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Ethicon Media Monitoring 6/7/2017
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Vaginal mesh controversy shows collective failure of the TGA and Australia’s specialists
Jun 6, 2017 | The Conversation
By Christopher Maher
Australian women are coming forward with stories of the negative impacts on their lives of transvaginal mesh implants, medical devices surgically inserted to prevent pelvic organ prolapse. -
Women step up pressure to ban pelvic mesh implants - the biggest health disaster of our time
Jun 7, 2017 | Wisbech Standard
By Kath Sansom
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.
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Vaginal mesh controversy shows collective failure of the TGA and Australia’s specialists
Jun 6, 2017 | The Conversation
By Christopher Maher
Australian women are coming forward with stories of the negative impacts on their lives of transvaginal mesh implants, medical devices surgically inserted to prevent pelvic organ prolapse.
A recent Australian consumer group survey reported more than 700 women said they had a mesh implant that had caused adverse effects. These included incontinence, severe chronic pain, problems walking, painful intercourse and even marriage breakdown. In the United Kingdom, hundreds of women are taking legal action against the National Health Service and the makers of mesh implants.
The Senate is conducting an inquiry into transvaginal mesh implants in Australia. The questions the inquiry aims to answer include why there is no accurate record of how many meshes have been inserted in Australia, and how we can guarantee safer introduction of new products in future.
So, how did we get to a place where hundreds of Australian women have allegedly had this surgery leading to lifelong complications?A history of transvaginal mesh
The pelvic floor is a group of muscles in the pelvic area that support the bladder, vagina and rectum. About 50% of women who have had children experience pelvic floor dysfunction. As many as 20% will require surgery for these conditions.
Pelvic floor dysfunction includes prolapse (falling through) of pelvic organs, such as the bladder, bowel or uterus (womb), through the vagina. It also includes stress urinary incontinence, which is involuntary urine leakage with activity such as sport, coughing or even walking.
The surgery and the medical devices used differ between these two conditions.
Stress incontinence
In the late 1990s, an innovative treatment for stress incontinence was introduced. This involved a permanent synthetic sling, called a mid-urethral sling, placed under the urethra (the tube through which urine travels from the bladder) to give it support.
By 2002, the mid-urethral sling became the most frequently performed incontinence surgery in Australia. This was because doctors saw the procedure was equivalent to, or better than, alternative procedures. The blood loss and operating time were less and recovery times were shorter than older procedures.
This clinical experience was later confirmed in large trials. But while we waited for the results of these, which were published from 2004 onward, many women gained from a highly effective and safe operation, demonstrating the benefits of the innovation.
Pelvic organ prolapse
Traditional surgery for pelvic organ prolapse involved repairing the torn connective tissue with sutures. This was called vaginal repair. Unfortunately, this surgery was associated with a high rate of the prolapse recurring.
Following the success of the sling tape in stress incontinence, and of mesh use for hernias, doctors and manufactures looked to introduce a mesh product to treat vaginal prolapse. This involved sheets of mesh being placed under the bladder, or in front of the bowel, to stop prolapse and prevent recurrence.
The Therapeutic Goods Association (TGA) approved a variety of transvaginal mesh kits for pelvic organ prolapse from 2003. As with the mid-urethral sling four years earlier, little supporting data on the safety and efficacy of these kits was initially available.
Due to a lack of detail in the Medicare codes used to record the surgeries, we are unable to accurately determine how many women underwent surgery. I estimate that around 150,000 tapes for stress urinary incontinence and between 30,000 and 40,000 transvaginal meshes for pelvic organ prolapse have been performed to date.Problems with vaginal mesh
Since the introduction of transvaginal mesh, long-term trials and reviews have demonstrated it has some advantages over traditional vaginal repair. These include reduced symptoms of prolapse and need to operate again. But the mesh kits also have disadvantages.
The mesh rubs or becomes exposed in the vagina in as many as 14% of cases. For some women, the exposure has no symptoms, but others experience bleeding, discomfort and painful intercourse.
At least half of the women in the studies reviewed needed surgery to treat the exposed mesh and sew over the vaginal tissue. The surgical correction is relatively straightforward and is generally successful.
Another problem is vaginal and groin pain, which affects 3-4% of women. Sometimes multiple surgeries are required to remove large portions of the mesh. The pain persists in as many as 25% of women, even after mesh excision, and may become chronic and disabling. Some find it difficult to maintain employment and intimate relationships.What regulatory bodies did
Following reports of these complications, the US Food and Drug Administration (FDA) issued alerts in 2008 and 2011 that the mesh carried serious risks. Many transvaginal mesh kits were voluntarily removed from the market. Most doctors in Australia stopped using the mesh for prolapse from 2012.
While the evidence of the benefits of the mid-urethral sling for urinary incontinence is overwhelming, some changes to the tapes were introduced from 2005 to decrease adverse events. The TGA approved these new mini-slings (or obturator slings) and specialists used these without evidence confirming whether they were safer or more effective than the traditional mid-urethral sling.
In 2015, an extensive Cochrane review showed 2-3% of women developed significant groin pain after surgery with the obturator slings. It also showed the obturator slings were not as effective as the traditional slings at the five-year mark. But the obturator slings were quicker to perform and had less bladder injury than the traditional mid-urethtral slings.
In 2016, specialist groups such as the Urogynaecology Society of Australia and the Australian College of Obstetricians and Gynaecologists undertook educational courses and later issued statements cautioning doctors about using the new slings.
Many of the affected women have asked how procedures could be performed on them when the full benefit-to-risk profile of the intervention was not yet known. It can be argued doctors wanted to provide new and better options. But, in hindsight, innovation and patient safety could have been far more closely aligned.
This could have been achieved if both the TGA and the specialists themselves had more thoroughly evaluated transvaginal meshes by ensuring these were used under the oversight of medical ethics committees. The well-established practice of performing large trials under the guidance of an ethics committee encourages innovation while ensuring patients are properly informed of the possible benefits and risks of the innovation.
While some Australian hospitals took this precautionary step, the fact it did not happen uniformly is a collective failure of both the TGA and specialists.Next steps
The Senate review will evaluate how sponsoring manufacturers interact with doctors performing surgical interventions, and how the broader medical community and public are educated about new interventions.
It is hoped the inquiry will inform the general community, doctors and industry of a clear and transparent pathway that balances the need for innovation and the responsibility for protecting patients.
Finally, while waiting on the inquiry’s deliberations, women should remain confident mid-urethral slings used for stress incontinence are an excellent intervention. Those undergoing prolapse surgery should also be reassured that highly trained specialists will carefully evaluate and perform surgery without the need for transvaginal mesh.
Those affected by ongoing complications associated with transvaginal mesh can be reassured Australian specialists are leaders in the management of these problems. Not only were we among the first in the world to report large trials that evaluated transvaginal mesh, we’ve also reported on the safety, technique and efficacy of mesh-removal procedures for vaginal pain in peer-reviewed publications.
We are fully supportive of the women who have experienced complications of transvaginal mesh. We look forward to working collaboratively at a national and local level, under the auspices of the Senate enquiry, to ensure we learn from the mistakes made when introducing transvaginal mesh into clinical practice.
https://theconversation.com/vaginal-mesh-controversy-shows-collective-failure-of-the-tga-and-australias-specialists-78605
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Women step up pressure to ban pelvic mesh implants - the biggest health disaster of our time
Jun 7, 2017 | Wisbech Standard
By Kath Sansom
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.
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.
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.
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.”
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
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