Preview Newsletter
Ethicon Media Monitoring 7/3/2017
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Class action over pelvic mesh implants set to begin
Jul 1, 2017 | The Courier Mail
By Janelle Miles
A LANDMARK class action against the manufacturers and distributors of pelvic mesh implants will begin in Sydney on Tuesday, as women continue to come forward with pain, ruined sex lives and broken relationships. -
MP calls for UK wide suspension on women’s mesh implants which have “ruined lives”
Jun 30, 2017 | Kath Sansom
By Cambs Times
The plea comes hot on the heels of criticism by a society which said surgeons have failed to report mesh problems. -
Transvaginal mesh devices are one of Australia's greatest medical scandals
Jul 3, 2017 | Newcastle Herald
IT has been nearly three years since the Newcastle Herald first wrote about transvaginal, or pelvic, mesh devices and a former University of Newcastle associate professor who implanted the devices, Richard Reid. -
Surgical mesh victim says patients have been betrayed
Jul 2, 2017 | Stuff.co.nz
By Cate Broughton
An Auckland woman implanted with surgical mesh later withdrawn from the market says patients are being abandoned by the medical community and the Government. -
Stinging attack over surgical mesh inaction by Winston Peters
Jul 3, 2017 | Stuff.co.nz
By Cate Broughton
The Government is trying to dodge class action by surgical mesh victims instead of acting to help them, New Zealand First leader Winston Peters says. -
NSW Health is investigating how a male company rep attended a woman's surgery without her knowledge
Jul 3, 2017 | Newcastle Herald
By Joanne McCarthy
NSW Health is investigating how a male pelvic mesh company representative was in a private hospital operating theatre during a woman’s intimate pelvic mesh surgery, without her knowledge or approval. -
KY Attorney General returns nearly $8MM to state General Fund
Jun 30, 2017 | Heartland News (In KFVS)
... Beshear is currently in civil litigation against Johnson & Johnson and its medical device unit, Ethicon, for its deceptive marketing of surgical transvaginal mesh.
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Class action over pelvic mesh implants set to begin
Jul 1, 2017 | The Courier Mail
By Janelle Miles
A LANDMARK class action against the manufacturers and distributors of pelvic mesh implants will begin in Sydney on Tuesday, as women continue to come forward with pain, ruined sex lives and broken relationships.
Queenslander Louise King, one of about 800 women who have registered to take part in the Federal Court action, has had ongoing pain since she had pelvic mesh inserted for a prolapsed vagina more than 10 years ago.
The 65-year-old was never able to have sex with her husband again.
“I didn’t have any trouble before the operation,” she said.
The couple had been married for 38 years when her husband, Paul, died of cancer in 2014.
Mrs King said she returned to her surgeon three times after her operation to advise him of her pain but was told: “There’s nothing wrong.”
Shine Lawyers special counsel Rebecca Jancauskas said the class action, set down for six months, was against Johnson and Johnson Medical Australia and subsidiary companies Ethicon Inc and Ethicon Sarl.
“We will say that they’ve breached product legislation in Australia and also that they’ve been negligent in their manufacture and supply of the implants,” Ms Jancauskas said.
“It’s a landmark case in terms of Australian class actions, both in terms of the number of people who have been affected and also the length of the trial.”
She said between 90,000 and 100,000 of the implants had been sold in Australia.
“We estimate that in the vicinity of about 8000 to 10,000 Australian women are likely to have suffered complications as a result,” Ms Jancauskas said.
“These are very intimate issues and women are reluctant to come forward and talk about them, understandably so,” she said.
“For that reason, many women have been suffering in silence. Their relationships often break down.
“Trying to remove the implants has been referred to by surgeons … as trying to remove chewing gum from hair. These implants become so intertwined with the tissue of the pelvis, it becomes very difficult, if not impossible, to remove in its entirely.”
The Senate is conducting an inquiry into pelvic mesh implants.
Ms Jancauskas said women could still join the class action.
http://www.couriermail.com.au/news/queensland/class-action-over-pelvic-mesh-implants-set-to-begin/news-story/b4bd49247d40c4c0701ef1368bcd6dd2
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MP calls for UK wide suspension on women’s mesh implants which have “ruined lives”
Jun 30, 2017 | Kath Sansom
By Cambs Times
The plea comes hot on the heels of criticism by a society which said surgeons have failed to report mesh problems.
Eight years ago the same society admitted it was concerned that guidelines for mesh were not being followed in all hospital trusts.
MP Owen Smith said today (June 30) that mesh is a global: “Scandal and one that’s under reported and misunderstood.”
He said: “There needs to be suspension of the use of this material,” because “there are other things that can be done, until we get greater clarity of how many women have had these awful reactions and whether its safe to use.”
Patient safety campaign Sling The Mesh is calling on health secretary Jeremy Hunt to halt mesh operations to fall in line with Scotland where a suspension was called for in June 2014.
This week it was confirmed the Scottish suspension would remain until 2018 - by then it will have been four years protection for women, yet there is no such safety net for patients in the rest of the UK.
Mr Smith said: “There are women all over the world who have had this treatment for prolapse and incontinence and a very high proportion, much higher than we appreciated, certainly much higher than the MHRA appreciated, have had really, really awful reactions and whose lives have been ruined.”
Speaking on BBC Radio Good Morning Ulster Mr Smith added: “In Scotland they suspended using this material, vaginal mesh, until they’ve sorted it out.
“In Northern Ireland we have an audit. In England we’re still waiting, after what seems to me to be a ridiculous amount of time, more than two years, for a report to come out,” he said.
In an open letter to the Government Sling The Mesh campaigners wrote to Mr Hunt saying: “There are no safeguards in place for women in England, Northern Ireland or Wales.
“This is morally wrong. We demand that this imbalance is redressed so the whole of the UK falls in line with Scotland.
The call for a UK wide suspension comes hot on the heels of a newsletter by the British Society of Urogynaecologists (BSUG) from two months ago which said there was a: “Lack of research regards outcome data.
“If all members were to use the database then there would be a very large cohort that could inform practice moving forward.”
They also identify: “Poor coding or lack of appropriate codes makes data collection and analysis difficult.”
The newsletter says that mesh for: “Prolapse should not be used in primary treatment and its use should be undertaken only after a multi discipline treatment (MDT) discussion.”
However, Sling The Mesh campaign is aware of women still being offered prolapse mesh as standard who have not been through the team approach.
Eight years ago, in 2009, an archived BSUG newsletter said: “There has been considerable discussion regarding industry-sponsored pelvic floor surgery courses held at the college.
“The concern was the lack of evidence-base and possible promotion of one particular mesh for prolapse surgery.
“We felt the recommendations might have been unreliable.
”There had been a proposal that BSUG audits the outcomes of their products on our database as industry/commercial trials are viewed by some with ‘suspicion’.
“The companies feel it would be more transparent if BSUG audited the outcomes.”
The newsletter goes on to say that they suspect NICE recommendations for mesh use “may not be followed in all Trusts.”
Those guidelines include ensuring patients are aware of the uncertain, long-term efficacy and safety, have been given written information about risks and that all mesh procedures are audited and regularly reviewed.
The newsletter says: “It is essential the guidelines are followed and we protect ourselves against potential litigation for failure to follow national guidelines.”
• The MHRA continue to say mesh risk is one to three per cent and the benefits outweigh the risk. Their figure is based on a study called the York Report from 2012.
• Scottish surgeon Wael Agur says mesh risk is more like 15 per cent - one in seven women suffering.
• A report by Linda Brubaker et al suggest risk could be as high as 42 per cent.
• A report by Serati et al suggest risk is 30 to 40 per cent.
• A report by Blavais et al shows risk is 15 per cent and the mesh can degrade.
• Scroll to 2:16 for the BBC Radio interview with Owen Smith.
http://www.cambstimes.co.uk/news/mp-calls-for-uk-wide-suspension-on-women-s-mesh-implants-which-have-ruined-lives-1-5086214
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Transvaginal mesh devices are one of Australia's greatest medical scandals
Jul 3, 2017 | Newcastle Herald
IT has been nearly three years since the Newcastle Herald first wrote about transvaginal, or pelvic, mesh devices and a former University of Newcastle associate professor who implanted the devices, Richard Reid.
A lot has happened since then.
Women left with devastating and permanent injuries and complications after pelvic mesh surgery for incontinence and prolapse formed a group, the Australian Pelvic Mesh Support Group, to break the silence about the extent of pelvic mesh problems.
More than 400 women registered for a landmark class action in the Australian courts against just one of the mesh manufacturers, Johnson & Johnson, that starts on Tuesday.
Another 350 women have registered for a class action case against a second major mesh manufacturer, and other women have launched legal cases against individual doctors.
Herald investigations have revealed the global reach of the transvaginal mesh catastrophe, and how even a senior medical specialist familiar with the issue has estimated the total mesh compensation payouts could be more than $20 billion, with at least 120,000 women seeking damages in America alone.
The Herald has also revealed the Australian backstory to the global mesh saga, and how an Australian doctor’s pelvic mesh device for incontinence was developed in America and cleared for use for prolapse surgery without evidence of its safety and efficacy for that purpose.
That clearance allowed other mesh device manufacturers to have their devices cleared for use under an American system that allows manufacturers to argue their devices are “substantially the same” as already-cleared devices.
In February Victorian Senator Derryn Hinch successfully argued for a Senate inquiry into transvaginal mesh devices, and how they were cleared for use in Australia as a surgical treatment for prolapse, which is a complication after childbirth.
In the past week Victorian and NSW health authorities have initiated investigations after allegations about mesh surgery in a public and private hospital, and serious allegations about the release of research papers on mesh.
What is clear, even before the Senate inquiry, is that regulators failed women for more than a decade.
http://www.theherald.com.au/story/4765139/regulators-failed-across-the-board-on-mesh/
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Surgical mesh victim says patients have been betrayed
Jul 2, 2017 | Stuff.co.nz
By Cate Broughton
An Auckland woman implanted with surgical mesh later withdrawn from the market says patients are being abandoned by the medical community and the Government.
Susan Hutchings, 67, is one of an unknown number of Kiwi patients implanted with a recalled mesh, Physiomesh Flexible Composite Mesh by Ethicon – a subsidiary of Johnson & Johnson.
The mother, grandmother and former accountant has had three failed hernia surgeries and has been left with a huge painful hernia "the size of a rockmelon" which has disfigured and humiliated her.
Hutchings said she felt alone and abandoned.
"I feel like when I went in, I had so much hope and trust and then to have it all fail, it feels like a betrayal."
Hutchings has had three different mesh products implanted for hernia repair since 2011.
In November 2015, a sheet of Physiomesh the size of a DVD case was implanted.
After each procedure the hernia returned, with the pain increasing each time.
In New Zealand, surgical mesh is routinely used in hernia repair to stabilise weaknesses in the abdominal wall.
However, there is no registry for surgical mesh and Medsafe does not pre-approve medical devices under the current regulatory system.
Ethicon recalled Physiomesh in June 2016 after unpublished data from two European mesh registries showed it had higher than average rates of complications.
Hutchings said she was devastated to discover the mesh used in her had been recalled.
"I felt numb. I don't know who I can trust, who I can believe."
Surgeons have not given Hutchings an explanation for the surgery failures but were adamant the mesh played no role.
Hutchings' doctor said sometimes hernias recur.
At an appointment in May her doctor said he would not help her with an ACC claim as very few hernia claims were accepted.
"He said 'you're on your own Susan'."
Apart from further, high risk surgery with mesh, there was no other treatment option, Hutchings was told.
"I don't want sympathy, I want to prevent this happening by surgeons being honest about the implants they are using and telling patients they have the potential to fail, and a national registry."
One of the founders of surgical mesh advocacy group Mesh Down Under Charlotte Korte said there were many people in her group who had Physiomesh implanted and were suffering complications.
The group has been calling for an inquiry in to surgical mesh and a national registry for mesh products since 2014.
Without a registry there is no way for Medsafe to monitor patients implanted with mesh, including mesh that is subsequently recalled.
Royal Australasian College of Surgeons (RACS) executive director of surgical affairs Richard Lander said surgeons rely on manufacturers and government agencies to assess medical devices for safety prior to release on the market.
He said RACS was not notified by the Ministry of Health or Medsafe about the recall of Physiomesh.
"Without a registry of patients with Physiomesh implanted the onus falls on individual surgeons to conduct post-market surveillance."
In a statement, Ethicon said Physiomesh Flexible Composite Mesh (for laparoscopic use) was available in New Zealand from 2011 until June 2016 when it was voluntarily removed from the worldwide market.
Healthcare practitioners who had used Physiomesh were informed about the recall and advised "they should continue to follow their patients in the usual manner".
"As a company, we are here to improve people's health and wellbeing, and we are always concerned when a patient does not receive the outcome they had hoped for."
Medsafe general manager Chris James said Ethicon added the product to the Medsafe medical devices database prior to sale in New Zealand and fulfilled the legal requirement for medical devices.
The recall notice was published on the Medsafe website but individual patients were not notified by Medsafe James said.
https://www.stuff.co.nz/national/health/94144426/surgical-mesh-victim-says-patients-have-been-betrayed
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Stinging attack over surgical mesh inaction by Winston Peters
Jul 3, 2017 | Stuff.co.nz
By Cate Broughton
The Government is trying to dodge class action by surgical mesh victims instead of acting to help them, New Zealand First leader Winston Peters says.
"Instead of saying these people need to be fixed up and fast, they're worried about what it will mean if they turn nasty and that, frankly, is irrelevant. They have a right to feel aggrieved."
Peters said mesh patients could take class action but the Government should accept responsibility and provide compensation.
"If you are able to get a legal argument or even public support for what should have been a legal argument, then the responsibility of the state can be identified and remediated."
Aucklander Susan Hutchings, 67, has been left with a huge painful hernia "the size of a rockmelon", which has disfigured and humiliated her, after being implanted with surgical mesh later withdrawn from the market.
Hutchings said she felt alone and abandoned, but did not want sympathy.
"I want to prevent this happening by surgeons being honest about the implants they are using and telling patients they have the potential to fail, and a national registry."
The Mesh Down Under support group, managed by Carmel Berry and Charlotte Korte, has been calling for pre-approval of mesh devices, a mesh registry, and tighter regulation for informed consent and compensation for mesh injuries since 2014.
ACC has received 780 claims for mesh injuries since 2005, at a cost of $12 million to the taxpayer, and four people have died from mesh-related complications.
Few of the recommendations made by a Health Select Committee inquiry in 2014 have been implemented, including a registry.
"The responsibility for this lies purely with [Minister of Health] Jonathan Coleman and he needs to be made accountable for the inaction on his part," Korte said.
Coleman said a registry for mesh devices would be considered as part of a new regulatory regime for therapeutic products in New Zealand.
"This is a major piece of work and the consultation is later than initially anticipated due to the number and complexity of the issues to be worked through."
Peters said the Government should act now.
"What do they mean by a wider review? For goodness sake, there are people with identifiable, problems right now and they have had them for considerable time and they need to be fixed up now, not wait around for some bureaucratic inside the belt review."
ACC barrister Warren Forster said class action was possible but the legal threshold was very high to sue for exemplary damages.
The complainant would have to prove various Government agencies, the manufacturers or doctors knew what the risks were for the mesh product or procedure and went ahead regardless.
A personal injury commissioner was needed to take responsibility for the mesh issue as so many different agencies were involved, Forster said.
Labour health spokesman David Clark said the slow response to mesh injuries reflected a lack of interest by the Ministry of Health and the minister overseeing it.
"It could have been addressed by now and we could be learning from that register already if the minister had followed up on the recommendations made."
Green Party health spokeswoman Julie Anne Genter said inaction on mesh was a funding issue.
"This is one more sign that Government departments do not have the resources they need to look after New Zealanders as they should."
https://www.stuff.co.nz/national/health/94302865/stinging-attack-over-surgical-mesh-inaction-by-winston-peters
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NSW Health is investigating how a male company rep attended a woman's surgery without her knowledge
Jul 3, 2017 | Newcastle Herald
By Joanne McCarthy
NSW Health is investigating how a male pelvic mesh company representative was in a private hospital operating theatre during a woman’s intimate pelvic mesh surgery, without her knowledge or approval.
The investigation, initiated on Friday after Newcastle Herald questions to Health Minister Brad Hazzard, is the second investigation launched by state health authorities in a week involving surgery by former University of Newcastle associate professor of gynaecology, Richard Reid.
They are in addition to a NSW Health Care Complaints Commission investigation of Dr Reid that will be heard by the NSW Civil and Administrative Tribunal in December, and at least five civil suits by women patients involving pelvic mesh surgery by him.
The Sydney Private Hospital investigation will include how NSW Health initially did not pursue a complaint in 2015 after incorrectly advising the woman patient that the man’s company was a member of a professional association, the Medical Technology Association of Australia (MTAA), which bound him by its code of conduct.
When the information was independently checked the MTAA said the company was not a member.
“NSW Health takes the concerns raised by the Newcastle Herald very seriously. The matter is being actively investigated,” a spokesperson said on Friday.
The woman was implanted with the Australian-manufactured Tissue Fixation System (TFS) pelvic mesh device in July, 2013 at Sydney Private Hospital by Dr Reid and device inventor Dr Peter Petros, only weeks after Dr Reid is alleged to have assisted with TFS surgery at Victoria’s Northern Hospital in June, 2013, without the public hospital’s knowledge or approval.
The woman had another three repair surgeries at the hospital between July and December, 2013 after serious complications.
After a complaint about the male company representative in the operating theatre, NSW Health advised he was not from Adelaide-based TFS Manufacturing, but from another pelvic mesh device company.
“The hospital director of the Sydney Private Hospital has advised that medical representatives are permitted admittance to the operating theatre at the discretion of the theatre manager in consultation with the surgeon. They are present to provide technical advice to the surgeon,” NSW Health’s private health care unit wrote in June, 2015.
The unit named the mesh device company and gave the incorrect advice that “all representatives from this company are members of the MTAA and are bound by their code of conduct”.
A NSW tribunal has heard evidence Northern Hospital gynaecologist Dr Max Haverfield trained Dr Reid in TFS surgery only weeks before the woman’s surgery.
Victoria’s new public hospital watchdog, Safer Care Victoria, is investigating allegations Dr Petros and Dr Reid assisted Dr Haverfield with TFS surgery at the hospital in 2010 and 2013 respectively, without the hospital’s knowledge or approval. It is investigating a separate allegation that Dr Haverfield conducted a TFS trial on 40 women at the hospital, without the hospital’s knowledge.
Safer Care Victoria is also investigating how a research paper on the trial was published by Dr Haverfield in 2015 saying the TFS trial had Northern Hospital ethics committee approval, when the hospital could find no record of such an approval.
The investigation followed Herald questions about the Northern Hospital surgery to Victorian Health Minister Jill Hennessy.
The investigations are in addition to a Senate inquiry into how the controversial pelvic – or transvaginal - mesh devices for prolapse surgery were cleared for use in Australia from 2003/04 without evidence of safety and efficacy. Prolapse surgery in women generally follows complications from childbirth.
The Senate inquiry was established after Victorian Senator Derryn Hinch compared transvaginal mesh devices with the drug Thalidomide, and told Federal Parliament mesh was “one of the greatest medical scandals and abuses of mothers in Australia’s history”.
A landmark Australian legal class action by 450 women implanted with just one company’s pelvic mesh devices, Johnson & Johnson, will start on Tuesday. It is estimated to run for six months.
Dr Reid did not respond to questions.
Sydney Private Hospital did not respond to questions. Correspondence seen by the Herald shows the hospital changed some procedures after the woman’s complaint, including requiring company representatives to sign a code of conduct on entering an operating theatre and wear identifying theatre clothing. Patients are also advised in writing that “it may be necessary to have a medical representative present during my surgery to provide technical support”.
http://www.theherald.com.au/story/4764907/male-company-rep-at-womans-pelvic-surgery/
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KY Attorney General returns nearly $8MM to state General Fund
Jun 30, 2017 | Heartland News (In KFVS)
FRANKFORT, KY (KFVS) -
As the current fiscal year ends, Kentucky Attorney General Andy Beshear has announced that his office has returned nearly $8 million to the state’s General Fund from a variety of civil settlements over the last 12 months.
According to a press release from his office, included in that amount is $574,000 Beshear returned today to the state’s General Fund from a settlement with a Johnson & Johnson subsidiary. Combined with Beshear’s Bryant Heating and Cooling Co. Inc. settlement, the AG’s office has secured more than $1 million for the state this week.
The Johnson & Johnson settlement resolves allegations that McNeil Consumer Healthcare Division, which is now a division of Johnson & Johnson Consumer Inc., promoted over-the-counter drugs as complying with federally mandated manufacturing standards even though the U.S. Food and Drug Administration found that some of its manufacturing facilities were not in compliance with federal standards between 2009 and 2011.
The drugs include Tylenol, Motrin, Benadryl, St. Joseph Aspirin, Sudafed, Pepcid, Mylanta, Rolaids, Zyrtec and Zyrtec Eye Drops – all manufactured and distributed by McNeil Consumer Healthcare Division.
“At a time when the state is facing a projected current fiscal year budget shortfall of $113 million, I’m proud my office is doing its part to secure millions of dollars for our state coffers,” Beshear said.
These civil settlements include Mortgage Electronic Registration Systems Inc. (MERS), Volkswagen, Hyundai-Kia, Bristol-Myers Squibb, Western Union, Target, Bryant Heating and Cooling Co. Inc. and Johnson & Johnson Consumer Inc.
Beshear is currently in civil litigation against Johnson & Johnson and its medical device unit, Ethicon, for its deceptive marketing of surgical transvaginal mesh.
http://www.kfvs12.com/story/35790526/ky-attorney-general-returns-nearly-8mm-to-state-general-fund
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