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Ethicon 11/30
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J&J Unit Workers Say Biz Knew Pelvic Mesh Device Risks
Nov 29, 2017 | Law360
By Bill Wichert
Johnson & Johnson unit Ethicon was aware of potential complications related to a pelvic mesh product before its launch in 2005, company officials said in deposition testimony presented Wednesday to a New Jersey state court jury hearing claims that the business withheld such information from doctors. -
Pelvic mesh case gets technical in Bergen courtroom
Nov 29, 2017 | North Jersey
By Richard Cowen
Jurors got an earful of techno-speak about the design and testing of pelvic mesh implants on Tuesday as the product liability case against Johnson & Johnson slogged through its second day in Superior Court. -
Australia bans transvaginal mesh products as 'too risky'
Nov 29, 2017 | The Guardian
By Melissa Davey
Transvaginal mesh products used by surgeons to treat pelvic organ prolapse have been quietly banned overnight by Australia’s medical devices regulator, which found the products are too risky. -
Pelvic Mesh Implants Have Now Been Banned In Australia
Nov 30, 2017 | Marie Claire
In what has been described as the greatest medical scandal in Australian history, hundreds of women across Australia have suffered horrific side effects from a simple medical device. -
Australia bans use of vaginal mesh implants
Nov 30, 2017 | Sky News
By Charlotte Lomas
An Australian watchdog has banned the use of controversial vaginal mesh implants for prolapse after a review found "the benefits do not outweigh the risks these products pose to patients". -
Therapeutic Goods Administration bans vaginal mesh insert products following class action
Nov 30, 2017 | AAP (in News.com.au)
By Rebecca Sullivan
The Therapeutic Goods Administration has banned the use of some transvaginal mesh products for use in the treatment of pelvic organ prolapse. -
Controversial vaginal mesh implants banned because of risk to prolapse patients
Nov 30, 2017 | ABC News
By Sopie Scott
Health authorities have banned controversial vaginal mesh implants for use in pelvic organ prolapse. -
Australia Has Banned The Use Of Some Mesh Implants
Nov 30, 2017 | Buzzfeed
By Gina Rushton
"Due to the poor quality of the studies undertaken, the evidence to support the use of these meshes for transvaginal pelvic organ prolapse repair, particularly, posterior repair, is not well established," the administration posted on its website on Wednesday night. -
Controversial pelvic mesh implants banned in Australia
Nov 29, 2017 | AFP (In Yahoo News 7)
Australia Thursday banned the use of pelvic mesh implants citing potential risks to patients, months after a major class action was launched against global healthcare giant Johnson & Johnson over alleged side effects. -
Controversial pelvic mesh devices banned in Australia by medical watchdog
Nov 30, 2017 | The Sydney Morning Herald
By Ebony Bowden
Vaginal mesh is to be banned in Australia after the medical regulator found the risk posed to patients by the device outweighed any benefits. -
Vaginal mesh implants banned in Australia
Nov 30, 2017 | Guardian Express
By Sarah Wledersehn
THE use of vaginal mesh implants for pelvic prolapse and incontinence has been banned in Australia. -
The NHS should be ashamed of itself say campaigners as Australia announces a ban on two types of pelvic mesh used in hospitals across Britain
Nov 29, 2017 | Wisbech Standard
By Kath Sansom
In addition, health watchdogs in Australia are banning one of four types of mesh tape to treat incontinence. -
Vaginal mesh products BANNED in Australia after more than 700 women left in debilitating and chronic pain launched class action lawsuit
Nov 30, 2017 | The Daily Mail Australia
By Kate Darvall
Vaginal mesh implants have been banned in Australia after more than 700 women who were left in horrific pain, launched a class action lawsuit. -
Suspend Vaginal Mesh Implant Use in Wales, Says Owen Smith
Nov 29, 2017 | Clawson news
The use of vaginal mesh implants for prolapses should be suspended in Wales, MP Owen Smith has urged.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
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J&J Unit Workers Say Biz Knew Pelvic Mesh Device Risks
Nov 29, 2017 | Law360
By Bill Wichert
Johnson & Johnson unit Ethicon was aware of potential complications related to a pelvic mesh product before its launch in 2005, company officials said in deposition testimony presented Wednesday to a New Jersey state court jury hearing claims that the business withheld such information from doctors.
Adam Slater, representing plaintiff Elizabeth Hrymoc, asked Ethicon employee Piet Hinoul in a 2012 video deposition about whether there are any risks or adverse events associated with the device that the company's medical affairs department didn't know about when the product hit the market in March 2005.
“There are no new adverse events that we ... weren't aware of at the time of launch,” said Hinoul, then serving as Ethicon's director of medical affairs.
But before Ethicon began selling its Gynecare Prolift pelvic floor support mesh product, company engineer Gene Kammerer recommended in a January 2005 email that it market Ultrapro mesh for pelvic floor repair instead, according to his video deposition. Kammerer suggested that Ultrapro would reduce erosion and the formation of scar tissue.
About three months later, Kammerer in an April 2005 email cited scarring problems associated with prolene soft mesh, also known as Gynemesh PS, which was used in the newly released Prolift, according to his deposition. Kammerer wrote that surgeons consulting on Prolift were asking for a better mesh than prolene soft.
In a November 2005 email, however, another company official indicated that Ultrapro could not be marketed for pelvic floor repair due to “commercial limitations,” Slater noted during Kammerer's deposition. The official said the market price for Gynemesh PS was much higher than that of Ultrapro.
“Replacing Gynemesh by Ultrapro would either reduce the market price, which is not good business, or the Ultrapro price would have to be increased, which is not possible,” the email read, according to Slater.
In the years that followed, doctors reported problems with patients who were implanted with Prolift, according to Hinoul's deposition.
For example, Slater noted during the deposition that Dr. Fah Che Leong said in a February 2009 email that he was involved in getting to the operating room a patient who had an anterior and posterior Prolift implanted by another physician. Leong said the patient had mesh extruding “literally everywhere,” according to Slater.
“This patient will have a permanently destroyed vagina, and I am only hoping to get her out of this without more morbidity,” the email read, according to Slater.
Slater asked Hinoul, “How many women would need to suffer this kind of damage to their vagina and these types of complications — just the number of women — before medical affairs would say that's too many to sell this product and this procedure?”
Hinoul said it was impossible to quantify an “algorithm to say if we reach this limit of adverse events, that becomes a reason to stop selling.” He said the company weighs the risks and benefits in determining whether to keep a product on the market.
Hrymoc, whose husband also is a plaintiff, is among the thousands of women nationwide who have filed suits alleging Ethicon and J&J failed to fully disclose risks associated with its Gynecare Prolift pelvic floor support mesh product, which was on the market from 2005 through 2012.
The Hrymocs’ suit is just the second pelvic mesh suit against Ethicon to go to trial in New Jersey, where the company is headquartered. The trial comes nearly a year after the New Jersey Supreme Court declined to review a jury’s $11.1 million award to the plaintiff in the first pelvic mesh trial.
Hrymoc said she had the Prolift implanted in 2008 to treat a pelvic prolapse, but that it contained a design defect and that the defendants knew it was risky but kept this information from consumers.
Hrymoc, who was 62 when she had the mesh implanted, says she has suffered vaginal pain and pain when having sex since then.
At the trial in Hackensack, New Jersey, Slater has noted that Ethicon began selling the device without giving doctors a warning related to patient sexual intercourse.
A doctor working for the company suggested the warning in a Jan. 11, 2005, email, as follows:
“WARNING: Early clinical experience has shown that the use of mesh though a vaginal approach can occasionally/uncommonly lead to complications such as vaginal erosion and retraction, which can result in an anatomical distortion of the vaginal cavity that can interfere with sexual intercourse. Clinical data suggest the risk of such a complication is increased in case of associated hysterectomy. This must be taken in consideration when the procedure is planned in a sexually active woman.”
Sean O'Bryan, then working on regulatory affairs for Prolift, later said in a Jan. 13, 2005, email that the product's instructions for use were most likely being printed and that the document should probably be left as is unless the change was absolutely necessary.
Scott Ciarrocca, then the research and development project leader for Prolift, replied in part, “We have already printed launch stock. This would be a 'next-rev' addition but they want it in there ASAP.” The warning ultimately was not included in the so-called IFU in 2005 or a revised version two years later, Ciarrocca testified Tuesday.
During a video deposition presented to jurors Wednesday, O'Bryan acknowledged that the decision about adding that warning to the IFU should not have been driven by whether the document needed to be reprinted.
“In fact, it would be inappropriate because that could jeopardize patient safety, right?” Slater asked him.
O'Bryan said, “That's correct.”
The Hrymocs are represented by Adam Slater and David Mazie of Mazie Slater Katz & Freeman LLC.
The defendants are represented by Judith Wahrenberger of Ruprecht Hart Weeks & Ricciardulli LLP, Philip Combs of Thomas Combs & Spann PLLC and William Gage of Butler Snow LLP.
The case is Elizabeth Hrymoc et al. v. Ethicon et al., case number L-13696-14, in the Superior Court of the New Jersey, County of Bergen.https://www.law360.com/articles/989262/j-j-unit-workers-say-biz-knew-pelvic-mesh-device-risks
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Pelvic mesh case gets technical in Bergen courtroom
Nov 29, 2017 | North Jersey
By Richard Cowen
Jurors got an earful of techno-speak about the design and testing of pelvic mesh implants on Tuesday as the product liability case against Johnson & Johnson slogged through its second day in Superior Court.
Plaintiff Elizabeth Hrymoc says the Prolift device that doctors implanted in her vagina in 2008 was faulty, and that Johnson & Johnson's research team knew there were problems with the product before it was put on the market in March 2005.
On Tuesday, Scott Ciarrocca, the project leader for the Johnson & Johnson subsidiary that designed the pelvic mesh implant, returned to the witness stand and spent most of the day leading jurors through a complex maze of design, testing and marketing strategies.
Ciarrocca tried to pursuade the jury that Ethicon did everything it could to ensure that the Prolift device was safe before it went on the market.
"Are you aware of any industry standard that Ethicon violated in the development of this product?" defense attorney Phil Combs asked Ciarrocca.
"No, I am not," Ciarrocca answered.
Hrymoc, who is from Middlesex County, is one of thousands of women nationwide who received pelvic implants made by Johnson & Johnson, leading to lawsuits seeking damages. Her case is only the second to come to trial in the state. In the first trial, a jury awarded the plaintiff, Linda Gross, $11.1 million in punitive and compensatory damages.
Adam Slater, Hrymoc's attorney, said he plans to put her on the witness stand sometime next week.
Ciarrocca, who headed the team that developed the product, was the first witness Slater called. He testified that Johnson & Johnson was looking for an alternative to traditional surgery to treat organ prolapse in women when it began working with a group of French doctors around 2002.
He said 50 percent of women experienced some organ prolapse as their vagina walls weakened with age, but traditional surgery hadn't been very successful in treating the condition. As an alternative, the French doctors were experimenting on cadavers using polypropylene mesh, which had been implanted to treat hernias since the 1970s.
Ciarrocca said Ethicon first had to develop tools to implant the mesh in women. Much of the defense's cross-examination was focused on the complex web of regulations, product design standards and testing procedures that Ethicon claims to have used.
"There were a lot of details and a lot of procedures that had to be followed," Ciarrocca said, as he tried to explain what each box meant in the massive flow chart that was beamed onto a screen in the courtroom. "There were lot of rules."
One box on the flow chart was labeled the Product Quality Plan, another was for the Design & Development Plan, and another for the Supply Chain Map, and Ciarrocca tried to explain what it all meant to the 10 jurors, all of whom have been issued notebooks by the court so they can keep track of all the highly technical information that is being thrown at them.
Slater said one of the issues in the trial will be the effectiveness of those tools when the mesh was implanted in Hrymoc.
Slater showed the jury an email from one of the French doctors, Axel Arnaud, dated January 2005, just two months before Prolift went on the market. Arnaud suggested that the instructional booklet that comes with the Prolift kit should include a warning that the implant procedure "occasionally/uncommonly leads to complications such as vaginal erosion and interfering with sexual intercourse." He also advised that the risk would be greater in women who had a hysterectomy.
But an Ethicon official in charge of regulatory affairs responded that the instructional booklet, which is known as an IFU, had already been approved by the product team and should not be changed. Ciarrocca also responded in an email that the first edition of the IFU had been printed and could be revised later.
Slater said it wasn't until 2007, two years after the Prolift product went on the market, that the IFU was reprinted to contain the warning.
Slater also queried Ciarrocca about the testing of the pelvic mesh while the product was being developed. There were two groups who were implanted with the mesh prototype, one French and one American, about 180 patients in all. And Ciarrocca said the results suggested that six months after implant, the vast majority of women were happy with mesh.
Ciarrocca said the failure rate in American women, calculated at 12.6 percent of the cases, was an improvement over the 40 percent failure rate that resulted from traditional surgery. A report showed to the jury said that overall, women had reported "significant improvements in their quality of life" and that "complications were low."
Slater said he plans to present an expert witness later in the trial who will rebut those findings. He said a 12.6 percent failure rate among such a small sample is actually quite high. When that figure is extrapolated over the entire population, it is actually much higher, he said.
http://www.northjersey.com/story/news/2017/11/29/pelvic-mesh-case-gets-technical-bergen-courtroom/901980001/
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Australia bans transvaginal mesh products as 'too risky'
Nov 29, 2017 | The Guardian
By Melissa Davey
Transvaginal mesh products used by surgeons to treat pelvic organ prolapse have been quietly banned overnight by Australia’s medical devices regulator, which found the products are too risky.
In an update posted on its website, the Therapeutic Goods Administration said the move followed its review of the latest international studies and an examination of the clinical evidence for each product supplied in Australia.Analysis What does pelvic mesh do and why are women suing over it? – explainerUrogynaecological mesh is used to treat stress incontinence and pelvic organ prolapse – and its use has triggered class actions in the US, UK and Australia
Read more
“Based on this new information, and since the publication by the TGA of the results of review into urogynaecological surgical mesh implants, the TGA is of the belief that the benefits of using transvaginal mesh products in the treatment of pelvic organ prolapse do not outweigh the risks these products pose to patients,” a statement from the TGA said.
“The TGA also considers that there is a lack of adequate scientific evidence for it to be satisfied that the risks to patients associated with the use of mesh products as single incision mini-slings for the treatment of stress urinary incontinence are outweighed by their benefits.
“It should be noted that mini-slings are different devices to mid-urethral slings, which are not being removed from the Australian Register of Therapeutic Goods.”
The changes to the register will take effect from 4 January.
Kath Sansom, the founder of the campaign group Sling the Mesh, said the TGA announcement was “proof of the growing realisation of the global scandal of surgical mesh implants”.
“It is yet more proof of worldwide institutional denial and how those tasked with monitoring patient safety have failed on an epic level,” she said.
“We demand the government suspends all pelvic mesh implants while a retrospective audit is carried out to find out the true level of suffering in this country ... thousands have suffered irreversible life-changing injuries.”
Some experts have argued the meshes that should never have been approved by the TGA for the treatment of prolapse. Adjunct Assoc Prof Ken Harvey from Monash University’s school of public health and preventive medicine said: “While it’s good the TGA has finally acted, it has taken far too long to remove these devices from the market, which raises many questions about the regulation of medical devices.”
He added: “All grist for the current class action law suits.”
More than 700 Australian women launched a federal court class action against the medical giant Johnson & Johnson in August, saying the transvaginal mesh medical implants had left them in debilitating pain and unable to have sex. Similar class actions have been launched worldwide. The decision in the Australian class action is expected to be handed down by the federal court next year.
It comes as draft guidelines issued by the UK’s health watchdog, the National Institute for Health and Care Excellence, recommended vaginal mesh operations to treat prolapse should be banned as a routine treatment in England.
A Senate inquiry into use of transvaginal mesh products is due to deliver its findings in the coming weeks.
The chief executive of the Health Issues Centre, Danny Vadasz, said removing transvaginal mesh products from the register was a welcome step but he was concerned the devices would still be available under the special access scheme. The scheme allows unapproved therapeutic goods to be approved for use in patients on a case-by-case basis.
“We think there are ample reasons for a total ban,” Vadasz said. “We can’t imagine which surgeon would still want to use mesh in the absence of evidence and with so many injured women.
“But, in the absence of a full ban, we must have a strong regulatory framework for special access, there must be timely public reporting on who is applying for these, for what indications and how many women are still receiving them.”
https://www.theguardian.com/society/2017/nov/30/australia-bans-transvaginal-mesh-products-as-too-risky
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Pelvic Mesh Implants Have Now Been Banned In Australia
Nov 30, 2017 | Marie Claire
In what has been described as the greatest medical scandal in Australian history, hundreds of women across Australia have suffered horrific side effects from a simple medical device.
Vagina mesh implants, used to treat prolapse or incontinence, have resulted in debilitating pain and serious infections for countless patients.
The use of the mesh implants has been the subject of a Senate inquiry as well as a class action against Johnson & Johnson earlier this year.
Now, Australia’s medical watchdog The Therapeutic Goods Administration (TGA) has banned Vaginal mesh implants in Australia.
The TGA examined deemed the devices too risky for women, the ABC reports.
"The TGA is of the belief that the benefits of using transvaginal mesh products in the treatment of pelvic organ prolapse do not outweigh the risks these products pose to patients," a spokeswoman said.
According to AAP, the decision was based on clinical evidence supplied in Australia plus published international studies.
The devices will be removed from the Australian Register of Therapeutic Goods as of January 4.
Senator Derryn Hinch, who led the Senate inquiry, tweeted in support of the move.
"Our campaign against transvaginal mesh, including public hearings before my Senate inquiry has paid off. Therapeutic Goods Administration yesterday banned mesh for pelvic organ prolapse. Thanks Sling the Mesh for your support," he wrote.
“Much credit for TGA mesh ban must go to the Australian Pelvic Mesh Support Group which has grown from 300 members to more than 1200 in a year."
https://www.marieclaire.com.au/pelvic-mesh-implants-banned-in-australia
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Australia bans use of vaginal mesh implants
Nov 30, 2017 | Sky News
By Charlotte Lomas
An Australian watchdog has banned the use of controversial vaginal mesh implants for prolapse after a review found "the benefits do not outweigh the risks these products pose to patients".
The Therapeutic Goods Administration has decided to remove the use of mesh products in the treatment of pelvic organ prolapse and single incision mini-slings which is used to treat urinary incontinence.
This move follows the news that NICE, the health watchdog in the UK, will recommend that mesh should be banned as a routine treatment for prolapse, a condition when organs such as the vagina, uterus or bowel fall down or slip out of place.
The draft guidance, seen by Sky News and due to be published next month, states that mesh implants for prolapse should now only be used for research purposes.
It does not affect the use of mesh for incontinence which accounts for the majority of operations.
Kath Sansom, founder of the campaign group Sling the Mesh, has welcomed the latest developments.
She said: "The TGA announcement in Australia is proof of the growing realisation of the global scandal of surgical mesh implants. In my opinion it is yet more proof of worldwide institutional denial and how those tasked with monitoring patient safety have failed on an epic level.
"We demand the Government suspend all pelvic mesh implants while a retrospective audit is carried out to find out the true level of suffering in this country."
The use of mesh for prolapse in the UK has fallen significantly in recent years, with growing evidence that it is less effective than traditional surgery and has higher rates of women experiencing problems.
Single incision mini-slings, SIMS, which have now been removed from use in Australia, have been the subject of a small trial in England.
Aberdeen University implanted the slings to 650 British women across the UK to compare its efficacy with another type of mesh.
Kath Sansom believes the ruling in Australia should prevent it from happening.
She said: "The UK SIMS trial is almost complete, yet in Australia they agree it must stop due to safety concerns.
"This should send out a very loud alarm bell in the UK for this trial to stop immediately and to contact all the women who had this sling to find out who is suffering.
"Authorities, surgeon societies and those in power in the UK have failed women and as result thousands have suffered irreversible life changing injuries."
This year Sky News reported that some medical professionals believe vaginal mesh is a bigger health disaster than the Thalidomide scandal, and more than 500 women are suing the manufacturers of vaginal mesh implants after experiencing serious complications.
An all-party parliamentary group led by MP Owen Smith is reviewing the use of mesh implants and calling for its suspension while more investigation into its safety takes place.
https://news.sky.com/story/australia-bans-use-of-vaginal-mesh-implants-11148807
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Therapeutic Goods Administration bans vaginal mesh insert products following class action
Nov 30, 2017 | AAP (in News.com.au)
By Rebecca Sullivan
The Therapeutic Goods Administration has banned the use of some transvaginal mesh products for use in the treatment of pelvic organ prolapse.
Based on new evidence, the TGA has found that the benefits of using transvaginal mesh products do not outweigh the risks to patients.
The TGA conducted a review following complaints from dozens of Australian women, who all said the device had left them in chronic pain.
More than 700 women have launched a class action against medical company Johnson & Johnson, claiming the implants caused horrible physical pain and left them unable to have sex.
“The TGA has today decided to remove transvaginal mesh products whose sole use is the treatment of pelvic organ prolapse via transvaginal implantation from the Australian Register of Therapeutic Goods (ARTG),” the TGA said in a statement.
“This follows a review by the TGA of the latest published international studies and an examination of the clinical evidence for each product included in the ARTG and supplied in Australia,” the statement said.
“Based on this new information ... the TGA is of the belief that the benefits of using transvaginal mesh products in the treatment of pelvic organ prolapse do not outweigh the risks these products pose to patients.
“The TGA also considers that there is a lack of adequate scientific evidence ... for it to be satisfied that the risks to patients associated with the use of mesh products as single incision mini-slings for the treatment of stress urinary incontinence are outweighed by their benefits.”
WHAT IS A VAGINAL MESH IMPLANT?
The mesh is a hammock made from a plastic called polypropylene. It has four hooks that are put into your hips to secure it to your bladder.
The idea is to help the pelvic floor muscles keep the internal organs in place, but more than 200 women have reported an “adverse event” to the Therapeutic Goods Administration as a result of the procedure.
In 2005, the TGA approved the use of pelvic mesh in Australia, but instead of trialling the product before making the decision, the Australian regulator simply followed the US’s approval in 2002.
The TGA later admitted the approval was “not mature” and “lacked rigour”, Fairfax reported.
http://www.news.com.au/lifestyle/health/health-problems/therapeutic-goods-administration-bans-vaginal-mesh-insert-products-following-class-action/news-story/729e82797998dfc529f33be57f534217
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Controversial vaginal mesh implants banned because of risk to prolapse patients
Nov 30, 2017 | ABC News
By Sopie Scott
Health authorities have banned controversial vaginal mesh implants for use in pelvic organ prolapse.
It comes after many women spoke to the ABCabout how the devices had left them in chronic, debilitating pain and with recurring infections.
The Therapeutic Goods Administration (TGA) conducted a review of international evidence and looked at the clinical evidence for the vaginal mesh devices.
"The TGA is of the belief that the benefits of using transvaginal mesh products in the treatment of pelvic organ prolapse do not outweigh the risks these products pose to patients," a spokeswoman said.
The mesh devices have left hundreds of Australian women with serious side effects including chronic pain, infections, and the inability to have sex, and are the subject of both a Senate inquiry and a class action.
Women such as Gai Thompson, who had a mesh device implanted nine years ago, said the product had ruined her life.
Authorities said there was also a lack of scientific evidence to justify the risks of so-called mesh "mini-slings" for stress urinary incontinence.
Women like Ms Thompson said the ban vindicated the concerns they had raised about the vaginal mesh implants.
"For so many years we've been told there's nothing wrong with us, that symptoms are either in our head or it's not because of the mesh," she said.
"I don't think people understand [there's not] one day from the time it's been put in that we haven't had pain — not one day."
The patient group Health Issues Centre also welcomed the announcement of the ban.
"We congratulate the women whose courage … has led to this historic move which is being acknowledged and welcomed by mesh-affected women around the world," the centre's CEO Danny Vadasz said.
But he said patient groups were concerned that some of the mesh devices would be available under a "special access scheme".
"We think there are ample reasons for a total ban," he said.
Patient groups said there must be timely public reporting on who is applying for the devices, for what reasons and how many women were still receiving the devices.
The mesh can only be sold until January 4, 2018.
A class action against mesh manufacturer Johnson and Johnson involving more than 700 women is underway, with legal representatives for the women claiming the pharmaceutical giant did not investigate proper clinical trials on the possible complications of the mesh.
http://www.abc.net.au/news/2017-11-30/controversial-vaginal-mesh-implants-banned-for-pelvic-prolapse/9209940
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Australia Has Banned The Use Of Some Mesh Implants
Nov 30, 2017 | Buzzfeed
By Gina Rushton
"Due to the poor quality of the studies undertaken, the evidence to support the use of these meshes for transvaginal pelvic organ prolapse repair, particularly, posterior repair, is not well established," the administration posted on its website on Wednesday night.
Urogynaecological meshes, sometimes known as transvaginal meshes, are inserted into women as a treatment option for pelvic organ prolapse (when the connective tissue securing the vagina and uterus to the pelvis gives way after childbirth), or urinary incontinence.
The review found the use of urogynaecological surgical mesh devices for stress urinary incontinence and abdominal pelvic organ prolapse repair was "adequately supported by the evidence".
An Australian Senate inquiry into transvaginal meshes is expected to report back in February next year.
It was set up to find out exactly how many women have had transvaginal mesh implants and, of those, how many experienced adverse side effects.
Queensland associate professor of urogynaecology Christopher Maher has estimated more than 200,000 mesh implant surgeries have been performed in Australia to date.
Half of the women who experienced adverse physical and psychological side effects after receiving a vaginal mesh implant have also suffered from a relationship breakdown after the procedure, the inquiry heard in September.
Women who couldn't have vaginal sex due to ongoing sexual dysfunction from urogynaecological mesh "repeatedly" reported their doctors suggested having anal sex instead, the inquiry heard in August.
More than 100 women have written to the inquiry — here are the most heartbreaking submissions.
Many submissions were from some of the 700 Australian women currently in court fighting Ethicon, a subsidiary of Johnson & Johnson, in a class action brought by Shine Lawyers which claims vaginal medical devices left women "suffering painful and life-altering complications".
An estimated 100,000 Australian women have been implanted with Johnson & Johnson mesh devices since 2000.
The lawyers representing the women have said there could be upwards of 8,000 Australians who have been implanted with one of the nine devices.
Johnson & Johnson said the company's pelvic mesh products had been developed in "close consultation with specialist surgeons" and were "backed by years of clinical research".
In its submission to the Senate inquiry, the company said the use of implantable mesh was supported by clinical research and was often the preferred option to treat pelvic conditions, including incontinence and pelvic organ prolapse.
https://www.buzzfeed.com/ginarushton/australia-has-banned-the-use-of-some-mesh-implants?utm_term=.od2ok9DVd#.fuNDVrz6q
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Controversial pelvic mesh implants banned in Australia
Nov 29, 2017 | AFP (In Yahoo News 7)
Australia Thursday banned the use of pelvic mesh implants citing potential risks to patients, months after a major class action was launched against global healthcare giant Johnson & Johnson over alleged side effects.
The mesh, implanted through surgery to fix pelvic floor damage and treat urinary incontinence and prolapse, is the subject of a parliamentary inquiry into potential complications and side effects.
It followed local media reports of women claiming the devices left them with severe and chronic pain.
The Therapeutic Goods Administration (TGA) said it had examined clinical evidence on the implants supplied in Australia and reviewed the latest published international studies.
"The TGA is of the belief that the benefits of using transvaginal mesh products in the treatment of pelvic organ prolapse do not outweigh the risks these products pose to patients," the government agency said in a statement.
It said there was also a "lack of adequate scientific evidence" that there were more benefits than risks to using them to treat urinary incontinence.
The products will be removed from the Australian Register of Therapeutic Goods from January 4 next year.
One procedure that uses the implants to treat incontinence, mid-urethral slings, was not banned.
One of the lead claimants in the Australian class action, Gai Thompson, welcomed the ban, telling public broadcaster ABC that women like her had been told there was "nothing wrong with us".
"I don't think people understand (there's not) one day from the time it's been put in that we haven't had pain -- not one day," she said.
The announcement came with British health watchdog NICE set to recommend the implants used to treat prolapse should be banned in England for routine operations, according to draft guidelines cited in media reports this week.
The Australian Johnson & Johnson lawsuit is on behalf of more than 700 women, with the legal firm representing them claiming up to 8,000 women in the country were believed to be impacted.
Johnson & Johnson has defended the mesh products, saying they were developed in consultation with surgeons and backed by clinical research.
The company faces 54,300 plaintiffs in pelvic mesh cases in the United States, the firm said in a report filed to the American Securities and Exchange Commission earlier this month.
The report added that there were class actions, personal injury cases or claims in various other countries including Britain, the Netherlands, Belgium, Israel and Canada.
https://au.news.yahoo.com/a/38067547/controversial-pelvic-mesh-implants-banned-in-australia/
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Controversial pelvic mesh devices banned in Australia by medical watchdog
Nov 30, 2017 | The Sydney Morning Herald
By Ebony Bowden
Vaginal mesh is to be banned in Australia after the medical regulator found the risk posed to patients by the device outweighed any benefits.
The Therapeutic Goods Administration announced the ban this week after an investigation which followed widespread complaints from women who said the implants left them in debilitating pain.
The mesh device implants were used to treat common problems after pregnancy, birth and hysterectomies.
"The TGA is of the belief that the benefits of using transvaginal mesh products in the treatment of pelvic organ prolapse do not outweigh the risks these products pose to patients," a statement read.
The authority also said there was a lack of scientific evidence to justify the risks of the mesh products for the treatment of stress-related incontinence.
Changes to the register will take effect from January 4, 2018.
Women who were fitted with the implants said they had been left in excruciating pain and with chronic infections. In some cases they were no longer able to have sex.
Campaigner Gai Thompson said her life had become a "living nightmare" after mesh surgery in February, 2008.
"We've lost so much that I can't believe in this day and age this can happen to women, that our lives are being destroyed and no one cares," Mrs Thompson told Fairfax Media last year.
In an incident report to the TGA, Mrs Thompson noted multiple urinary tract infections leaving her resistant to some antibiotics, chronic and severe pelvic pain, chronic bowel problems, incontinence, multiple areas where the mesh had eroded her vagina, and that she was unable to stand for any length of time, suffered constant fatigue and stress, and had needed successive surgeries and treatments.
She was unable to work and as a consequence she and her husband had been forced to sell their home, Mrs Thompson said.
It's understood the banned mesh products were only used in a minority of prolapse cases with tape products still well regarded by urogynaecologists for treating urinary stress incontinence.
Health Issues Centre CEO Danny Vadasz welcomed the announcement but said it was disappointing some devices would still be available under a special access scheme.
"We think there are ample reasons for a total ban. We can't imagine which surgeon would still want to use mesh in the absence of evidence and with so many injured women," Mr Vadasz said.
"What does this decision mean for women with stress urinary incontinence, for which mesh is still recommended?"
He also congratulated the women who courageously campaigned for the ban, calling the TGA decision a "historic move".
Caz Chisholm, who set up the Australians Pelvic Mesh Support Group, said doctors, regulators and the manufacturers of the mesh devices had catastrophically failed women.
"We were guinea pigs, we didn't know until it was too late," she told Fairfax Media in March.
Ms Chisholm said many women were not told the risks of transvaginal mesh surgery and so did not give informed consent.
"Current systems still don't allow the true extent of this disaster to be known," she said.
"For so many women, you're left feeling you're the only one experiencing these extreme consequences.
"It's only when women join the group they are able to say 'Oh my God, it's not just me. I'm not going crazy'," she said.
In America tens of thousands of mesh victims have taken manufacturers and doctors to court and been awarded damages of as much as $12.5 million.
More than 700 Australian women launched a federal court class action against medical giant Johnson & Johnson in August, with the decision expected to be handed down by the federal court next year.
Calling for a senate inquiry into transvaginal mesh products, Senator Derryn Hinch told Federal Parliament the devices rivalled Thalidomide as one of Australia's worst health scandals
The Senate inquiry heard how victims unable to have vaginal sex after mesh surgery "repeatedly" reported that their doctors suggested anal sex as an alternative.
More than 40 mesh devices were cleared for use by Australia's peak health regulator, the TGA, without clinical evidence of safety and efficacy, and despite strong warnings from three Australian specialists as early as 2003, including Newcastle gynaecologist Alan Hewson, that some surgical mesh procedures "cannot be recommended".
http://www.smh.com.au/national/health/controversial-pelvic-mesh-devices-banned-in-australia-by-medical-watchdog-20171129-gzvoa9.html
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Vaginal mesh implants banned in Australia
Nov 30, 2017 | Guardian Express
By Sarah Wledersehn
THE use of vaginal mesh implants for pelvic prolapse and incontinence has been banned in Australia.
Based on new evidence the Therapeutic Goods Administration (TGA) has found that the benefits of using transvaginal mesh products do not outweigh the risks to patients.
The TGA conducted a review following complaints from dozens of Australian women, who all said the device had left them in chronic pain.
“The TGA has today decided to remove transvaginal mesh products whose sole use is the treatment of pelvic organ prolapse via transvaginal implantation from the Australian Register of Therapeutic Goods (ARTG),” a statement on Thursday said.
https://www.communitynews.com.au/guardian-express/news/vaginal-mesh-banned-australia
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Nov 29, 2017 | Wisbech Standard
By Kath Sansom
In addition, health watchdogs in Australia are banning one of four types of mesh tape to treat incontinence.
Known as single incision mini slings, they were implanted in 650 women in 35 UK hospitals, in the last three years.
Locally, the Queen Elizabeth Hospital at King’s Lynn, recruited women to this trial.
In Britain, NICE will call for a stop to operations using vaginal mesh prolapse devices in a ruling being officially announced on December 20.
The guidelines say the mesh implants should only be used for research and not routine operations - campaigners have welcomed the ruling saying it is a back door ban.
Sling The Mesh issued a statement saying: “This is proof of the growing realisation of the global mesh scandal.
“It shows a world wide institutional denial and how those tasked with monitoring patient safety have failed on an epic level.
“We demand the Government suspend all pelvic mesh implants while a retrospective audit is carried out to find out the true level of suffering in this country.
“Authorities, surgeon societies and those in power in the UK have failed women and as result thousands have suffered irreversible life changing injuries. The NHS, MHRA and government ministers should be thoroughly ashamed of themselves.”
In Australia, health watchdogs the Therapeutic Goods Administration, the TGA, said it is banning two types of mesh - transvaginal prolpase mesh and mesh mini slings for incontinence - after realising there are not enough studies to support its use.
Since Australia’s mesh review began in 2013, 45 devices have been removed from use.
Australian campaigner Caz Chisholm said: “I am relieved. Women worldwide have been begging their medical governing bodies for many years to do what the TGA have done.
“It is a big step towards recognition of the suffering of so many women. There is however, a way to go before we see the stress incontinence meshes withdrawn.
“I am still struggling to understand why the incontinence tapes are still considered the gold standard when the percentage of women damaged by them is equal to the prolapse meshes and the complications can be debilitating and catastrophic.
“The battle to ban all mesh continues.”
MP Emma Hardy criticised the UK watchdog, the MHRA, which wants women to report problems to the Yellow Card scheme, except most have never heard of it.
In the UK the full NICE guidelines on mesh sling tapes to treat incontinence, and prolapse mesh inserted via the stomach, are due out in 2019.
MP Owen Smith and Emma Hardy are calling for those guidelines to be published earlier amid concerns from hundreds of patients across Britain.
Some implants can cut into the vagina, nerves, tissue, bladders, bowels and wombs and hundreds of women have been left in permanent crippling pain, unable to walk, work or have sex.
The mesh implants are made of polypropylene and manufactured by different companies. The devices support weakened tissue that causes incontinence or prolapse often caused by childbirth.
The main brand used in England are those by Johnson and Johnson.
MP Emma Hardy said the UK watchdog, the MHRA says women need to report to their Yelllow Card scheme, except most have never heard of it.
http://www.wisbechstandard.co.uk/news/australia-mesh-pelvic-vaginal-tga-nice-sling-1-5300590
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Nov 30, 2017 | The Daily Mail Australia
By Kate Darvall
Vaginal mesh implants have been banned in Australia after more than 700 women who were left in horrific pain, launched a class action lawsuit.
The medical watchdog found the risks of vaginal mesh implants far outweighed the benefits of the product, which was used to treat pelvic prolapse and urinary incontinence.
Hundreds of Australian women claimed the mesh left them with debilitating, chronic pain and left them unable to have sex again.
The Therapeutic Goods Administration decided this week to remove transvaginal mesh for the sole purpose of pelvic prolapse and single incision mini-slings from the Australian Register of Therapeutic Goods (ARTG) as a result of a review of the latest international studies.
The review was conducted following dozens of complaints by women across Australia, saying the implants had left them with chronic, debilitating pain and unable to have sex.
'Based on this new information, and since the publication by the TGA of the Results of review into urogynaecological surgical mesh implants, the TGA is of the belief that the benefits of using transvaginal mesh products in the treatment of pelvic organ prolapse do not outweigh the risks these products pose to patients,' a TGA statement said.
'The TGA also considers that there is a lack of adequate scientific evidence before the TGA for it to be satisfied that the risks to patients associated with the use of mesh products as single incision mini-slings for the treatment of stress urinary incontinence are outweighed by their benefits.'
The bans take effect from January 4.
A Senate inquiry into transvaginal mesh products was launched in February after Senator Derryn Hinch labelled their use in Australia as one of the country's worst health scandals. The findings of the inquiry are due to be handed down in early 2018.
The ruling of a class action launched in August by more than 700 Australians against manufacturer Johnson & Johnson is also expected to be handed down by the federal court next year.
Hundreds of women launched a class action in the federal court earlier this year.
The women claimed to have suffered horrific and chronic pain from the implants.
Rebecca Jancauskas from Shine Lawyers said 'many now live in excruciating pain, suffering terrible side effects that impact all aspects of their lives'.
'This class action is about righting the wrong against these women, who will suffer pain and complications for the rest of their lives,' Ms Jancauskas said.
Speaking to Daily Mail Australia in July, Louise King said the vaginal mesh left her with debilitating chronic pain.
'I've had so much bad health since that operation. There are days that i can't get out of bed and there are days that i try to do things and i just can't,' she said.
Ms King said she was given 'no choice' but to have the mesh implant when she suffered a vaginal prolapse in 2006.
'I was told this was the only option,' she said.
Ms King also said she was unable to have sex with her husband after the operation.
'Before he even entered me i was screaming, it was agonising,' she said.
'We tried a few times but he became really scared to touch me. He got to a point where he couldn't touch me.'
http://www.dailymail.co.uk/news/article-5131213/Vaginal-mesh-implants-banned-Australia-medical-watchdog.html
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Suspend Vaginal Mesh Implant Use in Wales, Says Owen Smith
Nov 29, 2017 | Clawson news
The use of vaginal mesh implants for prolapses should be suspended in Wales, MP Owen Smith has urged.
Campaigners gathered in Westminster on Wednesday to hear for its use to be halted and a public inquiry held.
Pontypridd MP Mr Smith, who chairs the all party parliamentary group on mesh, called for a suspension in Wales.
A Welsh Government spokesman said its use “is being kept under constant review”.
Mesh implants, which include different types of plastic tape and slings, are used to ease incontinence and to support organs such as the vagina, uterus, bowel, bladder or urethra which have prolapsed after childbirth.
Some have caused painful and debilitating complications for patients, with hundreds of UK women .
The polypropylene meshes are still prescribed on the NHS across the UK, however recent reviews in England and Scotland said they should not be routinely used for pelvic organ prolapse.
Mum-of-three Karen Preater has campaigned for them to be outlawed, after saying and left her “aged 40, yet feeling 100”.
She travelled to the Westminster debate from Rhyl, Flintshire, and said she was disappointed by the decision.
“What more evidence do they need, how bad do things have to get before they look into things?” she said.
“Hold a review, a public inquiry because that’s what needs to happen to get the correct figures and actually get a hold of this whole scandal.”
The National Institute for Health and Care Excellence will update guidelines on the use of mesh in the new year.
Mr Smith said he hoped cabinet secretary for health in Wales, Vaughan Gething, would at least consider a suspension until then.
“I think we could be thinking in advance of certainty on the guidelines, or suspending the use of mesh,” he said.
“Not banning it outright but suspending it in Wales and England, and right across the whole of the UK – that’s what we want, that’s what the campaigners want.”
The Welsh Government’s task and finish group looking at the issue met for the first time on Monday. It says the situation with regarding vaginal mesh and tape is being kept under constant review.
The UK Body that regulates medical products – the MHRA – said the benefits outweigh the risks.
http://clawsonnews.com/suspend-vaginal-mesh-implant-use-in-wales-says-owen-smith/
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