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.
Please share what you have learned!
Twitter: @JjrkCh

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.

No comments:

Post a Comment