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Ethicon Media Monitoring 11/6/2017
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HSE admits lack of patient data on ‘risky’ implants
Nov 6, 2017 | The Times
By Ellen Coyne
The HSE does not know how many women in Ireland could be affected by a controversial vaginal procedure that has been found to be extremely high-risk in other countries. -
Carlow mum tells of her horror after transvaginal mesh implant leaves her bed bound and crippled with pain
Nov 4, 2017 | The Sun
By Fiona Ellis
Janet Roche, 48, had a transvaginal mesh implant fitted but has warned other women 'don't do it... it's not worth it' as the procedure can go 'dramatically wrong' -
Australia's health watchdog accused of 'too close' relationship with industry
Nov 5, 2017 | The Border Mail
By Joanne McCarthy
Australia's drug and medical device watchdog, the Therapeutic Goods Administration, needs a complete overhaul to distance it from the health industry and allow consumers to sue it for negligence, say academics and consumer advocates after the regulator quietly announced moves to classify all pelvic mesh devices high risk after years of controversy. -
No. 351-Transvaginal Mesh Procedures for Pelvic Organ Prolapse.
Nov 6, 2017 | UroToday
This guideline reviews the evidence related to the risks and benefits of using transvaginal mesh in pelvic organ prolapse repairs in order to update recommendations initially made in 2011. -
Texas Plaintiff Joins Flood of Lawsuits Citing Ethicon Physiomesh Problems
Nov 6, 2017 | Lawyers and Settlements
By Gordon Gibb
Atlanta, GAEthicon Physiomesh may be off the market at the behest of its manufacturer, but that hasn’t stemmed the flood of lawsuits that have been piling up in multidistrict litigation. In this case, the surgical mesh lawsuit has been filed by a plaintiff with the surname Flood.
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HSE admits lack of patient data on ‘risky’ implants
Nov 6, 2017 | The Times
By Ellen Coyne
The HSE does not know how many women in Ireland could be affected by a controversial vaginal procedure that has been found to be extremely high-risk in other countries.
New figures have shown that more than 3,000 Irish women were treated for stress incontinence or pelvic prolapses in 2015 and 2016, but the health service does not know how many had a transvaginal mesh implanted.
The mesh tape is inserted into the vagina to support the bladder, womb or bowel as part of a treatment for incontinence or prolapse issues after childbirth. Removal involves a major operation because the implants are designed to be permanent and become embedded in surrounding tissue.
Some patients have experienced debilitating and sometimes permanent pain years after the procedure. More than 800 women are taking legal action against the NHS in Britain and the manufacturers of the mesh. The use of the implants has been suspended in Scotland and it has been reclassified as a high-risk procedure in Australia and the US.
Louise O’Reilly, Sinn Féin’s health spokeswoman, said that reported issues with the mesh in other countries required closer examination by the Irish health services. “Ireland can’t be an outlier, it can’t be the case that women are having complications from these devices everywhere else in the world and it’s not happening here,” she said.
She expressed concern that the HSE had not recorded the number of women who had had the mesh tape implanted. In response to parliamentary questions from Ms O’Reilly, the HSE said that in 2015, 817 women were treated for prolapse issues, with 728 treated last year. In 2015, 864 women were treated for stress incontinence, with 735 women treated in 2016. It does not have data for how many were treated with the mesh.
Kilian McGrane, programme director of the national women and infants health programme, said that the HSE also did not know how many women in Ireland were taking legal action because of pain and discomfort after the procedure.
Ms O’Reilly said the HSE had to explain why it did not appear to consider the issue as “significantly” as other health services around the world. “We currently have no database of how many women received these device implants. The health service from GPs to acute hospital consultants do not have the requisite skills to identify and deal with any issues that could be arising from these implants and women are not aware that they may be at risk of complications from it because this issue is only recently coming to light,” she said.
She has called on Simon Harris, the health minister, to ensure that private and HSE surgeons who performed the procedure write to women with mesh implants to outline possible side-effects and complications that they could experience.
More than 92,000 women had mesh tape installed in England between April 2007 and March 2015. About one in 11 experienced problems. The legal action against the UK’s national health service targets manufacturers including Johnson & Johnson, the US pharmaceutical giant, which has paid tens of millions of dollars to affected women in America. Johnson & Johnson’s subsidiary Ethicon said it was “vigorously defending litigation” and said its devices had helped millions of women. More than 400 Scottish women are taking legal action because of the same issue.
https://www.thetimes.co.uk/edition/ireland/hse-admits-lack-of-patient-data-on-risky-implants-dj3tscwtw
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Nov 4, 2017 | The Sun
By Fiona Ellis
Janet Roche, 48, had a transvaginal mesh implant fitted but has warned other women 'don't do it... it's not worth it' as the procedure can go 'dramatically wrong'
She said: “The pain was that bad, I couldn’t even move. It scared the life out of me. I couldn’t think straight when it started, and I never knew when it was going to kick off.
For mum-of-four Janet, from Tullow, Co Carlow, choosing to get the procedure is the biggest regret of her life.
She said: “The incontinence wasn’t even that bad, it was inconvenient and it was suggested to me this might be a quick solution. And I thought, ‘If it’s 20 minutes, why not?’
“It is the single worst decision I ever made. It’s devastated my entire life. I did it for quality of life. I have two older kids, and two younger ones. But I have no quality of life.
“It’s devastating what I’ve missed. I never took a tablet before the procedure. I lost my job for a start, I was customer care in McDonalds in Carlow here. I’ve had to go on invalidly pension.
“My husband William, he’s my carer now. I can’t contribute to my family. Even money wise, we still have a mortgage and bills. It’s very, very hard to stay positive.”
Janet had a partial removal of the mesh in April, and has seen slight improvement, but still has remnants in her legs and is dependent on medication.
She explained: “It goes up and down through the muscle and comes out through your thighs.
“Pain-wise, I get terrible pains in my legs and terrible pins and needles in my feet because the mesh is still in my legs.”
Urging other women to be aware of the procedure’s potential problems, Janet added: “Don’t do it, it’s not worth it. They have to know when it goes wrong, it goes drastically wrong.”
Sinn Fein health spokesperson Louise O’Reilly has called for the use of transvaginal mesh to be immediately addressed by the HSE and Department of Health.
The Health Products Regulatory Authority told O’Reilly that it does “not routinely collect or maintain information on the number of women in Ireland who have received transvaginal mesh devices or vaginal mesh implants”.
But to date the body has identified two unconfirmed reported incidents in respect of transvaginal mesh devices and vaginal mesh implants.
O’Reilly said: “I believe that this is only the tip of the iceberg and that the HSE need to immediately conduct a review into how many patients received a transvaginal mesh implantation as part of a healthcare procedure.”
https://www.thesun.ie/fabulous/1759150/carlow-mum-tells-of-her-horror-after-transvaginal-mesh-implant-leaves-her-bed-bound-and-crippled-with-pain/
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Australia's health watchdog accused of 'too close' relationship with industry
Nov 5, 2017 | The Border Mail
By Joanne McCarthy
Australia's drug and medical device watchdog, the Therapeutic Goods Administration, needs a complete overhaul to distance it from the health industry and allow consumers to sue it for negligence, say academics and consumer advocates after the regulator quietly announced moves to classify all pelvic mesh devices high risk after years of controversy.
"The current regulatory framework is a complete bypass of the interests of consumers. They don't have a stake at the table," said University of Canberra academic Wendy Bonython, after the TGA said the new classification would mean "higher evidentiary requirements" before new devices are approved for use in Australia, and for existing approved devices.
The move comes more than a decade after many pelvic mesh devices were cleared for use by the TGA with little or no independent evidence of safety and efficacy.
The announcement on the TGA's website on October 26 also follows evidence at a Senate inquiry about the devastating and permanent consequences of mesh surgery for thousands of Australian women, and a class action by women against mesh manufacturer Johnson & Johnson.
Dr Bonython and University of Canberra associate professor Bruce Arnold told the Senate inquiry the TGA's "industry-funded model of regulation" raises questions about the regulator's independence in the wake of a string of device scandals, including pelvic mesh, joint prostheses, breast and contraceptive implants, cardiac stents and pacemakers.
The failures indicate "systemic weaknesses in the prevention of and response to foreseeable harms", with the "enormous" cost borne by individuals and the broader community, they said.
"Trying to run a regulator on a shoestring, particularly a medical device regulator, is a bit of a false economy because if we're not investing in the regulator, chances are we're going to be subsidising its failures through things like the National Disability Insurance Scheme or Medicare, or lack of productivity," Dr Bonython said.
"There needs to be a clear break between the regulator and the parties they're trying to regulate."
The two academics called on the Senate inquiry to investigate legislated indemnity provisions that protect the TGA from being sued for negligent performance of its regulatory functions.
"The TGA can't be sued for negligence. It doesn't matter how negligent the regulator, it can get away with it, which is problematic because it removes any incentive towards carefulness," Dr Bonython said.
There was a "lack of political will" to make hard decisions to protect consumers, she said.
"We've been writing about this since 2010. In that time we've seen a number of device scandals, inquiries, class actions, but we haven't actually seen much in the way of meaningful action on the floor of parliament. This is looking like a recurring pattern. Why are we getting so many dodgy implants?"
The medical profession's "fair degree of lobbying power" and pharmaceutical companies as "big ticket players in the economy" were issues when it came to consumer protections, she said.
In evidence to the Senate inquiry, Dr Bonython said the TGA's approval of some devices, including pelvic mesh devices, on the basis of post-market monitoring was "problematic".
"At the very least it needs to be flagged as an experimental device until such time as there is a sufficient body of evidence indicating that it's safe to use," Dr Bonython said.
Gynaecologist Professor Christopher Maher, who first raised concerns about a pelvic mesh device in a paper in 2003, told a Senate inquiry hearing that the TGA was "the first level of oversight" for new devices and drugs, but pelvic mesh devices were approved without independent evidence of safety and efficacy.
Professor Maher told the inquiry he had "sort of a frosty relationship" with the TGA after raising serious questions about pelvic mesh devices during internal reviews by the regulator over a number of years.
"With hindsight, I think, everyone in the TGA would say they wished that they didn't allow these products through when there wasn't much evidence supporting those products," Professor Maher said.
The Federal Government-funded Consumers Health Forum of Australia, representing state consumer health groups, told the Senate inquiry the approval and marketing of pelvic mesh devices for more than a decade represented a "catastrophic system-wide failure", that included the TGA and its processes.
The TGA's adverse events reporting system to detect serious drug and device problems was described by women as "something of a black hole, with lots of information going into it but nothing visible coming out", the forum said.
Forum member and Victorian Health Issues Centre chief executive Danny Vadasz said the nexus between companies, the medical profession and the TGA was "insidious and undermines the integrity of our regulatory system".
"What quality of guardianship can you expect when the poacher is paying the wages of the gamekeeper?" Mr Vadasz said.
"The government must act to give the TGA financial independence from big pharma, to raise the evidentiary bar on safety and quality and to be held accountable for its singular purpose, to protect the safety of the public.
"Until we have such legislative reform public health will remain hostage to the sales and marketing targets of medical device manufacturers."
Forum member and Western Australian Health Consumers Council executive director Pip Brennan said the "appalling outcomes some women had experienced from TGA-approved pelvic mesh implants highlights a fundamental flaw in how our regulatory system is working".
"The recent quiet announcement of the up-classification of mesh devices still does not reassure as there is no guarantee consumers will be provided with relevant consent documentation and there is still no commitment to create a register to track the devices being implanted," Ms Brennan said.
"There must be a separation between income for our regulatory body, and the approval of devices. No one has a higher stake in a medical device than the patient who is having something permanently implanted, and yet consumers are not at the decision-making table of the TGA. This needs to change."
Federal Health Minister Greg Hunt's office referred questions to the TGA, which "totally rejected" claims it had a too-close relationship with industry because of its funding model.
"Industry has no say whatsoever in how TGA spends the revenue it receives from other industry charges. This system has been in place for more than 20 years and there has been no evidence of any sort of 'regulatory capture'," a spokesperson said.
"Other medicines and device regulators internationally also are fully or significantly funded by industry fees and charges and operate in the same way. This takes the burden off the taxpayer for such time-consuming scrutiny.
"It is accepted as best regulatory practice for regulators to have a good understanding of and working relationship with the regulated entities. So, while the TGA meets frequently with industry and other stakeholders, including consumer and healthcare groups, it maintains a professional but arm's length relationship and does not include them in any final decision-making once consultations are completed."
The TGA said it accepted evidence from an expert committee in 2008 that recommended it continue to monitor meshes, but the reported rate of complications was low. By 2013 an internal TGA report acknowledged its adverse event reporting system only received 10-20 per cent of all adverse events because it relied on manufacturers to report complications.
The TGA has not prosecuted one mesh manufacturer for failing to report complications, despite it being a criminal offence carrying a jail term and substantial fine.
In 2014 the regulator cancelled the first of more than 40 pelvic mesh devices and increased monitoring and reporting requirements for remaining devices.
In its statement the TGA said "it must be emphasised that the TGA does not regulate clinical practice and decisions by doctors to use these devices".
http://www.bordermail.com.au/story/5035272/australias-health-watchdog-accused-of-too-close-relationship-with-industry/?cs=7
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No. 351-Transvaginal Mesh Procedures for Pelvic Organ Prolapse.
Nov 6, 2017 | UroToday
This guideline reviews the evidence related to the risks and benefits of using transvaginal mesh in pelvic organ prolapse repairs in order to update recommendations initially made in 2011.
Gynaecologists, residents, urologists, urogynaecologists, and other health care providers who assess, counsel, and care for women with pelvic organ prolapse.
Adult women with symptomatic pelvic organ prolapse considering surgery and those who have previously undergone transvaginal mesh procedures for the treatment of pelvic organ prolapse.
The discussion relates to transvaginal mesh procedures compared with other surgical options for pelvic organ prolapse (mainly about vaginal native tissue repairs and minimally about other alternatives such as biological and absorbable vaginal mesh and abdominally placed surgical mesh).
The outcomes of interest are objective and subjective success rates and intraoperative and postoperative complications, such as adjacent organ injury (urinary, gastrointestinal), infection, hematoma/bleeding, vaginal mesh exposure, persistent pain, dyspareunia, de novo stress urinary incontinence, and reoperation.
PubMed, Medline, the Cochrane Database, and EMBASE were searched using the key words pelvic organ prolapse/surgery*, prolapse/surgery*, surgical mesh, surgical mesh*/adverse effects, transvaginal mesh, and pelvic organ prolapse.
were restricted to English or French language and human research. Articles obtained through this search strategy were included until the end of June 2016. Pertinent new studies were added up to September 2016. Grey literature was not searched. Clinical practice guidelines and guidelines of specialty societies were reviewed. Systematic reviews were included when available. Randomized controlled trials and observational studies were included when evidence for the outcome of interest or in the target population was not available from systematic reviews. New studies not yet included in systematic reviews were also included. Only publications with study groups larger than 20 individuals were selected because this criterion was used in the largest meta-analysis referenced in this guideline. A total of 1470 studies were obtained; after selecting only applicable studies and excluding duplicates, 68 manuscripts were reviewed and included.
The content and recommendations were drafted and agreed upon by the principal authors and members of the Urogynaecology Committee. The Board of the Society of Obstetricians and Gynaecologists of Canada approved the final draft for publication. The quality of evidence was rated using the criteria described in the Grading of Recommendations Assessment, Development and Evaluation methodology framework. The Summary of Findings is available upon request.
It is expected that this guideline will benefit women with pelvic organ prolapse by ensuring that health care providers are aware of outcomes related to transvaginal mesh procedures and steps in the management of related complications. This should guide patient-informed consent before such procedures are undertaken. The benefits clearly outweigh the potential harms or costs of implementation of this guideline, although no direct harms or costs are identified.
Evidence will be reviewed 5 years after publication to decide whether all or part of the guideline should be updated. However, if important new evidence is published prior to the 5-year cycle, the review process may be accelerated for a more rapid update of some recommendations.
RECOMMENDATIONS.
Journal of obstetrics and gynaecology Canada : JOGC = Journal d'obstetrique et gynecologie du Canada : JOGC. 2017 Nov [Epub]
Maryse Larouche, Roxana Geoffrion, Jens-Erik Walter
http://www.urotoday.com/recent-abstracts/pelvic-health-reconstruction/stress-incontinence/99796-no-351-transvaginal-mesh-procedures-for-pelvic-organ-prolapse.html
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Texas Plaintiff Joins Flood of Lawsuits Citing Ethicon Physiomesh Problems
Nov 6, 2017 | Lawyers and Settlements
By Gordon Gibb
Atlanta, GA Ethicon Physiomesh may be off the market at the behest of its manufacturer, but that hasn’t stemmed the flood of lawsuits that have been piling up in multidistrict litigation. In this case, the surgical mesh lawsuit has been filed by a plaintiff with the surname Flood.
Plaintiff Amy Flood, a woman from Texas, received Ethicon Physiomesh Composite Mesh in October 2015 to repair a hernia. The mesh in question, measuring 10cm by 15cm, was placed by way of a laparoscopic incisional procedure that avoids a more invasive impact to skin, muscle and underlying tissue and instead uses a tube through which a rolled-up section of mesh is inserted by way of a small incision and guided into place by a surgeon using a camera, before deploying the mesh at the appropriate site.
Laparoscopic surgery has been found to lessen blood loss, speed healing and reduces the strain on hospital resources. However, the fallout has been an increase transvaginal mesh and hernia mesh lawsuits.
Amidst a growing parade of complaints and surgical mesh side effect lawsuits, Ethicon voluntarily recalled the Physiomesh product from the market last year.
“Defendants’ Physiomesh was defectively designed and/or manufactured, was not reasonably safe for its intended use in hernia repair, and the risks of the design outweighed any potential benefits associated with the design,” Flood’s lawsuit states. “As a result of the defective design and/or manufacture of the Physiomesh, there was an unreasonable risk of severe adverse reactions to the mesh or mesh components including: chronic pain; recurrence of hernia; foreign body response; rejection; infection; inadequate or failure of incorporation/ingrowth; migration; scarification; deformation of mesh; improper wound healing; excessive and chronic inflammation; adhesions to internal organs; erosion; abscess; fistula formation; granulomatous response; seroma formation; nerve damage; tissue damage and/or death; and other complications.”Flood asserts in her hernia mesh lawsuit that the product caused painful surgical mesh complications that necessitated revision surgery. Her lawsuit names Ethicon, Inc. as well as Johnson & Johnson, Inc. and was filed in US District Court for the Eastern District of Texas, Marshall Division on October 9 of this year (Case No. 2:17-cv-689). It is expected that Flood’s lawsuit will join others in multidistrict litigation before US District Judge Richard Story in US District Court, Northern District of Georgia (IN RE: Ethicon Physiomesh Flexible Composite Hernia Mesh Products Liability Litigation, Case No. 1:17-md-02782).
https://www.lawyersandsettlements.com/articles/transvaginal-mesh-tvt-sling/transvaginal-mesh-lawsuit-tvm-surgical-22690.html
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