticks to help them walk.





Studies with high risk figures include:
An American study which show 42 per cent of women suffer complications - 20 per cent of them serious.
• An Italian study which found risk rate was 30 to 40 per cent.
• An American review which says the risk of pain following a mesh operation is 31 per cent.
• A Canadian study which found problems for 27.9 per cent of women.
A Canadian review that says 22.3 per cent of women risk suffer painful infections.
• A Canadian study discovered poor outcomes for at least 15 per cent of women.
• The FDA say the hooks used to implant mesh can cause damage for up to almost 30 per cent of women.
Almost 20 years after the operation was launched, women say the world must wake up to the fact that mesh implants are not a “gold standard” fix.
Surgeon Firouz Daneshgari, said: “By any modern industrial standards of quality, a 30–40 per cent rate of adverse events is simply unacceptable.
“Can any of us imagine what would happen if one-third of all cars, computers, food packages, or any other commodity we purchase would fail or result in recalls?
“Moreover, it is unlikely that the manufacturer would remain in business after such recalls and failures.”
In the UK, the NHS and MHRA say the benefits outweigh the risk, which they say is as low as one in 100 women.
However, they base their figures on a review called the York Report, carried out in 2012.
Campaigners say the studies in it are flawed as many are short term - as little as six weeks post operation - so do not capture the true picture. Some problems don’t cut in until months or years later.
The UK York Report says the risk of losing or suffering a reduced sex life can be as high as 13.5 per cent while the risk of pain can be as high as six per cent and erosion as high as 5.8 per cent.
However, it averages out its figures of risk to just one to three per cent - a figure quoted in most UK patient information leaflets.
Sling The Mesh campaigner Ann Boni said: “How bad has this got to be before the authorities admit mesh has lifelong disabling risks?”
If a woman suffers complications, then removal is major surgery, Mrs Boni added, but said many surgeons push women to only have part of the mesh tape taken out.
A partial removal takes around half an hour while a full removal can take up to two hours - making it clear that partials are preferred on a cost basis.
A survey carried out by patient support group, Sling The Mesh, found that a full removal can relieve symptoms for almost six out of ten women - 57.14 per cent.
A partial removal, however, left only two out of ten women - 21 per cent - feeling like it had improved things.
Mrs Boni said: “Mesh is designed as a permanent implant and was launched onto the market without the benefit of robust, quality clinical trials. “No thought was given to how it was going to be removed when complications arose.
“It is easier to perform a partial removal but what must be impressed on surgeons is that if women seek removals they must be given full removals because at least the patient stands a chance of getting some quality of life back.
“Partial removals can leave women worse off months or years down the line as mesh continues to shrink, migrate into pelvic organs, harbour infection and the foreign body reaction continues to activate an adverse immune response”
“Surgeons know that if there are problems it is very difficult to fix. So why do they still implant it?”
• A study called Prospect said more than one in ten women suffer complications following a prolapse mesh operation.

• A study, which includes UK mesh removal specialist Suzy Elneil as author, says there should be a red card system for new medical devices. It also says not all women should be considered for mesh as previous pelvic or lower abdominal surgery may mean adhesions. Also some women may have a congenitally distorted pelvis or been traumatised by other causes such as childbirth. http://www.europeanurology.com/article/S0302-2838(11)00868-2/pdf

http://www.wisbechstandard.co.uk/news/women-step-up-pressure-to-ban-pelvic-mesh-implants-the-biggest-health-disaster-of-our-time-1-5051244



Friday, April 21, 2017

Regulatory Watchdogs Complicit With Medical Device Industry: A Case In Mesh

NHS and medical devices regulator tried to limit scandal over vaginal mesh implants

Minutes show NHS England and MHRA worked together to try to ‘avoid media attention’ of problems faced by women

Friday 21 April 2017 11.19 EDT
Last modified on Friday 21 April 2017 12.43 EDT
NHS bosses and the watchdog that oversees medical devices tried to limit public exposure of the scandal over vaginal mesh implants that have harmed hundreds of women.
Minutes of a meeting held in October 2016 show that NHS England and the Medicines and Healthcare Products Regulatory Agency (MHRA) agreed to “avoid media attention” over the implants, despite the fact they were seeking to encourage patients to report any complications.
More than 800 women sue NHS and manufacturers over vaginal mesh implants


The document, obtained by the Press Association, records an agreement to “take the press element out” of the “yellow card” campaign to record adverse reactions experienced by vaginal mesh patients, suggesting that it could be incorporated into a wider effort, “of which mesh is one element, to avoid media attention on mesh”.


The apparent cooperation between NHS England and the MHRA to minimise media focus on the debilitating problems increasingly associated with the implants appears to breach the NHS’s duty – reiterated regularly by the health secretary, Jeremy Hunt – to be open and transparent over patient safety failings.
NHS England and the Department of Health both refused to comment on the minutes of the meeting.
MHRA officials said the minutes were more than six months old and the conversation noted in them was one of many conversations held during one of many oversight meetings about the issue.
The campaign, when it begins, will aim to ensure that both women and healthcare professionals know that there is no time limit on reporting complications with mesh devices. It will include engagement with the media, officials stressed. 
An MHRA spokeswoman said: “Patient safety is our highest priority and we are committed to help address the serious concerns raised by some patients. MHRA strongly encourages the reporting of issues related to all medical devices. When promoting reporting it is important to strike a balance between causing undue concern to patients who may benefit from a procedure and making sure they are aware of the potential complications.”
One possible reason for the NHS to want to limit exposure of the issue could be to reduce the number of potential lawsuits faced by the health service.
More than 800 women are suing the NHS and the manufacturers of the implants after suffering serious complications, it emerged this week. Some women reported that implants had cut into their vaginas, with one woman saying she was left in so much pain that she considered suicide. Others have been left unable to walk or have sex, according to the BBC.
Vaginal mesh implants are used to treat incontinence after childbirth or pelvic organ prolapse, where the womb or bladder bulge against the walls of the vagina. Between 2006 and 2016, more than 11,000 women in England were given the implants to treat prolapse or incontinence, NHS data shows.
About 11% to 12% of users have reported problems, while lawsuits in the US have already seen about $2bn (£1.5bn) paid to affected women.
Campaigners say that hundreds more women have come forward after learning of the group planning to sue.

What's your experience of vaginal mesh implants?

Kath Sansom, who runs the campaigning website and Facebook group Sling the Mesh, says the number of women contacting her has risen from a few people a day to more than 200 in the past 24 hours.
“It’s always the same story,” she said. “There are so many women who were told it was just them, that they were a one-off. They can’t believe there are others out there. So many people are told it’s back pain, endometriosis, gall bladder pain, scar tissue. And so many of them accept it, you trust medical professionals.”
Data from the MHRA, which has been looking at the issue since 2011 after complaints from women, shows more than 1,000 adverse incidents have been reported in the past five years. 
Despite the problems that have emerged the MHRA insists the best current evidence supports the continued use of the implants to resolve health conditions that could themselves cause serious distress to patients.
A report into the issue from a working party led by NHS England admits there is a huge lack of data on complications from the devices. Published studies on mesh implants do “not tell the whole story” and there are gaps in NHS knowledge about their safety, it added.

https://www.theguardian.com/society/2017/apr/21/nhs-vaginal-mesh-implants-scandal-suppress-media


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