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Ethicon Media Monitoring 10/24/2018
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'Hundreds more' vaginal mesh implants need removal due to complications within a decade
Oct 24, 2018 | The Independent
By Alex Matthews-King
Hundreds more women in England who received vaginal mesh implants to treat incontinence will need the procedure reversed, a study suggests. -
Pelvic mesh: Obstetrician says profession must learn from scandal, calls for register
Oct 24, 2018 | ABC News.au
By Carla Mascarenhas
An Australian obstetrician has urged the medical profession to learn from the pelvic mesh scandal to ensure it never happens again.
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'Hundreds more' vaginal mesh implants need removal due to complications within a decade
Oct 24, 2018 | The Independent
By Alex Matthews-King
Hundreds more women in England who received vaginal mesh implants to treat incontinence will need the procedure reversed, a study suggests.
In a study of nearly 100,000 English women, 3,137 (3.3 per cent) required the implant to be removed within a decade. This is a third larger than the number of reversals reported in an NHS audit of the procedure.
NHS England estimated just 2.6 per cent had to be removed because of complications, but the rate may be even higher for younger women as 4.4 per cent of those aged 18 to 39 had a removal.
Researchers from the London School of Hygiene and Tropical Medicine found that overall, 6.9 per cent of women who had the procedure needed a further operation, but the reasons why were not recorded.
Dr Lucia Dolan, co-author of the study and consultant gynaecologist told The Independent: “Women undergo tape removal when a complication has occurred.
“There are no temporary mesh procedures – the expectation is that they are permanent.”
“Unfortunately many women who have mesh tapes removed will experience incontinence again,” Dr Dolan added.
Urinary incontinence will affect one in three women at some point in their lives, but mesh implants commonly used to treat the condition have been linked to life-changing side effects.
Mesh implants have been the subject of law suits involving thousands of women in the US, UK and elsewhere who have been left with injuries when their implants deform, lacerating soft tissues of the vaginal canal and causing pain and disability.
In England NHS, trusts were told the devices should be a “last resort” and should only be implanted under “high vigilance”.
This requires all doctors who perform the procedure to be experienced in using the devices and all patients to be regularly followed up with to ensure any side effects are reported.
While rigid mesh implants used to treat organ prolapse after childbirth have been linked to the most acute side effects, the flexible mesh tapes more widely used to treat incontinence – and thought to be safer – have also been called in to question.
An NHS England estimate found that 500 mesh removal operations were taking place each year because of complications. Between 2008 and 2017 the NHS audit found 2,639 mesh tape removals among the 100,516 women who had the implants for stress incontinence.
But the latest findings published in the Journal of the American Medical Association on Tuesday suggest it could be even higher. Based on NHS medical records for 95,000 women in England who had mesh implants between 2006 and 2015, more than 3,000 had a removal.
The authors note that the gradual decrease in mesh operations – falling 50 per cent over this period – is “likely to reflect concerns about longer-term complications, outcomes, and risk of further surgery after [mesh] insertion”.
https://www.independent.co.uk/news/health/vaginal-mesh-implant-urinary-incontinence-women-pain-disability-lawsuit-nhs-a8597956.html
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Pelvic mesh: Obstetrician says profession must learn from scandal, calls for register
Oct 24, 2018 | ABC News.au
By Carla Mascarenhas
An Australian obstetrician has urged the medical profession to learn from the pelvic mesh scandal to ensure it never happens again.
Earlier this month Health Minister Greg Hunt issued a national apology to women who had suffered debilitating effects from mesh implants used to treat prolapse or incontinence.
Port Macquarie Base Private Hospital associate professor of obstetrics and gynaecology Ray Hodgson said the product had slipped through the cracks and the medical profession needed to examine why those cracks existed.
"My understanding is that mesh has been used for a number of years in other parts of the body," he said.
"The most common area for the use of the mesh is treatment of hernias without much in the way of complications.
"The mistake … is that people thought mesh was being used quite safely without much in the way of complications of hernias, therefore it will be safe in the vagina."
Dr Hodgson said the vagina had thinner tissue than the abdomen or groin where hernias were treated, so mesh was more likely to find its way to the surface and cause extrusions and reactions.
"In other areas … where the tissue is thicker, that sort of extrusion of mesh is much less common," he said.
"We must learn from our mistakes.
"This was a mistake by the Therapeutic Goods Administration (TGA) and it was a mistake by medical practitioners to accept the TGA's approval when the thorough long-term studies had not been performed."
The TGA has been contacted for comment.Register for new products 'a must'
Dr Hodgson has treated 100 women with pelvic mesh implants and said about six had had problems, with about three having the implants completely removed.
He still supports the use of mesh products for incontinence, but would like to see a compulsory register that would require health professionals to report problems with mesh products, despite the Federal Government only committing to a voluntary national register.
He said a register was needed for all new products.
"We need to fix this system so that this type of approval of what has turned out to be a risky product is no longer able to occur," Dr Hodgson said.
"There needs to be some type of register that accurately identifies a number of people receiving a new product so as soon as significant problems occur they can be identified."
Call for all mesh implants to be banned
Newcastle obstetrician and gynaecologist George Angus does not support the use of any mesh products.
"The early complication rates were unacceptably high … I was not satisfied that the response of 'There is a learning curve and complications will become less' was valid," he said.
Dr Angus said polypropylene strips for incontinence should not be used.
Mid-north coast woman Louise (not her real name), who had a mesh implant commonly known as a mid-urethral sling, to treat stress urinary incontinence five years ago, concurs.
She suffered a range of problems including chronic groin pain and constant urinary tract infections. She has recently had the device removed.
Louise said all transvaginal mesh implants, including those used for incontinence, should be banned until a full review of all evidence of outcomes in Australian women implanted was conducted.
"The last 20 years has seen a creep towards the overuse in younger, fitter women with milder original symptoms," she said.
She said any register must be retrospective, including an audit of all mesh implants as far back as records began, held by an independent body.
https://www.abc.net.au/news/2018-10-24/medical-profession-must-learn-from-pelvic-mesh-mistakes-doctor/10419242
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