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Incontinence operations: Women reassured over safety
Jul 1, 2015 | BBC
Independent experts are reassuring women a common type of surgery for urinary incontinence is safe and effective. -
Incontinence operation ‘relatively safe’
Jul 1, 2015 | The Courier
A large-scale review of controversial surgery for stress urinary incontinence (SUI), a common condition which affects around 170,000 women in the UK, shows it has been found to be "relatively safe" health experts have said. -
*New* Mesh Maker Covidien Agrees to Settle 11,000 Claims
Jun 30, 2015 | Mesh Medical Device News Desk
By Jane Akre
Covidien will settle some of the 11,000 pelvic mesh claims it has pending in federal court,Reuters reports citing court documents. -
Hello July Moon and Mesh News Desk Readers
Jul 1, 2015 | Mesh Medical Device Newsdesk
By Jane Akre
...As someone who spent 25 years working in newsrooms around the country, including CNN as a reporter and anchor, I believe I know an important story and I’ve never seen one virtually ignored by the media powers that be like pelvic mesh and hernia mesh...
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Incontinence operations: Women reassured over safety
Jul 1, 2015 | BBC
Independent experts are reassuring women a common type of surgery for urinary incontinence is safe and effective.
The Scottish government had suggested hospitals consider a temporary suspension of the "mesh" procedure.
And several patients had said the implants had destroyed their quality of life and caused excruciating pain.
But Cochrane Collaboration scientists said their analysis of 81 studies found such problems were rare.
They said the procedure was generally safe in the short to medium term but admitted there was a lack of long-term data and said more figures were needed to be sure of safety beyond five years after surgery.
According to the group, some 14,000 procedures are carried out in England each year to treat stress incontinence - an involuntary leak of urine when pressure builds in the bladder - for example during coughing and sneezing.
About six million women suffer from this across the UK, many affected after childbirth.
The operation involves inserting a sling implant made of artificial mesh to support the muscles of the bladder.
But a growing number of problems reported by patients - such as the mesh eroding and damaging nearby tissues - led doctors to think again.
Hundreds of implant-related claims have been brought to the Scottish courts, with cases also seen in the US and Canada.
Meanwhile, figures from the UK regulator, the MHRA (Medicines and Healthcare Products Regulatory Agency), show there have been 124 adverse reactions reported about mesh implants since the beginning of this year.
And experts acknowledge this may not reveal the full extent of problem, as some women do not report the issues they face.
But the Cochrane group said its research showed the complication rate is low.
And the researchers said most people who had had the procedure felt their quality of life had improved.
They said women should be able to make an informed choice, taking all the risks into account.
But Kath Sansom, a freelance journalist who lives in Cambridgeshire, said she experienced almost constant burning pain after going through the procedure last year.
She told the BBC: "Pre-op I was a super-fit mum... now it's as though I am trapped in the body of an 80-year-old.
"I feel like I'm being cut with cheese wire.
"The operation has succeeded in so much as I'm not incontinent any more... but my quality of life has been destroyed."
And Kate Langley, a preschool play worker who lives near Eastbourne, Sussex, said she had been in and out of hospital since having the operation, with complications giving her crippling pain.
Ms Langley told the BBC: "I'm screaming sometimes I'm in so much pain... and financially we're in massive debt because I haven't been able to work."
She said it had also taken a toll on her marriage.
"It's hard if you don't really have a love life," she said.
Scottish ministers are awaiting the results of an inquiry likely to be published in the autumn and to include evidence gathered by the Cochrane group.
Most women are advised to try non-surgical therapy first, including pelvic floor exercises to strengthen key muscles. But if this fails, an operation is often the next option.
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Incontinence operation ‘relatively safe’
Jul 1, 2015 | The Courier
A large-scale review of controversial surgery for stress urinary incontinence (SUI), a common condition which affects around 170,000 women in the UK, shows it has been found to be "relatively safe" health experts have said.
Some of those who have received the procedure suffered painful and debilitating complications, with reports of women suffering internal lacerations that have made their quality of life worse than it was before.
The problems led Health Secretary Shona Robison to ask health boards to suspend the operation until an independent inquiry has been published, while court action is being taken in the UK, the United States and Canada.
A Cochrane review found that the procedure, which involves inserting a mesh sling to support the muscles of the bladder by either the groin or abdomen, results in similar cure rates of 70%-80%.
The groin procedure, known as transobturator insertion, carried a lower risk of bladder damage during the operation with around six women in 1,000 experiencing this compared with 50 in 1,000 who had the abdomen procedure, known as the retropubic route.
But the analysis of 81 trials found that the transobturator operation led to more short-term groin pain and there was some evidence that women who had it were more likely to need a repeat operation later.
Professor Cathryn Glazener of the University of Aberdeen, who has carried out previous research on the surgery and is part of the independent review, said: "Overall the operations have been found to be relatively safe and relatively effective."
She added this would "suggest these operations would or should be available to women given choice and adequate information about it".
Lead author Dr Abigail Ford, from Bradford Teaching Hospitals NHS Foundation Trust, said: "This is a very significant review informing women about the minimally invasive surgical options available for the treatment of this very debilitating condition.
"It helps to clarify the pre-existing evidence on the effectiveness of these approaches and their side-effects in the short term, as well as introducing longer term evidence of efficacy and safety.
"It helps to give women more information to make an informed choice."
The independent review is due to be published in the autumn, with today's findings forming part of it.
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*New* Mesh Maker Covidien Agrees to Settle 11,000 Claims
Jun 30, 2015 | Mesh Medical Device News Desk
By Jane Akre
Covidien will settle some of the 11,000 pelvic mesh claims it has pending in federal court,Reuters reports citing court documents.
There is no word on the amount of settlement dollars being offered and no specificity on the number of outstanding product liability claims that will be included in the settlement.
This would be the third pelvic mesh maker that has entered into settlement discussions to end a number of product liability claims naming its products. Covidien makes transvaginal mesh and bladder slings that are sold by different companies, particularly C.R. Bard.
The majority of the 100,000 pelvic mesh product liability claims remain pending, many in U.S. District Court in the So. District of WV.
Last July, Covidien announced plans to take $180 million from its third quarter profits to pay the costs associated with lawsuits. Covidien also agreed to indemnify the maker from certain claims. See theMesh News Desk story here.
Indemnify means to compensate the party for its losses or to guarantee it will cover damages in the future. See the legal definition here.
The $180 million charge reportedly came after discussions with plaintiff attorneys, Henry Garrard and Blasingame, Burch, Garrard & Ashley, P.C.
In a a pretrial order, Judge Joseph Goodwin writes Covidien has appointed Special Master Cathy Yanni (PTO #181) to resolve the claims related to its product.C.R. Bard is facing 11,656 product liability claims in this federal court. This is the fourth highest number of claims among seven defendant companies. See. So District of WV website here.
Covidien History
Anti Mesh rally in WV federal court.
Covidien was born of the business conglomerate Tyco International before being sold to Medtronic Inc. for $43 billion in a deal that merged two of the world’s largest implant and medical supply companies.
Minneapolis-based Medtronic then moved its base to Dublin where a more favorable tax burden is found, reports Marketwatch however technically Covidien is run from Mansfield, Mass.
Judge Goodwin presides over 75,000 cases against seven mesh manufacturers including American Medical Systems, C.R. Bard, Ethicon (J&J) Boston Scientific, Coloplast, Cook Medical and Neomedic. Covidien is not named as a defendant but is named in some cases as a co-defendant (See Carolyn Jones 2:11-cv-00114, for supplying mesh to C.R. Bard).
In the Jones case, C.R. Bard is named as a defendant along with Covidien Inc. D/B/A Sofradim Production, a Delaware corporation with business located in Mansfield, Massachusetts. Bard and Covidien designed, manufactured, marketed, packaged, labeled and sold the product. In her case (Jones) the mesh was the Avaulta Synthetic Support System. Bard and Covidien also make Avaulta Solo and Avaulta Plus meshes used to “restore normal vaginal structure after a pelvic organ prolapse.”
Settlements So Far
The Covidien announcement is the third mesh maker to announce mass settlements to the many pending plaintiffs, women injured by the polypropylene mesh implants. So far American Medical Systems (Endo) has agreed to set aside $1.6 billion to settle about 40,000 claims. Recently, Boston Scientific announced it planned to settle some of its pending transvaginal mesh claims.
Johnson & Johnson has settled individual claims either preceding or during litigation (See Budke case here) but otherwise has announced no settlement plans. Cook, Neomedic, Coloplast have not offered any settlements to women.
Judging from the SEC filings of the various companies involved there are in excess of 100,000 pelvic mesh product liability claims globally. #
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Hello July Moon and Mesh News Desk Readers
Jul 1, 2015 | Mesh Medical Device Newsdesk
By Jane Akre
If you are new to this issue – first of all, I’m sorry. I’m not mesh injured but talk to many women who are and I agree with the assessment that this is the darkest chapter in women’s healthcare. And now with 100,000 lawsuits and the number growing all of the time, it’s almost unfathomable that pelvic mesh is still being placed transvaginally. But it is.
I’m a journalist who began this website nearly four years ago with the goal of putting a face on the women who have been injured. Since then, so many lawyers have told women not to appear in public and tell their story, that the medical and legal areas have grown. There is no shortage of news unfortunately.
I still find it unbelievable that mainstream media is not making this front page news. As someone who spent 25 years working in newsrooms around the country, including CNN as a reporter and anchor, I believe I know an important story and I’ve never seen one virtually ignored by the media powers that be like pelvic mesh and hernia mesh. It is a huge oversight but hopefully this website and the efforts of readers in their own communities are slowly changing the tide.
Please use the Search Bar to go back into the archives. It’s all there!
How did we get here? July 13, 2011 was a very important date. That was the day the U.S. Food and Drug Administration issued a Safety Communication that pelvic mesh complications are “not rare” and suggested mesh not be a first line treatment for prolapse and incontinence.
But industry pressure strongly influences medicine as you’ve likely seen first hand. Certainly we’ve seen in trials. Having attended six or so by now, I’ve been amazed at the information that lawyers have found – from the Material Safety Data Sheet issued by the resin makers that say polypropylene is NOT to be made into implantable medical devices (pelvic mesh) to emails that show how hell bent the manufacturers were to get their share of the market at a “premium price.” All for an experimental procedure that had never been tested on humans!
We see now how this massive human experiment went awry with 100,000 women the victims of negligence and the pursuit of profits.
Just FYI
This site is NOT a legal referral service, and is not connected to any law firm or medical provider. As a publisher, the advertiser model has worked well for years for newspapers and magazines and with 5,000 to 10,000 readers a day – why not advertise on Mesh News Desk? As with many independent news sources, readers contributions are always welcome to keep me focused on the mesh issues as they break.
As a journalist, I still follow the Society of Professional Journalists Code of Ethics and try to talk to both sides of every issue and provide you the links so you can further uncover this mesh mystery with me.
Four years ago, I formed Independent News Group LLC, a for profit corporation, to work on these under-reported stories that deserve to see the light of day. I’ll keep reporting the mesh-related news as long as I can keep this site going. Any questions reach out – Janeakre@meshnewsdesk.comI’m pretty easy to reach and will answer your questions. I’m certainly interested in taking submissions from any writers who want their point of view heard on these pages from anywhere around the globe!
MND is NOT a legal referral service! It is written by your editor, a long-time journalist who finds this to be the most incredible story under-reported story I’ve ever encountered that needs to be brought to light, front page news if you will. Women and families need to be empowered with information so they can take control of their own medical future.
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Thank you all! Hang in there friends. A new year, renewed determination!
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