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Ethicon Media Monitoring 12/21/2016
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Mesh implants treatment brings unnecessary risks says study
Dec 20, 2016 | BBC
By Lucy Adams
Using mesh implants to treat pelvic prolapse brings unnecessary risks, according to new research. -
Study warns against mesh implants as first-line treatment
Dec 21, 2016 | STV News
Mesh implants should not be recommended as a first-line treatment for certain conditions, according to a new study. -
‘400 mesh implants carried out’ despite suspension call
Dec 20, 2016 | The Scotsman
Around 400 mesh implant operations have been carried out since ministers called for them to be suspended, MSPs have heard. -
Mesh implants deemed ‘unnecessary risk’
Dec 21, 2016 | The Scotsman
By Lizzy Buchan
Controversial vaginal mesh and graft implants have been described as “an unnecessary risk” as a major study found the techniques were no more effective than standard treatment for incontinence and female prolapse. -
Mullins Pelvic Mesh Trial Set for March
Dec 20, 2016 | Mesh Medical Device Newsdesk
After much delay, the Mullins case, a defective pelvic mesh trial of 31 women, is scheduled for March of next year.
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Mesh implants treatment brings unnecessary risks says study
Dec 20, 2016 | BBC
By Lucy Adams
Using mesh implants to treat pelvic prolapse brings unnecessary risks, according to new research.
But the findings, published in The Lancet, suggested mesh does not lead to more complications than other types of surgery for treating incontinence.
The study, the first of its kind, looked at treatment and hospital readmission over the past 20 years.
Its conclusions are expected to influence the Scottish government policy on the use of mesh transplants.
In June 2014, the then Health Secretary Alex Neil called for health boards to suspend their use pending investigations into their safety. And he set up an independent review of mesh.What's the issue with mesh implants?
This latest study forms part of that review.
It is one of two complimentary mesh studies to being published. Both found that using mesh to treat pelvic prolapse leads to a higher level of complications than other surgery.
But - contrary to expectations - the study found that hospital readmission rates were similar to those for other types of incontinence surgery not involving mesh.
It found that more than one in ten of the women treated for incontinence with mesh implants were readmitted to hospital because of complications.
Within five years more than 2,000 women were readmitted. But the proportion of those readmitted to hospital after other surgery for incontinence is similar at around 11%.
The study has been published just days after BBC Scotland revealed that more than 400 women have received mesh implants since the Scottish government called for their use to be suspended in 2014 because of safety concerns.
The research was led by Dr Rachael Wood, a consultant in public health medicine at the Information Services Division.
She said: "It's important to consider the results for prolapse and incontinence separately. With prolapse the study found that mesh is less effective and more likely to lead to complication.
"Mesh for prolapse should not be recommended as a first line treatment. But for incontinence the study supports the use of mesh.
"Stress urinary incontinence and pelvic organ prolapse are common conditions affecting many women and substantially reducing their quality of life. It is important that safe and effective treatments can be offered to women affected by incontinence and prolapse."
She added: "We hope that our study will help women who are contemplating treatment to make a more informed decision."
Dr Wael Agur, a consultant gynaecologist and lead clinician on the study, said some of the results were surprising.
The study only looked at hospital readmission within five years of treatment. But he warned that complications could present more than a decade later.
"It is a lifetime risk," he told BBC Scotland.
"We know of patients who have developed complications 14 years later. This study is so important but it is just one piece of the puzzle.
"The study looked at those who were readmitted to hospital after surgery but did not look at the severity of the complications nor the impact on quality of life."
Mesh implants are used by surgeons to treat pelvic organ prolapse and incontinence in women, and sometimes in men.
Over the past 20 years, more than 20,000 women in Scotland have had mesh or tape implants. But some have suffered painful and debilitating complications.
In 2014, a number of campaigners gave evidence to Holyrood's petitions committee. Several of them were in wheelchairs - unable to walk because of surgical complications.
As a result, the then Health Secretary Alex Neil wrote to health boards requesting a suspension in the use of mesh implants by the NHS in Scotland pending an investigation into their safety.
Since then, Greater Glasgow and Clyde has used the implants more than any other health board - with 178 mesh and mesh tape implants. NHS Lothian have performed 146 mesh and tape implants.
The boards still using mesh implants said they discussed all the potential risks with patients before surgery.
Elaine Holmes of Scottish Mesh Survivors said: "The ISD report is flawed because of the very way the department collects figures.
"Their data is collected using the number of patients who required a hospital bed. Mesh injured patients treated as outpatients at clinics or by their GP's have not been counted or included in this study.
"We know of patients who have endured multiple removals, some have endured a dozen procedures or more, but they are still only counted by ISD as having had just one complication. That is plainly wrong.
"The study also fails to highlight the severity of the complications or the impact they have had on a patient's life, a glaring omission since so many of us have ended up in wheelchairs and crippled for life."
She added: "The ISD study has also only looked at figures dating back five years, the very minimum that can be considered 'longer term' despite the fact many extremely painful mesh injuries do not come to light until 10 or even 15 years after the original surgery.
"It may take years for a polypropylene mesh implant to harden, shrink or fragment, moving through the body and causing crippling side effects."
http://www.bbc.com/news/uk-scotland-38381890
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Study warns against mesh implants as first-line treatment
Dec 21, 2016 | STV News
Women suffering from painful complications have taken their case to HolyroodMesh implants should not be recommended as a first-line treatment for certain conditions, according to a new study.
The procedure can be used to treat women suffering from prolapse and bladder problems but an independent review was ordered in 2014 after patients who had been left suffering from painful complications took their case to Holyrood.
A new study published in The Lancet on Wednesday found that current evidence supports the use of mesh procedures for incontinence and for prolapse of the top of the vagina.
However, mesh procedures for prolapse involving the bladder or bowel were less effective than non-mesh operations and much more likely to lead to longer-term complications.
The study was carried out by the NHS Information Services Division (ISD), which was asked to undertake an independent analysis of the outcomes following mesh and non-mesh operations carried out in Scotland.
ISD public health medicine consultant Dr Rachael Wood, who led the study, said: "Some mesh procedures are likely to be relatively safe and effective for some patients.
"Having said that, the results of this study show that mesh procedures should not be recommended as first-line treatment for prolapse of the bladder or bowel.
"Women considering mesh surgery, or concerned about complications, should speak to their GP or surgeon in the first instance."
In June 2014, the then health secretary Alex Neil asked health boards to suspend the use of the implants after a campaign by women who have suffered serious side effects.
On Tuesday, MSPs heard that around 400 mesh implant operations have been carried out since ministers called for them to be suspended.
The figure was quoted by Labour MSP Neil Findlay, who told the Scottish Parliament of the "devastating life-changing consequences" experienced by some women who have had the procedure.
For the study published in The Lancet, ISD worked with colleagues from various universities, looking at hospital discharge records for women undergoing operations for incontinence and prolapse, which is where the bladder, womb or bowel pushes down into the vagina causing discomfort.
They were able to analyse their post-surgery outcomes and examine the safety and effectiveness of mesh surgery for incontinence and prolapse.
Dr Wood said: "Stress urinary incontinence and pelvic organ prolapse are common conditions affecting many women and substantially reducing their quality of life.
"It is important that safe and effective treatments can be offered to women affected by incontinence and prolapse.
"We hope that our study will help women who are contemplating treatment to make a more informed decision."
Health secretary Shona Robison on Tuesday said the Scottish Government has no authority to withdraw the products and confirmed that a review on the issue will be published early next year.
Speaking on Tuesday, she said: "The request to suspend procedures will remain until the independent review's recommendations have been put in place.
"In light of the Scottish Government's request, the number of women receiving mesh implants has fallen.
"However, if women are experiencing very distressing symptoms and still want to proceed then I would want to give my reassurance that prior to a decision to have the mesh implant, all clinicians are expected to have a detailed discussion with their patients with the risks explored and explained so that a shared decision can be made and fully informed consent taken."
https://stv.tv/news/east-central/1376257-study-warns-against-mesh-implants-as-first-line-treatment/
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‘400 mesh implants carried out’ despite suspension call
Dec 20, 2016 | The Scotsman
Around 400 mesh implant operations have been carried out since ministers called for them to be suspended, MSPs have heard.
The figure was quoted by Labour MSP Neil Findlay, who told the Scottish Parliament of the “devastating life-changing consequences” experienced by some women who have had the procedures.
Health Secretary Shona Robison said the Scottish Government had no authority to withdraw the products as she confirmed a review on the issue would be published early next year.
Transvaginal tapes and meshes are used in the treatment of pelvic organ prolapse and stress urinary incontinence.
In June 2014, then health secretary Alex Neil asked health boards to suspend the use of the implants after a campaign by women who have suffered serious side effects.
Mr Findlay told Ms Robison on Tuesday: “Organ damage, loss of kidney, bladder removal, excruciating constant chronic pain, pelvic inflammation, pierced vaginal wall, nerve damage, mental breakdown, a reliance on wheelchairs and walking aids, husbands and partners injured during intercourse and family and marital breakdown - just some of the devastating life-changing consequences experienced by women who have been implanted with transvaginal mesh.
“Now we find, according to the media, another 400 Scottish women have been implanted since the so-called Scottish suspension in 2014. What message does the cabinet secretary have for these women?”
Ms Robison said: “The Scottish Government has no authority to withdraw these products. That is the role of the MHRA and they have not done so.”
She said that if women wanted to go ahead with the procedures, they could make an informed decision to do so in consultation with their clinician “with absolute clarity and information about the risks”.
She did not confirm the 400 figure, saying instead the information would be in the forthcoming review report.
Ms Robison said: “The request to suspend procedures will remain until the independent review’s recommendations have been put in place.
“In light of the Scottish Government’s request, the number of women receiving mesh implants has fallen.
“However, if women are experiencing very distressing symptoms and still want to proceed then I would want to give my reassurance that prior to a decision to have the mesh implant, all clinicians are expected to have a detailed discussion with their patients with the risks explored and explained so that a shared decision can be made and fully informed consent taken.”
http://www.scotsman.com/news/400-mesh-implants-carried-out-despite-suspension-call-1-4322410
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Mesh implants deemed ‘unnecessary risk’
Dec 21, 2016 | The Scotsman
By Lizzy Buchan
Controversial vaginal mesh and graft implants have been described as “an unnecessary risk” as a major study found the techniques were no more effective than standard treatment for incontinence and female prolapse.
Mesh implants operations were suspended in Scotland in 2014 due to concern over complications, which left women with infections, bleeding and abdominal pain.
It was reported this week that more than 400 women have received mesh and tape implants since the ban was brought in two years ago.
Researchers led by Aberdeen University compared synthetic mesh or biological grafts against standard native tissue repairs in 1,348 women with prolapse, where pelvic organs bulge into the vagina.
They found the mesh implant caused a number of complications and failed to offer any clear benefits.
The study, published in The Lancet journal, also found no significant difference between those who had the mesh or graft surgery, compared to the standard native tissue repair, up to two years after surgery.
Professor Cathryn Glazener, who led the study, said: “Because mesh did result in a number of complications, with no clear benefits, we conclude its use for these procedures could be considered an unnecessary risk. Therefore we consider that mesh should only be used in the future in high quality clinical trials aimed at improving the results of vaginal prolapse surgery.”
A separate review, commissioned by NHS Scotland, found mesh procedures for incontinence could be supported but mesh procedures for prolapse involving the bladder or bowel were less effective and likely to lead to complications.
Dr Rachael Wood, of Information Services Division, said: “Some mesh procedures are likely to be relatively safe and effective for some patients. Having said that, the results of this study show that mesh procedures should not be recommended as first line treatment for prolapse of the bladder or bowel. Women considering mesh surgery, or concerned about complications, should speak to their GP or surgeon in the first instance.”
http://www.scotsman.com/news/mesh-implants-deemed-unnecessary-risk-1-4322487 -
Mullins Pelvic Mesh Trial Set for March
Dec 20, 2016 | Mesh Medical Device Newsdesk
Mesh Medical Device News Desk, December 20, 2016 ~ After much delay, the Mullins case, a defective pelvic mesh trial of 31 women, is scheduled for March of next year.
Mullins has been set many times before, but it appears that Judge Joseph Goodwin has finally set March 6, 2017 as the first day for the largest consolidation of women into one case against Johnson & Johnson over its transvaginal mesh.
The case is Mullins et all (Case No. 2:12-cv-02952), filed in the Southern District of West Virginia where cases are consolidated in multidistrict litigation. The defendant corporation is Ethicon, a division of Johnson & Johnson, one of seven defendants in this mass tort that contains more than 96,000 product liability lawsuits naming defective pelvic mesh.
All 31 of the plaintiffs have common questions of fact – all are from West Virginia and all were implanted with the Tension-Free Vaginal Tape (TVT) to treat incontinence. There are different implanting physicians but one of them is Dr. Eddie Sze, formerly of WV University Hospital.
All of the women claim injuries ranging from chronic pain and infection, mesh migration and shrinkage, painful sex, nerve pain and other problems. Most have had multiple surgeries to try and remove the polypropylene mesh used to treat incontinence.
TVT was introduced in the U.S. in 1998. It remains on the market and is still referred to as the “Gold Standard” treatment for incontinence, by some in the medical community (here).
The Mullins defective product case was last scheduled to be heard April 2016. At that time it included 37 plaintiffs, some of who may have settled their cases or had them remanded back to state court.
It includes allegations of design defect, manufacturing defect, negligence, a failure to warn, breach of express warranty, breach of implied warranty, loss of consortium and punitive damages.
One reader to MND feels having so many plaintiffs in one trial is a plaintiff advantage. “Think about this: if a design harms only one person, the jury will wonder if maybe that person was unique somehow. If a design harms 37 people, it is more obvious that the problem is the design/device.”
The last trials that were held in Charleston, were Tyree v Boston Scientific (2:12-cv-08633) (coverage of the trial is here), which concluded November 4, 2014.
In Tyree, four plaintiffs – Wilson, Tyree, Campbell and Blankenship, who had all been implanted with the Obtryx mesh, received compensatory damages totaling $18.5 million.
The Bellew v. Ethicon case, (No. 2:13-cv-22473), also held in Charleston, WV, settled after a four-day trial in March 2015.
Here is a MND story. More background on the legal issues in the Bellew case are here.
Trial will commence March 6, 2017 at 8:30 am.
http://www.meshmedicaldevicenewsdesk.com/mullins-pelvic-mesh-trial-set-march/
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