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Ethicon Media Monitoring 12/1/2017
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'Historic' targeted ban on pelvic mesh devices does not go far enough, say women and health groups
Dec 1, 2017 | Newcastle Herald
By Joanne McCarthy
A TARGETED ban of Australian pelvic mesh devices this week is “too little, too late”, say women and health consumer groups calling for a total ban on all pelvic mesh devices. -
Controversial pelvic mesh implants banned because of risk to patients
Dec 1, 2017 | ABC Online
Patients and health groups have welcomed a decision by Australian health authorities to ban controversial vaginal mesh implants used to correct pelvic organ prolapse in women. -
RANZCOG supports vaginal mesh ban
Dec 1, 2017 | news.co.au
By Sarah Wiedersehn
The president of RANZCOG has called for more good quality research to guide the appropriate use of vaginal mesh for prolapse, while supporting the TGA's ban. -
Brave women fighting for justice. Former Wisbech Grammar School student, now a journalism undergraduate, writes on the vaginal mesh implant scandal
Dec 1, 2017 | Wisbech Standard
By Cesca Brindley
Former Wisbech Grammar School pupil Cesca Brindley, a journalism student at Strathcylde University, takes an in depth look at the vaginal mesh implant scandal. -
Use of post-childbirth device to be reviewed
Nov 30, 2017 | IOL
For years women have complained of damage caused by the plastic mesh inserted to treat post-childbirth injuries - complaints that seemed to fall on deaf ears, until now. -
Australia bans Vaginal Mesh products as ‘too risky’
Nov 30, 2017 | The Legal Examiner
By Shezad Malik
Australia bans Vaginal Mesh products as ‘too risky’ according to a report in the Guardian newspaper.
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'Historic' targeted ban on pelvic mesh devices does not go far enough, say women and health groups
Dec 1, 2017 | Newcastle Herald
By Joanne McCarthy
A TARGETED ban of Australian pelvic mesh devices this week is “too little, too late”, say women and health consumer groups calling for a total ban on all pelvic mesh devices.
The Therapeutic Goods Administration’s ban on some prolapse and incontinence sling devices from January 4 because of the risks involved is “a step towards recognition of the suffering of so many women”, but “the battle to ban all mesh continues”, said Australian Pelvic Mesh Support Group founder Caz Chisholm.
Health Issues Centre chief executive Danny Vadasz said there was “ample reason” for a total ban on all pelvic mesh. The implanting of more than 100,000 devices in women over more than 20 years was a tragedy and catastrophe that exposed a health system “not accountable to the people it was built to serve”.
The TGA announced on Wednesday that a final group of prolapse mesh devices implanted through the vagina would be banned from January, along with a group of problematic mesh slings to treat incontinence. In both cases a TGA review found little or no evidence to back their safe use in women, despite many devices being on the Australian market for years.
The move follows damning Senate inquiry public hearings, a long-running legal class action by more than 850 women against mesh manufacturer Johnson & Johnson, numerous confidential settlements and complaints against doctors, and a campaign led by the Newcastle Herald.
The TGA said it had removed 45 devices from the Australian market – with multiple variants – since a review in 2013, prompted by the growing global scandal about pelvic mesh and action by America’s Food and Drug Administration.
The decision came only weeks after the TGA announced plans to upgrade all remaining mesh devices to high risk.
Ms Chisholm and Mr Vadasz said they struggled to see why some stress incontinence devices remained on the market. Although there was long-term evidence supporting their use, the complications experienced by some women were severe, permanent and incapacitating, they said.
“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.
Australian Pelvic Mesh Support Group member Andrea Walter said a survey of members showed 70 per cent had severe complications after surgery using “gold standard” incontinence devices that would remain on the market after the latest ban comes into effect.
The TGA’s action was “the start of validation mesh can cause terrible complications”, Ms Walter said.
Mesh campaigner Gai Thompson, who suffered catastrophic injuries after she was implanted with a Johnson & Johnson Prolift mesh device in 2008, said the ban was “too little, too late”.
In a complaint to the TGA in 2011 she said her life had become “a living nightmare”, but it was simply filed and not taken seriously.
“Why has it taken so long? The TGA treated us with complete disdain. A group of us met with them in May last year and they were so dismissive, just like the doctors have been dismissive. For years we’ve been saying these devices have destroyed women’s lives, and no-one was listening,” Mrs Thompson said.
“The only reason this is happening now is because of the publicity. They have been so condescending. How many women have had their lives destroyed because these people didn’t act when they should? Why were these devices ever let on the market when clearly there was no evidence they could be safely used?”
Victorian woman Jan Wise, who said she was “rotting from the inside”because of the pig-based biological mesh implanted in her in 2012, said the ban showed women should have been believed.
“This journey has been very hard and very long for many of us coming forward, but it needs to remain out in the open so that human beings are no longer treated with the utter contempt and disrespect shown to so many women,” Ms Wise said.
“This was done by people we had so trusted to help us.”
Mr Vadasz said the pelvic mesh device exposed Australia’s health system.
“Nobody has taken responsibility for the pain and suffering of countless women and that leads to the ultimate tragedy of the mesh debacle – if there is no one to accept accountability then there is no one to validate the experiences of all those injured women with the simple acknowledgement ‘sorry’,” he said.
“The ultimate tragedy of mesh is that it demonstrates that our world class health system, as unarguably great as it is, is not accountable to the people it was built to serve. We need to make it so.”
http://www.theherald.com.au/story/5093245/women-warn-they-wont-stop-until-a-total-ban-on-pelvic-mesh/
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Controversial pelvic mesh implants banned because of risk to patients
Dec 1, 2017 | ABC Online
Patients and health groups have welcomed a decision by Australian health authorities to ban controversial vaginal mesh implants used to correct pelvic organ prolapse in women.
In recent years, many women have reported chronic pain or being unable to walk or have sex after the implant surgery.
Now the Therapeutic Goods Administration says it has reviewed the safety of the implant and decided the risks outweighed the benefits.
Carolyn Chisholm established the Australian Pelvic Mesh Support Group in 2014 — at first the group had 15 members, and now it has 1,200 members.
http://www.abc.net.au/radionational/programs/breakfast/pelvic-mesh-implants-banned-because-of-risk-to-patients/9214714
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RANZCOG supports vaginal mesh ban
Dec 1, 2017 | news.co.au
By Sarah Wiedersehn
The president of RANZCOG has called for more good quality research to guide the appropriate use of vaginal mesh for prolapse, while supporting the TGA's ban.
The Royal Australian and New Zealand College of Obstetricians and Gynaecologists supports the "cautious" decision of the medical watchdog to ban the use of vaginal mesh implants for pelvic prolapse.
However, it has called for good quality research to guide its appropriate use.
Dozens of women have complained of chronic pain or being unable to have sex after an implant, and the use of vaginal mesh has been the subject of a Senate inquiry on its use in Australia.
Based on a review of the evidence, the Therapeutic Goods Administration (TGA) this week announced it will remove transvaginal mesh products used solely to treat pelvic organ prolapse from the Australian Register of Therapeutic Goods (ARTG).
Similarly, single incision mini-slings - commonly used to treat urinary incontinence - will also be removed from the ARTG due to a lack of "adequate scientific evidence" to show that the benefits outweigh the risk.
The changes to the registry take effect from February 4.
"It has become clear that the evidence underpinning the safety and usefulness of mesh used for prolapse is of questionable value. RANZCOG takes on board the decision made by the TGA as the regulatory body for Australian implants," RANZCOG President, Professor Steve Robson, said in a statement on Friday.
"Until such time that the evidence of scientific studies provides a more persuasive argument in favour of mesh kits in the treatment of vaginal prolapse, RANZCOG supports this cautious approach."
Mr Robson also noted that the TGA has not removed mid-uretheral slings from the ARTG.
There are numerous types of vaginal mesh and earlier this year the RANZCOG president stated he would not support a blanket ban.
The Consumers Health Forum has renewed calls for the introduction of a mandatory register to record problems with implants, and for the medical profession to take a more active role in alerting the TGA when problems emerge.
http://www.news.com.au/national/breaking-news/ranzcog-supports-vaginal-mesh-ban/news-story/d3ed906c30a0f424e6a32a19190501e9
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Dec 1, 2017 | Wisbech Standard
By Cesca Brindley
Former Wisbech Grammar School pupil Cesca Brindley, a journalism student at Strathcylde University, takes an in depth look at the vaginal mesh implant scandal.
Cesca, 21, was inspired to write on the mesh implant disaster as part of her final degree coursework. She has known Sling The Mesh founder Kath Sansom for nearly 10 years after attending the same school as her eldest daughter.
Cesca said “These are brave efforts of a struggling but strong network of women in campaign groups across the world.
THE MESH DISASTER
“Three years ago, I was training to cycle the Marin Trail at Snowdon and now I’ll never be able to. I can never run again, I have had to give up high board diving, I have to be careful how I walk, how I sit, how I move. And this is a good recovery.”
These words, spoken by Kath Sansom, could have been avoided.
Kath is one of thousands of women worldwide whose recommended surgery for incontinence after childbirth has torn their bodies and lives apart. Anguish and betrayal runs deep amongst the suffering groups of mesh survivors who say doctors failed to mention their “quick fix” was actually a permanent implant with the potential for organ rupture, lifelong pain and in some cases complete disability.
The treatment in question is the transvaginal mesh implant, habitually used to treat pelvic organ prolapse and incontinence after childbirth.
Women now left unable to sleep, work or raise their family were not made aware that few decent quality clinical trials were carried out to verify its safety before being permanently lodged inside of them.
Kath, journalist and mother-turned-activist had the implant in 2015 and recently removed, leaving only its stains of mutilation. Self-confessed “super energetic, super crazy”, she is now coming to terms with the fact that she will never again be the same woman.
She logs onto her Facebook support page every single day to read heart-breaking stories from women who are battling a pain that nobody can see and that no cocktail of drugs can relieve.
Some turn to alcohol to help ease the pain. Rather than giving up, Kath has spent the past two and a half years directing her energy into fighting to ensure what she describes as a “human rights issue” never ruins the life of another woman.
Once the mesh, a small plastic net-like contraption has been fitted, it has the potential to become embedded in organs, cutting tissues and causing nerve damage.
The removal process Kath described as like trying to pull chewing gum from your hair, yet the agony for some is so severe that approximately 1 in 15 women undergo surgery to do just that.
She said: “The pain is unbelievable. You literally can’t put it into words. There are women who suffer from PTSD, anxiety and depression because of it. Then we are called hypochondriacs or accused of being dramatic.”
Such attitudes spur Kath’s commitment to her own ‘Sling the Mesh’ campaign which has seen members of affected women go from 10 to over 4,500 since its creation in June 2015.
Whilst the aim is largely to stop and bring justice to those suffering, the group has provided a safe-haven for women who have lost everything, left with nowhere to turn. Kath is putting a voice to many which have until now stayed quiet.
For years several women were told that they were the ‘mystery patient’, that their horrifying symptoms were exaggerated or unrelated to the implant.
Under-reporting contributed to symptoms being dismissed, in addition to surgeons being what Kath refers to as “groomed into thinking mesh is the best thing”.
But now, the resilience and determination of women like herself coupled with increased media coverage has given confidence to many more to come forward.
The destruction goes further than its physicality and Kath spoke passionately of women who have lost everything, being brought to tears as she told me of one of the many stories which keeps her motivated to act in the face of opposition:
“I was sat there in my little newspaper office, doing something mundane, you know, writing up a charity bake sale or something. And then a message pops up from someone on the Sling The mesh page. And it’s a woman whose pain is so severe she is telling me that she just can’t go on anymore, that she wants to end her life.”
Doctors are now trained almost exclusively in mesh procedure, unable to execute traditional operations such as the Burch colposuspension which requires more time and ability.
Unaware that such options even existed, or not encouraged to pelvic floor physiotherapists, thousands of women like Kath jumped at the opportunity to receive a treatment described as low-risk, despite inconsistent data now suggesting otherwise.
Unfortunately, recalling mesh products would place the NHS in an embarrassing position of both admitting guilt in using faulty products and having insufficient numbers of doctors trained in alternative treatments.
Kath commented: “Regulation is shocking. You trust your government, the NHS, your doctors, you listen to them, only to find out there is next to no regulation at all.”
Speaking to a researcher of the ‘Transvaginal Mesh Expert Group’, who wished to remain anonymous, it is clear these feelings are not reflected amongst the medical community. She is sceptical of claims and recognises that symptoms may have arisen due to other reasons.
However until adequate investigation is carried out this cannot accurately be confirmed.
She commented: “Yes, a minority do experience complications but for thousands of others it is a successful operation”. Whilst true, for some women it was over a decade before symptoms appeared and currently, no longitudinal study exists to confirm whether all women who have had the operation won’t eventually be subject to a similar fate.
She added with certainty that the threshold does need to be “much higher” with surgery considered a last resort. She is of the belief that patients are properly informed and questioned whether it should be a government decision to deny women treatment if they want it.
“Calling for a blanket ban is taking away women’s rights to choose”, she told me, though this point is raised by the women who feel their rights were taken away when doctors misled them into potentially dangerous surgery.
Whilst the motives of women picking up the broken pieces of their lives are questioned, some are left wondering if those of the professionals should be too.
The independent inquiry which first set the ball rolling in 2014 was deemed a whitewash by the patient representatives and, despite their protests, was published in their name.
This means the political journey may be longer than hoped. Many want the outcome to see mesh use discontinued or at the very least, sufficient research and consultation to identify its risks.
Compensation for a diminished quality of life is not on everybody’s agenda.
Kath’s hope is that women never have to suffer in the same way again. She believes that they were used as guinea pigs for something with little research and certainly lacking in-depth investigation.
The treatment of women as equals appears to have been bypassed by a desire for profits.
Alex Neil, former Secretary for Health, met with me and spoke of the similar stories he had heard which urged him to take a stand. Having met with victims in 2014 he says that evidence cannot be denied.
He confirmed Kath’s belief that surgeons enjoyed weekends away with bonuses in their pockets from manufacturers who aggressively pushed the mesh to market and recognised that “the current system does not work”.
As the mesh was not subject to clinical trial before being put to market, initially its potential side-effects were not properly tested or investigated.
Alex Neil told me that unbelievably, this is legally the case due to MRHA legislation, reflecting a worrying disregard in regulation for people’s wellbeing.
Many women say this was not mentioned to them when they were told the mesh was the perfect choice.
Despite opposition, Mr. Neil was the man to call for the 2014 public inquiry into mesh treatment after seeing first-hand the devastation it had caused.
He is still working alongside campaigners who believe the final report to be missing evidence. He said that it was no more than a “moral obligation” to ensure justice is brought to them and that he has hopes for a global conference within the next year to fully address the use of mesh and its consent process.
Whilst there are women who will never again be able to live the same way, hope still exists for the future through the brave efforts of a struggling but strong network of women across the world.
The mesh survivors have their faith in the cause and are determined to ensure justice is brought.
• Cesca plans to go into a career of writing, broadcasting or investigative journalism She said: “I want to bring attention to issues like these which are too often ignored in the face of sensational news.”
http://www.wisbechstandard.co.uk/news/former-wisbech-grammar-school-mesh-implant-sling-cesca-brindley-1-5302471
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Use of post-childbirth device to be reviewed
Nov 30, 2017 | IOL
For years women have complained of damage caused by the plastic mesh inserted to treat post-childbirth injuries - complaints that seemed to fall on deaf ears, until now.
This is because it was recently reported that the UK government health-care adviser, the National Institute for Health and Care Excellence (Nice), is going to recommend that the controversial implant should no longer be routinely used due to “serious safety concerns”.
A guidance document from the institute, to be published on December 22 but which has been leaked, says using the mesh for pelvic organ prolapse (POP) operations, where the material is inserted through the vagina to support the womb, should no longer be routinely offered and should be available for research only.
Further guidance is due in 2019, but after pressure from MPs and Sling the Mesh - a group representing 4400 injured women - it is expected the final guidance will be brought forward and a complete ban recommended.
An estimated 200 000 women across the UK have had the implants since they were introduced in the late 1990s to treat incontinence or repair damage where ligaments supporting the womb have collapsed.
A large proportion of women given the mesh have not had problems, but as Good Health has highlighted, in some it has fragmented and “migrated”, cutting through tissue and causing nerve damage, chronic pain and infection, leaving them unable to walk properly, work or have sex.
The safety admission has opened the floodgates to one of the biggest compensation claims in NHS history. David Golten, a London lawyer representing more than 500 women, believes hundreds more will come forward and damages “could run into billions”.
“It is the first time medical authorities have admitted this procedure is dangerous,” he told Good Health.
For the women affected it’s a vindication - of sorts, says Kath Sansom, who set up Sling the Mesh and has suffered permanent damage to her coccyx as a result of the procedure. “Doctors tried to make us feel we were making a fuss about nothing.
“The latest publication in a scientific journal in September, using the NHS’s data, showed at least 10% of women implanted with this mesh suffer complications requiring overnight hospital treatment, and we know the real figure is much higher.”
Grandmother Jemima Williams, 57, has had 18 operations to remove fragments of the mesh since 2002, when it was implanted to treat her post-childbirth incontinence. Williams, who is married to a GP, suffers chronic pain, walks with a stick and has been told she will need a colostomy bag because of permanent nerve damage.
“There are many of us who have been told we can’t take legal action because it is too long after surgery,” she says. “We are going to start pressuring the government to lift the 10-year bar on litigation.”
The claims will centre on whether women were warned of the risks and so gave informed consent for the operation, whether surgeons botched the implants, and, most importantly, whether the mesh was suitable for use in the first place. Although the mesh starts off flexible, it seems to become brittle after implanting. Once it has broken up and begun to “migrate”, removal becomes near impossible without causing further damage.
Williams has been on a long waiting list to see Sohier Elneil, a consultant urogynaecologist at University College Hospital in London, who has developed a rare expertise in treating women whose meshes have disintegrated.
“Removing this material is a real problem and has now become a major part of my clinical practice,” Elneil says.
Carl Heneghan, a professor of evidence-based medicine at Oxford University and a campaigner for better regulation of medical devices, says these women were suffering terribly.
Heneghan says the use of the tape for pelvic prolapse was accepted by the Medicines and Healthcare Products Regulatory Agency (MHRA) in 2005, after what he says was minimal testing of one year.
“Why, in the first place, didn’t they say the mesh should only be used in the context of research?” he told Good Health. “Why has the MHRA spent 12 years ignoring the evidence this mesh is dangerous?”
Kath Sansom says there has been no guidance on what women who already have the mesh should now do.
“Should they be demanding to have it removed, or what?” she asks. “We know it can break up more than 10 years after it’s implanted. Lots of women, including those who don’t have problems, must now be very worried.”
Meanwhile, women with incontinence or prolapse are in the dark about whether or not they should accept a mesh implant, or insist on being referred to a consultant with the skills to do a “native tissue” repair.
This procedure, which involves complex internal stitching, has fallen out of favour since the introduction of the mesh, which seemed to offer a quicker and cheaper alternative.
https://www.iol.co.za/lifestyle/health/use-of-post-childbirth-device-to-be-reviewed-12204098
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Australia bans Vaginal Mesh products as ‘too risky’
Nov 30, 2017 | The Legal Examiner
By Shezad Malik
Australia bans Vaginal Mesh products as ‘too risky’ according to a report in the Guardian newspaper.
Transvaginal mesh medical products used by surgeons to treat pelvic organ prolapse and stress urinary incontinence have been banned by Australia’s government medical devices regulator.
The Therapeutic Goods Administration (TGA) has determined that the products are too risky after a review of international studies and an examination of the clinical evidence for each product supplied in Australia.
According to the TGA, “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.”
UK moves to ban Vaginal Mesh products
The UK’s health watchdog, the National Institute for Health and Care Excellence, has recommended vaginal mesh operations to treat prolapse should be banned as a routine treatment in England.
U.S. More than 100,000 injured women nationwide
More than 100,000 defective product liability and personal injury lawsuits have been filed by injured women against AMS/Endo and other major manufacturers of transvaginal mesh products, including Bard, Boston Scientific, Coloplast, and Johnson and Johnson.
Vaginal Mesh Injury Lawsuits
The majority of mesh injury cases have been consolidated for pretrial proceedings as part of an MDL, or multidistrict litigation, with the cases centralized before U.S. District Judge Joseph Goodwin in the Southern District of West Virginia.
Seven different MDLs are currently centralized before Judge Goodwin, including those made by Bard, AMS, Boston Scientific, Ethicon, Coloplast, Neomedic and Cook Surgisis Biodesign mesh lawsuits.
J&J, said in SEC filings in February that it was defending 54,800 cases over its mesh implants, while Boston Scientific said it faced 43,000 mesh claims. Both companies have settled some mesh suits. The mesh implants have generated billions of dollars in profits for these companies.
Vaginal Mesh made from polypropylene plastic
Over the past 15 years, the vaginal mesh has been used for the repair of pelvic organ prolapse and female stress urinary incontinence. Serious design defects have been associated with surgical mesh which is made from non-absorbable polypropylene plastic and the mesh manufacturers were warned that the material was not safe to be used in humans.
The plastic mesh is linked to major side effects in women, in some cases, the injuries were catastrophic, including recurrent pelvic and bladder infections, erosion of the mesh into the vagina and other vital organs.
AMS-Endo Vaginal Mesh lawsuit final settlement
In 2014, Endo was the first major mesh and bladder sling manufacturer to settle mesh injury claims. The company initially agreed to pay about $830 million in AMS vaginal mesh settlements, then in August 2015, the company announced it added $1.53 billion for litigation and settlement costs, and then later tossed in another $834 million for vaginal mesh litigation.
Endo announced this summer, that an additional $775 million will be set aside to resolve another 22,000 mesh claims. Endo hopes that this final settlement will resolve all known claims, but Endo admits that it is possible further injury claims may be filed.
FDA “No benefit from Vaginal Mesh”
The FDA warned that it had received thousands of adverse event reports involving problems with vaginal mesh products.
The FDA concluded that there was no evidence that transvaginal mesh provides any additional benefits when compared to more traditional surgery for treatment of pelvic organ prolapse.
In 2012, the FDA notified the mesh manufacturers that they undertake medical studies to determine the safety of transvaginal mesh products, and establish whether they have an unreasonable risk of injury for women. In 2016, the FDA labeled the vaginal mesh devices as “HIGH RISK.”
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