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Ethicon Media Monitoring 7/27/2017
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Philly judge reverses pelvic mesh win for Johnson & Johnson
Jul 27, 2017 | Mass Device
By Brad Perriello
A Pennsylvania state court judge last week overturned part of a jury verdict that gave Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon its first win in five pelvic mesh trials in Philadelphia. -
Opinion: Why the US Can’t Get its Mesh Message Out
Jul 26, 2017 | Mesh Medical Device Newsdes
The following is one woman’s opinion on why the US is not having the same outcome in getting out its mesh message to the media. What she doesn’t mention is that law firms representing the injured have all warned their clients to keep quiet and suffer in silence, unlike the united and vocal voices in Scotland and England -
UK Mesh Report- A Whitewash?
Jul 27, 2017 | Mesh Medical Device Newsdesk
A report from the UK government stops short of calling for an outright mesh ban such as is underway in Scotland. -
NHS England releases report on vaginal mesh devices
Jul 26, 2017 | Medical Plastics News
A report has been released by the NHS on the use of vaginal mesh implants in women following controversy surrounding the devices. -
One in two pelvic mesh patients readmitted to hospital with complications: nib
Jul 27, 2017 | Newcastle Herald
By Joanne McCarthy
NEARLY one in two women insured by nib for pelvic mesh surgery have required readmission to hospital because of complications, the health insurer said in a submission to the Senate inquiry into pelvic mesh devices. -
Despite Growing Lawsuits and Injuries, the Hernia Mesh Market is Expected to Grow
Jul 26, 2017 | The Ring of Fire
By KJ McElrath
As of July 17th, there were no fewer than 84 lawsuits pending against Johnson & Johnson subsidiary, Ethicon, Inc., citing injuries caused by its Physiomesh hernia repair products as the cause of action. That number represents an increase of nearly 20% over the previous month.
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Philly judge reverses pelvic mesh win for Johnson & Johnson
Jul 27, 2017 | Mass Device
By Brad Perriello
A Pennsylvania state court judge last week overturned part of a jury verdict that gave Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon its first win in five pelvic mesh trials in Philadelphia.
Last month a jury in the Philadelphia Court of Common Pleas cleared Ethicon in the fourth pelvic mesh bellwether to go to trial there, despite finding that the company’s TVT-Secur product was defectively designed and that Ethicon failed to warn of its risks.
Kimberly Adkins had sued in 2013, alleging that the TVT-Secur mesh she was implanted with in July 2010 to treat urinary incontinence caused her injuries. After a 12-day trial, the jury agreed with Adkins’ defective-design and failure-to-warn claims but decided that her injuries were not caused by the device.
But a July 19 decision by Judge Michael Erdos reversed the win, ordering Ethicon to face damages on the defective design claim. Erdos also denied Adkins’ arguments over one of the jurors and the defective design claim, according to court documents.
The win had been the first in the Philly court for J&J, which was hit in April with a $20 million blow in the 3rd bellwether to go to trial there. Another Philadelphia jury also found for the plaintiff, awarding $13.5 million in February 2016; a Pennsylvania state judge in January upheld that verdict. And in December 2015, a jury added $7 million in punitive damages to the $5.5 million in compensatory damages it leveled against Ethicon in the 1st of the mass tort cases.
Ethicon has asked the U.S. Supreme Court to review another pelvic mesh loss, after losing an appeal of the $3.3 million verdict over its TVT-O pelvic mesh. A jury in the U.S. District Court for Southern West Virginia found for Jo Huskey in September 2014s. A federal judge later shot down Ethicon’s bid to overturn the verdict and denied the company’s move for a new trial; Ethicon then appealed to the U.S. Court of Appeals for the 4th Circuit, which denied the appeal. Ethicon’s petition for certiorari to the Supremes, filed May 23, alleges that the appellate court improperly excluded product review evidence after misreading the relevant precedent.
http://www.massdevice.com/philly-judge-reverses-pelvic-mesh-win-johnson-johnson/
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Opinion: Why the US Can’t Get its Mesh Message Out
Jul 26, 2017 | Mesh Medical Device Newsdes
Mesh Medical Device News Desk, July 26, 2017 – The following is one woman’s opinion on why the US is not having the same outcome in getting out its mesh message to the media. What she doesn’t mention is that law firms representing the injured have all warned their clients to keep quiet and suffer in silence, unlike the united and vocal voices in Scotland and England.
She also omits that there have been successful rallies organized by MAM Mesh Awareness Movement that have brought together many women to stand present at court and at a J&J Shareholder’s meeting.
Let’s not forget Johnson & Johnson has a family of products and is also a major mesh manufacturer. Media might be loathe to bite the advertising hand that feeds.
Here is the Opinion of Still Standing, who is herself a mesh injured woman:
“I debated whether to respond to this call for one voice.
“I’ve stated my observation about this before, but here goes. One of the reasons American mesh injured women are not getting the attention it deserves is there is not one voice, one message that we could rally around. Take a look at the communication the British, Scottish and Australian women are putting out there. They want pelvic mesh removed from the market until further study. It is consistent and has great merit. It is a clear message that other non mesh people can get behind.
“They are not jumping in and excoriating the justice system, they are not saying that all polypropylene in any device should be removed from the market, they are not drawing scientific conclusions about mesh based on just their opinion, they are not pitted against each other with unkind remarks about who should be in their group and who shouldn’t based on some arbitrary judgement about who has the most pain and suffering. They are not saying the government is conspiring to hurt them because they are women.
“Here is what they are doing.
“They have crafted a message for the future. They do not want other women to suffer the way that they have suffered. This is a group that is fighting to prevent this from happening in the future. I’m sure they all want justice for themselves, but that is not the narrative they are using in this request to ban pelvic mesh. I even saw in one articles that she wanted two women to be prepared for an interview at Parliament.
“They are carefully controlling this message so that physicians and other people in power to make this happen hear that one true message that the press can rally around.
It is working. We could learn a lot about how they have handled this issue.” ###
http://www.meshmedicaldevicenewsdesk.com/turn-us-cant-get-mesh-message/
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Jul 27, 2017 | Mesh Medical Device Newsdesk
Mesh Medical Device News Desk, July 26, 2017 ~ A report from the UK government stops short of calling for an outright mesh ban such as is underway in Scotland.
Anger is erupting at a newly released government report on transvaginal mesh.
The report released this week is here.
At least 7,800 women in the UK have been implanted with polypropylene transvaginal mesh used to treat incontinence and pelvic organ prolapse.
U.S. manufacturers export their meshes globally so mesh injuries are showing up in Australia and New Zealand, Israel, Scotland, Ireland, Britain, So. Africa, among other countries.
The Daily Mail reports the three-year investigation by NHS England calls for a helpline to support victims and concludes there are many more women then are known who have been injured by surgical mesh, but it rejects calls for a ban.
The report says surgeons should be adequately trained to implant pelvic mesh. At the present time, any gynecologists can implant mesh. And it says women should receive informed consent. What is rarely discussed is what constitutes “Informed Consent” since no one agrees on an estimated number of injuries expected to occur from various mesh implant procedures.
Talks about informed consent, improving reporting and offering all appropriate treatments, non surgical mesh and non-mesh to patients. But what is informed consent? And how can doctors deliver it when they don’t agree on the percentage of complications?
The summary talks about ideals, goals and best practices, the use of a national database and appraisal system- things not practically in force now. If anything it encourages surgeons to be performing at least 20 sub-urethral slings procedures every year to stay current.
The group still support the use of mesh for incontinence although encourages further research.
As far as mesh for pelvic organ prolapse or POP?
“The use of vaginal mesh in primary procedures to treat POP is not supported by the current evidence and this should not be offered routinely for the first surgical intervention.”
This is also the standing of the FDA because of the awareness of complications that arise later after the procedure, even up to ten years after a POP mesh implant.
MESH COMPLICATION REPORTING
The “Yellow Card” is a reporting system that is supposed to record adverse event, not unlike the MAUDE system that is part of the U.S. Food and Drug Administration. Sling The Mesh campaigner, Kath Sansom tells Mesh News Desk no one is aware of it so it is not used. This report urges women to make their complication reports to the Yellow Card.
The Daily Mail quotes Teresa Hughes who has been an active mesh campaigner after her implant in 2006. “All the doctors I’ve seen think this material should be banned. We wanted a proper register of how many meshes were implanted, how many were removed and mandatory reporting of problems to get a scale of the problem. ‘This inquiry and the way we have been dealt with has been utterly disgraceful, and whitewash is the only word for this report.’
Hughes was one of seven representatives from victims group who reported to the Mesh Oversight Group, headed by the National Health Service.
The Daily Mail reports one year after the group was formed three years ago, the group stopped intake from involved doctors.
Dr. Suzy Elneil tells the newspaper she thinks the government hopes this problem will just go away.
“They insist the complications are only 1 to 3 percent, but that’s ignoring data showing complications averaging up to 40 percent in some studies.”
Anti-mesh campaigns criticize the Mesh Oversight Group for having conflicts of interest with industry that makes mesh implants.
An interim report was issued by the Mesh Working Group in December 2015 here.
While it encourages more reporting of adverse events and collection of that data, informed consent is important and should be reviewed every two years. Informed consent might take longer. It does not call for any ban into the procedure or on the use of transvaginal mesh.The question was would it be another whitewash as campaigners called the Scottish report on mesh, which is here. (March 2017). ###
http://www.meshmedicaldevicenewsdesk.com/uk-mesh-report-whitewash/
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NHS England releases report on vaginal mesh devices
Jul 26, 2017 | Medical Plastics News
A report has been released by the NHS on the use of vaginal mesh implants in women following controversy surrounding the devices.
The Mesh Oversight Group Report was released in response to the 2015 Mesh Working Group Interim Report.
Both reports are about the use of the devices to treat stress urinary incontinence (SUI) and pelvic organ prolapse (POP) in women.
The report states that the devices are a safe option for women suffering from SUI and POP which can occur following childbirth. A number of women across the world have spoken out about the pain they’ve experienced because of the implants. More so, a number of court cases have been launched again Johnson & Johnson, a high-profile manufacturer of the device.
A number of recommendations are made in the report to help improve the information surrounding the use of the device and also the consent process of treatment involving the implants.
In particular the report states that improvements should be made to surgical practice and training, clinical guidance and standards should be updated and GPs should be made aware of any post-operative problems. Women should also have greater access to clinical expertise.
The report goes on to state that any problems caused by the implants should have improved recording processes for a larger picture of the seriousness of the issue. Women should also be made more aware of the pros and cons of the treatment option. Patient information leaflets will be made available at GP practices.
Other developments include changes to the way surgery is recorded by hospitals and surgeons, and named units where a multi-disciplinary team of health professionals can advise women who are experiencing problems.
In the report, professor Keith Willett says: “It is right and proper for those who deliver, lead and regulate health care to listen to patients’ concerns and work with all parties to resolve them. A programme of work was initiated in response to concerns from women who developed complications following surgery using vaginal mesh devices to treat stress urinary incontinence (SUI) and treat pelvic organ prolapse (POP). These women felt their concerns had been ignored. I recognised there were issues to be addressed.”
Willett goes on to say that the recent report should be read in conjunction with the Independent Review of Transvaginal Mesh Implants in Scotland which had its final release in March 2017.
http://www.medicalplasticsnews.com/news/medical-devices/nhs-england-releases-report-on-vaginal-mesh-devices/
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One in two pelvic mesh patients readmitted to hospital with complications: nib
Jul 27, 2017 | Newcastle Herald
By Joanne McCarthy
NEARLY one in two women insured by nib for pelvic mesh surgery have required readmission to hospital because of complications, the health insurer said in a submission to the Senate inquiry into pelvic mesh devices.
Of 138 women who have had mesh implants for incontinence or prolapse repair between 2011 and March this year, 60 were readmitted to hospital for further treatment, nib executive for benefits and provider relations, Dr Justin Vaughan, said in the submission released on Tuesday before a first public hearing in Melbourne on August 3, and Perth in August 25.
Complications range from “mechanical failure and other issues affecting nearby organs through to infection”, Dr Vaughan said.
The nib figures, while conceded by Dr Vaughan as providing a “limited window on the issue”, directly challenge public statements by Australian regulators, doctors’ organisations, medical colleges and manufacturers that complication rates – particularly for incontinence devices – are low.
They also clash with figures by Australia’s peak device regulator, the Therapeutic Goods Administration, showing only 99 Australian women had adverse events after mesh surgery between 2012 and 2016.
In an internal document in 2013 the TGA conceded it only received between 10 and 20 per cent of adverse event reports, in a system that relies on mesh device manufacturers as the only mandatory reporters of complications.
No manufacturer has been prosecuted for failing to report a mesh device adverse event to the TGA, despite thousands of Australian women reporting serious complications, and penalties of up to $180,000 and a 12-month jail term.
nib chief executive Mark Fitzgibbon on Wednesday said the pelvic mesh scandal exposes fundamental weaknesses in the Australian health industry, including a lack of transparency about doctors’ skills and histories that leaves patients at risk in a system “still back in the 19th century”.
Change comes when patients start reporting poor experiences. Sadly, typically, it takes controversies before there’s change.- nib chief executive Mark Fitzgibbon.
nib paid out $1.6 million in benefits to 138 women implanted with pelvic mesh devices for incontinence and prolapse between 2011 and March this year, and an additional $330,000 to treat 60 of the women readmitted to hospital after complications.
The health insurer’s Dr Justin Vaughan labelled the TGA figure an “under-reporting of the issue if nib customer incidence is used as a measure”, in a submission to the mesh inquiry calling for a clinical registry for any at-risk prosthetic devices in Australia to “enable more accurate assessment and risk management”.
“Other prostheses have been identified as causing significant injuries to patients, for example the metal on metal hip replacements, and where there is a risk there has been a clinical registry to provide ongoing monitoring,” Dr Vaughan said.
In the case of pelvic mesh devices the TGA continues to rely on manufacturers reporting adverse events, in addition to doctors and patients voluntarily reporting, despite an internal TGA report in 2013 acknowledging doctors had a low level of awareness of the adverse events reporting system.
In an interview on Wednesday nib chief executive Mark Fitzgibbon said the mesh scandal highlighted the need for patients to have much greater access to information about the health practitioners treating them, and the trust relationship between doctor and patient needed to be brought into the 21st century.
“Change comes when patients start reporting poor experiences. Sadly, typically, it takes controversies before there’s change,” Mr Fitzgibbon said.
Information on the clinical performance of doctors is missing and where there is information it’s not transparent, he said.
A doctor’s history of complaints, investigations and legal actions and settlements was also largely beyond the public and health insurers, including nib which established the website Whitecoat in 2011 to provide opportunities for patients to give feedback about their health experiences.
“If some doctor has been sued, we’d never know that,” he said.
“We want to provide patients with a large amount of patient feedback. We also do patient outcome measures where we go back to them 6-12 months after treatment and ask how they’re going,” Mr Fitzgibbon said.
Very few (if any) hospitals or specialist doctors make their rates of complications publicly available. This means that women rarely have access to full information about the surgery and the ramifications.- Australian College of Midwives chief executive Ann Kinnear.
“Had more women known about the negative outcomes other women had experienced from mesh surgery they would have been more informed about the possible consequences.
“Most patients put their faith in GPs and specialists to do the right thing, and they rely on the fact their providers are certified by Medicare. But there’s no information from other patients about their experiences with doctors, and this is the vacuum Whitecoat’s trying to fill.”
Mr Fitzgibbon’s call for greater transparency in the health system was backed by a submission to the Senate inquiry from Australian College of Midwives chief executive officer Ann Kinnear, who said “very few (if any) hospitals or specialist doctors make their rates of complications publicly available”.
“This means that women rarely have access to full information about the surgery and the ramifications. In addition, very few specialist doctors provide information about their own level of skill and training with this specific procedure,” Ms Kinnear said.
The college has called on the Senate inquiry to recommend specialist doctors should be required to publish their skill and training with pelvic mesh procedures, and public and private hospitals should be required to publish their complication rates.
The nib submission – the only submission by a health insurer made available on the Senate inquiry’s website – reveals the large sums paid by insurers and Australia’s health system for pelvic mesh devices over the past 15 years.
Insurers are required to pay about $800 per device in benefits once they are cleared for use by the Therapeutic Goods Administration, nib’s Dr Justin Vaughan said.
More than 100 mesh devices were cleared for use in Australia over the past 15 years, with more than 15,000 of just one device – the now cancelled Tissue Fixation System (TFS) device developed by Australian Dr Peter Petros – sold in that time.
The nib figures do not give a breakdown of whether the complication rates relate to mesh devices for incontinence – including Johnson & Johnson TVT devices repeatedly described as “gold standard” by some doctors and groups, and the subject of a Federal Court class action – or transvaginal polypropylene mesh devices, which the Royal Australian and New Zealand College of Obstetricians and Gynaecologists said are “not recommended as the first line treatment of any vaginal prolapse”.
http://www.theherald.com.au/story/4814835/clash-of-mesh-figures/
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Despite Growing Lawsuits and Injuries, the Hernia Mesh Market is Expected to Grow
Jul 26, 2017 | The Ring of Fire
By KJ McElrath
As of July 17th, there were no fewer than 84 lawsuits pending against Johnson & Johnson subsidiary, Ethicon, Inc., citing injuries caused by its Physiomesh hernia repair products as the cause of action. That number represents an increase of nearly 20% over the previous month.
Despite this increase in litigation, the number of hernia repair surgeries using mesh devices has been growing – and this growth is projected to continue. According to recent market research, synthetic mesh products such as the Physiomesh are expected to lead this trend. Last year, synthetic meshes accounted for nearly 64% of global sales, largely because “incredible clinical acceptance from surgeons and the government” – and their lower costs. Over 46% of hernia repair mesh devices are sold in the U.S. and Canada.
While the price of hernia repair mesh may be relatively low, it has proven to be very costly to many patients in terms of their health and well-being. In some cases, that cost has been the patient’s life.
Last December, the U.S. Food & Drug Administration reported ten fatalities associated with the Ethicon Physiomesh device. Among the injuries attributed to hernia mesh are severe chronic pain, perforated organs, infections and complications caused by erosion of the mesh. Although Ethicon issued a recall for the Physiomesh in April 2016, many of these devices remain implanted in patients because of the difficulty in removing them.
The Ethicon Physiomesh received FDA approval in 2010 through the highly questionable510(k) Pre-market Clearance process. Over the next six years, there were an estimated 300,000 patients who wound up receiving the device before it was finally recalled. Significantly, Ethicon’s “urgent” Field Safety Notice fails to note any deaths or injuries resulting from the product. All it says is that “recurrence/reoperation rates…using ETHICON PHYSIOMESH™ Composite Mesh were higher than the average rates of the comparator set of meshes among patients” in two selected European registries. The company “believes the higher rates to be a multifactorial issue (including possible product characteristics, operative and patient factors), but has not been able to fully characterize these factors.”
According to plaintiffs, the problem lies with the defective design of the Physiomesh. Similar to the pelvic mesh that was the cause of action in previous litigation, the Physiomesh is made from synthetic woven, non-absorbable polypropylene plastic filaments, which is then coated with an absorbable film coating. According to Ethicon, the purpose of the film coating is to ease incorporation of the mesh into the patient’s tissues, thereby reducing the rate of inflammation.
Instead, it has had the opposite effect. According to the complaint, when the device is implanted into the patient,
“...the impermeable multi-layer coating of the Physiomesh prevents fluid escape, which leads to seroma formation, and which in turn can cause infection, abscess formation and other complications…[providing] a breeding ground for bacteria in which the bacteria cannot be eliminated by the body’s immune response, which allows infection to proliferate.”
The case will be heard in the Northern District of Georgia, with the Honorable Judge Richard Story presiding. An initial conference is scheduled for August 1st.
https://trofire.com/2017/07/26/despite-growing-lawsuits-injuries-hernia-mesh-market-expected-grow/
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