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Ethicon Media Monitoring 8/15/2017
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Potentially damaging surgical mesh kits still on hospital shelves with doctors unaware of cancellation
Aug 15, 2017 | ABC Online
By Sophie Scott and Alison Branley
Federal health authorities say they have not done a recall of potentially damaging women's health products despite reports at least one hospital has been stockpiling controversial mesh devices. -
[Video] Lamborghinis, ski trips used to market mesh implants to surgeons, documents show
Aug 15, 2017 | ABC Online
By Sophie Scott
The prospect of owning luxury cars and trips to the Swiss Alps were among the incentives used by a pharmaceutical giant to market a surgical device that has ruined the lives of hundreds of Australian women. -
Emails show doctors' bizarre attitudes to women's health
Aug 15, 2017 | ABC Online
By Sophie Scott and Alison Branley
On the opening day of a class action brought by Australian women against pharmaceutical giant Johnson and Johnson, lawyers made a splash by referencing an email between French gynaecologists. -
Surgeons Incentivized with Lamborghinis and Swiss Alps Ski Trips Internal J&J Docs Show
Aug 14, 2017 | Mesh Medical Device Newsdesk
ABC News Australia (Australia Broadcast Company) reports (here) that the pelvic mesh scandal in that country was incentivized by mesh makers who offered surgeons a jet-set lifestyle if they used the medical devices. -
Will my aunt’s dementia halt her driving? - DR ROSEMARY answers your health questions
Aug 14, 2017 | Express.co.uk
By Rosemary Leonard
Q: Two years ago I had a vaginal mesh implant fitted to cure an incontinence problem after the birth of my children.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
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Aug 15, 2017 | ABC Online
By Sophie Scott and Alison Branley
Federal health authorities say they have not done a recall of potentially damaging women's health products despite reports at least one hospital has been stockpiling controversial mesh devices.
A Senate inquiry into the number of women affected by surgical mesh kits for the treatment of incontinence and prolapse after childbirth has heard that the Therapeutic Goods Administration (TGA) has not done any recalls.
It has led to concerns some women might have had selected devices implanted even after they were pulled from the market and that it could continue to happen.
Federal health authorities say they have not done a recall of potentially damaging women's health products despite reports at least one hospital has been stockpiling controversial mesh devices.
A Senate inquiry into the number of women affected by surgical mesh kits for the treatment of incontinence and prolapse after childbirth has heard that the Therapeutic Goods Administration (TGA) has not done any recalls.
It has led to concerns some women might have had selected devices implanted even after they were pulled from the market and that it could continue to happen.
But the inquiry's chair, Senator Rachel Siewert, said that contradicted other evidence heard by the panel that devices had been stockpiled.
Professor Skerritt said the regulator did not believe there were "significant supplies" of the cancelled products in the stock chains of hospitals.
He confirmed the TGA was "only aware of one case where a particular hospital had large stocks of a product".
"It would be a rather unusual decision by surgeons to say 'hang it, it's cancelled, I'm going to use it anyway'," he said.
"I imagine whether it's their insurer or the hospital they're operating [they] would tend to take a fairly serious view of that sort of behaviour."
But the inquiry also heard it was unlikely surgeons even knew that certain devices had been cancelled.
Senators asked the TGA why then specialist doctors had told the inquiry they were under the impression that no products had been cancelled and there were no safety concerns about them.
"How can we as a committee be assured that in fact those devices, if the profession doesn't know these devices haven't been cancelled, how can we be assured they're not being used?" Senator Siewert asked.
At its peak, there were about 100 various mesh kit products on the market.
About 70 have either been cancelled or removed from sale and today there are 12 to 25 versions of the product still available.Calls for a national register of devices
The TGA told senators there was a general difficulty with medical devices and monitoring their effects.
Similar issues have emerged with joint replacements in recent years.
"Often, adverse events aren't apparent in the first year/years," Professor Skerritt said.
The Royal Australia and New Zealand College of Gynaecologists and Obstetricians has called for a funded register of mesh devices to track devices and their impact.
"This is an example if a register had been funded, set up and properly administered a lot of the problems would have become obvious early on," president Steve Robson said.
The college was involved in setting up a voluntary register but said a mandatory one was needed.
"The big issue with a register isn't so much putting the person on the register in the first place it's the enormous resources that have to be put into following them up," Professor Robson said.
"It's a very expensive long-term commitment that would require clear government backing and resourcing."
The average cost of setting up individual registers is $1 million to $2 million.
The TGA said its Review of Medicine and Medical Devices Regulation recommended the establishment of a registry for all high-risk implantable devices.
"Such a registry may include urogynecological meshes," a spokeswoman said.
She said the Government deferred this recommendation to consult further on how such a registry could be "managed and funded in the future".
http://www.abc.net.au/news/2017-08-15/potentially-damaging-vaginal-mesh-kits-still-on-hospital-shelves/8805520
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[Video] Lamborghinis, ski trips used to market mesh implants to surgeons, documents show
Aug 15, 2017 | ABC Online
By Sophie Scott
The prospect of owning luxury cars and trips to the Swiss Alps were among the incentives used by a pharmaceutical giant to market a surgical device that has ruined the lives of hundreds of Australian women. Documents obtained exclusively by Lateline show the extent to which Johnson and Johnson oversold its vaginal mesh products, which are used to treat incontinence and prolapse after childbirth. ABC medical reporter Sophie Scott reports.
TranscriptEMMA ALBERICI, PRESENTER: The prospect of owning luxury cars and taking ski trips to the Swiss Alps: that is how a major pharmaceutical company marketed a surgical device that has left hundreds of Australian women in debilitating pain.
Documents obtained exclusively by Lateline show the extent to which Johnson & Johnson oversold its mesh implants, used to treat incontinence and prolapse after having children.
Now, the women who have been left damaged are facing another battle: to have their implants surgically removed.
ABC medical reporter Sophie Scott has our story.
SHAUNA CAHILL, PATIENT: Well, if you read what's in that brochure, you would definitely put your hand up.
STEVE ROBSON, PROF., COLLEGE OF GYNAECOLOGISTS: I think the regulation of marketing of devices is critically important.
CAROLYN CHISHOLM, PATIENT ADVOCATE: You know, it is a quick fix.
(Footage of Shauna Cahill looking on as her children play basketball on the front nature strip of their house)
SHAUNA CAHILL: Practice. Practice, practice.
SOPHIE SCOTT, REPORTER: Surgical mesh was no 'quick fix' for Shauna Cahill. The mother of two is doing her best to parent from a wheelchair.
SHAUNA CAHILL: I can't do grocery shopping. I can't vacuum my own floor. I can't play with my kids.
DAUGHTER: OK, Mummy.
SHAUNA CAHILL: Can you help me up the hill, sweetheart?
(To Sophie Scott) Day-to-day my kids, who are eight and 10, have to do far more than any other child who is eight or 10. On a bad day my son would have to take me to the toilet.
(To her daughter) Thanks, sweetie.
(To Sophie Scott; visibly upset) I feel like I have failed my kids. I feel like I have robbed them of their childhood. I feel like I have failed my partner.
SOPHIE SCOTT: Shauna has been in a wheelchair after her surgeons implanted a medical device, known as mesh, to help treat the incontinence and prolapse she suffered after the birth of her children.
SHAUNA CAHILL: But from the minute I woke up from surgery, I just knew that there was something not quite right. The pain in my groin was indescribable.
Every day there is pain, but I just had to learn to keep going because I have got kids and I can't just hop into bed and not get up.
It is embarrassing. I had friends over the other day and they went to leave and I went to stand up and I was wet through. And I could smell it and it was horrible. All I could do was apologise.
Shauna is among hundreds of Australian women with debilitating side effects from the use of meshes, slings and tapes that range from severe chronic pain to constant infections. The products are both the subject of a class action and a Senate inquiry.
(Footage of inquiry hearing by the Senate Standing Committee on Community Affairs, 3 August)
RACHEL SIEWERT, GREENS SENATOR FOR WA: The profession doesn't know that these devices have been cancelled. How can we be assured they are not being used?
JOHN SKERRITT, ADJUNCT PROF., DEPUTY SECRETARY, THERAPEUTIC GOODS ADMINISTRATION: It would be hard for them to get it because...
(Footage ends)
SHAUNA CAHILL: I wasn't told that any of this could happen. I was told it was a straightforward procedure and I would be as good as in new.
SOPHIE SCOTT: Now, documents obtained exclusively by Lateline show the extent to which doctors and patients were oversold on the use of these women's health products. The documents have been tendered to the Federal Court as part of a class action against one maker of meshes, Johnson & Johnson.
One marketing document suggests using images from a Swiss ski resort, sailboat and Lamborghini to sell doctors on mesh.
At the time, the alternative was a far longer procedure using a woman's own tissue. The materials claim the new mesh procedure can be done in eight minutes, allowing doctors to do five procedures before lunch. At about $950 for a sling, and $900 for the operation, that is almost $10,000 in one morning.
Internal documents reveal concerns were raised as far back as 2009. In one, a Johnson & Johnson specialist writes to a manager to suggest surgeons believe the company is making a "huge mistake" by commercialising their latest brand of mesh. Customers feel they are "rushing to market" and opening up the use of mesh to "unqualified surgeons".
THIERRY VANCAILLIE, PROF., GYNAECOLOGIST: It does indeed make the procedure easier and therefore there was a tendency to operate on more patients. And yeah, it has probably been a bit oversold.
SOPHIE SCOTT: In a statement, Johnson & Johnson says it is not able to comment on the documents because the class action is still going. It says it complies with government safety requirements and follows the industry code of conduct.
A spokeswoman says they "have confidence in the safety and efficacy of these mesh products. They are backed by scientific research."
Fourteen months after her original surgery, Shauna has just had the mesh, which was from a different manufacturer, removed in a Melbourne hospital to try to reduce her pain.
SHAUNA CAHILL: I am really relieved that I don't have the mesh inside me anymore. It can't cause any more damage.
SOPHIE SCOTT: But for women like Shauna, who wanted the mesh removed, there are limited options in Australia.
STELLA CHANNING, PATIENT: There is not one surgeon in Australia that can fully remove it. They can only do partial removals.
UNIDENTIFIED PERSON (to Stella Channing): So how have you been feeling?
SOPHIE SCOTT: Perth mother of three Stella Channing had a mesh implanted in 2011.
STELLA CHANNING: I found out a week later that I had a mesh in me called ProLift, which was the largest, most invasive mesh that's on the market. And so standing up, it is like a trampoline string. It just all pulls.
I went back to the original implanting surgeon and he acted as if I was the only one that had an issue with this mesh.
It is shaking my faith in the medical fraternity, definitely. So I have actually basically stopped looking for medical help here in Australia.
STEVE ROBSON: If women have had complications, symptoms, adverse outcomes from a mesh procedure and they have gone back to their surgeon and have not got a fair hearing, that is wrong.
SOPHIE SCOTT: Thierry Vancaillie is a leading gynaecologist and has just returned from the United States, where he has learned to remove the devices from a surgeon that women are lobbying to have brought to Australia.
THIERRY VANCAILLIE: There is a debate going on whether or not the mesh needed to be removed. And I believe that Dr Veronikis has shown that he achieves better results in pain management.
Physicians here in Australia tend to believe that complete mesh removal is not necessary in most cases. I am not quite sure that is the right approach. I mean, the future will tell.
CAROLYN CHISHOLM: I have done a poll. Seventy per cent of women who have had partial removal are worse off after their partial removal.
And you know, I don't know why RANZCOG (the Royal Australian and New Zealand College of Obstetricians and Gynaecologists) are saying that partial removal is acceptable, because it is not.
I think there is a lot of arrogance in this particular industry. I think that mesh is a real big money-making business for surgeons. You know, it is a quick fix.
STEVE ROBSON: And I think you have to respect the judgement call of the surgeon who wants to do the minimum amount of surgery. We need to be clear that most women who have had mesh used for prolapse operation have actually had a very good result. And a very big majority of women who've had a tape, a mesh tape used for urinary incontinence have had a very good result indeed.
I am not sure why some women have felt that they need to go to America. So we have just set up and publicised a list of units that are able to help women when they have mesh complications like this.
SOPHIE SCOTT: Health authorities maintain they are taking action.
(Footage of inquiry hearing by the Senate Standing Committee on Community Affairs, 3 August)
JOHN SKERRITT: We have cancelled 44 products. We also have put conditions of inclusion on a number of them.
SOPHIE SCOTT: But the women still suffering have a message for those in charge:
CAROLYN CHISHOLM: Please put a suspension on mesh immediately, until there are some long-term studies done, because we don't want any more women injured.
STELLA CHANNING: Listen to us women. We are telling you that we are suffering and we are in pain. You know, we have been told that we are collateral damage. That - shame on them that they would say that!
This is my life. It has destroyed my life.http://www.abc.net.au/lateline/content/2016/s4718370.htm?section=world
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Emails show doctors' bizarre attitudes to women's health
Aug 15, 2017 | ABC Online
By Sophie Scott and Alison Branley
On the opening day of a class action brought by Australian women against pharmaceutical giant Johnson and Johnson, lawyers made a splash by referencing an email between French gynaecologists.
In it, one of the doctors is sending a group reply to a Johnson and Johnson marketing manager when he states he, "would not like my wife to undergo this procedure".
He was talking about the use of surgical mesh to treat pelvic problems after childbirth.
Now a full copy of that email has been tendered to the court and it gives a full picture of the attitudes of these health specialists towards their patients.
In the emails, the doctors are discussing whether to ask women in detail about the impacts of surgical mesh on their sex lives when one of the doctors appears to resort to hyperbole to make his point:
"It is no less true that sodomy could be a good alternative!"
The correspondence goes on to to detail how one gynaecologist is reluctant to talk to middle-aged women with pelvic floor injuries about "fellatio, sodomy, the clitoris with or without g-spot" while another writes about "investments" being "remunerated".Lives ruined
This email chain would be nothing more than a strange sideshow were it not for the Australian victims of surgical mesh who've spoken to the ABC about their experiences.
They tell of feeling like failures because they're in too much pain to be intimate with their partners, of husbands who've been injured by mesh that's pervaded women's vaginal walls.
They tell of partners who've cheated.
They tell of marriages that haven't survived.
Mothers have told us about the jobs they've had to give up from chronic pain, about the children they can't play with or cook dinner for.
They've been told they've got "adverse effects", when for them their lives have been ruined.
Many have returned to their treating surgeons to talk about their pain and suffering, only to be told something similar to what the French gynaecologists' said.
One was told: "There's more than one way to skin a cat."
The Royal Australian and New Zealand College of Obstetricians and Gynaecologists, maintains the mesh devices have helped many women suffering effects of incontinence and prolapse.
Yet this is not the first time the medical fraternity has had to deal with the fallout from problematic medical devices.
They've been through these hoops before with joint replacements, breast implants and cardiac devices.'Collective failure'
Some doctors have broken ranks and spoken out, saying there was, "a collective failure of both the TGA [Therapeutic Goods Administration] and specialists".
Urogynaecologist associate professor Chris Maher from the Royal Brisbane Hospital and the University of Queensland, wrote for The Conversation that some problems could have been avoided if devices were used under the supervision of medical ethics committees.
The TGA has tried to learn the lessons of the past.
Its recent review of Medicines and Medical Devices Regulation recommended a registry for all high-risk implantable devices, and this could include mesh.
But it says the Federal Government shelved such a registry because of cost and fear of unintended consequences.
The Government says it wants to consult further on how to manage and fund a registry.
While affected women would welcome the Government's diligent approach this time around, they tell us they can't understand a profession that would allow a potentially damaging product to be rushed to market but not rush a registry that would regulate the use of such products.
http://www.abc.net.au/news/2017-08-15/emails-show-doctors-bizarre-attitudes-to-womens-health-problems/8805710
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Surgeons Incentivized with Lamborghinis and Swiss Alps Ski Trips Internal J&J Docs Show
Aug 14, 2017 | Mesh Medical Device Newsdesk
Mesh Medical Device News Desk, August 14, 2017 ~ Wealth and Status, Reputation/Ego listed as Key Values for doctors using an Ethicon/ Gynecare TVT polypropylene pelvic mesh.
“Surgery is the Cha-ching thing”
RETIRE RICH
ABC News Australia (Australia Broadcast Company) reports (here) that the pelvic mesh scandal in that country was incentivized by mesh makers who offered surgeons a jet-set lifestyle if they used the medical devices.
The information is revealed in internal Johnson & Johnson documents, part of a federal court class action trial underway in Sydney, Australia, that pits 700 Australian (AU) women against the healthcare giant, maker of pelvic mesh implants used to treat incontinence and prolapse. The plaintiffs claim life-altering injury from the permanent polypropylene implants.
There is no subtle suggestion from J&J in the marketing script that adopting mesh implants into your medical practice can make you wealthy. In fact, it is probably the most blatant indictment of medical devices marketed for money revealed so far in pelvic mesh litigation.
WHO WAS THIS MESSAGE FOR?
A document from Johnson & Johnson entitled “The Practice Driven Physician,” describes him as a highly motivated doctor, looking to make his practice more efficient and profitable, and to enhance his reputation and revenue. Surgeons could insert four devices “before lunch” and make $10,000.
As a result he would enjoy Wealth and Status, Reputation/Ego as one of the “Key Values.”
He is “less inclined to attend multiple conferences.”
A cover of Fortune Magazine was included with the words “Retire Rich.”
The script shows the typical conversation J&J hears from doctors using its products. Just back from a week in St. Moritz skiing, picking up the Lamborghini on Friday “An amazing machine.”
One unnamed doctor allegedly writes in the talking points, “I use your products because I can do more procedures in less time with better reimbursement.”
The memo says a TVT-O can be implanted in eight minutes.
In the U.S. courts, the TVT-O has been found defectively designed by at least three different juries.
Barrister Tony Bannon (senior counsel of New South Wales) has said there was a “tidal wave” of aggressive marketing to surgeons and patients suggesting mesh was a “quick and easy” operation. None of the plaintiffs would have consented to the operation had they had true informed consent outlining the “true risks” of the mesh, he told the court in the first week of this trial that began July 4.
The Shine Law firm is representing the women in this class action, the largest in AU history.
See the document here The Practice Driven Physician.
PROSIMA DOCUMENT
As early as 2009, documents just released in this class action, show concerns were raised inside the company about the Prosima.
Following a Prosima “summit” some said “rushing to market” was a “huge mistake” and opening up the use of the product to “unqualified surgeons.”
Insiders to J&J admit that Prosima has a 30% failure rate. The push to Prosima occurred after surgeons were losing faith in the Prolift procedure, another mesh designed to treat pelvic organ prolapse. It was launched to compete with Boston Scientific’s Pinnacle and AMS’s Elevate.
See MND story here.
Prolift, Interceed and Versapoint were listed with the word “NOT” before them.
The brands pushed in this document include Gynecare Thermachoice, TVT Morceluex, (for hernia) and Prosima.
Prolift and Prosima were two of four meshes voluntarily removed from the market by J&J in June 2012. See MND story here.
Johnson & Johnson would not comment on the documents presented in this class action.
At least 3,000 Australian women have been left with injuries from serious to catastrophic, according to a Senate inquiry in Melbourne, AU last month.
See Prosima document here, AU Class Action on Prosima.
TRAVEL TO ST. LOUIS
With an estimated 100,000 mesh implants used in Australia, ABC News reports Sydney gynecologist Professor Theirry Vancaillie has just returned from St. Louis where he studied with Dr. Dionysios Veronikis on how to do full mesh removals, a difficult task most doctors will not attempt.
“I believe that Dr. Veronikis has shown that by removing mesh in a number of, several hundreds of cases, that he achieves better results in pain management, “ Dr. Vancaillie is quoted as saying by ABC.
Australian women find themselves travelling to the U.S. to have a full mesh removal.
Caz Chisholm, founder of the Australian Pelvic Mesh Support Group found in her poll that “70 percent of women who’ve had a partial removal are worse off after their partial removal.”
SENATE INQUIRY
Members of the Australian Pelvic Mesh Support Group, who want a ban on the devices, called a nationwide inquiry and the Senate responded.
Victorian Senator Derryn Hinch campaigned for the inquiry, calling mesh “one of the greatest scandals against women in Australian history.”
During the first day of the two-day hearings earlier this month, two doctors testified who are also set to be expert witnesses for Johnson & Johnson in an ongoing class action trial in Sydney.
Joanne McCarthy reports for The Herald (here) that Dr. Anna Rosamilia admits she “should have disclosed” she would be giving evidence for the company.
“I wasn’t aware that I needed to,” she told the paper.
Dr. Peter Dwyer, also an expert witness for J&J, told the inquiry that patients have died from these devices, mesh used to treat prolapse and incontinence, when surgeons put them in the wrong place. Training on mesh surgery was “falling between the gaps a bit.”
Mesh manufacturers should not be doing the training of doctors he said. Dr. Dwyer said “on occasion the rep does come into the operating theatre.”
There will be another public hearing August 25th in Perth, AU. ###
LEARN MORE:
ABC News, July 4, 2017, Class Action begins against J&J in Sydney Courtroom Includes 700 Plaintiffs
http://mobile.abc.net.au/news/2017-07-04/class-action-vaginal-mesh-implants-johnson-and-johnson/8674106www.Pelvichealthsolutions.com was established by J&J for women to find out more about the procedures. no longer opens except with dot.ca
Mesh News Desk, September 23, 2015, Plaintiff’s Expert Outlines J&J’s Push to Market Prosima Pelvic Mesh
https://www.meshmedicaldevicenewsdesk.com/plaintiffs-expert-outlines-jjs-rush-to-market-of-prosima-pelvic-mesh/Mesh News Desk, July 24, 2017, Australian Health Advocates Articulate Goals for Mesh-Injured
https://www.meshmedicaldevicenewsdesk.com/australian-health-advocates-articulate-goals-mesh-injured/Newcastle Herald, August 4, 2017, A Melbourne Senate inquiry hearing was told up to 3000 women left with serious mesh injuries, Joanne McCarthy
http://www.theherald.com.au/story/4832324/peak-health-body-scathing-on-mesh-history/Mesh News Desk, March 16, 2017, Australian Investigation into Transvaginal Mesh Leads to Trials and Senate Inquiry
https://www.meshmedicaldevicenewsdesk.com/australian-investigation-transvaginal-mesh-leads-trials-senate-inquiry/The Age, March 14, 2017, Pelvic Mesh Devices Hit by Allegations of Research Fraud, Experimental Surgery on Thousands of Women, Joanne McCarthy
http://www.theage.com.au/national/health/pelvic-mesh-devices-hit-by-allegations-of-research-fraud-experimental-surgery-on-thousands-of-women-20170313-guxcljMesh News Desk, June 2012, Four J&J Vaginal Meshes to be Removed from Market
https://www.meshmedicaldevicenewsdesk.com/four-jj-vaginal-meshes-named-will-be-removed-from-market/ -
Will my aunt’s dementia halt her driving? - DR ROSEMARY answers your health questions
Aug 14, 2017 | Express.co.uk
By Rosemary Leonard
Q: Two years ago I had a vaginal mesh implant fitted to cure an incontinence problem after the birth of my children.
I have had intermittent pain since, although I am still able to work and carry out normal everyday tasks.
I read that some women are now planning to take legal action against manufacturers of the mesh, arguing that it is not fit for purpose. I am now very worried. Should I have it removed?
Can this be done on the NHS?
A: Vaginal mesh implants are used to treat incontinence and pelvic discomfort caused by weakening of the vaginal walls.
Between 2011 and 2016 more than 11,000 women in England were fitted with them and the treatment was a success for many.
However in some women the mesh appears to have shrunk or started protruding through the vaginal wall, causing pain and an inability to have sex.
Data from the Medicines Healthcare products Regulatory Agency, the medicines watchdog, has shown that more than 1,000 adverse incidents associated with mesh implants have been reported and more than 800 women are apparently suing the NHS and implant manufacturers.
If you are having problems that might be related to your mesh then see your GP and ask for a referral to a gynaecologist.
If you require corrective surgery it should be done on the NHS.
https://www.express.co.uk/comment/columnists/dr-rosemary-leonard/840867/dementia-driving-DVLA-license-assessment-Alzheimers
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