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Ethicon Media Monitoring 12/3/2018
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Better monitoring of mesh implants needed: Duffy
Dec 2, 2018 | Derry Journal
By Kevin Mullan
The publication of new data on the number of local women who have undergone a controversial procedure to treat incontinence (SUI) and pelvic organ prolapse (POP) after child birth has been welcomed by a local councillor. -
Family want answers as mesh cited in mother’s death
Dec 3, 2018 | Herald Scotland
Great-grandmother Eileen Baxter, 75, died in August from multiple organ failure at the Royal Infirmary of Edinburgh. -
Heartbroken family of mesh implant gran demand answers over her shock death
Dec 2, 2018 | Scottish Daily Record
By Sarah Ward
The family of the first woman in Scotland to have 'mesh implant' listed as an underlying cause of death are demanding answers from the NHS. -
Grieving family demand answers over great-grandmother’s mesh death
Dec 1, 2018 | The Scotsman
By Kevan Christie
A grieving son whose mother was the first person in Scotland to have mesh implant surgery listed as an underlying cause of death is demanding answers from the regulator who approved the product. -
Eastbourne mum’s ‘horrific pain’ leads to campaign and desperate plea
Nov 30, 2018 | Eastbourne Herald
By Juliet Mead
An Eastbourne mum who has been campaigning to Sling the Mesh has set up a Go Fund Me page for the cause -
Pelvic Mesh Trial Lawyer Slams MDL Settlements as 'Puny,' Opposing Leadership's Fee Petition
Nov 30, 2018 | Law.com
By Max Mitchell
As the pelvic mesh MDL has begun to settle, attorneys on the leadership committee have asked the federal court overseeing the litigation’s massive inventory to set aside 5 percent of the awards for common benefit fees and expenses. -
Hernia mesh concerns grow among men as more patients report surgery complications
Dec 1, 2018 | ABC News.au
By Alison Branley
Marc Russell has spent his life travelling the globe to surf some of the world's biggest breaks and ride his motorbike through the most breathtaking landscapes.
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Better monitoring of mesh implants needed: Duffy
Dec 2, 2018 | Derry Journal
By Kevin Mullan
The publication of new data on the number of local women who have undergone a controversial procedure to treat incontinence (SUI) and pelvic organ prolapse (POP) after child birth has been welcomed by a local councillor. But Sinn Féin’s Sandra Duffy has warned there remain gaps in our knowledge of the use of vaginal mesh implants, which, it’s believed, can cause chronic pain, in 10 per cent of women.
Last year the ‘Journal’ revealed that from April 2012 to April 2017 515 procedures involving the use of synthetic mesh were carried out on women in the North West. This week the Department for Health has published a new ‘Retrospective review of surgery for urogynaecological prolapse and stress urinary incontinence using tape or mesh experimental statistics, Northern Ireland, April 2008 - March 2017’.
Colr. Duffy said: “The audit reviewed data on procedures carried out between 2008 and 2017 to determine the frequency of such surgery and the rate of subsequent removals. “More information is always useful but unfortunately the gaps in this document tell us more about the state of record keeping than the actual issue.
The analysis doesn’t include variables such as the type of mesh used, the surgical technique used or patient profiles as these are not collected as part of the hospital inpatient system. The data also doesn’t record the severity of the condition before surgery or any subsequent complications.”
https://www.derryjournal.com/news/better-monitoring-of-mesh-implants-needed-duffy-1-8722787
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Family want answers as mesh cited in mother’s death
Dec 3, 2018 | Herald Scotland
Great-grandmother Eileen Baxter, 75, died in August from multiple organ failure at the Royal Infirmary of Edinburgh.
She had been fitted with sacrocolopexy mesh repair – an implant to fix a pelvic organ prolapse five years earlier – but a week before her death suffered internal bleeding, sickness and diarrhoea.
Mrs Baxter’s grieving children, Mark and Audrey Baxter, have met with senior politicians to discuss the circumstances surrounding their mother’s death.
It led to the Scottish Government announcing a halt in the use of transvaginal mesh, with only a limited number of operations to be considered for women already on the waiting list.
Mr Baxter said: “The one question I did ask, which I thought was relevant, is there’s a bacteria that comes from this mesh.
“The surgeon has said that there was a lot of bacteria in my mum’s body, so I’m specifically looking for them to tell me where this bacteria came from. I know that the bacteria that comes from the mesh can break down the immune system and then the body can’t cope with any antibiotics.
“So I’m still waiting on answers to the questions I have surrounding my mother’s death.”
Mrs Baxter, from Loanhead, Midlothian, was described as "the life and soul of the party” before her death.
Multiple organ failure was listed as directly leading to her death, but the sacrocolopexy mesh repair was listed as an underlying cause.
The implants are medical devices used by surgeons to treat pelvic organ prolapse and incontinence in women.
The mesh, usually made from synthetic polypropylene, is used to repair damaged or weakened tissue.
More than 20,000 women in Scotland have had the implants over the past 20 years, but some have suffered painful and debilitating complications.
An investigation into Mrs Baxter’s death is being carried out by associate medical and nurse directors at NHS Lothian.
The Baxter family agreed a list of questions for the health board to answer.
Mr Baxter added: “It looks like the pharmaceutical companies never provided enough information.”
https://www.heraldscotland.com/news/17271359.family-want-answers-as-mesh-cited-in-mothers-death/
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Heartbroken family of mesh implant gran demand answers over her shock death
Dec 2, 2018 | Scottish Daily Record
By Sarah Ward
The family of the first woman in Scotland to have 'mesh implant' listed as an underlying cause of death are demanding answers from the NHS.
Great-grandmother Eileen Baxter, 75, died in August from multiple organ failure at the Royal Infirmary of Edinburgh.
She had been fitted with sacrocolopexy mesh repair - an implant to fix a pelvic organ prolapse five years earlier, but a week before her death suffered internal bleeding, sickness and diarrhoea.
Eileen's grieving children, Mark and Audrey Baxter, have met with senior politicians to discuss the circumstances surrounding their mother's death.
It led to the Scottish Government announcing a halt in the use of transvaginal mesh, with only a limited number of operations to be considered for women already on the waiting list.
Mark said: "The one question I did ask, which I thought was relevant, is there's a bacteria that comes from this mesh.
"The surgeon has said that there was a lot of bacteria in my mum's body, so I'm specifically looking for them to tell me where this bacteria came from.
"I know that the bacteria that comes from the mesh can break down the immune system and then the body can't cope with any antibiotics.
"So I'm still waiting on answers to the questions I have surrounding my mother's death."
Eileen, from Loanhead, Midlothian, was described as "the life and soul of the party" before her death.
Multiple organ failure was listed as directly leading to her death, but the sacrocolopexy mesh repair was listed as an underlying cause.
The implants are medical devices used by surgeons to treat pelvic organ prolapse and incontinence in women.
The mesh, usually made from synthetic polypropylene, is used to repair damaged or weakened tissue.
More than 20,000 women in Scotland have had the implants over the past 20 years, but some have suffered painful and debilitating complications.
An investigation into Eileen's death is being carried out by associate medical and nurse directors at NHS Lothian.
As part of this process, the Baxter family agreed a list of questions which the health board say they will endeavour to answer.
Mark added: "The way things are going it looks like the pharmaceutical companies never provided enough information.
"There's been a lack of transparency and communication between the companies that make the mesh, the NHS and the governments."
Dr Catherine Calderwood, the chief medical officer for Scotland, has again written to the Medicines and Healthcare products Regulatory Agency (MHRA) to seek assurances that the safety of mesh products has been properly tested.
In the letter to the MHRA, Dr Calderwood said: "I remain concerned about a number of issues, in particular in relation to mesh implants, where I do not yet feel the MHRA has satisfactorily evidenced the safety of these products."
https://www.dailyrecord.co.uk/news/scottish-news/heartbroken-family-mesh-implant-gran-13676285
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Grieving family demand answers over great-grandmother’s mesh death
Dec 1, 2018 | The Scotsman
By Kevan Christie
A grieving son whose mother was the first person in Scotland to have mesh implant surgery listed as an underlying cause of death is demanding answers from the regulator who approved the product.
Great-grandmother Eileen Baxter died in August from multiple organ failure after being admitted to hospital with internal bleeding, sickness and diarrhoea a week earlier.
The 75-year-old previously underwent sacrocolopexy mesh repair – an implant to fix a pelvic organ prolapse.
Her son Mark Baxter, from Loanhead in Midlothian, and his sister Audrey have met health secretary Jeane Freeman to discuss their mother’s death and the implications of the wider use of mesh.
This led to the Scottish Government announcing a halt in the use of transvaginal mesh, with only a limited number of operations to be considered for women already on the waiting list.
Dr Catherine Calderwood, the chief medical officer for Scotland, has again written to the Medicines and Healthcare products Regulatory Agency (MHRA) to seek assurances the safety of mesh products has been properly tested.
An investigation into Eileen Baxter’s death is being carried out by associate medical and nurse directors at NHS Lothian. As part of this process, the Baxter family agreed a list of questions which the health board say they will endeavour to answer.
Mark Baxter said: “The one question I did ask, which I thought was relevant, is there’s a bacteria that comes from this mesh. The surgeon has said that there was a lot of bacteria in my mum’s body, so I’m specifically looking for them to tell me where this bacteria came from.
“I know that the bacteria that comes from the mesh can break down the immune system and then the body can’t cope with any antibiotics. So I’m still waiting on answers to the questions I have surrounding my mother’s death.”
Baxter welcomed the decision taken by the Scottish Government to pursue the MHRA for answers regarding the thoroughness of the regulation of the mesh devices on the back of an article published in the British Medical Journal in October.
He said: “The way things are going it looks like the pharmaceutical companies never provided enough information. “There’s been a lack of transparency and communication between the companies that make the mesh, the NHS and the governments.”
In the letter to the MHRA, Calderwood said: “I remain concerned about a number of issues, in particular in relation to mesh implants, where I do not yet feel the MHRA has satisfactorily evidenced the safety of these products.”
https://www.scotsman.com/news/grieving-family-demand-answers-over-great-grandmother-s-mesh-death-1-4837926
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Eastbourne mum’s ‘horrific pain’ leads to campaign and desperate plea
Nov 30, 2018 | Eastbourne Herald
By Juliet Mead
An Eastbourne mum who has been campaigning to Sling the Mesh has set up a Go Fund Me page for the cause. Kate Langley, along with more than 7,000 other women had vaginal mesh fitted after suffering from mild bladder weakness following the birth of her two children.
Unfortunately the mesh has caused her horrific pain and she has been campaigning ever since.
She said, “I have become so desperate for help that I have decided to ask my friends, family and even people who don’t know me for help.
“This has been a difficult decision to ask but I can no longer bear the daily pain that I suffer with.”
The campaign against the mesh, know as TVT, started a few years ago and has received a large amount of media attention in a bid to raise awareness and encourage the government to stop this operation.
Kate added, “Amazingly in July 2018 after our campaigning the operation has currently been suspended which is amazing but we are now desperate for a permanent ban to end anymore horrific suffering.”
Kate’s nightmare started in 2012 when she had the TVT inserted. She said, “Little did I know this decision was to alter my future life drastically. “
Since having the procedure, she has endured more than 50 hospital admissions suffering agonising pain.
She says the mesh has become ‘hardened and sharp like a cheese wire’. It has cut through her vagina, urethra, oburator nerve and bladder.
She said, “I’ve had to call more ambulances than I can remember due to collapsing in agony, suffering with childbirth like contraction pain needing IV morphine.”
Kate, having already undergone three removal operations, needs further surgery to give her a pain-free future. Visit www.gofundme.com/kate-langley039s-barbaric-mesh-mess to help.
https://www.eastbourneherald.co.uk/news/eastbourne-mum-s-horrific-pain-leads-to-campaign-and-desperate-plea-1-8724338
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Pelvic Mesh Trial Lawyer Slams MDL Settlements as 'Puny,' Opposing Leadership's Fee Petition
Nov 30, 2018 | Law.com
By Max Mitchell
As the pelvic mesh MDL has begun to settle, attorneys on the leadership committee have asked the federal court overseeing the litigation’s massive inventory to set aside 5 percent of the awards for common benefit fees and expenses. With the settlements already topping $7 billion, that means more than $360 million is set to distributed among the firms.
However, at least two firms are opposing the request, with one saying the hold-back amount is far too much.
On Monday, attorneys with Philadelphia-based Kline & Specter filed a response opposing the 5 percent set-aside request. The highly critical filing contends that the federal cases have settled for “puny” amounts compared to the multimillion-dollar verdicts juries have been willing to award both in state and federal courts.
“The leaders in this litigation did the worst possible thing to the detriment of all plaintiff mesh victims and their attorneys: they settled their inventories way too cheaply, making it difficult for other attorneys to settle their cases reasonably,” attorney Shanin Specter said in the filing.
According to the filing, the average award for the tens of thousands of cases that have settled is about $40,000, while the average award for the cases that have gone to trial is about $9.8 million.
Specter’s firm took a leading role in several pelvic mesh cases that were tried in Philadelphia state court, including winning a $57 million verdict last year.
In the filing, Specter suggests that the set-aside amount be halved from the leadership committee’s request.
The firm’s filing also faults the leadership team with taking too many cases to effectively handle, saying the “discounted settlements were driven by the sheer enormity of the number of claims” and the “inability” of the lawyers to fully work up their inventories.
“It’s been an open secret in this litigation that the ‘leadership’ took too many cases to effectively litigate themselves. By doing so and by not associating other lawyers to help discover and try their cases, they were forced to settle,” Specter said in the filing. “This wasn’t bad for ‘leadership’ because a large number of small fees on small settlements is still a large number. But it mistreated the women they represent. And it mistreated the other plaintiff’s counsel who were stuck behind this low bar set by the leadership.”
Andrus Wagstaff in Colorado also filed a notice of intent to oppose the petition for the 5 percent set aside. The notice did not outline the crux of the firm’s objection, but the notice did say that it hired Blank Rome attorney Andrew Williamson to represent the firm in the dispute.
Georgia attorney Henry Garrard of Blasingame, Burch, Garrard & Ashley, who is chairman of the fee and compensation committee, said he plans to file a response Monday, and declined to comment further, other than saying, “There is a lot to the story that’s not in their objection.”
The pelvic mesh MDL consists of seven separate consolidated litigations against some of the largest medical product manufacturers in the country. According to federal records, the litigation topped out at nearly 107,000 claims, and, as of Nov. 15, the seven consolidated litigations have an inventory of 37,299.
On Nov. 12, Garrard filed the petition requesting the 5 percent award. According to the petition, 94 law firms submitted more than 900,000 hours of time, and the committee has recognized nearly 680,000 of those hours as contributing toward the litigation’s common benefit.
The petition also noted that the current value of the settlements is roughly $7.25 billion, and the total amount for settlements is expected to be around $11 billion. With the requested 5 percent set aside, that would make the total amount expected for the common benefit fund to reach $550 million.
The response from Kline & Specter, however, said the MDL leadership failed to secure a global settlement, and that the petition largely ignores the work done in the state court litigation that benefited the federal MDL, such as obtaining the verdicts, which, the filing said, weakened the defendants’ position and drove settlements.
“Given the paltry recoveries for the injured women in this successful-in-the-courtroom, surrender-at-the-settlement-table mass tort, it is more equitable for the common benefit fee to be half of the requested amount and to remit their proportionate share of these saved funds to the injured women,” Specter said in the filing.
Neither Williamson nor Aimee Wagstaff of Andrus Wagstaff returned a message seeking comment Friday.
https://www.law.com/thelegalintelligencer/2018/11/30/pelvic-mesh-trial-lawyer-slams-mdl-settlements-as-puny-opposing-leaderships-fee-petition/
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Hernia mesh concerns grow among men as more patients report surgery complications
Dec 1, 2018 | ABC News.au
By Alison Branley
Marc Russell has spent his life travelling the globe to surf some of the world's biggest breaks and ride his motorbike through the most breathtaking landscapes.
But today the 42-year-old adventurer spends much of his time bedridden and needs a cane to get around.
All it took to ground this wandering spirit was a jammed truck door.
"I gave it my all and ended up popping a groin hernia," he said.
Mr Russell was told he would need day surgery and would be able to return to work after a month.
But a year later and after being seen by more than 30 specialists, he lives in constant pain.
During the surgery doctors used surgical mesh to repair his hernia. Mr Russell said the product had left him crippled.
It is a similar product to those used in women to treat pelvic prolapses, which was the subject of a Senate inquiry and a national apology.
Mr Russell has had to give up his job, and it has affected his sexual function and his relationships.
"I feel like I'm failing as a father, I don't feel I'm the role model that I should be," he said.
The Melbourne man is one of a growing number of men who have come forward with complications from mesh used in hernia surgeries.
It comes after well-publicised problems with the use of surgical mesh and slings used to treat pelvic prolapse and incontinence in women.
In those cases, mesh was initially approved for use because of a belief in the medical community that the material had been successfully used for many years to treat hernias.
But Mr Russell estimates he has been in contact with up to 1,000 Australians who have suffered complications from having the product in hernia surgery.
He runs a Facebook group to support those who have been affected.
"Politicians, the medical fraternity — just need to wake up and realise this is real," Mr Russell said. "The TGA [Therapeutic Goods Administration] really need to step up their game."
Many men in pain are putting up with 'new normal'
Mr Russell's experience has been backed by the Health Issues Centre in Victoria, which has launched a national survey of patients' experiences with medical devices.
It comes after the ABC partnered with the International Consortium of Investigative Journalists (ICIJ) to expose a series of flaws in the way medical devices are regulated in Australia and overseas.
Health Issues Centre chief executive Danny Vadasz said they had been contacted by more than 140 patients in less than two weeks and already clear patterns had emerged.
More than half of those who had been in touch had concerns with the use of mesh in hernia, bowel or general surgery.
And while women can also have hernias, Mr Vadasz said many of those getting in touch were men.
"There is a lot of men who've been suffering low to moderate pain since their hernia repair work who simply put up with a new normal in their lives," he said.
Associate Professor Nabeel Ibrahim runs the Hernia Institute of Australia, a clinic specialising in hernias.
He said in many cases mesh drastically reduced the chances of hernias returning, whereas in the past other surgical techniques often failed.
"Australia-wide, we carry out, in the groin, approximately 50,000 [operations] a year. We hear only of a small number of unfortunate incidences," he said.
"The big picture is a positive picture."
But he said there had been problems with some polypropylene mesh products, with slow-growing infections a real risk associated with some procedures.
He also pointed to overdiagnosis and treatment of hernias as a contributing problem, saying many were not life-threatening and did not always require surgery.
"In most cases of hernia complications we really have to consider possible technical factors, diagnostic factors and maybe also patient factors," he added.'I've lost another relationship because of this issue'
To date, many of the complaints about medical devices have been from women — about breast implants, transvaginal mesh and contraceptive implants.
Following the ABC and ICIJ investigation, the ABC has been contacted by a number of men who have had serious complications from devices.
Another patient struggling after his surgery is Perth man Alan Brown.
He got a penile implant after having his prostate removed due to aggressive cancer. But he says he now regrets that.
The 64-year-old said it would have been easier to deal with radical cancer treatment, than the side effects of losing his prostate.
The father-of-two experienced impotence after the initial cancer surgery.
"After losing a couple of relationships I thought [the device] was a good idea," he explained.
But the product had given him mild incontinence and extreme pain during ejaculations.
"I spoke to the my urologist and he just kept saying, 'Take two Panadol'. Lately I've lost another relationship because of this issue," he said.
Mr Brown said, in hindsight, he would not have agreed to get the device.
"I think as men we tend not to talk about it, but I think it's time we did," he said.
Sydney man Robert Bosetti has been left totally incontinent from a device that has failed.
The former electrician had prostate cancer four years ago and was left with mild incontinence.
After his initial treatment failed, his specialist recommended something called an "artificial sphincter". It's a device that allows patients to manually control their urination.
But Mr Bosetti said he had problems from the start.
"I ended up going to the emergency department," he said.
The 67-year-old is now completely incontinent and has been advised to have a second device, but he has lost faith in the medical community.
"I believe their gadget failed," he said. "I feel like they're experimenting, if it doesn't work they do another one and I'm the guinea pig."
In a statement, the makers of the device, Boston Scientific, said the technology around its product had been available for 46 years.
"It is unfortunate that this patient had a negative experience. A recent study of more than 27,000 men who received the device showed that the device significantly and positively impacted quality of life," it said.TGA maintains it approves and monitors all devices
Other areas of concern the Health Issues Centre survey has already identified include joint replacements, contraceptive implants and devices used in obesity surgery.
"This is indicative of a significant failure in the quality and safety system," Mr Vadasz said.
"In particular the TGA and its low barrier to allow devices into the market."
The Therapeutic Goods Administration announced earlier this week all surgical mesh products had been reclassified to the highest risk category for devices.
This will make it harder for new products to get on the market, and once on shelves they would have to be more closely monitored.
The regulator maintains it approves and monitors all devices based on the potential risk versus benefit of the product.
"We do assess the clinical data, including clinical safety, on our medium and high risk devices," the TGA's deputy secretary Professor John Skerritt said.
Mr Vadasz said it did not mean everyone with mesh or a medical device should be concerned.
"We're not saying implants generally are bad, but we can't ignore the fact that in some circumstances they fail and that can be catastrophic."
https://www.abc.net.au/news/2018-12-02/hernia-mesh-concerns-grow-among-men-surgery-complications/10570182
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