Preview Newsletter
Ethicon Media Monitoring 1/31/2018
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West Virginia Woman Hopes to Go It Alone in Mesh Case Against J&J
Jan 30, 2018 | Mesh Medical Device Newsdesk
Mary Dickson will take her mesh case ahead Pro Se, without an attorney, if Judge Joseph Goodwin allows that to happen. -
Vaginal mesh: England review into scale of harm
Jan 30, 2018 | BBC
The government has agreed to carry out a full audit of how many women in England have suffered complications as a result of vaginal mesh implants. -
Implant sufferers win inquiry
Jan 31, 2018 | The Times
By Charlie Parker
The government has begun a full audit of how many women have suffered complications as a result of vaginal mesh implants. -
Vaginal mesh review to investigate true scale of complications
Jan 31, 2018 | The Guardian
By Hannah Devlin
A full retrospective audit of women who have undergone vaginal mesh surgery has been launched by the government to establish how many have experienced complications following the procedure. -
Justice at last? Health officials to investigate scandal-hit vaginal mesh implants that have left thousands of women 'suicidal'
Jan 30, 2018 | The Daily Mail
By Stephen Matthews
Health officials have today announced they will launch an investigation into the scandal-hit vaginal mesh implants. -
Vaginal mesh complications too severe to be inflicted on patients, court told
Jan 31, 2018 | The Guradian
By Christopher Knaus
Pelvic mesh class action against companies owned by Johnson & Johnson hears closing submissions -
Mesh surgery: over 100,000 cases to be examined
Jan 31, 2018 | The Yorkshire Post
By Alex Wood
Campaigners have welcomed a Government decision to conduct a retrospective audit into vaginal mesh surgery. -
Ladies in Spalding back calls to ‘Sling the Mesh’
Jan 30, 2018 | Spalding Today
By Jan Whitbourn
On Saturday afternoon many local ladies attended a ‘Sling the Mesh’ meeting held at The Punchbowl in Spalding. -
Surgical mesh split leaves woman unable to walk
Jan 31, 2018 | Deccan Chronicle
As a mother of six, Amy Whitaker has experienced pain. -
Government to investigate scale of harm caused by vaginal mesh implants
Jan 30, 2018 | iNews
A full audit into the number of women who have suffered complications from vaginal mesh implants is to be carried out by the government. -
'A huge win for campaigners': Thousands of vaginal mesh cases to be reviewed in England
Jan 30, 2018 | thejournal.ie
THE ENGLISH GOVERNMENT has launched a retrospective audit of all women who had surgery involving a vaginal mesh implant since 2005. -
Campaigners celebrate as the Department of Health agrees to carry out a wide reaching audit into mesh complications
Jan 31, 2018 | Cambs Times
By John Elworthy
The news is being celebrated by campaigners who say that finally the voices of women whose lives have been ruined are being heard. -
U.K. Government to Conduct Audit of Transvaginal Mesh Complications
Jan 31, 2018 | RX Injury Help
By Laurie Villanueva
The government of the United Kingdom (U.K.) has agreed to conduct a retrospective audit of all women in that country who have undergone transvaginal mesh surgery since 2005. -
Government announces audit into vaginal mesh devices
Jan 30, 2018 | Medical Plastics News
The government has announced that it will conduct an audit into the number of women who have been harmed by vaginal mesh implants. -
Regulatory action on surgical mesh products
Jan 31, 2018 | New Zealand Doctor
Medsafe has today announced the outcomes of recent regulatory action on surgical mesh products in New Zealand. -
Supply of some surgical mesh products stopped following Medsafe request for safety information
Jan 31, 2018 | Stuff.co.nz
By Cate Broughton
A range of surgical meshes will no longer be supplied for use in New Zealand, but patient advocates are concerned many devices will still be available. -
Medsafe bans surgical mesh products
Jan 31, 2018 | Otago Daily Times
Nine surgical mesh products have been removed from supply in New Zealand after recent regulatory action by Medsafe to check the products’ safety. -
Health officials disappoint injured women
Jan 31, 2018 | Newsroom
By Teuila Fuatai
How a request for updated safety information on surgical mesh devices turned into a two-day ordeal. Teuila Fuatai reports. -
The mesh scandal: Where are we now?
Jan 31, 2018 | Medical Plastics News
The pelvic mesh scandal isn’t going away with many women reporting severe adverse effects of the product. Reece Armstrong has been following events and outlines where we are now.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
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West Virginia Woman Hopes to Go It Alone in Mesh Case Against J&J
Jan 30, 2018 | Mesh Medical Device Newsdesk
Mesh Medical Device News Desk, January 30, 2018 ~ Mary Dickson will take her mesh case ahead Pro Se, without an attorney, if Judge Joseph Goodwin allows that to happen.
This is an update on plaintiff Mary Dickson, who does not have an attorney but does have the will to prove her mother’s death was due to two Ethicon transvaginal mesh implants.
See Part One here.
The good news is that Mary Dickson has her mesh case in Wave 7 in the Ethicon MDL before Judge Joseph Goodwin.
It and 150 others are set for trial in May 15, 2018, in this transvaginal mesh multidistrict litigation (MDL) which is slowly being whittled down from a high of 104,000 plaintiffs against seven mesh manufacturers. See Dickson, So District WV, (No. 2:15-cv-02800).
See PTO_269 Setting Wave 7 for trial May 2018
She represents her mother’s estate. Vada Mae Smith died September 13, 2016 after her ongoing infections could no longer be treated with antibiotics. She was 73 years old.
Vada Mae Smith
Vada suffered in and out of nursing homes and hospice for about 15 years with this problem after the implantation of a TVT (Tension-free vaginal tape) Blue in 2001 and a TVT-O in 2006, both made by Ethicon, a division of Johnson & Johnson.
Mary knows the case well. She promised Vada she would take the case forward.
Vada never knew what was causing her problems until she saw the ads on television. “I think that’s what I have” she informed her daughters, Mary and Ruth, now deceased. Vada did not understand, nor had she been told she had been implanted with two polypropylene medical devices to treat incontinence and pelvic organ prolapse.
For many years the daughter tried to have doctors identify her pain, the reason her legs collapsed, the reason the infections and a bad smell were unrelenting. There were no answers. The surgeries she did have, no one found the mesh.
But Mary collected more than 3,000 pages of her mother’s medical history and located the time, doctor and date of the two implants.
Mary found two law firms to represent her.
She insisted they revise the complaint to include new information she found. The Tension Free Vaginal Tape (TVT) Blue System implanted in Vada in 2001 would not be cleared by the FDA’s 510(k) process for another 70 days. It was therefore considered “investigational” under the Food and Drug Administration’s own rules and should not have been marketed or used.
And Mary found the second mesh, the TVT-O, had been implanted and wanted that added to the complaint.
But the lawyers didn’t want to take the case forward. Plaintiffs who have not had mesh revisions or removals generally represent the lowest tier of compensation. Conversely, those plaintiffs with the most mesh removal attempts are generally in the highest tier and receive the most compensation.
In Vada’s case, no doctor could ever find her meshes, so no removals were attempted.
Mary also found two hospice referrals with UTI antibiotic resistant and she thought it was very important information a jury should hear.
“All I wanted for them to do was revise the complaint to have the additional information I found,” she says to MND today. Mary parted ways with her lawyers.
She plans to take the case of personal injury, and defective design forward as a Pro Se litigant. She has indicated her wishes before Judge Goodwin who has yet to lift a “stay” on the case waiting for her to find another attorney.
“I requested the stay on this case be lifted and have asked for permission to supply the court with all of the documents to proceed and prepare for trial. I’ve requested a new and timely deadline for this case to proceed for a May 15, 2018 trial and intend to be ready to present this case and ask to be granted permission to be recognized as Pro Se.”
Pro Se Litigant
Pro Se is Latin for “on one’s own behalf.”
She cites to the court Elmore vs McCammon, a 1986 Texas case which gives a Pro Se litigant special conditions.
While courts are prohibited from giving legal advice, a judge can guide a Pro Se litigants to stay on course. Mary also wants her filing fee waived which can be granted if the case is not frivolous or malicious.
She would like to receive documents electronically filed in her mother’s case, just like a plaintiffs’ attorney.
Johnson & Johnson lawyers have taken notice.
J&J wanted her to have notarized waivers from family members that they agreed to Mary continuing. She did. And Mary had to substantiate there were no creditors in line wanting to be paid from her estate.
The implanting doctor, Dr. Lassere had been set for deposition by J&J last November. Mary wants to be alerted to the new date. She wants to depose the doctor who did Veda’s autopsy who found the mesh. The scar tissue was so dense he could barely retrieve the remnants, but it was there.
Ethicon’s representative was present, and even took custody of some slides and cuts. He is represented by Butler Snow, one of many law firms representing Ethicon.
She has to prove the TVT-Blue was defective in design, that Ethicon was using it before it received FDA clearance and that the TVT-O is also defectively designed and that Ethicon breached its warranty to users.
She has to prove there was an alternative design available. She has to prove that the meshes implanted in her mother caused her death, and that J&J destroyed documents that were not supposed to be destroyed and were on a litigation hold for use in transvaginal mesh cases.
It will cost money to fly in experts, who will want to be paid. Many have already appeared in other trials and can be introduced on videotape.
All of this is pending the stay being lifted.
A tall order for a woman who graduated high school and used to work as a bartender.
“The mesh is still being implanted by J&J more will suffer because of it. I can’t see just being discouraged from telling the truth. That’s what the court system is for. I promised my mom I would tell it. She asked me to file the lawsuit. I knew nothing about mesh. She was told it was bladder lift. A new type of bladder lift, it was a mini-lift. She never had informed consent and never signed any papers.”
There have been bumps along the way.
One of them was a recent computer hack.
Mary was on the phone for three days with AOL. It included a phony Facebook page linked to her email address listing many phone numbers (including Mesh News Desk) but not linked to Facebook. It had Mary’s image. AOL told her it had had complaints with this Chinese marketing company before.
All she needs is the go ahead from Judge Goodwin. ###
https://www.meshmedicaldevicenewsdesk.com/west-virginia-woman-hopes-go-alone-mesh-case-jj/
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Vaginal mesh: England review into scale of harm
Jan 30, 2018 | BBC
The government has agreed to carry out a full audit of how many women in England have suffered complications as a result of vaginal mesh implants.
Women have long complained about the implants - which are used to hold up pelvic organs to treat incontinence and prolapse - causing agony by cutting into tissue.
It is estimated more than 100,000 UK women have had a mesh fitted.
Most of them suffer no ill effects, NHS England says.
It is not clear how many women have experienced mesh complications.
§ Case studies: Mesh led to 'excruciating pain'
§ Hundreds suing NHS over vaginal implants
§ What's the issue with mesh implants?
But more than 800 women are taking legal action against the NHS and mesh manufacturers.
Mesh treatment for prolapse has been a particular concern.
When a prolapse occurs, doctors sometimes insert a plastic mesh, made of polypropylene, into the wall of the vagina to act as scaffolding to support organs - such as the uterus, bowel and bladder - that have fallen out of place.
The National Institute for Health and Clinical Excellence recently said this surgery should effectively be banned.
Another smaller device made from the same material, called a tape, which is used to stem the flow of urine from a leaking bladder, has a much lower risk of complications, experts say.
The Department of Health have confirmed that their intention is for the mesh audit to take place, but have yet to release details.
The Royal College of Obstetricians and Gynaecologists (RCOG) advises women: "If you are considering a procedure using mesh, you should have a detailed discussion with an expert healthcare professional about the benefits and risks of the surgery for you. If you decide to go ahead with a procedure using mesh, the operation should only be performed by a specialist with expertise in this technique."
A Scottish Government spokesperson said: "In Scotland we asked NHS Scotland health boards to suspend the use of mesh in 2014 due to clinical concerns. That suspension will remain in place until we are satisfied all necessary procedures, approvals, and restrictions are in place."
http://www.bbc.com/news/health-42871621
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Jan 31, 2018 | The Times
By Charlie Parker
The government has begun a full audit of how many women have suffered complications as a result of vaginal mesh implants.
In the past decade, about 100,000 women have had a mesh fitted. It is inserted into the vaginal wall to treat incontinence and prolapse.
More than 800 women are taking legal action against the NHS and mesh manufacturers after the device tore into tissue. Some women have been left in permanent pain, unable to walk, work or have sex. Last year Kate Langley told the Victoria Derbyshire programme on BBC Two: “The mesh had cut its way through like cheese-wire.”
Kath Sansom, founder of the campaign group Sling the Mesh, said: “After two decades of mesh use with poor audit, the government is finally hearing the voices of women whose lives have changed beyond repair.”
The Royal College of Obstetricians and Gynaecologists advises women: “If you decide to go ahead with a procedure using mesh, the operation should only be performed by a specialist with expertise in this technique.”
The audit will be completed by April.
https://www.thetimes.co.uk/article/implant-sufferers-win-inquiry-nw337cqvd
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Vaginal mesh review to investigate true scale of complications
Jan 31, 2018 | The Guardian
By Hannah Devlin
Audit of NHS data to establish how many women have experienced problems following implant surgery
A full retrospective audit of women who have undergone vaginal mesh surgery has been launched by the government to establish how many have experienced complications following the procedure.
In the past decade, more than 100,000 women have had vaginal mesh surgery to treat urinary incontinence, which is common after childbirth, according to NHSfigures. But there is disagreement about the scale of problems linked to the devices, with campaigners saying women have been exposed to unacceptable risks.
Most mesh devices were launched without clinical trials, meaning the complication rates were never established prospectively.
Official guidance has suggested the figure is 3-5%, but recent research has suggested the true complication rate could be between 10-15% and a Guardian investigation found that up to 1 in 15 women subsequently require partial or full removal of their implant.
The audit, due to be completed by April, involves linking data on patients’ conditions and the type of surgery to subsequent hospital treatment and consultations in the NHS.
The investigation comes after a series of meetings with an all-party parliamentary group on surgical mesh implants set up by the Labour MP Owen Smith, which looked into the safety of mesh devices.Doctors 'not told about full risk of vaginal mesh implants'
Read more
“Over the last two years I’ve been urging ministers to conduct an investigation to fully determine problems related to mesh surgery,” said Smith. “I’m delighted that the government has listened to our concerns and has now agreed to undertake this audit to get a better understanding of complications related to mesh surgery.”
Kath Sansom, founder of the campaign group, Sling the Mesh, said: “After two decades of mesh use with poor audit, the government is finally hearing the voices of women whose lives have changed beyond repair.
Sansom added that a survey of members of the campaign group showed that many had suffered chronic pain, had lost their partners, left their jobs and been affected by anxiety and depression due to complications from surgery.
The announcement of an audit comes a few months after Australia and New Zealand heavily restricted the use of its mesh products for some pelvic surgery.
https://www.theguardian.com/society/2018/jan/30/vaginal-mesh-review-to-investigate-true-scale-of-complications
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Jan 30, 2018 | The Daily Mail
By Stephen Matthews
· The Department of Health and Social Care will begin conducting a national audit
· This will tell them exactly how many women have been affected by the devices
· Thousands of victims claim to have been left on the brink of suicide from mesh
· The procedure is often dished out by surgeons following childbirth problems
· Campaigners have welcomed the decision to investigate the usage of mesh
Health officials have today announced they will launch an investigation into the scandal-hit vaginal mesh implants.
The Department of Health and Social Care will begin a national audit to determine exactly how many women have been affected by the controversial devices in England.
Thousands of furious victims claim to have been left to endure unbearable pain and on the brink of suicide from the 'barbaric' procedure, often dished out following childbirth problems.
But the true percentage of complications is unknown, with the Government having repeatedly been accused of sweeping the issues under the carpet.
Campaigners have welcomed the decision to investigate the usage of mesh, amid mounting pressure for a complete ban, backed by MailOnline.
NHS England estimates 100,000 women have undergone the procedure since it was introduced for surgeons to treat incontinence and prolapse in the 1990s.
Chiefs have remained adamant that only three per cent of patients will experience complications of vaginal mesh, which can curl, twist and cut through tissue.
However, an array of trials into mesh - made of brittle plastic - have revealed the true rate of serious side effects is likely to be nearer the 10 per cent figure.
At least 4,800 women have suffered lacerations and nerve damage from the mesh in England, but only 1,000 have reported it to the MHRA.
However, campaigners stress these are just the tip of the iceberg and that actually there are thousands more - but they have been kept silent.
Despite the risks, which have been widely publicised in recent months, most women experience no problem and doctors are adamant the procedure is beneficial.
Kath Sansom, founder of Sling The Mesh, welcomed the announcement. The audit will begin in the coming weeks.
She told MailOnline: 'It is time this damage stopped. There are no long term studies that truly capture the level of suffering, women are ignored and belittled by surgeons who do not log problems on any database, women are on the brink of suicide.
'And all for an operation that was not life saving but was supposed to improve quality of life.
'We have heard of surgeons who tell patients the implant is like a soft ribbon, another says it hugs the bladder like a teddy bear, others surgeons deny it is mesh and insist it is tape, some say it is not polypropylene it is plastic yet it is the same thing.
'The truth its it is a harsh piece of plastic with razor sharp edges in the most private part of a woman’s body and when it goes wrong it causes total devastation.'
She added: 'The biggest tragedy is that it has taken so long for the Government to sit up and take notice.
'Tribute must go to all of the campaigners across the UK who have worked so hard raising awareness on this issue, some since 2007.
'Sadly it took a journalist being mesh injured for it to get the widespread media coverage it deserves and for the Department of Health and Social Care to know they could no longer bury their heads in the sand.'
The All-Party Parliamentary Group on surgical mesh implants demanded the audit, which is expected to be completed in April.
Patients already given vaginal mesh implants will be tracked and followed, allowing for health chiefs to get the clearest answer yet on their safety.
MP Owen Smith, chair of the APPG on surgical mesh implants, announced he was 'delighted' that the Government has listened to concerns.
'Over the last two years I’ve been urging Ministers to conduct an investigation to fully determine problems related to mesh surgery,' he said.
'I’m delighted the government has listened to our concerns and has now agreed to undertake this audit to get a better understanding of complications related to mesh.
'I hope the audit will provide crucial answers about the proportion of women adversely affected by mesh surgery.'
Sling The Mesh has more than quadrupled in size since last April when the scandal came to light, with 5,300 women now backing their cause.
The campaign group blasted the Government's 'weak' decision back in December to recommend a ban on vaginal mesh implants for one procedure.
Nice, which advises the NHS, announced the surgery should only be banned for prolapse - when organs fall out of place, and not incontinence.
It is believed of the women in Sling The Mesh who have been given the controversial implant, three quarters were fitted with the device to treat their incontinence.
The Nice verdict came after the Government released its three-year investigation into the mesh scandal last September. It rejected calls for a ban at the time
It followed the landmark news from New Zealand that all forms of pelvic mesh would be banned - becoming the first major country to do so.
Officials in the country declared in December they would remove the controversial implants from supply and limit the use of surgical mesh products.
Tiresome fights by campaigners, backed by MailOnline, has also led to Australian health officials making a similar move for prolapse operations.
Watchdogs in the country banned the use of vaginal mesh implants for prolapse earlier in the same month after a review found benefits 'do not outweigh the risks'.
Vaginal mesh has been subject of various legal proceedings across the world, with figures suggesting more than 100,000 are suing manufacturers of the devices.
The scandal came to light last April, when the NHS tried to dodge media attention over the implants that left hundreds of women in agony.
Senior doctors immediately called for a public inquiry into the controversial mesh, with some claiming the scandal could be akin to thalidomide.
At the time, 800 women were suing the NHS and device manufacturers. However, it is unsure how many women are now looking to take action in Britain.
Mesh, introduced 20 years ago and dubbed 'gold-standard', was promoted as a quick, cheap alternative to complex surgery for incontinence and prolapse.
Because it did not require specialist training to implant, victims of the procedure have since begged for tougher regulations to conduct such surgery.
Vaginal mesh has been considered a high-risk device for nearly a decade in the US, with bodies accepting up to 40 per cent of women may experience injury.
Some studies, published in an array of scientific journals, have shown that pain, erosion and perforation from the surgery can strike up to 75 per cent of women.
The alarming evidence prompted officials in three US states to suspend the practice and saw them call for an urgent review into its safety.
Scottish officials asked for it to be suspended in Scotland in 2014 pending a similar review, but hundreds of women are still believed to be having the surgery.
Leading mesh manufacturer Johnson & Johnson was forced to pay out $57 million last September to a woman fitted with the implant.
Ella Ebaugh, 51, from Philadelphia, was awarded the eight-figure sum after a jury found the company to be negligent and its product defective.
http://www.dailymail.co.uk/health/article-5326155/Officials-announce-investigation-vaginal-mesh.html
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Vaginal mesh complications too severe to be inflicted on patients, court told
Jan 31, 2018 | The Guradian
By Christopher Knaus
Pelvic mesh class action against companies owned by Johnson & Johnson hears closing submissions
An Australian gynaecologist felt the complications of transvaginal mesh implants were so alarming that he could not “inflict” the product on his patients, a court has heard.
A federal court class action against companies owned by Johnson & Johnson is currently in its final stages, drawing to a close hearings that have spanned more than seven months.
The case involves about 700 women who had mesh and tape products implanted to treat pelvic prolapse or stress urinary incontinence, both common complications of childbirth.Vaginal mesh implants: 'I really thought I was dying'
Read more
The women, represented by Shine Lawyers, allege flaws with the devices all but ruined their lives, causing severe chronic pain, making intercourse impossible and taking a significant psychological toll.
The mesh eroded internally in many cases, has caused infections and is near impossible to completely remove, the court has heard.
The products have been the subject of class actions in the United Kingdom, United States and Australia, and have since been removed from the Australian market, although likely remain in hospital stocks.
Counsel for the 700 Australian women, Tony Bannon SC, this week began his closing submissions in the federal court. On Wednesday he summarised the evidence of Andrew Korda, a professor of gynaecology and obstetrics at the University of Western Sydney.
Korda said the risks of the devices were so great that he would only use them in the most severe cases, usually when treating cancer patients who had previously undergone radical surgeries. He said the gravity of the complications he had seen in some patients far outweighed the benefits of the devices.
“These patients had such alarming problems and poor quality of life that I felt like I could not inflict these problems on any patients that came to me for treatment for prolapse,” Korda said.
Korda also said the published literature did not adequately reflect or explain the seriousness of the complications.
“In my view it does not reflect the devastation [of] some of the complications of mesh surgery,” he said.
The court on Wednesday again heard accounts from women who had suffered a “cascading” series of complications from the implants. One woman described the pain as feeling like “I’ve been ripped apart from the inside”.
The women were forced to settle for a “new normal” of degraded health and constantly felt “anxious, discouraged and desperate”, losing self-esteem and confidence.
Earlier in the case the court heard allegations that Johnson & Johnson had aggressively marketed the devices to surgeons as a cheap, easy alternative to treating pelvic prolapse, which would give them significant profits.
The class action alleges the risks of the devices were downplayed and were not properly communicated in product information. Bannon argued on Wednesday that the warnings of potential complications are still inadequate.
Others in the medical sector believe inaccurate media reporting has unnecessarily caused alarm among patients, leaving them fearful of mesh procedures, regardless of relative safety or efficacy.
The New Zealand general surgeon, Steven Kelly, wrote in the New Zealand Medical Journal last year that the reporting had “done great harm to the reputation of mesh abdominal wall and groin hernia repair”.
The class action has included revealing evidence about the way women are treated by some within the medical industry. A series of emails between French doctors involved with the company revealed disturbing attitudes towards female patients.
In the emails, doctors suggest anal intercourse could be an option for women suffering painful intercourse due to complications. “It is no less true that sodomy could be a good alternative!” one doctor wrote.What does pelvic mesh do and why are women suing over it? – explainer
Read more
Another discussed the difficulty of raising sexual matters with his patients, saying he could be treated as a “sex maniac” or “pervert”.
The court has also heard Johnson & Johnson wanted to discourage French health authorities from publishing a report critical of the devices.
It heard a journal article supportive of the safety and efficacy of the devices failed to disclose its authors’ links to Ethicon, Johnson & Johnson’s product development arm. Ethicon had paid the authors’ consultant fees and reviewed the original study protocol and a presubmission draft of the manuscript. The journal had been forced into an “embarrassing” correction two years later.
The devices have also been the subject of an Australian Senate inquiry.
Closing submissions continue before Justice Anna Katzmann.
https://www.theguardian.com/society/2018/jan/31/vaginal-mesh-complications-too-severe-to-be-inflicted-on-patients-court-told
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Mesh surgery: over 100,000 cases to be examined
Jan 31, 2018 | The Yorkshire Post
By Alex Wood
Campaigners have welcomed a Government decision to conduct a retrospective audit into vaginal mesh surgery.
The move was one of the key demands of the All Party Parliamentary Group (APPG) on Surgical Mesh Implants.
West Hull and Hessle MP Emma Hardy, vice chair of the APPG, said: “I’m delighted that the government has listened to our concerns and has now agreed to undertake this audit to get a better understanding of complications related to mesh surgery. I hope the audit will provide crucial answers about the proportion of women adversely affected by mesh surgery.”
The Department of Health and Social Care audit will provide the most accurate data possible about how many women in England have had mesh implanted, and how many have experienced problems after surgery.
The procedures involve inserting a plastic mesh into the vagina to support the bladder, womb or bowel, in cases of urinary incontinence and organ prolapse.
NHS England estimates over 100,000 women have been operated on using mesh and that complications affect between 3-5% of cases.
However some recent studies suggest serious complications occur for one in ten women.
Kath Sansom, Founder of Sling the Mesh said: "After two decades of mesh use with poor audit, the Government is finally hearing the voices of women whose lives have changed beyond repair.
"A survey of 570 women in Sling The Mesh shows a third have suffered mesh slice into their vagina or organs and eight out of ten have pain walking or sitting.
"Six out of ten have lost partners because of the strain while seven out of ten have lost sex lives. A third have had to give up work because of pain.
"Not surprisingly six out of ten suffer depression and anxiety."
The study is expected to be completed by April.
The
https://www.yorkshirepost.co.uk/news/mesh-surgery-over-100-000-cases-to-be-examined-1-8988995
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Ladies in Spalding back calls to ‘Sling the Mesh’
Jan 30, 2018 | Spalding Today
By Jan Whitbourn
A weekly column by Jan Whitbourn of Tulip Events Management
On Saturday afternoon many local ladies attended a ‘Sling the Mesh’ meeting held at The Punchbowl in Spalding.
Steph and Pete Williams held the event and provided lunch. It was amazing how many women came to share their own experience with others and experts, not knowing how common the issue actually is.
Mesh implants are used for incontinence and pelvic organ prolapse, often caused by childbirth, which can cause severe pain.
Opinions are split about if the mesh causes pain. The mesh was used after tests on animals which couldn’t show the pain, and women feel that they’re human guinea pigs.
TVT mesh has been used by the NHS since 1997, the most commonly used mesh implant; over 120,000 women in the UK have had it in the last 10 years.
Prolapse mesh has been used on the NHS since 2002. There are serious patient consent problems under Montgomery Ruling.
It’s incredible how people have been affected and the media are now taking part and helping to stop ‘Mesh’ being used. The emotional impact is huge; the suffering and mental health problems it causes and the problems of surgical mesh method has led to legal cases with manufacturers worldwide and national concerns about safety.
If you want to know more about ‘Sling the Mesh’ contact Steph and Pete at the Punchbowl or follow on Facebook and Twitter @meshcampaign.
https://www.spaldingtoday.co.uk/news/ladies-in-spalding-back-calls-to-sling-the-mesh-1-8356455
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Surgical mesh split leaves woman unable to walk
Jan 31, 2018 | Deccan Chronicle
As a mother of six, Amy Whitaker has experienced pain.
But she was left feeling the most excruciating kind when a operation to remove a pelvic hernia didn't go to plan, the Daily Mail reported. The minute I opened my eyes, I felt intense pain; it was instantaneous,' the mother from Georgia (US), told the Daily Mail.
Whitaker's doctor used a surgical mesh to 'stem' the surgical site instead of closing it with stitches. The doctor has places the mesh too low causing a tear in the nerve connecting her clitoris, anus, vulva and pelvis.
Having to battled the rare condition called pudendal neuralgia, Amy was unable to cook or tend to her children. For a year, her life revolved around doctors' appointments, pain and prescription opioids. The intense pain made her unable to perform basic human functions like sitting, using the toilet, even having sex.
Fentanyl and a nerve pain drug called Lyrica offered her some relief. However, it was an injection of amniotic fluid that began to give Whitaker her physical life back. She is still weak physically but is getting her strength back as time goes on.
https://www.deccanchronicle.com/lifestyle/health-and-wellbeing/300118/surgical-mesh-split-leaves-woman-unable-to-walk.html
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Government to investigate scale of harm caused by vaginal mesh implants
Jan 30, 2018 | iNews
A full audit into the number of women who have suffered complications from vaginal mesh implants is to be carried out by the government.
Thousands of women have said the mesh left them in chronic pain and unable to lead their normal lives.
It is estimated more than 100,000 women have had the implants, which are used to hold up pelvic organs to treat incontinence and prolapse.
The audit is set to identify the extent of the problems caused, with most women thought to have no serious issues following the procedure.
NHS lawsuit
Concern over the treatment has been raised in recent years, with more than 800 women currently suing the NHS.
The National Institute for Health and Clinical Excellence recently said this surgery should effectively be banned.
Chrissy Brajcic, a vaginal mesh campaigner, died from sepsis earlier this month following a four-year battle.
It is reported that the sepsis had been caused by her mesh implant, which gave her recurrent infections.
The Government is yet to outline details of the audit, but the Department for Health confirmed it is due to take place.
New Zealand ban
New Zealand became the first country in the world to completely ban the mesh in December 2017.
New Zealand’s medical body Medsafe said: “As a consequence of the Australian TGA review of surgical mesh for urogynaecological use, and subsequent regulatory action, there is a case for Medsafe to question the safety of certain devices.”
Australia became the first country to take action when it restricted the use of mesh in prolapse surgery in November.
Benefits and risks
The Medicines and Healthcare products Regulatory Agency (MHRA) says mesh implants are effective for the majority of women.
The MHRA insist the complication rate of vaginal mesh implants is between 1-3 per cent, despite latest NHS figures showing it to be as much as 10 per cent.
The Royal College of Obstetricians and Gynaecologists (RCOG) advises women: “If you are considering a procedure using mesh, you should have a detailed discussion with an expert healthcare professional about the benefits and risks of the surgery for you.
“If you decide to go ahead with a procedure using mesh, the operation should only be performed by a specialist with expertise in this technique.”
https://inews.co.uk/news/health/government-investigate-scale-harm-caused-vaginal-mesh/
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'A huge win for campaigners': Thousands of vaginal mesh cases to be reviewed in England
Jan 30, 2018 | thejournal.ie
THE ENGLISH GOVERNMENT has launched a retrospective audit of all women who had surgery involving a vaginal mesh implant since 2005.
The announcement comes after global scrutiny of these devices as thousands of women across the world – including in Ireland – are reporting life-changing complications after these procedures.
Vaginal mesh devices, which are made of a type of plastic called polypropelene, are used in surgeries to address stress urinary incontinence and pelvic prolapse, conditions women can suffer after natural childbirth.
Reported complications include erosion of the mesh into the vaginal wall, chronic pain and recurrent urinary tract infections. Many affected women have also spoke about the negative impact it had on their sex lives, as they experience pain during intercourse.
The UK’s health watchdog NICE had already recently recommended a ban of one of these devices – the type commonly used to treat pelvic prolapse – advising that doctors only use it for research purposes
The watchdog said there were “serious but well-recognised safety concerns” around the use of this product.
Now the government in England has launched a full retrospective review of the cases of all women who had surgery since 2005. Sky News reports the results of the audit are expected to be announced in April after data is collected and analysed on patients’ conditions, the types of surgeries and any subsequent hospital admissions.
Pain
Women in Ireland who have experienced health problems after operations using mesh devices are calling for the government here to launch a similar audit.
The Mesh Survivors Ireland campaign protested outside the Dáil last week before giving a presentation to a number of TDs inside.
Speaking to TheJournal.ie at the protest, Lesley-Anne Stephens said she was told this would be her fix for stress urinary incontinence.
“As it is, I’m incontinent and in pain,” said Stephens, who, at 39, needs a walking stick for support.
In 2016, 728 patients in Ireland underwent a procedure to address pelvic prolapse while a further 735 had operations for stress urinary incontinence.
After the stories of a number of Irish woman were highlighted by TheJournal.ie, Health Minister Simon Harris ordered a report on the use of these devices from his department’s Chief Medical Officer. And last week Taoiseach Leo Varadkar expressed his “sympathy and concern” for the women suffering from complications.
“Any response from the Government, the HSE and the Department of Health will be compassionate and understanding and respectful of the pain and suffering of anyone who is enduring complications as a result of an operation. Further, any actions taken by government will have to be guided by best clinical advice from the experts in the field and it will have to be evidence-based.”
https://www.thejournal.ie/vaginal-mesh-audit-3823759-Jan2018/
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Jan 31, 2018 | Cambs Times
By John Elworthy
The news is being celebrated by campaigners who say that finally the voices of women whose lives have been ruined are being heard.
The Department of Health and Social Care has today announced it accepts the case made by the All Party Parliamentary Group (APPG) on Surgical Mesh Implants and campaigners to conduct the retrospective audit into vaginal mesh surgery.
This comes after a series of meetings with the Minister for Health, Lord O’Shaughnessy, and is one of four key demands.
MP Owen Smith, chairman of the APPG on surgical mesh implants, said: “Over the last two years I’ve been urging ministers to conduct an investigation to fully determine problems related to mesh surgery.
“I’m delighted that the government has listened to our concerns and has now agreed to undertake this audit to get a better understanding of complications related to mesh surgery.
“I hope the audit will provide crucial answers about the proportion of women adversely affected by mesh surgery.”
Kath Sansom, founder of Sling the Mesh, said: “After two decades of mesh use with poor audit, the Government is finally hearing the voices of women whose lives have changed beyond repair.
“A survey of 570 women in Sling The Mesh shows a third have suffered mesh slice into their vagina or organs and eight out of ten have pain walking or sitting.
“Six out of ten have lost partners because of the strain while seven out of ten have lost sex lives. A third have had to give up work because of pain. Not surprisingly six out of ten suffer depression and anxiety.
“It is time this damage stopped. There are no long term studies that truly capture the level of suffering, women are ignored and belittled by surgeons who do not log problems on any database, women are on the brink of suicide. And all for an operation that was not life saving but was supposed to improve quality of life.”
A survey conducted by the 5,300 strong group Sling The Mesh shows that more than eight out of ten women were not warned of risks.
Kath said: “We have heard of surgeons who tell patients the implant is like a soft ribbon, another says it hugs the bladder like a teddy bear, others deny it is mesh and insist it is tape, some say it is not polypropylene it is plastic yet that is the same thing.
“The truth its it is a harsh piece of plastic in the most private part of a woman’s body and when it goes wrong it causes total devastation.”
The Department of Health and Social Care audit will help the NHS better understand complications related to surgery using mesh for incontinence and prolapse.
The audit involves linking data on patients’ conditions and the type of surgery to subsequent hospital treatment and consultations in the NHS. Once those data have been gathered and analysed, they will be published by the Department.
The work is expected to be completed by April.
The study will provide the most accurate data possible about how many women in England have had mesh implanted, and how many have experienced problems after surgery.
NHS England estimates more than 100,000 women have been operated on using mesh and that complications affect between 3-5 per cent of cases. However campaigners say serious complications occur for at least one in ten.
The announcement comes ahead of an APPG meeting this evening in Parliament, where MPs from all political parties will meet with Kath and fellow campaigners alongside clinicians.
http://www.cambstimes.co.uk/news/department-of-health-audit-mesh-implants-sling-mesh-1-5373908
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U.K. Government to Conduct Audit of Transvaginal Mesh Complications
Jan 31, 2018 | RX Injury Help
By Laurie Villanueva
Laurie Villanueva is an attorney with Bernstein Liebhard LRX Injury Help
The government of the United Kingdom (U.K.) has agreed to conduct a retrospective audit of all women in that country who have undergone transvaginal mesh surgery since 2005.
According to The Guardian. the audit is the first of its kind in the country and is intended to provide a definitive look at the number of women who were adversely affected by the implants.
The country’s National Health System estimates that more than 100,000 women in the U.K. have received transvaginal mesh devices to treat pelvic organ prolapse or stress urinary incontinence. Officially, the rate of complications has been placed at 1-3%, but some studies suggest that the true rate could run as high as 15%.
The audit, which is to be completed by April, comes as patient advocates call on U.K. medical device regulators to ban transvaginal mesh.
“After two decades of mesh use with poor audit, the government is finally hearing the voices of women whose lives have changed beyond repair,” Kath Sansom, founder of the group, Sling the Mesh, told The Guardian.What Is the FDA Doing About Transvaginal Mesh?
The U.S. Food & Drug Administration (FDA) began reviewing transvaginal mesh in 2008, amid an increasing number of reports linking the implants to serious and life-changing complications, including:
· Erosion or protrusion of the mesh from the soft tissues
· Chronic pain
· Pain during sexual intercourse
· Infections around the mesh
· Urinary tract problems
· Bleeding from the area round the mesh
· Damage to nearby organs
· Scarring and adhesions
· Mesh contraction (shrinkage)
In July 2011, the FDA warned that transvaginal mesh complications associated with pelvic organ prolapse repair were not rare, a position that represented a significant change from the agency’s earlier stance.
In 2016, the FDA reclassified transvaginal mesh indicated for prolapse repair as Class III (high risk) medical devices, making the devices ineligible for the agency’s 510(k) clearance program. This program allowed the implants to come to market without undergoing human clinical trials.U.S. Transvaginal Mesh Litigation
Tens of thousands of women throughout the United States have filed transvaginal mesh lawsuits since the FDA issued its first warning in 2008. These lawsuits accuse device manufacturers of failing to conduct proper testing to ensure the safety and efficacy of their implants. Plaintiffs further claim that the defendants concealed the dangers associated with the devices and failed to provide doctors and patients with adequate warnings of their risks.
31 transvaginal mesh trials been convened in the ensuing years, with plaintiffs prevailing in 23 cases. A significant percentage of claims have also been settled, though thousands remain pending in federal and state courts throughout the country.
https://www.rxinjuryhelp.com/news/2018/01/30/u-k-government-to-conduct-audit-of-transvaginal-mesh-complications/
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Government announces audit into vaginal mesh devices
Jan 30, 2018 | Medical Plastics News
The government has announced that it will conduct an audit into the number of women who have been harmed by vaginal mesh implants.
The news comes after the All Parliamentary Group (APPG) on Surgical Mesh Implants met with minister for health Lord O’Shaughnessy.
Made from polypropylene, vaginal mesh devices have caused a number of issues for women, including but not limited to, chronic pain, psychological damage and even erosion into organs. They are commonly used after childbirth to treat pelvic organ prolapse and incontinence.
The NHS, alongside the department of health and social care, will look at how many women have had mesh implants and how many have experienced problems. It will involve collating patients’ data including conditions and treatments within the NHS relating to vaginal mesh surgery. The work is expected to be completed by April.
The audit is expected to help the NHS better understand the complications that can result from surgery using mesh.
The news comes after NICE recommended that the use of vaginal mesh products be banned from treating prolapse.
It is estimated that over 100,000 women have been treated using mesh implants by the NHS. Out of these cases, NHS believes that complications affect between 3-5% of patients, though campaigners and experts think the rate of complications is higher.
Chair of the APPG on Surgical Mesh Implants, MP Owen Smith, said: “Over the last two years I’ve been urging ministers to conduct an investigation to fully determine problems related to mesh surgery. I’m delighted the government has listened to our concerns and has now agreed to undertake this audit to get a better understanding of complications related to mesh. I hope the audit will provide crucial answers about the proportion of women adversely affected by mesh surgery."
Kath Sansom, founder of Sling the Mesh, a vocal campaign group against the devices, said: “After two decades of mesh use with poor audit, the government is finally hearing the voices of women whose lives have changed beyond repair.
"A survey of 570 women in Sling The Mesh shows a third have suffered mesh slice into their vagina or organs and eight out of ten have pain walking or sitting. Six out of ten have lost partners because of the strain while seven out of ten have lost sex lives. A third have had to give up work because of pain. Not surprisingly six out of ten suffer depression and anxiety."
https://www.medicalplasticsnews.com/news/government-announces-audit-into-vaginal-mesh-devices/
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Regulatory action on surgical mesh products
Jan 31, 2018 | New Zealand Doctor
Medsafe has today announced the outcomes of recent regulatory action on surgical mesh products in New Zealand.
In December 2017, Medsafe used the provisions in the Medicines Act 1981 to request safety information from four suppliers of surgical mesh products in New Zealand.
Section 38 of the Medicines Act 1981 permits the Director-General of Health to request safety information from a supplier should there be reason to believe a medical device is unsafe.
This action followed the Australian TGA (Therapeutic Goods Administration) review of surgical mesh for urogynaecological use, and subsequent regulatory action.
"All four companies contacted have responded and have confirmed that all products removed from the Australian register are no longer supplied in New Zealand,” says Chris James, Group Manager, Medsafe.
This means:
All surgical mesh products whose sole use is the treatment of pelvic organ prolapse via transvaginal implantation will no longer be supplied
One product, a single incision mini-sling for the treatment of stress urinary incontinence, is also now no longer supplied in New Zealand.
This action only relates to use of surgical mesh in pelvic organ prolapse via transvaginal implantation and one single type of mesh for stress urinary incontinence. This action does not affect the ongoing supply of surgical mesh products for other uses such as hernia repair or stress urinary incontinence.
For those products where changes to warnings in the Instructions for Use were required to be made by the TGA, companies have advised Medsafe these changes have either been implemented or will be implemented once the wording has been agreed.
Medsafe will be continuing to work with these companies to ensure changes are implemented in New Zealand as soon as possible.
“The section 38 review and restrictions are the strongest action possible under current legislation,” says Mr James.
“As with all medical devices, Medsafe continues to monitor the use of surgical mesh products. Information for surgeons and patients is published on the Medsafe website.
"Patients who are considered for surgery, where there is potential for the implantation of surgical mesh products, should be fully informed about the benefits and risks of treatment and informed consent obtained.”
Further information
Medsafe has been informed that the following products are no longer supplied in New Zealand:
Boston Scientific NZ Ltd
Solyx
Uphold LifeCulpan Medical
Coloplast – 9 modelsEndotherapeutics NZ Ltd
TOA Sling
TVA Sling
Multi Purpose Sling
BSC Mesh
EndoGYNious
Ophira Minislinghttps://www.nzdoctor.co.nz/article/undoctored/regulatory-action-surgical-mesh-products
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Supply of some surgical mesh products stopped following Medsafe request for safety information
Jan 31, 2018 | Stuff.co.nz
By Cate Broughton
A range of surgical meshes will no longer be supplied for use in New Zealand, but patient advocates are concerned many devices will still be available.
All mesh devices surgically implanted through the vagina to treat pelvic organ prolapse and one product used to treat stress urinary incontinence will no longer be supplied, Medsafe group manager Chris James says.
Medsafe restricted access to the devices under section 38 of the Medicines Act 1981 following Australia's Therapeutic Goods Administration (TGA) review and ban of the devices.
Under the Act, the director-general of health is permitted to request safety information from a supplier "should there be reason to believe a medical device is unsafe".
Other mesh products for hernia repair or stress urinary incontinence were not affected by the action.
The TGA had requested changes to warning information for some products, and the companies involved told Medsafe they either had made or would soon make the changes once the wording had been agreed upon.
Carmel Berry, from patient advocacy group Mesh Down Under, said it was unclear whether suppliers of those products had provided evidence of safety.
A working group – including a urologist, Mesh Down Under, gynaecologists and surgeons – have been developing advice for patients about mesh procedures used to treat stress urinary incontinence in women.
It would not be possible to provide women with the best advice without more information about the changes suppliers had made, Berry said.
"It's important Medsafe clarify what products have met requirements of Section 38 of the Medicines Act and the director-general of health has been satisfied they are safe."
PRODUCTS NO LONGER SUPPLIED IN NZ:
Boston Scientific NZ LtdSolyx
Uphold Life
Culpan MedicalColoplast – 9 models
Endotherapeutics NZ LtdTOA Sling
TVA Sling
Multi Purpose Sling
BSC Mesh
EndoGYNious
Ophira Minisling
https://www.stuff.co.nz/national/health/101032457/supply-of-some-surgical-mesh-products-stopped-following-medsafe-request-for-safety-information
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Medsafe bans surgical mesh products
Jan 31, 2018 | Otago Daily Times
Nine surgical mesh products have been removed from supply in New Zealand after recent regulatory action by Medsafe to check the products’ safety.
Medsafe decided to ban the supply of the mesh for operations such as pelvic organ prolapse and stress urinary incontinence after the Australian Therapeutic Goods Administration (TGA) reviewed surgical mesh for urogynaecological use, and took regulatory action.
ACC figures also showed that the mesh had cost at least $13 million in injury payouts in the past 12 years.
In December 2017, Medsafe used the provisions in the Medicines Act 1981 to request safety information from four suppliers of surgical mesh products in New Zealand.
The companies included Boston Scientific NZ Ltd, Culpan Medical, Endotherapeutics NZ Ltd and Johnson & Johnson Medical NZ.
Medsafe group manager Chris James today said all four companies had responded and confirmed that all products removed from the Australian register are no longer supplied in New Zealand.
This means all surgical mesh products whose sole use is the treatment of pelvic organ prolapse via transvaginal implantation will no longer be supplied, and one product, a single incision mini-sling for the treatment of stress urinary incontinence, is also no longer supplied in New Zealand.
This action does not affect the ongoing supply of surgical mesh products for other uses such as hernia repair or stress urinary incontinence.
Companies have also told TGA they have made its required changes to warnings in the instructions for use, or will when the wording has been agreed.
James said Medsafe would continue to work with the companies to make sure the changes are made in New Zealand as soon as possible.
“As with all medical devices, Medsafe continues to monitor the use of surgical mesh products. Information for surgeons and patients is published on the Medsafe website.
“Patients who are considered for surgery, where there is potential for the implantation of surgical mesh products, should be fully informed about the benefits and risks of treatment and informed consent obtained,” he said.
List of affected products:
Boston Scientific NZ Ltd
Solyx
Uphold Life
Culpan Medical
Coloplast – 9 models
Endotherapeutics NZ Ltd
TOA Sling
TVA Sling
Multi Purpose Sling
BSC Mesh
EndoGYNious
Ophira Minisling
https://www.odt.co.nz/news/national/medsafe-bans-surgical-mesh-products
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Health officials disappoint injured women
Jan 31, 2018 | Newsroom
By Teuila Fuatai
How a request for updated safety information on surgical mesh devices turned into a two-day ordeal. Teuila Fuatai reports.
Implementing solutions to a decade-long medical saga that has already cost taxpayers $13 million in injury payments appears to be a non-priority for health officials in 2018.
As far back as 2008, post-surgery problems with transvaginal mesh procedures were flagged with ACC. Initially, only 14 people who underwent repair surgery for either incontinence or pelvic organ prolapse, and were implanted with surgical mesh, were identified as suffering unexpected and severe complications between 2005 and 2008.
Ten years later, a slew of injured patients impacted with life-debilitating injuries due to surgical mesh implants have hit headlines around the world, with various jurisdictions, including Scotland and Australia, undertaking official inquiries into the product. Class-action suits involving hundreds of women have also been launched against product manufacturers, and some health authorities, in Australia, the US and the UK.
Locally, New Zealanders have not escaped the damage either. Latest ACC figures show in the 12 years to June 30, at least 800 injury claims relating to surgical mesh have been lodged. Injury payouts totalled $13.2 million in that time.
Despite this, and a major Ministry of Health announcement in December which effectively limited and even removed the use of some surgical mesh products used for gynaecological procedures, follow-through into the new year has been severely lacking.
Over the past two days, Newsroom has tried to obtain an update from the Ministry — which is responsible for the country’s therapeutic goods watchdog Medsafe — over whether mesh supply companies have adhered to its December 11 announcement requiring safety information for products in New Zealand.
The announcement followed changes imposed by Medsafe’s Australian counterpart, the Therapeutic Goods Administration (TGA), after it reviewed surgical mesh products. While the Australian legislation dictated companies had 20 working days to adhere with the the TGA’s new safety requirements — enacted on November 28 — New Zealand’s Medicines Act allows companies 45 days.
That deadline lapsed on Thursday, January 24.
After a series of phone calls, emails and texts between Newsroom and the Ministry — carrying on from Monday into Tuesday — not even the request of confirming whether mesh supply companies had submitted safety information during the 45-day period was answered by Ministry officials. Notably, in its December announcement, the Ministry stated it had been in contact with four companies which supplied the local market.
“Medsafe is using powers under the Medicines Act 1981 to require suppliers to provide safety information about their devices.
“Under section 38, Medsafe has written to four companies: Boston Scientific NZ Ltd, Culpan Medical, Endotherapeutics NZ Ltd and Johnson & Johnson Medical NZ Ltd requesting safety information or confirmation that the companies will comply with the Australian requirements.
“Medsafe understands from its communications with these companies that they intend to comply with the requirements by 4 January 2018,” the Ministry said at the time.
Initially, Newsroom was told to place its query under the Official Information Act (OIA) — a process which can take up to 20 working days for a response. When this was contested on the grounds that the information “should be readily available as it is concerns medical devices currently on the market”, the Ministry then said the information could be “commercially sensitive”, and officials required the timeframe enabled under the OIA to review it.
Meanwhile, The TGA website has had updated safety information on various mesh devices since December 22. A further update was loaded onto the site on January 4.
By early afternoon Tuesday, a Ministry spokesperson told Newsroom an official statement in response to its query would be sent in about 30 minutes — however that never came through.
Instead, an email at 3.55pm came through which stated: “the Minister’s office will be in touch with you”.
Associate Health Minister Julie Anne Genter — who only took over the surgical mesh portfolio in December — said yesterday she had not been briefed on the matter.
The latest set of actions from the Ministry have disappointed those injured by surgical mesh.
Carmel Berry, co-founder of the 500-strong patient advocate group Mesh Down Under, said they had been trying to work with relevant medical colleges to produce a “comprehensive patient information brochure".
“We need to know which products are to remain available for use in New Zealand to ensure that this brochure is current and accurate."
Charlotte Korte, who founded the group in 2012 with Berry, called for clearer systems: “We feel that due to the gravity of the surgical mesh issue it is important for the government to show that transparency is of the utmost importance".
At 10.30am this morning, Medsafe announced it had heard from the four companies it contacted as a result of the TGA review.
“All four companies contacted have responded and have confirmed that all products removed from the Australian register are no longer supplied in New Zealand,” Chris James, group manager at the authority said.
According to the announcement, affected products are those used only for repair of pelvic organ prolapse. A single incision mini-sling product, used to treat stress urinary incontinence, was also identified as no longer in supply in New Zealand.
Medsafe also said it was working with companies that needed to update “instructions for use” for mesh products, and had not yet completed the process.
In total, nine surgical mesh devices from three companies were listed as “no longer supplied in New Zealand”. No products from Johnson & Johnson were listed.
https://www.newsroom.co.nz/2018/01/30/79503/health-officials-disappoint-injured-women
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The mesh scandal: Where are we now?
Jan 31, 2018 | Medical Plastics News
The pelvic mesh scandal isn’t going away with many women reporting severe adverse effects of the product. Reece Armstrong has been following events and outlines where we are now.
In July 2017, 60 women marched towards Westminster to meet with MPs to discuss the life-changing effects that had occurred due to mesh implants.
While not the first public admission about the devastating effects of mesh, it was perhaps the most symbolic. Women shared their harrowing stories about how mesh had changed their lives for the worse, detailing chronic pain, psychological damage and even the removal of organs after mesh had eroded in their body.
Mesh implants are made from polypropylene and are used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI) after childbirth. The meshes, a common treatment for SUI and POP, are designed to provide extra artificial support for weakened or damaged tissue.
Shortly after that meeting in July, the NHS published its Mesh Oversight Group Report [1] stating that the use of ‘mesh to treat women with SUI and POP is a safe option’.
While the report outlined recommendations to help improve access to information, consent and clinical guidance, it ultimately resulted in patient leaflets being available in GPs and a change in the way that problems caused by the mesh are reported.
The campaign group, Sling the Mesh, which organised the parliamentary meeting responded with criticism about the report.
The group’s leader, Kath Samson, said: “They should have looked at product safety, not at ways to fix women once things have gone wrong. How can a major study of mesh not look at mesh safety?
Since the report, diligent campaigning from women all over the world has brought attention to the mesh implants with multiple court cases being brought against the device manufacturers.
In October last year, Johnson & Johnson, one of the major manufacturers of the mesh implants, was taken to court by a woman in the US for injuries caused by the company’s mesh implant.
Ella Ebaugh had a mesh implant operation in 2007 after suffering from incontinence. After her condition didn’t improve, she had a second mesh device implanted. However, Ebaugh suffered from a range of complications such as pelvic pain and urethral erosion and had to undergo three corrective surgeries.
Ebaugh ended up receiving $57 million in damages from Johnson & Johnson after the court ruled that the company was liable for causing injury and that its devices were negligently and defectively designed.
Unfortunately, mesh implants have been the result of much worse complications for a certain number of women. Between 2008 and 2010 for instance, the FDA found that there were ‘seven reported deaths associated with POP repairs’[2]. More so, in November last year a 42-year-old woman from Canada died from sepsis caused due to what her family believes was mesh related troubles.
In that same month here in the UK, health watchdog NICE recommended that vaginal mesh products be banned from treating prolapse due to safety concerns. The news came as a small victory for women even after calls for a public inquiry into the devices was rejected by the parliamentary under-secretary of state for health, Jackie Doyle-Price.
About the news, Owen Smith, chair of the All Party Parliamentary Group on Surgical Mesh Implants, said he was “pleased that NICE have listened to women” but added that “they should have gone further and followed the example set by New Zealand this week in banning mesh altogether for pelvic operations.” [3]
Whilst the NHS doesn’t have to act on the recommendations set out by NICE, it may suggest that a ban on the devices is on the horizon. Currently, NICE is developing guidelines into the use of mesh for SUI and POP, though this won’t be published until 2019.
A long time to wait but it does seem like the UK and indeed the rest of the world is pushing towards better regulation and clinical use of mesh products. What we can hope for is that the UK follows examples set by Australia and New Zealand, both of which have banned the devices due to concerns over safety. Until then, women need to be made aware of the health and psychological problems that can be caused by mesh, though thankfully we have a number of strong and altruistic campaigners raising awareness here in the UK.
https://www.medicalplasticsnews.com/news/the-mesh-scandal-where-are-we-now/
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