Preview Newsletter
Ethicon Media Monitoring 3/11/2019
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A first step… Sufferers applaud the Health Secretary after she paves way to bring US mesh surgeon to Scotland
Mar 10, 2019 | The Sunday Post
By Marion Scott
Health Secretary Jeane Freeman has paved the way for a top US surgeon to come to Scotland to carry out pioneering mesh removal operations. -
Health Secretary ‘convinced’ mesh ban was correct decision
Mar 8, 2019 | Press Association (In the Sunday Post)
A ban on mesh implants will not be lifted until there is a “high vigilance, restricted-use” protocol put in place, Health Secretary Jeane Freeman has said. -
Mesh victims will be given more help, Health Secretary says
Mar 9, 2019 | The National
By Jane Cassidy
Work will be carried out to consider how care can be improved for women who have experienced complications after vaginal mesh surgery, Health Secretary Jeane Freeman has announced. -
Leading manufacturer exits vaginal mesh market
Mar 8, 2019 | ICIJ
By Simon Bowers
One of the biggest manufacturers of vaginal mesh implants, C.R. Bard, is ending all production and marketing of the controversial products after years of campaigning by women around the world. -
Bard Mesh Implants Pulled from UK
Mar 8, 2019 | Mesh Medical Device News Desk
By Jane Akre
The mesh manufacturer, C.R. Bard will no market it polypropylene (PP) mesh implants in the United Kingdom according to the government. -
Bard pulls mesh implants from EU
Mar 8, 2019 | MedTech Dive
By Nick Paul Taylor
BD subsidiary C.R. Bard is permanently withdrawing its urogynaecological mesh devices for stress urinary incontinence and pelvic organ prolapse from the European market, the Medicines and Healthcare products Regulatory Agency communicated Thursday. -
Joan Isaacs gave evidence against the Catholic Church while struggling after pelvic mesh surgery
Mar 11, 2019 | Newcastle Herald
By Joanne McCarthy
A Catholic Church child sexual abuse survivor who prayed for death to relieve extreme pain after pelvic mesh surgery has accused key elements of Australia's health system of acting like the church over the mesh scandal. -
OPINION: We accept product failure in our health system that we wouldn't consider in cars or food, says consumer advocate
Mar 9, 2019 | Newcastle Herald
By Danny Vadasz
The car and food industries understand that. Remember when we used to hear of cars described as "lemons". Those of you who have grown up under the post 1960s Toyota Total Quality Control (TQC) System may not be familiar with the concept of a congenitally flawed vehicle, but you will be familiar with what happens today when something does go wrong. Recalls. Publicity. Public acknowledgment of problems. -
‘Action needed‘ over problems of mesh surgery
Mar 9, 2019 | Wilcox Guardian
By Jen Stanley
A young woman who has suffered health problems since having mesh surgery said “something needs to be done”. -
J&J Wants Philly Judge Booted From Further Mesh Trials
Mar 8, 2019 | Law 360
By Jeannie O'Sullivan
A Johnson & Johnson unit on Thursday urged the lead judge of Philadelphia County's complex litigation center to keep his fellow jurist from presiding over any further pelvic mesh trials against the company because of that judge's mother's pending case against the company over a different J&J product. -
State Supreme Court hears mesh case
Mar 8, 2019 | Missouri Lawyers Media
By Jessica Shumaker
A woman who is believed to be the first nationally to bring claims against two makers of transvaginal-mesh devices in one trial is asking the Missouri Supreme Court to rule for the first time that a corporation may be impeached for prior convictions. -
What is pelvic organ prolapse?
Mar 10, 2019 | SCNow
By Vincent S. Scott
Pelvic prolapse occurs when the pelvis loses its support structure due to damage.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
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Mar 10, 2019 | The Sunday Post
By Marion Scott
Health Secretary Jeane Freeman has paved the way for a top US surgeon to come to Scotland to carry out pioneering mesh removal operations.
The decision came after an emotionally charged meeting between mesh implant victims and Ms Freeman at the Scottish Parliament last Tuesday.
The move means that US surgeon Dr Dionysios Veronikis, who has developed his own highly successful mesh implant removal procedures, should now be able to come here to carry out operations and train medical staff. Last night the apparent change of heart was welcomed by campaigners and victims.
Immediately before their meeting with the Health Secretary, in a debate in the Scottish Parliament, Ms Freeman had insisted that Scottish surgeons have the required skills to carry out removal operations.
She told MSPs: “Let me repeat: full mesh removal is available in Scotland.”
She then met with mesh victims Claire Daisley, 49 and Lorna Farrell, 53, both of whom are in wheelchairs, along with Karen Neil, 52 and Susan Doyle, 54, who told her they had lost all trust in Scottish surgeons after suffering crippling injuries from mesh implants, and attempts to remove them.
Also present at the meeting was Belfast law lecturer Mary McLaughlin, 55, who told how she went from being virtually bedridden for three years after a mesh implant, to being able to walk without pain just eight weeks after Dr Veronikis removed the device.
During the meeting Ms Freeman looked taken aback as she saw face-to-face the raw emotion and frustration of the women who have fought for seven years to have their voices heard.
Ms Daisley said she told Ms Freeman: “Mesh left me in terrible pain. But after so-called experts here tried to take it out, I’ve been left in even more pain, and now I’m about to lose my bladder and bowel and I’m stuck in a wheelchair too.
“That’s what Scottish surgeons did to me and far too many other women who are now in the same boat.”
Meanwhile, Ms Farrell said she had wept with anger as she challenged Ms Freeman over continuing to listen first to the same surgeons who had implanted mesh.
Three days later, on Friday, Ms Freeman chose International Women’s Day to announce a change of approach.
She said: “Following this week’s debate at the Scottish Parliament I have listened carefully to the views of women who have been affected by complications. I had the opportunity to meet some of them in person after the debate and I found what they told me deeply moving.
“This sub-group will look at a range of options to see how the care and support for these women can be improved. Where reasonable, I want them to ensure that women have some choice regarding the place of treatment and the clinicians involved.
“Senior health board medical managers, academic and European advisers, and advocates for the affected women will all contribute to this work. The first meeting will be held as soon as is practicable and I will write to campaigners within a month to set out the probable timescales.”
The announcement was applauded by victims who say Freeman must move quickly as too many lives have already been lost and destroyed.
Karen Neil, 52, from Clydebank, said: “We don’t have time for more years of committees and arguing. We need surgical attention right now.
“Every one of us are not only living with excruciating pain, we are living with the constant reality that any one of the constant infections that dog our lives could turn into deadly sepsis. We have already lost too many women to this scandal.
“We are relieved and delighted Jeane Freeman finally heard our voices and did the right thing. The best thing she can do now is get Dr Veronikis here as quickly as possible.”
Consultant urogynaecologist Wael Agur said: “This is an extremely positive move for Scotland.”
Labour’s Neil Findlay said: “For seven years Scottish mesh survivors fought to protect other women around the world, knowing none of their campaign would benefit them. This is the first time they have asked for help themselves, I’m heartened their request may become a reality.”
Chris Harding, of the British Association of Urological Surgeons, said: “I am pleased to hear of the Scottish government’s decision regarding engagement with overseas surgeons for mesh removal.
“We have extremely skilled surgeons in Scotland and the rest of the UK but the experience some overseas experts can bring will help us develop our mesh removal skills even further.”
Former Health Secretary Alex Neil, who is still calling for Scotland to host a global mesh conference to discuss a worldwide strategy, said: “I welcome the action by the Scottish government.”
https://www.sundaypost.com/fp/a-first-step-sufferers-applaud-the-health-secretary-after-she-paves-way-to-bring-us-surgeon-to-scotland/
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Health Secretary ‘convinced’ mesh ban was correct decision
Mar 8, 2019 | Press Association (In the Sunday Post)
A ban on mesh implants will not be lifted until there is a “high vigilance, restricted-use” protocol put in place, Health Secretary Jeane Freeman has said.
Health boards in Scotland were ordered to immediately halt the use of vaginal mesh implants in September, with thousands of women having received the treatment.
Many women say they have suffered painful and debilitating health complications as a result of the procedure.
The use of mesh was suspended in all but “extraordinary circumstances” in Scotland in 2014.
The Scottish Government said a sub-group of medical directors and senior clinical managers will be asked to consider a range of measures to help improve care for women who have received a mesh implant.
Ms Freeman said: “Last September, I announced a complete halt to all transvaginal mesh procedures and that will only be lifted when I am satisfied that a high vigilance, restricted-use protocol has been fully implemented.
“I remain convinced that was the right decision but it is also important that we do everything possible for the women who have suffered injury as a result of complications from procedures already carried out.
“Following this week’s debate at the Scottish Parliament, I have listened carefully to the views of women who have been affected by complications.
“I had the opportunity to meet some of them in person after the debate and I found what they told me of their experience deeply moving.”
She added: “This sub-group will look at a range of options to see how the care and support for these women can be improved.
“In particular, and where reasonable, I want them to ensure that women have some choice regarding the place of treatment and the clinicians involved.
“Senior health board medical managers, academic and European advisers, and advocates for the affected women will all contribute to this work.
“The first meeting will be held as soon as is practicable and I will write to campaigners within a month to set out the probable timescales.”
Among the group’s considerations will be the sharing of experience and techniques from Europe and the US, and examining education and training requirements.
The Scottish Government said a meeting with a representative group of campaigners will be arranged to seek their views on service development.
Scottish Conservative interim leader Jackson Carlaw said he welcomed the announcement from the Health Secretary.
“This is a step forward for women in Scotland seeking full mesh removal and is a great result for campaigners – Elaine Holmes, Olive McIlroy and Marion Scott,” he said.
“This announcement opens the door to more clinical working with mesh experts in other parts of the world.
“This battle has been a protracted one but this does look like a victory.
“I now very much hope that the SNP Government will stick to their word and give mesh survivors these much-needed options.”
https://www.sundaypost.com/news/uk-news/health-secretary-convinced-mesh-ban-was-correct-decision/
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Mesh victims will be given more help, Health Secretary says
Mar 9, 2019 | The National
By Jane Cassidy
Work will be carried out to consider how care can be improved for women who have experienced complications after vaginal mesh surgery, Health Secretary Jeane Freeman has announced.
A sub-group of the medical directors and senior clinical managers accountable for this work will be asked to look at a number of issues, including the sharing of experience, techniques and learning from within Europe and the USA and how best to identify what needs to be done to provide the service patients require.
A meeting with campaigners will be held in order to seek their views on service development.
Freeman said: “Following this week’s debate at the Scottish Parliament, I have listened carefully to the views of women who have been affected by complications.
“I had the opportunity to meet some of them in person after the debate and I found what they told me deeply moving.
“This sub-group will look at a range of options to see how the care and support for these women can be improved. In particular, and where reasonable, I want them to ensure that women have some choice regarding the place of treatment and the clinicians involved.
“The first meeting will be held as soon as is practicable and I will write to campaigners within a month to set out the probable timescales.”
https://www.thenational.scot/news/17488375.mesh-victims-will-be-given-more-help-health-secretary-says/
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Leading manufacturer exits vaginal mesh market
Mar 8, 2019 | ICIJ
By Simon Bowers
One of the biggest manufacturers of vaginal mesh implants, C.R. Bard, is ending all production and marketing of the controversial products after years of campaigning by women around the world.
Campaigners applauded the decision but queried why it had not been made sooner. Bard halted the use of certain mesh products in the United States almost seven years ago amid concerns raised by women and regulators.
Since then, Bard has paid out hundreds of millions of dollars in settlements and damages in the U.S. to women who said they were harmed by mesh. At the same time, the company continued selling mesh outside the U.S., where different laws meant the threat of costly lawsuits was lower.
Bard’s decision to shut down its remaining mesh business comes three months after the International Consortium of Investigative Journalists’ Implant Files investigation revealed how light-touch regulation has made Europe a honeypot for firms marketing little-tested medical devices.
Despite widespread warnings about the safety of mesh, Bard’s parent company Becton Dickinson insisted its decision to exit all markets was “a business decision and not a safety concern,” as was the partial retreat from the U.S. in 2012.
In a statement to ICIJ, a spokesman for Becton Dickinson said: “Yesterday [March 7], BD announced our decision to discontinue the manufacture and sale of [vaginal mesh] products in all remaining markets worldwide, so we no longer sell these products in any market.”
He added: “While thousands of women over many years have benefited from the safe use of these products, we have decided to stop production … to focus on other strategic priorities.”
For years, campaign groups in Europe and elsewhere have raised concerns about the safety of vaginal mesh, which is used as a treatment for urinary incontinence or organ prolapse. Mesh products were marketed as a less invasive alternative to surgery.
Campaigners point out that mesh has left large numbers of women with chronic pain and other debilitating symptoms.
Kath Sansom, founder of U.K.-based campaign group Sling The Mesh, said: “The decision is being celebrated by campaigners but the news is tinged with sadness, knowing how many healthy women have had their lives shattered, all because they trusted they were having a simple fix.”
In 2011, the U.S. Food and Drug Administration issued a report saying that patient harm caused by mesh was “not rare.” In January the following year, it ordered several leading manufacturers, including Bard, to carry out new studies because it was “concerned with the potential safety risks.”
Instead of carrying out those studies, Bard withdrew its Avaulta mesh from the U.S. market. At the time, almost 90 percent of mesh manufacturersdiscontinued their products in the U.S. or changed the product’s indication.
Bard and other manufacturers who chose in 2012 to withdraw products in the U.S. continued to market them in Europe and elsewhere.
Carl Heneghan, professor of evidence-based medicine at Oxford University in the U.K., said: “Failing products and an unwillingness to develop evidence of safety underpins the vast majority of medical device withdrawals.” He predicted other manufacturers are likely to follow Bard’s lead and withdraw from mesh products.
Heneghan said that growing safety concerns around mesh meant governments should require doctors to follow up with all women with these devices.
Kate Kristmundsson, from Lolland in Denmark, was implanted with Bard mesh product Avaulta Plus in February 2012 and since then has been in pain every day. She told ICIJ’s Danish media partners DR that she had complained to Bard, but the company refused to help, partly because she had not sent them the mesh, some of which was still in her body.
Asked about Bard’s decision to continue marketing mesh outside the U.S. after 2012, Kristmundsson said: “I can’t believe it. I simply do not understand why there is no one who could have stopped it. It’s deeply shocking.”
A Becton Dickinson spokesman said: “Business decisions can vary region to region depending on current market conditions in that region. This can result in a company deciding to introduce and/or discontinue products at different times in different regions of the world.”
The Implant Files was a collaborative investigation involving more than 250 journalists at different media organizations around the world.
It was inspired by Dutch journalist Jet Schouten. In 2014, using secret filming, Schouten set out to prove how easy it was to get a license to market a medical device in Europe. She took the plastic net packaging from mandarin oranges and attempted to pass it off as surgical-grade mesh.
To accompany the plastic netting, Schouten produced a bogus technical file, full of deliberate design flaws. With documentary-making colleagues from Avotros, she then filmed certification firms, known as notified bodies, discussing her work. None of them spotted any concerns.
https://www.icij.org/investigations/implant-files/leading-manufacturer-exits-vaginal-mesh-market/
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Bard Mesh Implants Pulled from UK
Mar 8, 2019 | Mesh Medical Device News Desk
By Jane Akre
The mesh manufacturer, C.R. Bard will no market it polypropylene (PP) mesh implants in the United Kingdom according to the government.
At one time it was a leading manufacturer of pelvic floor and incontinence mesh in the world.
The announcement was made Thursday (here) – All pelvic mesh made by C.R. Bard will be pulled from the United Kingdom, according to a medical device alert issued by the government.
The Guardian has more here. Sky News has more here.
The UK regulatory agency MHRA (Medicines and Healthcare products Regulatory Agency) said in a statement:
“Bard has taken the decision to stop production of these devices as part of its business strategy. They are stopping production rather than continuing to invest in clinical data to support additional EU requirements. Therefore, implanted devices don’t need to be removed.”
Polypropylene mesh is used to support the pelvic floor or the urethra to treat incontinence. Bard PP mesh has been the subject of more than 15,500 defective product lawsuits in the U.S. and thousands more around the globe.
At one time, Bard was facing the fourth largest number of product liability trials, behind Ethicon (Johnson & Johnson), Boston Scientific, and AMS. Altogether consolidated cases amounted to more than 104,000 U.S. lawsuits.
Bard removed its pelvic meshes from the U.S. market in June 2012 after being ordered by the FDA to undergo post-approval marketing studies for three years on mesh-implanted women. By removing the products, the FDA relieved the company of monitoring the health of women who had been implanted.
ANTI-MESH CAMPAIGNERS
The head of an anti-mesh group in Britain, Kath Sansom, of Sling the Mesh, says most pelvic organ prolapse mesh (POP) made in the UK is made by Bard.
Sansom tells Mesh News Desk that the group is delighted that hospitals across Great Britain must clear its shelves of Bard urogynaecological [sic] mesh products.
“This is huge news for campaigners and means until further notice, no women’s pelvic mesh operations are allowed in this country.
“It is also tinged with sadness because this operation has destroyed hundreds of women’s lives. Every day we see women struggling to cope with excruciating pain, some suicidal, 7/10 have lost their sex lives and many report failing marriages. For those with children at home, it affects them terribly. Some children end up having to be caretakers.”
“The J&J alternative is a Prolene mesh that has to be cut to fit, unlike the Bard pexy prolapse mesh kits.”
She cites the Baroness Cumberlege, who led a UK-wide safety review in July 2018, with the move. Cumberlege insists conditions for safety need to be met before the use of pelvic mesh can be considered safe.
Those conditions include insisting that surgeries be conducted by surgeons who are appropriately trained and only if they do them regularly. The review also recommends the creation of a registry to track any complications.
Scotland suspended the use of mesh for stress incontinence in 2014. Mesh complications include erosion, chronic infection and pain, mesh shrinkage, and autoimmune issues, among other problems.
MORE ON BARD
C.R. Bard, located in Murray Hill, New Jersey, was purchased by Becton Dickson (BD) in April 2017 for $24 billion.
C.R. Bard faced its first bellwether case in Charleston, WV in August 2013 in the Cisson trial. MND was there, the story is here.
At one time from its Covington, Georgia plant Bard made:
Avaulta Plus™ BioSynthetic Support System for POP ( Pelvic organ prolapse)
Avaulta Solo™ Synthetic Support System for POP
Faslata® Allograft – human graft tissue
Pelvicol® Tissue for SUI (stress urinary incontinence)
PelviSoft® Biomesh for SUI
Pelvitex™ Polypropylene Mesh for SUI
In August 2015, Bard agreed to settle 3,000 pelvic mesh cases for $200 million. In 2014, Bard agreed to a $21 million settlement to resolve 500 defective product lawsuits.
Bard (BD) continues to make hernia mesh including 3D Light Mesh, 3D Mesh, Bard Mesh for ventral or inguinal hernia repair, Bard Mesh Pre-shaped for hernia repair, and large pore Bard Soft Mesh.
SLING THE MESH
The online group, Sling the Mesh was formed in June 2015 and now has more than 7,300 members. It is the largest single support group for mesh injured. U.S. campaigners tend to form individual groups on Facebook so it is difficult to get a handle in the U.S. on the actual number of mesh-injured.
Sansom says in a statement, “It is disappointing that the Government do not think women with Bard mesh implanted need to be recalled or have this product removed. We also question why Bard does not want to carry out additional clinical trials required under EU regulations.”
One member of Sling the Mesh said “Bard nearly killed me two years ago. I lost ¾ of my bowel and I’m still suffering.”
The MHRA stopped short of any condemnation of the products saying, “It’s important to note, there are no specific safety concerns associated with this recall and there is no need for people to have the device removed or have any extra follow-up checks.”
Government guidelines under NICE (National Institute for Health and Care Excellence) should be released next month. In December 2017 it recommended vaginal prolapse mesh surgery be banned.
The mesh community believes mesh to be used only as a very last resort when other non-mesh surgical options have been tried.
MP Owen Smith chairs the All Party Parliamentary Group into mesh. He led a debate in the House of Commons last month where he said that toasters and plugs get tougher checks than medical implants. Smith wants National Registries and tougher regulations for all medical implants.
The debates in Parliament can be seen here.
POP mesh was first used in the UK in 2002. Incontinence mesh (slings) use began in 1997, one year before the U.S.
With this announcement prolapse mesh kit use ends in Great Britain.
Incontinence mesh was suspended in the UK in July of last year pending a UK wide safety review led by Baroness Julia Cumberlege.
https://www.meshmedicaldevicenewsdesk.com/bard-mesh-implants-pulled-from-uk/
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Bard pulls mesh implants from EU
Mar 8, 2019 | MedTech Dive
By Nick Paul Taylor
Dive Brief:
BD subsidiary C.R. Bard is permanently withdrawing its urogynaecological mesh devices for stress urinary incontinence and pelvic organ prolapse from the European market, the Medicines and Healthcare products Regulatory Agency communicated Thursday.
The company framed the action as a response to the need to invest in clinical data to keep the products on the market once Europe's new device rules comes into force next year.
Mesh implants have been the subject of lawsuits, regulatory scrutiny and investigations around the world in recent years amid reports of adverse events.
Dive Insight:
Reports of adverse events linked to mesh implants, and accusations that doctors and regulators were slow to respond have led to calls for more medical device oversight, including an ongoing U.K. probe into whether "systemic failures" occurred. These probes have restricted use of mesh implants, shrinking the market opportunity.
While the company maintains that its devices are safe, a confluence of factors means they are no longer attractive economically.
"We have decided to stop production of these devices to focus on other strategic priorities rather than continue to invest in clinical data to support additional EU requirements," BD said in a statement shared with Sky News.
Under the old and incoming legislation, the European Union treats most implantable and long-term surgically invasive devices as Class IIb products. The key difference, from Bard's perspective, is that the incoming legislation specifically singles out surgical meshes as an exception to the rule. Under the rules that will come into force next year, surgical meshes are Class III devices.
That change, which has been mirrored by Australian authorities, and other aspects of the legislation mean developers of mesh devices will need to perform clinical investigations unless they meet the criteria for exemption. Implantable and Class III devices already on the EU market need “sufficient clinical data” to be exempt from the requirements.
In the U.S., FDA is currently reviewing PMA applications for pelvic organ prolapse mesh products from Boston Scientific and Coloplast, the only two companies seeking to stay in a market that has become more strictly regulated in recent years.
Bard expects to complete the withdrawal within two weeks but it will take longer than that to fully extricate itself from the legacy of its mesh business. As of the end of September, BD was defending more than 1,300 product liability claims involving Bard's line of pelvic mesh devices.
https://www.medtechdive.com/news/bard-pulls-mesh-implants-from-eu/550061/
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Joan Isaacs gave evidence against the Catholic Church while struggling after pelvic mesh surgery
Mar 11, 2019 | Newcastle Herald
By Joanne McCarthy
A Catholic Church child sexual abuse survivor who prayed for death to relieve extreme pain after pelvic mesh surgery has accused key elements of Australia's health system of acting like the church over the mesh scandal.
"I went to the Catholic Church and there was minimising, inaction and denial. I complained after mesh surgery and the response was the same from the health system. It was just denying, denying, denying there was a problem with mesh for years," said Joan Isaacs, who was one of the first Catholic survivors to give evidence to the child abuse royal commission in 2013.
"In the past we've trusted doctors, just like the church. We put doctors up on a pedestal, just like priests and bishops, and both groups have minimised and denied when vulnerable people have been hurt. There's not much difference."
She told the royal commission the church's Towards Healing process for abuse survivors was "re-abuse", and wept this week as she talked about similar feelings while dealing with the health system, including the Therapeutic Goods Administration which approved mesh devices for use in Australia.
"I went to the Catholic Church and there was minimising, inaction and denial. I complained after mesh surgery and the response was the same from the health system. It was just denying, denying, denying there was a problem with mesh for years. I feel rage."
Child sexual abuse and pelvic mesh survivor Joan Isaacs.
"I feel rage. The Catholic Church gets up there and says it is praying for victims, and too many in the health system say they're sorry for women left to deal with the consequences of pelvic mesh, but what are they actually doing for them?" Mrs Isaacs said.
"Has anything happened at all to change the way devices are approved because of what happened to too many women implanted with mesh?"
She has backed a call for a judicial inquiry into Australia's role in developing mesh devices from the late 1980s, made by the daughter of a woman who committed suicide in 2015 after failed mesh surgery, and a national forum in Melbourne in April to make health reforms a federal election issue.
Mrs Isaacs said the mesh scandal showed the need for an overhaul of Australia's medical device approval processes. In 2018 an International Consortium of Investigative Journalists report revealed how poor regulations and vested interests allowed dangerous and malfunctioning devices onto the market around the world, putting patients’ lives at risk.
Mrs Isaacs said the often callous treatment of many women experiencing severe and permanent complications after pelvic mesh surgery was little different from her treatment by the church.
Similarities between the two issues struck her regularly, including as she gave evidence to the royal commission in December, 2013.
"A child can't give consent to a sexual act. A woman patient can't give informed consent to having a medical device implanted in her body through her vagina, without information about the likely risks. Women weren't warned of the risks or how these devices were approved without the kind of evidence we're entitled to believe is there," she said.
Mrs Isaacs was implanted with a pelvic mesh device for prolapse, a complication linked to childbirth, in 2006. In a 2018 Senate inquiry submission she recounted "dreadful" immediate and ongoing pain after the surgery, difficulty sitting for any period, and difficulty emptying her bowel and bladder leading to self-catheterisation.
Over the next six years Mrs Isaacs required 10 further surgeries to address complications including mesh migration impacting the bladder, rectum and vagina, repeated severe infections and increasingly severe pain leading to an "explosion" of internal pain in 2010 where she believed she would die.
Three months after most of the mesh was removed in August, 2011 Mrs Isaacs had further surgery where another pelvic mesh "sling" was implanted. Mrs Isaacs told the Senate inquiry she agreed to the surgery after a doctor advised there was "no other good alternative for me".
One year later, and less than two weeks before then Prime Minister Julia Gillard established the child abuse royal commission in November, 2012, Mrs Isaacs had the second mesh removed by a female surgeon after further serious complications.
It was removed only months after she "begged and begged" another doctor to inject a pain blocker into her vagina because it would "keep me from killing myself".
Mrs Isaacs gave evidence to the royal commission about appalling treatment by the Catholic Church in the late 1990s after the priest who sexually abused her as a child was jailed for his offences. She gave the evidence in December, 2013, one year after the mesh removal surgery.
"The people at the royal commission were wonderful. They knew I couldn't sit for very long. They put a cushion in the witness box and a couch in the witness room so that I could watch the hearing while lying down with a blanket," she said.
She has letters to the TGA complaining about mesh and to her local MP, the then shadow health minister Peter Dutton, complaining about the TGA's lack of responses, or claim that mesh complaints were extremely low while "many thousands of these mesh devices have been implanted and proven to be effective".
Mrs Isaacs repeatedly complained that doctors were not required to report mesh injuries to the TGA, and weren't reporting them. She also complained that although mesh manufacturers were mandatory reporters under legislation, and could be prosecuted for not reporting mesh device injuries, they were not reporting them, which made a mockery of any TGA statements about low mesh surgery adverse events.
A Newcastle Herald investigation found the TGA knew only a small percentage of mesh complications were being reported by manufacturers, but has so far failed to prosecute any mesh manufacturers.
"It is a case of regulatory capture. The TGA is captured by the medical device industry," Mrs Isaacs said.
She was horrified to learn about the lack of evidence behind many mesh devices as revealed by the Herald and in court cases, including Australia's largest class action by hundreds of women against mesh manufacturer Johnson & Johnson. A decision in that case is expected soon.
"Money drives the health system but patients don't know that, and it has to stop. All these things have to be made clear to the public, and doctors have to be made mandatory reporters when things go wrong, just like the church," she said.
"And people need to know what this thing has done to women, and why it went on for so long."
In response to questions a TGA spokesperson said the agency did not prioritise innovation and ready availability of medical devices over public safety.
It operated as a "cost-recovery agency", where it recovered its costs through annual charges, application, evaluation and inspection fees imposed on sponsors and manufacturers of therapeutic goods, including medical devices.
"Regulatory decisions made by the TGA are governed by the Therapeutic Goods Act and related regulations, legislative instruments and guidance. Decisions are made by the Secretary of the Department of Health or their delegate in accordance with legislative requirements, without regard to the fees paid by the applicant," the spokesperson said.
https://www.theherald.com.au/story/5932702/just-like-the-church-abuse-survivor-slams-health-system-over-mesh/
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Mar 9, 2019 | Newcastle Herald
By Danny Vadasz
The car and food industries understand that. Remember when we used to hear of cars described as "lemons". Those of you who have grown up under the post 1960s Toyota Total Quality Control (TQC) System may not be familiar with the concept of a congenitally flawed vehicle, but you will be familiar with what happens today when something does go wrong. Recalls. Publicity. Public acknowledgment of problems.
If someone suffers food poisoning from a maverick can of tuna there are systems in place to recall every product by unique batch number from every shelf in every distribution point in the country within days.
In the consumer goods world, the idea that faulty products could be left in the marketplace for decades is inconceivable. Surely the same should hold for our health system?
Australia’s health quality and safety regime, which was shown wanting in the case of transvaginal (through the vagina) mesh implants, is not just having a bad hair day. When the Health Issues Centre challenged the glaring under-reporting of adverse outcomes associated with mesh by collecting more than 2000 cases in six weeks, we signalled that beyond the tragedy of widespread injury was the tragedy of system failure.
Since then there has been a Senate Inquiry, a ministerial apology and formal government adoption of the inquiry recommendations. But has anything been solved?
Last November the Health Issues Centre, in response to consumer alerts, conducted wide ranging research to determine which other medical devices demonstrated a pattern of failure. Perhaps unsurprisingly, the most frequently cited product was mesh used for hernia treatment.
This time the research was not intended to quantify the scale of the problem, just to identify products that warranted further investigation. But what stood out glaringly across all circumstances was a consistent consumer experience reflective of multiple points of system failure.
In this context the regulator, the Therapeutic Goods Administration, has generally been the whipping boy for allowing inadequately tested devices to market. And certainly there is an element of Catch 22 in a framework that allows manufacturer self-audits to validate devices deemed to be level one low-risk, but relies on post-market monitoring to identify level 3 high-risk problems that triggers a clinical trial.
But our research tells us this is only one aspect of a perfect storm of system failure.
The survey results for hernia mesh indicate 87 per cent of respondents believed they were given insufficient pre-operative information to enable them to make an informed choice. Many claimed if they had known the risk and potential impacts they would not have gone ahead.
This is a clear failure to obtain mandatory informed consent. But even if surgeons and doctors want to enable an informed decision about a medical device procedure, they can’t. That would require disclosing the risk profile for the product. But Australia does not register medical devices, nor do we currently require unique identifiers to enable us to track a product from manufacture to implant - similar to dog microchips.
Unlike cans of tuna, we have no way of knowing how many pelvic and hernia mesh devices have been implanted and how many have failed. When you add to that the woeful under-reporting of adverse outcomes it becomes impossible to quantify risk.
To further confound the problem many consumers found themselves challenged about whether they experienced an adverse outcome. Both pelvic and hernia mesh patients reported gross minimalisation of their symptoms. Many were made to feel responsible for their injury.
There appears to be an unwillingness or inability by a section of the medical profession to countenance that their own best efforts may sometimes result in life-ruining outcomes.
Patients confirm their high regard for and trust in their physicians. This leads to a sense of betrayal when subsequent unintended outcomes are dismissed or trivialised. Patients could be expected to demonstrate forgiveness when something unexpectedly goes wrong but their dismay turns to anger and bitterness when they encounter clinicians in denial of an inconvenient truth.
The flaws in our system extend way beyond the specific circumstance of mesh – whether we look at the lack of informed patient consent, the absence of device registration, the gross minimalisation of injury by clinicians, leading to under-reporting of adverse outcomes, or the inadequacy of post-event treatment pathways.
The problems exist even without product failure.
Systems aren’t perfect and even if they were, humans aren’t. The car industry understood this by going beyond TQCs and introducing a Customer Follow-up System so that when things do go wrong, there is a back-up plan to deal with unintended consequences.
We need the same duty of care applied to our bodies as we get for our cars. Perhaps we should allow the car industry to run the health system.
https://www.theherald.com.au/story/5944169/auto-industry-should-run-our-health-system/
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‘Action needed‘ over problems of mesh surgery
Mar 9, 2019 | Wilcox Guardian
By Jen Stanley
A young woman who has suffered health problems since having mesh surgery said “something needs to be done”.
Chloe Thurston from Wiltshire, who had a mesh implant operation aged 15 for an internal prolapse, told the her life was still affected five years on.
Ms Thurston was warned of the risks involved when she underwent the surgery in 2013, but was still dismayed when it went wrong.
It is believed she may be the youngest UK patient to have had the procedure.
A year since , the woman leading it told the hundreds of women had come forward and she had heard some “horrendous” stories.‘Couldn‘t really walk‘
Ms Thurston said she expected the operation to be “a quick fix” of her prolapse, also known as a sagging bowel, but discovered it was “the complete opposite”.
“I got an infection somewhere in my body,” she said.
“When I went home, I was obviously in a lot of pain, so I couldn‘t really walk and then I started to have bleeding, discharge and all sorts.”
A year later, even though the prolapse went away, she was still suffering problems.
Her doctor has more recently diagnosed her condition as a bowel dysfunction, and said it was exacerbated by the biological mesh procedure.
Ms Thurston said she was not offered any other less invasive treatment such as physical therapy prior to her surgery.
Five years after her operation, Ms Thurston may have to have the mesh removed.
“Something needs to be done, it‘s five years down the line now and this is my life at home that‘s getting affected,” she said.
The is not naming the hospital or surgeon involved in Ms Thurston‘s case, but they said they were sorry to hear she was unhappy and would welcome the chance to discuss her care.
Baroness Julia Cumberlege, who is leading the government review, said she had been shocked by some of the “horrendous” stories she had heard.
The review was announced in February 2018 by then health secretary Jeremy Hunt, after complaints from many patients about the use of surgical mesh implants used to treat pelvic organ prolapse and incontinence after childbirth.
Baroness Cumberlege said what struck her was how little research had been done in the past about the use of mesh.
“To introduce a new product and not to have done proper research is actually inexcusable,” she said.
“Once a new product is used then we want to be absolutely certain that there is a proper follow up. We want to ensure there is a proper database so that we know which surgeon inserted which particular mesh and into whom.
Baroness Cumberlege said she believed the “most important thing” was to “stop these sort of things happening in the future”.
“We want to ensure the patients who have suffered will have a chance to have their voices heard. We have been appalled by the way they have been dismissed in the past,” she added.
https://wilcoxguardian.com/action-needed-over-problems-of-mesh-surgery/33170/
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J&J Wants Philly Judge Booted From Further Mesh Trials
Mar 8, 2019 | Law 360
By Jeannie O'Sullivan
A Johnson & Johnson unit on Thursday urged the lead judge of Philadelphia County's complex litigation center to keep his fellow jurist from presiding over any further pelvic mesh trials against the company because of that judge's mother's pending case against the company over a different J&J product.
Medical device maker Ethicon Inc. is seeking a reassignment order from Judge Arnold L. New because Judge Kenneth J. Powell Jr. has “repeatedly denied” motions to recuse himself from presiding over cases within the mass tort, in which women have claimed the device caused permanent injuries, according to motion. So far, Judge Powell has presided over three cases that went to trial and one that settled, and has been assigned to a fifth.
Two of the cases that were tried are on appeal, and post-trial motions are underway in the other one. Judge Powell is set to preside over yet another trial starting Monday.
The proceedings the judge has overseen have a “history of non-disclosure, of commentary, and of rulings that create the appearance of bias and warrant recusal. Therefore, the determination should be made by an independent judge on a full record,” Ethicon said.
The last pelvic mesh case Judge Powell handled led to a $41 million jury verdict in January. Suzanne Emmet’s case marked the eighth over mesh-related injuries that Ethicon has faced in Philadelphia County since December 2015, and it is the sixth to end in a damage award against the company.
Echoing the other lawsuits in the mass tort, Emmet and her husband, Michael, alleged that Ethicon had negligently designed the mesh implants at issue in the case and had failed to provide proper warnings that the devices could erode through soft tissue in the pelvis and cause permanent scarring and other injuries.
After discovering the potential conflict, Ethicon unsuccessfully sought Judge Powell’s recusal in the Emmet case as well as one lodged by Diana Perigo.
In November, before Emmet’s case went to trial, Judge Powell inked a one-page order indicating his refusal to step away from the case. The judge didn’t issue an opinion outlining his reasoning.
Ethicon made clear in its current motion that the company isn’t in the habit of making such requests.
“Defendants note that they have participated in this mass tort program for years and have not asked for the reassignment of any judge until the circumstances of the current situation developed,” Ethicon said in its motion Thursday.
Attempts to leave a message with Judge Powell in his chambers Friday evening were unsuccessful.
Ethicon is represented by Kenneth A. Murphy, D. Alicia Hickok and Melissa A. Merk of Drinker Biddle & Reath LLP.
The plaintiffs are represented by Lee B. Balefsky of Kline & Specter PC and Clayton Clark of Clark Love & Hutson.
The case is In Re Pelvic Mesh Litigation, case number 829, in the Philadelphia County Court of Common Pleas.https://www.law360.com/articles/1136901/j-j-wants-philly-judge-booted-from-further-mesh-trials
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State Supreme Court hears mesh case
Mar 8, 2019 | Missouri Lawyers Media
By Jessica Shumaker
A woman who is believed to be the first nationally to bring claims against two makers of transvaginal-mesh devices in one trial is asking the Missouri Supreme Court to rule for the first time that a corporation may be impeached for prior convictions. Eve Sherrer, of Durant, Oklahoma, was diagnosed with pelvic-organ prolapse and stress urinary ...
Access to full text unavailable – subscription required.
Story can be found here: https://molawyersmedia.com/2019/03/08/state-supreme-court-hears-mesh-case/
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What is pelvic organ prolapse?
Mar 10, 2019 | SCNow
By Vincent S. Scott
Pelvic prolapse occurs when the pelvis loses its support structure due to damage.
Most often this is related to women who have given birth, because the pelvic floor is a delicate structure of very fine muscle tissue attached to the pelvis. Child bearing can cause disruption to this structure. Generally, the more children a woman gives birth to, the more it can affect them.
Also, over time, gravity can also be a factor in pelvic organ dropping. Gravity pulls the bladder, uterus and rectum into the opening caused by child birth.
It’s possible for women who don’t have any children to be affected by pelvic organ prolapse.
Coughing and women born with poor tissue support can also cause prolapse over the years. We don’t quite know why, but sometimes women don’t develop the pelvic floor strength needed to last a lifetime. Occupations requiring constant strain by lifting or exertion, chronic coughing and pulmonary disease can also be a factor in developing prolapse.
Typically, women age 40 to 70 years old can develop it. This equates to about 30 to 50 percent of women. Sometimes women might have prolapse and not know it. This is because it doesn’t cause any problems readily noticeable. Among women who are in the 30 to 50 percent category, 11 percent of those will require surgery.
I recommend women get evaluated when they start to feel something protruding through the vaginal opening or constant pelvic pressure. Sometimes patients might see a bulge or have a sensation of sitting on something. Urologically, a sign of prolapse might be women who notice leaking of urine becoming a problem.
Treating pelvic organ prolapse ranges the full scope of conservative to surgical treatment options. Remember, only 11 percent of patients with prolapse end up having surgery. Patients can participate in pelvic floor muscle therapy and learn how to strengthen their pelvic floor muscles.
Another conservative approach involves fitting and placing a device called a vaginal pessary. This device is similar to a contraceptive diaphragm and is used to treat urinary incontinence or prolapse.
Materials and shapes have changed over time, but pessaries have been around quite a while. It resembles a tampon and can be worn all the time. A pessary is a good option for women who are not good candidates for surgery or don’t want to have surgery.
The surgical side of treatment is all about trying to help restore the pelvic organs into their proper position. This involves using ligament and support structures that are already in the body. A native tissue repair involves reattaching the vagina to the pelvis and has shown to have good success. This procedure doesn’t involve using synthetic graphing material.
Another option is to use permanent synthetic mesh material to resupport the vaginal wall. This option is most well-known, because versions of it have come under fire by the Food and Drug Administration (FDA) for causing complications after surgery. The vast majority of women who have undergone mesh procedures do very well and have better, long-term anatomical outcomes.
There also are biological graft materials made from human, cow or pig tissue, which is sterilized and made suitable to implant into patients. What’s different about these tissues is they are not considered permanent. This is because the patient’s own biological tissue grows into it and eventually replaces the biological graft material.
My goal as a urogynecologist is to help patients with their quality of life. Treatments are designed to help deal with discomfort, anatomical issues or even embarrassment.
Many factors determine success rates for patients treated for pelvic organ prolapse. Studies tell us we can expect a 60-90 percent success rate.
Diabetes, smoking and obesity are especially at risk for prolapse over time. Women need to know there is help available. Many don’t know we have techniques that are effective in alleviating symptoms associated with pelvic organ prolapse.
Many women live a healthy life with it. If you’re willing to get evaluated, it’s very likely one of these treatments will be helpful to you.
https://www.scnow.com/living/health/article_ffe28036-42bb-11e9-bc36-e721604d01e7.html
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