Preview Newsletter
Ethicon Media Monitoring 8/4/2017
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'Mesh implants have cut through vaginal walls and wounded genitals': Mother highlights scandal of 'gold-standard' NHS treatment that has ruined the lives of hundreds of women
Aug 3, 2017 | The Daily Mail
By Alexandra Thompson
A mother has highlighted how an NHS 'gold-standard' treatment is ruining the lives of hundreds of women. -
Women 'left in wheelchair' after vaginal mesh implant
Aug 3, 2017 | BBC
Vaginal medical mesh implant should be banned to stop women having painful complications, campaigners have said. -
A Melbourne Senate inquiry hearing was told up to 3000 women left with serious mesh injuries
Aug 4, 2017 | Newcastle Herald
By Joanne McCarthy
AUSTRALIA’S peak health care commission has told a Senate inquiry that up to 3000 Australian women have been left with injuries ranging from very serious to catastrophic after pelvic mesh surgery that is no longer recommended as a front line treatment. -
Welcome August – A Hot Mesh Mess
Aug 3, 2017 | Mesh Medical Device Newsdesk
By Jane Akre
...Settlements are being crafted and people call and ask if they can fire their lawyer! They are not what plaintiffs envisioned, with any capacity to fix them for now and the future. -
Defense Win in Transvaginal Mesh Lawsuit Reversed
Aug 4, 2017 | Lawyers and Settlements
By Gordon Gibb
Philadelphia, PAThe lone transvaginal mesh lawsuit won by manufacturer Johnson & Johnson in the Philadelphia pelvic mesh mass tort was short-lived, after the judge overseeing the case in the Philadelphia Court of Common Pleas granted the plaintiff’s post-trial motion for a damages hearing.
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Aug 3, 2017 | The Daily Mail
By Alexandra Thompson
· Women have been left wheelchair bound and unable to have sexual intercourse
· Surgeons frequently have a conflict of interest if they are given research grants
· More than 800 women are suing the NHS over crippling mesh complications
· Yet, a surgeon argues it is difficult to know if the procedure itself causes pain
· NICE is due to announce updates to mesh implant guidance in February 2019
A mother has highlighted how an NHS 'gold-standard' treatment is ruining the lives of hundreds of women.
Vaginal mesh implants are offered to women suffering from stress urinary incontinence or pelvic organ prolapse, yet more than 800 are suing the NHS and the implants' manufacturers after suffering crippling pain that has left them unable to have sex or even walk.
The NHS has even been accused of sweeping such complications under the carpet in an effort to dodge media attention.
After the tireless pursuits of campaigns, including 'Sling the mesh', to have the implants suspended, NICE is expected to announce updates to its mesh guidance in February 2019.
Speaking on BBC Radio 4's flagship show Woman's Hour, 'Sling the mesh' campaign leader Kath Samson, who had the procedure back in 2007, spoke of how the 20-minute 'solution' to mild urine leaks has cut some women's partners' genitals during sex.
The programme also had a gynaecologist's perspective, who argued it is often unclear whether the mesh itself is to blame for women's pain, while adding that many women successfully have the implant without any complications.
Yet, Ms Samson accused such doctors of having a conflict of interest, arguing they frequently receive research and travel grants when carrying out investigations on behalf of implant manufacturers.
Mother-of-two Ms Samson, 47, had an implant fitted in March 2015 after suffering mild urine leakage while exercising following the birth of her daughter Daisy in 2007.
Doctors told her the procedure lasted only 20 minutes and was minimally invasive, with any pain disappearing after around two weeks.
Yet, when Ms Samson, from Cambridgeshire, was continuing to battle crippling pain in her legs and genitals weeks after the procedure, an internet search told her she was one of many women all over the world suffering life-changing complications. She has since had her implant removed.
Ms Samson said: 'My story is minor compared to some. In some women the mesh has shrunk and sliced through their vaginal walls and they've not realised until its cut their partners during intercourse.
'For some women its cut through their bowels or bladders. Women are in wheelchairs or need sticks to help them walk.'
Although supporters of the mesh argue there are numerous studies confirming the implant's safety, Ms Samson says these are highly flawed.
She said: 'A lot of studies are very short term or are on animals who can't speak of a loss of sex life or quality of life.'
Ms Samson adds many trials only last up to around two years, yet some women who have had the procedure may not experience complications until nearly a decade later.
She said: 'In one woman the mesh sliced through her urethra and she is in chronic pain eight years later; relying on painkillers and just sitting at home watching Netflix.'
Surgeons have a conflict of interest to support mesh implants
Ms Samson believes many doctors have a conflict of interest that spurs them to claim vaginal mesh implants are safe.
She told MailOnline: 'A lot of surgeons are paid for research or given travel fellowships and are put up in a nice hotel if they research a certain type of mesh
'They won't turn around and say 'they're bad and we're not happy about.'
Dr Mark Slack, consultant gynaecologist and urogynaecologist, who also appeared on Woman's Hour, told MailOnline: 'Conflicts of interest are declared in all publications when there has been funding by the manufacturer.
'There is insufficient public funding to fund all of the research that needs to happen.
'The articles that I have written have been written scientifically and objectively for which I received no payment.
'All I have ever been paid for is a consultancy fee, which is a standard business arrangement.'
'Millions are happy with the outcome'
Dr Slack, who is based in Cambridge, argues there are good and bad mesh implant operations, with many women finding the procedure to be a solution to debilitating urinary incontinence or organ prolapse.
He said: '[When complications occur] it's difficult to know if the mesh caused it or the incorrect technique to put it in.
'There are many millions who had very effective solutions to a debilitating problem and are very happy with the outcome.
'There are some operations that have very low complication rates and I'm scared we'll throw the baby out with the bath water [if the mesh is suspended].'
Yet, Dr Slack and Ms Samson both agree pelvic floor exercises can be a highly effective way of preventing and treating urinary stress incontinence, which women should try before considering having an implant fitted.
In response to claims the NHS deliberately ignored mesh implant complications, Professor Keith Willett, medical director for acute care at NHS England, said: 'We are now providing more consistent information to women [with stress urinary incontinence (SUI) or pelvic organ prolapse (POP)] and their clinicians, better care and support in the way of 18 self-declared centres with the specialist experience and skills to assess women suffering from distressing complications and making improvements to data collection which will in turn lead to greater evidence on the safety and efficiency of devices.
'I am reassured that this momentum will continue due to the commitment from NICE to update and develop further guidance related to the care of women with SUI and POP.
'Our collective vision is that future patients recognise that they have been part of a shared decision-making process, understand the alternatives, benefits and risks, experience fewer complications and when complications do occur that they are treated promptly and effectively.'
http://www.dailymail.co.uk/health/article-4756752/Vaginal-mesh-implants-cut-people-s-genitals.html
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Women 'left in wheelchair' after vaginal mesh implant
Aug 3, 2017 | BBC
Vaginal medical mesh implant should be banned to stop women having painful complications, campaigners have said.
Hundreds of women across the UK say the procedure - used to treat incontinence and prolapse after childbirth - has left them physically and mentally scarred.
A report by the NHS England-led Mesh Working Group, published last week, said the use of mesh was still "a safe option".
The Welsh Government said it was going to set up a working group to "consider the latest recommendations and determine what further action we may need to take".
Carole Williams told BBC Wales Today she was frightened of ending up in a wheelchair unless the mesh was removed.
http://www.bbc.com/news/av/uk-wales-40819291/women-left-in-wheelchair-after-vaginal-mesh-implant
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A Melbourne Senate inquiry hearing was told up to 3000 women left with serious mesh injuries
Aug 4, 2017 | Newcastle Herald
By Joanne McCarthy
AUSTRALIA’S peak health care commission has told a Senate inquiry that up to 3000 Australian women have been left with injuries ranging from very serious to catastrophic after pelvic mesh surgery that is no longer recommended as a front line treatment.
The Australian Commission on Safety and Quality in Health Care was highly critical of specialist training, information to women about pelvic mesh risks, the treatment of women after serious mesh complications and the failure of doctors to respond when they sought help.
“The women have reported these problems. For anyone to suggest they haven’t reported them is nothing short of nonsense. It’s what people have done with those reports, or haven’t done with them, that is the issue,” commission chief executive, Adjunct Professor Debora Picone told the inquiry during a public hearing in Melbourne.
Commission clinical director Dr Robert Herkes said 40 women interviewed during consultations in four Australian cities had complications that were “undoubtedly overwhelming those women’s lives”.
“The bulk of the women were separated or divorced. Only one woman held down a job. For those women the complications were catastrophic,” Dr Herkes said.
Many of the women did not know they had been implanted with mesh devices until they searched for explanations for complications including chronic infections, disabling pain, erosion of the mesh into other organs and an inability to have sex.
The women have reported these problems. For anyone to suggest they haven’t reported them is nothing short of nonsense. It’s what people have done with those reports, or haven’t done with them, that is the issue.- Associate Professor Debora Picone
“We’ve been extremely concerned by the issues raised by the women we’ve talked with about the informed consent process, and particularly the informed consent process in relation to mesh surgery to treat prolapse,” Professor Picone said.
“In fact some of the conversations we’ve had with women, informed consent has really been absent. There’s no question about that in our minds.”
She described “so-called patient information leaflets” about pelvic mesh surgery as “hopelessly inadequate”, and said the commission felt very strongly that “major steps” needed to be taken on credentialing of doctors who implant mesh devices.
The Senate inquiry into pelvic mesh was called after Australian Pelvic Mesh Support Group founder Caz Chisholm and other members spoke with Victorian Senator Derryn Hinch. He campaigned for an inquiry into “one of the greatest scandals against women in Australian history”.
It is hearing evidence from women who received mesh implants through the vagina for prolapse treatment – now not recommended as a front line treatment after complication rates of at least 10 per cent – and mesh for incontinence, with lower complication rates and recognised evidence of safety and efficacy.
At the first hearing day two doctors who gave evidence conceded they should have declared they were to appear as expert witnesses for Johnson & Johnson in the company’s defence of a class action brought by more than 700 women after mesh surgery for incontinence and prolapse treatment.
Dr Anna Rosamilia told the inquiry she “should have disclosed” that she would be giving evidence for the company after appearing as a representative of Monash Health at the inquiry.
“I wasn’t aware that I needed to,” she said.
Dr Peter Dwyer, who will also give evidence for Johnson & Johnson, told the inquiry most of these companies have got strict ethical protocols that they stick to, before conceding he was an expert witness for the company.
Dr Dwyer told the inquiry that specialist training on mesh surgery was “falling between the gaps a bit”.
“If they’re placed in the wrong place… I mean, patients have died from these devices. They’ve got to be placed correctly,” he said.
Mesh manufacturers, which have been training doctors, should not be left to train them, he said.
Medical colleges had been “very happy to pass this on to special interest groups to manage these problems”, he said.
In response to a question from Mr Hinch about mesh company representatives being present in operating theatres while women are being implanted with mesh devices via the vagina, Dr Dwyer said “on occasion the rep does come into the operating theatre”.
“It’s not unusual for them to come into theatre at times. As long as they’re not directing the operation or interfering in other ways,” Dr Dwyer said.
The inquiry will hold another public hearing in Perth on August 25.
http://www.theherald.com.au/story/4832324/peak-health-body-scathing-on-mesh-history/
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Welcome August – A Hot Mesh Mess
Aug 3, 2017 | Mesh Medical Device Newsdesk
By Jane Akre
Mesh Medical Device News Desk, August 3, 2017 ~ Hello and Welcome to Mesh Medical Device News Desk, aka Mesh News Desk
It’s hot in most parts of the country, especially in Florida where the MND campus is located, and there is a lot going on in Mesh World, unfortunately much of it is being done behind the scenes.
Settlements are being crafted and people call and ask if they can fire their lawyer! They are not what plaintiffs envisioned, with any capacity to fix them for now and the future. Not only does the lawyer take a portion, but insurance wants to be reimbursed, any liens, Medicare, etc. What’s left is a pittance for most women.
Then there are the exceptions.
Some women have a law firm that communications with them and has provided some reasonable settlement. Keep in mind, none of these reflect on pain and suffering, future medical care, loss of job or consortium.
If you have had a mesh complications- speak out – others need to know that some percentage will not do well with polypropylene mesh! It is still used everyday by the medical community. Australia and the UK are raising their voices now and they are being heard.
There are alternatives to a mesh implant for hernia and prolapse and incontinence. Ask you doctor if you are a candidate. Travel to Shouldice Clinic in Toronto to get your hernia fixed. It will cost less than in the States with a much better outcome. Listen to the Ralph Nader interview with Dr. Bendavid of Shouldice here.
I apologize for not being able to answer your calls. There is too much to do and I’m not a lawyer or a doctor. Send me an email if you need a doctor referral, based on the recommendations from others, not my personal experience.
Want to help the effort? I’ve added BeautyCounter product line to Mesh News Desk, here is my website. I use them and they are excellent, made in the US and without toxins, parabens, pthlates etc.
The FDA doesn’t regulate skin care products for us or our kids. Here is a video on their mission, which means 1,500 questionable ingredients are omitted from their products!
Best News – The Environmental Working Group ranks them top notch in their Skin Deep review of consumer products! Not available in stores, only through person to person. I get a percentage of sales which helps keep MND percolating along.
Hoping this is a win-win!!!!.….I’ve got an idea to send a product to a woman in need with your help, so thank you in advance. More in a upcoming newsletter.
Thank you friends. Stay cool and stay strong.
Jane Akre,
Editor, Mesh Medical Device News Deskhttps://www.meshmedicaldevicenewsdesk.com/august-hot-mesh-mess/
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Defense Win in Transvaginal Mesh Lawsuit Reversed
Aug 4, 2017 | Lawyers and Settlements
By Gordon Gibb
Philadelphia, PAThe lone transvaginal mesh lawsuit won by manufacturer Johnson & Johnson in the Philadelphia pelvic mesh mass tort was short-lived, after the judge overseeing the case in the Philadelphia Court of Common Pleas granted the plaintiff’s post-trial motion for a damages hearing.
Plaintiff Kimberly Adkins had alleged transvaginal mesh complications. Her transvaginal mesh side effects lawsuit was the fifth to go to trial in the Philadelphia mass tort. The previous four trials had ended with verdicts favoring the plaintiff. However, Adkins’ case went to the defense after a jury in the Philadelphia Court of Common Pleas determined that the pelvic mesh manufactured by Ethicon, a subsidiary of Johnson & Johnson, had not caused the damages claimed in Adkins’ lawsuit.
The defense verdict, issued June 9, was brief. Ten days after the verdict was handed down, Adkins was back with a one-page motion requesting a hearing to consider damages. In her motion, filed June 19 the plaintiff argued the jury’s determination that the product had been defectively designed but not the cause of the plaintiff’s injuries went against the weight of the evidence.
“Even if the jury disbelieved plaintiffs testimony, found the testimony inconsistent or concluded plaintiff was exaggerating her injuries, the jury was not free to reject the undisputed consensus of both sides’ experts and the treating physician that plaintiff suffered some injury from the implantation of mesh,” the motion said.
A month later, on July 19 Judge Michael Erdos sided with the plaintiff and granted her motion for a damages hearing, contending that the jury’s findings were inconsistent on the issue of whether the alleged design defect caused the injuries, agreeing the case should proceed to a damages hearing.
Adkins, in her post-trial motion, noted that an expert for the defense testifying at the original trial had only disputed the possibility that transvaginal mesh complications related to her current, present-day complaints. However, the expert witness admitted that TVM mesh manufactured by Ethicon was likely to have caused the plaintiff’s initial injuries.She also took issue with one of the jurors, who was a biopharmaceutical engineer with GlaxoSmithKline. Adkins noted that the juror had made certain comments pertaining to the potentiality of transvaginal mesh complications stemming from pre-existing injuries. The plaintiff also suggested that the outcome of her case could potentially have an economic impact on the juror, given the juror’s employer. The judge however chose not to accept those portions of the plaintiff’s post-trial motion related to the juror.
The reversal of the defense verdict is a compelling result, given that the first four trials ended in plaintiff awards worth millions of dollars each. The original defense verdict in this case, leaving the plaintiff with nothing, was a significant first win for the defense in the Philadelphia mass tort.
But not for long.
The case is Kimberly Adkins v. Ethicon Inc. et al., Case No. 130700919, in the Court of Common Pleas of Philadelphia County, Pennsylvania.https://www.lawyersandsettlements.com/articles/transvaginal-mesh-tvt-sling/transvaginal-mesh-lawsuit-7-22480.html
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