Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
Please share what you have learned!
Twitter: @JjrkCh

Tuesday, August 22, 2017

AMS (American Medical Systems,now Endo and J&J (Johnson & Johnson/JNJ) HARM Women FOR PROFIT in AU



  • Joanne McCarthy  AUGUST 22 2017 - 12:11PM

The Australian Medical Association acted as exclusive distributor of an Australian-invented pelvic mesh device for women that helped spark a global pelvic mesh scandal after it was sold and registered for use in America in 2001.
The AMA's marketing of the Intravaginal Sling (IVS) Tunneller device as an "Australian medical design breakthrough" to treat incontinence and prolapse, despite women's reports of complications in Western Australian public hospital trials from as early as 1989, was "a long way from our proudest hour", said current AMA president Dr Michael Gannon.

Australian Medical Association national president Dr Michael Gannon confirmed the AMA promoted and distributed a pelvic mesh device for women that helped spark a global pelvic mesh scandal. 
"It is unfortunately the case that many women have been injured by these kinds of operations. To call this a tragedy is not overstating it at all," he said, after confirming a wholly-owned subsidiary of the AMA's Western Australian branch promoted and exclusively distributed the IVS device.
It was a controversial decision that "I'm sure they now regret", and which some Perth gynaecologists continued to be unhappy about more than 15 years later, he said.

"I can only answer that in good faith the AMA WA thought it was a good product. History will not judge that decision kindly. It already has not judged that decision kindly," Dr Gannon said.

His comments come only months after the Royal Australian and New Zealand College of Obstetricians and Gynaecologists conceded there was "very little robust information" of the long term safety of some prolapse mesh devices, despite estimates more than 30,000 Australian women received them.

The IVS Tunneller's sale to Tyco Health and registration in America in April, 2001 was used by pharmaceutical giants, including Johnson & Johnson, to register their own prolapse devices by arguing they were "substantially the same" as IVS and subsequent devices, without producing independent evidence of safety. They were then cleared for use in Australia.

More than 700 Australian women alleging serious and permanent injuries after pelvic mesh surgery for incontinence and prolapse are suing Johnson & Johnson in a Federal Court case in Sydney.

An Australian Medical Association document describing the IVS Tunneller device as an "Australian medical design breakthrough" to treat incontinence and prolapse in women.
Another 300 Australian women are registered for a second class action against American Medical Systems (AMS), which developed pelvic mesh devices including Perigee and Apogee. Apogee was cleared for use in America in 2004, after AMS argued it was "substantially the same" as the Australian-invented IVS Tunneller.
Dr Gannon, a Western Australian obstetrician and gynaecologist, said he was aware of "hundreds of operations" by Perth specialists trying to "remedy the damage" caused by mesh devices including the IVS.

Australian Pelvic Mesh Support Group members fought for a Senate inquiry into how pelvic mesh devices were cleared for use in Australia. 
"I have been personally involved in the care of women who have suffered greatly from bladder dysfunction, bowel dysfunction and sexual dysfunction because of some of these devices," he said.
It was a "regulatory failure that so many individual women were damaged".
"The TGA (Therapeutic Goods Administration) takes great care when it looks at new medicines entering the market, but I don't think they are resourced to take the same care with devices. We would like to see them use the same blowtorch on devices as applies to medicines," he said.
Perth woman Jeanette McKinnon, who said she "wanted to vomit" several weeks ago when a specialist confirmed she was implanted with at least two mesh devices at the Bentley public hospital in 2004 and 2005, allegedly without her knowledge or consent, was outraged when told of the AMA's involvement.
"I'm absolutely horrified. I'm so angry I'm shaking. That this has been allowed to go on, and the AMA's been involved. How dare they? We're human beings," Mrs McKinnon said.
The IVS Tunneller device was developed during experiments on 13 large dogs in 1987 by inventor Dr Peter Petros and other Royal Perth Hospital doctors.
A WA East Metropolitan Health Service spokesperson confirmed Royal Perth Hospital approved a research study in 1989 into the IVS device and procedure. It was granted standard clinical practice status by the hospital's ethics committee in 1993.
A Medical Journal of Australia report in July, 1994 acknowledged many doctors were critical of the procedure.
In February 2001, only two months before the IVS Tunneller was cleared for use in America as an incontinence and prolapse device, the Royal Australasian College of Surgeons found there was "no peer-reviewed, good quality evidence available to determine the safety and efficacy of the IVS procedure to treat women's incontinence". There was no assessment of its use to treat prolapse.
In a paper in 2003 called "Intravaginal Sling Distress", three Australian specialists, including Newcastle gynaecologist Alan Hewson and Brisbane gynaecologist Chris Maher, reported "disconcerting complications" in women after IVS surgery, including infections, pain syndromes and "symptoms debilitating to the patient's and partner's quality of life".
"Until further data on the safety and efficacy of the IVS procedures is available they cannot be recommended," they concluded.
A 2010 Melbourne Mercy Hospital for Women review of 10 years of pelvic mesh surgery found the IVS device had significantly higher rates of pain, mesh erosion and infection complication rates than eight other devices reviewed.
Dr Petros did not respond to Newcastle Herald questions.
In a paper in 2012 Dr Petros said his "early experimental studies" had been "wrongly" used as "an intellectual cornerstone to justify the use of mesh in prolapse surgery".
In the paper he distanced himself from the global mesh scandal, saying complications were related to "large sheet" mesh adopted by some companies, and not the small tapes advocated by him which preserved "vaginal elasticity".
In a submission to a Senate inquiry into pelvic mesh devices, which will hold its second public hearing in Perth on Friday, Dr Petros referenced his 1990 paper produced after trialling the Intravaginal Sling procedure on "13 female mongrel dogs", in association with Royal Perth Hospital and the University of Western Australia.

http://www.watoday.com.au/wa-news/australian-medical-association-president-confirms-ama-was-role-in-pelvic-mesh-scandal-20170822-gy1hzj.html


Tuesday, August 8, 2017

Douglas Kohrs, AMS (American Medical Systems), Endo: Criminals Go To Jail - Executives Pay 'Settlements'


Published on August 8, 2017 by Laurie Villanueva  FiDA Highlight


Endo International PLC has announced new agreements to settle “virtually all known” U.S. transvaginal mesh lawsuits involving devices manufactured by its American Medical Systems unit.
In a statement issued yesterday, the company disclosed that it would reserve another $775 million to resolve the remaining U.S. claims. With the additional reserves, Endo will have now set aside more than $2.6 billion to cover costs associated with transvaginal mesh settlements.
“While it remains possible that additional claims will be filed, we believe today’s announcement will assist most mesh claimants to move forward with their lives and will permit Endo to move forward with an even greater focus on executing against our core strategic priorities,” said Paul Campanelli, Endo’s President and Chief Executive Officer.
Under the new agreements, Endo will begin making installment payments in the fourth quarter of 2017. The installments will continue through the fourth quarter of 2019.
Roughly 22,000 transvaginal mesh lawsuits remain pending in the American Medical Systems litigation, all of which were filed on behalf of women who allegedly suffered serious complications after the devices eroded into their vaginal wall. The majority of claims are pending in a federal multidistrict litigation now underway in the U.S. District Court, Southern District of West Virginia.
Nationwide Transvaginal Mesh Litigation
Transvaginal mesh products were once widely-used to treat women suffering from pelvic organ prolapse and stress urinary incontinence. However, the U.S. Food & Drug Administration (FDA) has issued several public health alerts since 2008 detailing life-changing complications potentially associated with the implants, including mesh erosion, chronic pain, organ perforation, incontinence, scarring and adhesions, chronic infections, and more.
In 2011, the FDA reversed its previous position regarding the frequency of transvaginal mesh complications in pelvic organ prolapse repair, stating it no longer considered these adverse events to be rare. The agency also expressed doubt that such procedures offered any additional benefits compared to traditional non-mesh prolapse repair.
Last year, the FDA finalized new regulations that, among other things, reclassified transvaginal mesh intended for use in prolapse repair as a high-risk medical device. The new rules also made the implants ineligible for the agency’s 510(k) clearance program, which had previously allowed such products to come to market without first undergoing human clinical trial.
While it appears that most cases involving American Medical Systems will soon be resolved, the litigation surrounding transvaginal mesh is far from over. Johnson & Johnson and its Ethicon, Inc. subsidiary still face roughly 55,000 pelvic mesh claims now pending in state and federal courts around the country.
Other device makers involved in the massive transvaginal mesh litigation include Boston Scientific Corp., C.R. Bard, Inc., Coloplast Corp., Cook Medical, Inc. and Neomedic.
Ethicon and the other defendants have settled some pelvic mesh lawsuits, but thousands of cases remain pending.
____________________________________________________________________
https://seekingalpha.com/article/4096349-endo-international-plc-endp-q2-2017-results-earnings-call-transcript?page=2   
Earnings conference call today with global banks and investors
Paul V. Campanelli - Endo International Plc
Yesterday, the company announced that it reached agreements to resolve virtually all known U.S. mesh product liability claims. Beginning in the second quarter of 2017, we aggressively executed a settlement strategy in connection with Endo's mesh litigation. We believe that these efforts which include global resolution with all key plaintiff attorneys; case management orders issued by courts overseeing mesh cases, and our goal of having additional orders entered by other courts; our decision to stop selling mesh products in March of 2016; settlements recently entered into by other mesh manufacturers and the corresponding decrease in attorney advertising, as well as the continued running of statutes of limitations will collectively deter future filings.
Importantly, we believe these actions will assist most mesh claimants to move forward with their lives and permit Endo to move forward with an even greater focus on executing against our core strategic priorities. We increased our mesh liability accrual by $775 million in the second quarter, which is expected to cover approximately 22,000 U.S. mesh claims subject to a claims validation process for all resolved claims as well as all of the known international mesh claims and other mesh-related matters. I'll let Blaise address this more fully as he discusses our financial performance.
Blaise Coleman - Endo International Plc
Moving to slide 11, on the mesh litigation settlements, Paul already discussed we've reached agreements to resolve virtually all known U.S. product liability claims relating to the transvaginal mesh products sold by Endo's AMS subsidiary. As to the financials, in the second quarter 2017, Endo recorded a $775 million mesh product liability charge, reflecting an estimate for the expected future payments related to the resolved U.S. mesh product liability claims, the small portion of known unresolved U.S. claims and all of the known international mesh product liability claims and all other mesh related matters.
As of June 30, 2017 the mesh liability accrual was approximately $1,295 million, with $359 million in the qualified settlement funds, leaving approximately $935 million to be paid into qualified settlement funds. We expect to pay approximately $160 million to $185 million into the qualified settlement funds or directly to plaintiffs during the second half of 2017, with the remaining payments into the qualified settlement funds continuing through the fourth quarter of 2019.
Question-and-Answer Session
Operator
Yes, sir. First question comes from Liav Abraham of Citibank. Your line is now open.
Liav Abraham - Citigroup Global Markets, Inc.
Good morning. A couple of questions.  

And then secondly, on your settlement on mesh, congrats for closing this out. Just a couple of clarifications. The settlement amount that you announced, is this a post-tax amount or pre-tax? I assumed it was pre-tax, so what would the tax shield be on that? And I also noticed that the number of claims covered by the agreement that was announced yesterday of 22,000 was a lot higher than what was disclosed in Q1 of 10,500. So, was this just a significant step-up in the number of new claims in the recent past few months? Thank you.
Paul V. Campanelli - Endo International Plc
Thank you. So, I'll take the environment question, then I'll talk a little bit about the increase in claims to 22,000 and Blaise will talk a little bit about your financial question. 

Regarding the mesh update in terms of the increase from 10,000 to 10,500 to 22,000, the starting point was is when I was asked to take over as CEO in late September and early October, it took me a period of time to evaluate the current strategy that Endo was pursuing.
And then after careful consideration, looking at where we're heading in terms of looking at this for a series of years, looking at – opining with internal and external counsel, as you know, we made some disclosures early in the, I guess, mid to late second quarter would probably be better way that we disclosed at that period of time, that there was approximately 10,500 claims that had been filed or asserted or that we believed that were likely to be filed or asserted.
And that was our starting point. However, later in that period of time, we did change our strategy. I got closer involved and we had an opportunity to meet with private plaintiffs and we started to negotiate. At that point in time, we received more information that we did not have earlier in that period of time. And we learned a lot more about unfiled claims that totaled approximately 22,000 claims. So we had to make a business decision. We looked at where the company was headed, we were looking at distraction; we were looking at the amount of time that we were investing into resolving the mesh claims.
So at that point in time, we looked at the number of claims and we negotiated to $775 million accrual. And we view this as an inflection point for the company. So while it was a difficult negotiation, we are now moving forward as a company. We're focused on operational execution and we can focus on our business.
So with that, I'll pass it over to Blaise and can talk a little bit about the financial aspect.
Blaise Coleman - Endo International Plc
Yeah, sure. So, just in terms of the pre- and post-tax question, just as a remainder, as we've previously discussed, one really needs to model taxes at a total enterprise level. So as we said for 2017, we expect to be in a net tax cash receipt position of $15 million. And for modeling purposes for 2018 and 2019, we're providing a range that our cash taxes paid will be between $15 million and $30 million at a total company level. And that would obviously include everything including the mesh payments that are new here that we'll have in 2018 and 2019.
Liav Abraham - Citigroup Global Markets, Inc.
Great, thank you.

Young Min Lee - Raymond James
Good morning. This is Lucas Lee in for Elliot. Thank you for taking our questions. So, as a follow-up to the dialogue around resolution of mesh litigation claims, understand that this resolves the vast majority of known and potential cases. But assuming there could still be some emerging cases, could you help us frame what the cap on liability is, potential liability is? We're just trying to get a sense of how many patients ultimately used the mesh product and then how many of those have turned into claims. Thank you.
Paul V. Campanelli - Endo International Plc
Yeah. So no, Lucas, we're not going to be able to quantify that for you. What you have to understand is the 22,000 that we disclosed is virtually all known claims. Now, moving forward, what we've done is we've talked about things that have occurred and what we've put in place to deter, and I mentioned this in my opening comments, right? What's in place to deter the assertion of weak or meritless case, right? The sheer nature of having the CMO in place, the case management order at the MDL level and also having a case management order in the state of Minnesota, whereby that is the home state of AMS, that in itself is going to deter, again, weak or meritless cases, right? So, there is a process in order to move cases forward.
The CMO in itself is a deterrent of having mass tort cases coming forward. So, that's one component. You've got to recall that we stopped shipping and selling the product in Q1 of 2016, so you have a timing issue. You also have the statute of limitations. That ranges state by state in a range of two to three and up to six years, but the bottom line is is you have a statute of limitations.
When you look at all of these components, I think we have positioned ourselves in a good place to move forward and away from mesh. So I hope I answered your question, Lucas.
Young Min Lee - Raymond James
All right. Thank you.

Ann-Hunter Van Kirk - BMO Capital Markets (United States)
Good morning. This is Ann-Hunter Van Kirk on for Gary. Thanks for taking our questions. What are your expectations for leverage over the next couple years in light of the mesh payment and are you considering any additional cost cuts to help pay down debt?
Paul V. Campanelli - Endo International Plc
Thanks. So Blaise you'll take this?
Blaise Coleman - Endo International Plc
Yeah. So thanks, Ann, for the question. I think as we told you for 2017, we expect to be in the high 4 times range from a leverage perspective. And as we've previously communicated, we do continue to aspire to leverage down over time back into the 3 times to 4 times range. In terms of timing of when we'll be able to achieve that leverage goal, although today's announcement around mesh removes one of the near-term uncertainties we've been facing in terms of developing a path and timeframe in order to achieve that goal, we're just not going to able to provide any specific timeline today, as there continues to be a number of key uncertainties, both in the near-term and mid-term that could impact the timing of delevering. But again, we will, as we talked about when we come to 2018 guidance, we'll certainly provide what our expectations are, both from a cash flow perspective and from a leverage perspective for 2018.
Paul V. Campanelli - Endo International Plc
On the cost-cutting side, and I think you've seen that we've made some very difficult decisions over the last 10 months.

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https://www.bizjournals.com/philadelphia/morning_roundup/2016/02/endo-shutting-down-astora-womens-health-division.html
Endo shutting down its women's health division
Feb 29, 2016, 4:04pm EST Updated Feb 29, 2016, 4:33pm EST

Senior Reporter
Philadelphia Business Journal

Endo International said Monday it is winding down its Astora Women’s Health division after failing to find a buyer for the business.
The company said it will cease business operations for Astora, based in Eden Prairie, Minn, by March 31 in part to “reduce the potential for product liability related to future mesh implants.”

Endo (NASDAQ: ENDP) and other medical manufacturers who make vaginal mesh products have been sued by patients allegedly injured by the makers of such products used to treat a variety of medical conditions including urinary incontinence and pelvic organ prolapse.
The company's stock closed down 21 percent to $41.81 per share Monday.
In August, Endo said it had set aide $1.53 billion for potential litigation and settlement costs, and the company said Monday it took an additional $834 million pre-tax charge during the fourth quarter related to vaginal mesh cases.
Endo, which is based in Dublin, Ireland, and has its U.S. headquarters in Malvern, said it will work with physicians to support their transition to alternative products.
The company, as part of its strategy to focus on global sales of its branded and generic pharmaceutical products, sold off its men’s and prostate health business last year to Boston Scientific in a deal valued at up to $1.65 billion.
Endo entered the urology device market in 2011 when it bought American Medical Systems Holding Inc. for $2.9 billion in 2011.
Last year, Endo bought rival generic drug manufacturer Par Pharmaceutical Holdings Inc. for $8 billion.
John George covers health care, biotech/pharmaceuticals and sports business.

Sunday, August 6, 2017

New Zealand Health Minister "Mansplains" Pelvic Surgical Mesh Scandal to Harmed Women



Teuila Fuatai
August 6, 2017  FiDA highlight
It has been almost 10 years since NZ's Government was alerted to an issue with surgical mesh. Since then, hundreds have suffered injuries from high-risk surgeries. Authorities, including Health Minister Jonathan Coleman, have passed the buck continuously. Teuila Fuatai investigates
Six years before Jonathan Coleman took up the health portfolio in 2014, 14 cases involving patients implanted with surgical mesh were flagged by ACC.
In each of these cases, patients had undergone repair surgery for either incontinence or pelvic organ prolapse. The implanted mesh, made out of polypropylene, was supposed to strengthen weakened tissue and muscle areas, and alleviate their symptoms. However, between 2005 and 2008, those patients all suffered unexpected and severe complications from the surgery.
Classed as “adverse events associated with the use of surgical mesh”, the patient cases were referred by ACC to Medsafe - the Ministry of Health unit responsible for therapeutic product regulation.
Those 14 people - whose surgeries took place at both public and private hospitals around New Zealand - triggered the first Medsafe review into surgical mesh. Importantly, they also laid the groundwork for what has become one of the country’s worst-handled mass medical botch-ups.
To date, ACC has approved 800 injury claims related to surgical mesh, costing at least $12 million to the taxpayer.
A two-year Health Select Committee review into the use of the products - also used in hernia repairs - has proven ineffective, with hundreds of patient horror stories, and a hefty, nine-year paper trail involving numerous Government bodies, members of the medical fraternity and politicians, showing a lack of management and accountability for the “surgical mesh problem”.
Mesh Down Under
Patient advocate group Mesh Down Under (MDU), headed by Charlotte Korte, Carmel Berry and Patricia Sullivan, has grown to nearly 500 members since it was founded in 2012. In that time, numerous petitions, communications and meetings with officials from ACC, Medsafe, the Ministry of Health, as well as the Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG), the Medical Council, the College of GPs, MPs and even Coleman himself, have taken place.
"It appeared [Coleman] was relying on advisors who were obviously not giving him the full picture."
Charlotte Korte

Most recently on July 28, Korte and Sullivan met with the Health Minister in Dunedin.
“We thought that we were finally making headway in getting that meeting, but it appeared he was relying on advisors who were obviously not giving him the full picture because he had no real idea of what the major concerns were,” Korte said.
First, the pair was told Coleman would only have 15 minutes to meet.
During that time, only two concerns about surgical mesh were discussed - and even that was rushed.
“He wanted to leave after the first concern was raised,” Sullivan said.
“His responses to our questions about the lack of progress in implementing Select Committee recommendations was completely unsatisfactory.
"He just told us that his advisors assured him they had been implemented, even when we pointed out they had not,” Korte said.
“Looking back, it seemed like a PR exercise to show he was meeting with an advocacy group. His attitude towards us and ongoing problems with surgical mesh has been extremely tough to understand and endure – especially since he is a GP,” Sullivan said.
“We see more New Zealanders being injured and have watched overseas authorities respond to the problem, yet the Health Minister seems apathetic in attitude and action.” 
Coleman’s response:
When questioned by Newsroom, Coleman was adamant his handling of the use of surgical mesh in New Zealand had been satisfactory.
“What I’ve said to the people [Korte and Suillivan] I met with...because they raised a couple of issues [was to]...put them in writing.”
“All the advice I’ve had is the [Health] Select Committee recommendations have been implemented, and that officials have followed up this issue in an appropriate way,” Coleman said.
Seven recommendations were released by the committee in June last year at the conclusion of its review into the use of surgical mesh. Prompted by Berry and Korte’s 2014 petition, a range of actions were recommended, including:
-       The development of a national surgical mesh register
-       Expansion of Medsafe’s role so it can assess the quality and safety of a medical device prior to its approval for use in New Zealand
-       A review of best practice around the informed consent process for surgical mesh procedures
-       Formalising the requirement for the ongoing education of surgeons in the use of mesh, and its removal
-       The use of a consistent coding system for surgical mesh by health practitioners, enabling the identification and monitoring of patients]
Documents from Medsafe the Ministry of Health, ACC and RANZCOG, dating as far back as July 2007, show these organisations were well-aware of serious gaps in New Zealand’s approach to the use of surgical mesh.
Notifications from overseas bodies, including the US Food and Drug Administration (FDA), Australia’s Therapeutic Goods Authority, and equivalent authorities in the UK, Canada and Europe, warning of severe complications associated with surgical mesh over that 10-year-period, were all received by the Ministry of Health, Medsafe and RANZCOG.
Even more concerning, are the similarities between the cautionary advice outlined in those documents - reviewed by Newsroom as part of this investigation - and the recommendations released last year by the committee.
“He [Coleman] needs to either step up, or step aside.”
Charlotte Korte
In one email dated May 22 2014 from Medsafe group manager Stewart Jessamine, two orders proposed by the FDA to address health risks associated with surgical mesh used in pelvic prolapse repair are discussed.
The email, sent to two senior MedSafe advisors and a senior media staffer, explained the FDA announcement but proposed no action regarding surgical mesh products in New Zealand.
At the time, the announcement prompted several manufacturers to pull mesh products from the US market because they could not show the FDA’s safety and effectiveness standards had been met.
“The redesignation of surgical mesh by the FDA to a higher risk category does not otherwise effect [sic] products approved in the past or those that are currently on the market, nor does it impose any further requirements on manufacturers clinicians to use these devices in any different way to that previously required,” Jessamine said in the email.
“The key issue is communication with the patient to explain the surgical procedure, what is proposed to be used in that procedure and what are the risks and benefits of use of one particalr [sic] surgical approach or material against another,” he continued.
“This requirement for disclosure and communications has always been in place and the FDA redesignation does not change or increase it.”
Another email from Jessamine referring to research commissioned by the executive arm of the European Union also demonstrated the selective approach MedSafe had when considering and endorsing information on surgical mesh.
Dated November 6 2014, the email was written 18 months before the Health Committee published its recommendations.
“If no health select committee reconsideration by the time the SCENHIR [Scientific Committee on Emerging and Newly Identified Health Risks of the European Commission] is published, I would be pushing for us to propose that the Minister [Coleman] consider not supporting Select committee reconsideration at all, (obviously this depends on result of European report),” Jessamine said.
Where are we now
Since meeting with Korte and Sullivan, Coleman has decided to “check” whether advice he has received from “the officials” has been correct.
When asked why he had not done this earlier, Coleman said he had been unaware of any dissatisfaction regarding the implementation process.
"There’s clearly a gap in the view of the people who I met ... compared to the advice I’m getting.”
Jonathan Coleman
“The first was that this was raised as a new and unresolved issue has been in the past two weeks,” he said last Monday [July 31].
“We had that [public] meeting on Friday the 14th of July, I was away for the next week, and then I met with them [Korte and Sullivan] last Friday [June 28th].”
However, Coleman - either directly or through his staff - received and answered numerous queries on surgical mesh from constituents like Korte and Sullivan, as well as fellow MPs, in the past six months.
Following his interview, Coleman also sent Newsroom a document outlining the “timeline” for committee recommendations, dated May 31, 2017.
The document referred to various discussions between health authorities and medical bodies, new ACC and Medsafe forms, updated information on surgical mesh on the Medsafe site, as well as the development of new therapeutics legislation for New Zealand.
It did not specify:
-       If and when a national surgical mesh registry would be created
-       What, if any, expansion of Medsafe’s role would occur to enable it to assess the quality and safety of a medical device before it is used in New Zealand
-       Any outcome regarding a review into best practice and the informed consent process for surgical mesh procedures
-       Whether ongoing education of surgeons working with surgical mesh would be formalised
-       Whether a consistent coding system for surgical mesh was being used by health practitioners so patients could be identified and monitored
When asked how long was needed to implement recommendations - particularly given the mounting number of injury claims - Coleman refused to identify a specific timeframe.
“I think the recommendations have or are in the process of being implemented, but I fully accept that...many things that are done by the Government may not happen as quickly as those who are affected by them would want them to happen,” he said.
“It also reflects there’s clearly a gap in the view of the people who I met...compared to the advice I’m getting from the Ministry. We just need to check whether that’s resolvable - that or there may just be some differences in perception.”
Lines in the sand
Coleman’s engagement with the issue, particularly in the past month, has pushed Korte and MDU to near breaking-point.
"I have not made a mistake. I have the deepest sympathy for all ... who have been affected by this."
Jonathan Coleman
Ït’s just not acceptable,” Korte said. “These people’s lives have been destroyed. How many more people’s lives have to be ruined before the Government and Jonathan Coleman start listening?"
“He needs to either step up, or step aside.”
“We need an independent commissioner to take charge, someone who is capable of fixing the problems associated with the surgical mesh issue and who can put patients first,”she said.
Meanwhile, Coleman has dismissed the idea.
“We're not appointing an independent commissioner.”

“I have not made a mistake. I have the deepest sympathy for all those people who have been affected by this,” he said.

https://www.newsroom.co.nz/2017/08/06/41379/surgical-mesh-a-decade-of-debilitation

FiDA addition:  Rebecca Solnit,  coined the term "mansplaining:"
It's the presumption that makes it hard, at times, for any woman in any field; that keeps women from speaking up and from being heard when they dare; that crushes young women into silence by indicating, the way harrassment on the street does, that this is not their world.

Friday, August 4, 2017

UK Parliament Hearing About Implant Device FAILURE


Deborah, left, with Owen Smith and Sling the Mesh - Kath Sansom 
Published: 09:34 Friday 04 August 2017  FiDA highlight

A woman who lives her life in excruciating pain after a medical operation four years ago, joined other women at Parliament last month in a campaign to get the surgical procedure banned in the UK. The Sling the Mesh Campaign is calling for an operation using pelvic mesh implants to be banned after thousands of women suffered serious health complications. Deborah Wood, of Bexhill, underwent an operation in 2013 but after experiencing numerous negative side-effects, including extensive bleeding and extremely painful sexual intercourse, she began the process of having the mesh removed. She said: “I have had five operations to remove the tape and I still have a small amount of tape and arms left in. I don’t think I can go through anymore operations. “For the past four years, I have been in chronic pain 24/7. I have nerve damage in my legs – the pain in my legs is constant, they feel like someone is driving red hot glass into my legs. I get a lot of pain in my vagina and my pubic bone. I don’t have any sensation in my bladder so I can’t tell when it is full or empty, I have to use catheters. “I am now left permanently disabled. I cannot walk very far, I need to use crutches, a wheelchair and mobility scooter. I have just been diagnosed with PTSD and I am now on antidepressants. “Before all of this happened I was at university getting a degree in photography and had a photography studio. I had to give that all up. “I am 49 years old and the thought I have to live the rest of my life in pain scares me.” Deborah travelled to London on July 18 with other members of the Sling the Mesh Campaign to meet with Labour MP Owen Smith, who has set up an All Party Parliamentary Group into mesh surgery. The mesh patch or vaginal tape, also known as TVT, TVTO and TOT, are used to treat incontinence and prolapse, often caused by childbirth. Politicians called for mesh operations to be suspended in Scotland in June 2014 and in May 2017, Scottish health secretary Shona Robison called for an independent expert to review a mesh safety report. The English mesh review was due out at the end of July 2017. Deborah added: “The TVT/TOT must stop in the UK. We need to get the public aware to prevent more horrific injuries. This mesh has ruined my life.” Visit https://slingthemesh.wordpress.com/ for details.


Read more at: http://www.bexhillobserver.net/news/health/woman-who-lives-in-constant-pain-calls-for-op-to-be-banned-1-8087506

Australian Inquiry: Pelvic Mesh Causes Catastrophic Harm


Joanne McCarthy

4 Aug 2017, 5:30 a.m.




Determined: Women pelvic mesh victims leave the Federal Court in Sydney as a six-month class action against pelvic mesh manufacturer Johnson & Johnson takes place. A Senate inquiry is considering how mesh was cleared for use in Australia.

AUSTRALIA’S peak health care commission has told a Senate inquiry that up to 3000 Australian women have been left with injuries ranging from very serious to catastrophic after pelvic mesh surgery that is no longer recommended as a front line treatment.
The Australian Commission on Safety and Quality in Health Care was highly critical of specialist training, information to women about pelvic mesh risks, the treatment of women after serious mesh complications and the failure of doctors to respond when they sought help.
“The women have reported these problems. For anyone to suggest they haven’t reported them is nothing short of nonsense. It’s what people have done with those reports, or haven’t done with them, that is the issue,” commission chief executive, Adjunct Professor Debora Picone told the inquiry during a public hearing in Melbourne.
Commission clinical director Dr Robert Herkes said 40 women interviewed during consultations in four Australian cities had complications that were “undoubtedly overwhelming those women’s lives”.
“The bulk of the women were separated or divorced. Only one woman held down a job. For those women the complications were catastrophic,” Dr Herkes said.
Many of the women did not know they had been implanted with mesh devices until they searched for explanations for complications including chronic infections, disabling pain, erosion of the mesh into other organs and an inability to have sex.
The women have reported these problems. For anyone to suggest they haven’t reported them is nothing short of nonsense. It’s what people have done with those reports, or haven’t done with them, that is the issue.
- Associate Professor Debora Picone
“We’ve been extremely concerned by the issues raised by the women we’ve talked with about the informed consent process, and particularly the informed consent process in relation to mesh surgery to treat prolapse,” Professor Picone said.
“In fact some of the conversations we’ve had with women, informed consent has really been absent. There’s no question about that in our minds.”
She described “so-called patient information leaflets” about pelvic mesh surgery as “hopelessly inadequate”, and said the commission felt very strongly that “major steps” needed to be taken on credentialing of doctors who implant mesh devices.
The Senate inquiry into pelvic mesh was called after Australian Pelvic Mesh Support Group founder Caz Chisholm and other members spoke with Victorian Senator Derryn Hinch. He campaigned for an inquiry into “one of the greatest scandals against women in Australian history”.
It is hearing evidence from women who received mesh implants through the vagina for prolapse treatment – now not recommended as a front line treatment after complication rates of at least 10 per cent – and mesh for incontinence, with lower complication rates and recognised evidence of safety and efficacy.
At the first hearing day two doctors who gave evidence conceded they should have declared they were to appear as expert witnesses for Johnson & Johnson in the company’s defence of a class action brought by more than 700 women after mesh surgery for incontinence and prolapse treatment.
Dr Anna Rosamilia told the inquiry she “should have disclosed” that she would be giving evidence for the company after appearing as a representative of Monash Health at the inquiry.
“I wasn’t aware that I needed to,” she said.
Dr Peter Dwyer, who will also give evidence for Johnson & Johnson, told the inquiry most of these companies have got strict ethical protocols that they stick to, before conceding he was an expert witness for the company.
Dr Dwyer told the inquiry that specialist training on mesh surgery was “falling between the gaps a bit”.
“If they’re placed in the wrong place… I mean, patients have died from these devices. They’ve got to be placed correctly,” he said.
Mesh manufacturers, which have been training doctors, should not be left to train them, he said.
Medical colleges had been “very happy to pass this on to special interest groups to manage these problems”, he said.
In response to a question from Mr Hinch about mesh company representatives being present in operating theatres while women are being implanted with mesh devices via the vagina, Dr Dwyer said “on occasion the rep does come into the operating theatre”.
“It’s not unusual for them to come into theatre at times. As long as they’re not directing the operation or interfering in other ways,” Dr Dwyer said.

The inquiry will hold another public hearing in Perth on August 25.
http://www.theherald.com.au/story/4832324/peak-health-body-scathing-on-mesh-history/

Tuesday, August 1, 2017

Please reTweet! Thank you!

Dr. Liv Tørres, Executive Director of the Nobel Peace Center in Oslo, Norway was the keynote speaker at #LWNC2017  Leadership Women National Conference in Dallas, TX July 29.  As a Leadership Women board member, I was privileged to meet and talk with her at length and share some information about this blog, my training as a 2010 FDA/CDRH Patient Representative, alliances with harmed patients and observations at state and Federal trials.  Patient safety is a global issue!

Sunday, July 23, 2017

American Healthcare Giant J&J Stonewalling in Australia: Transvaginal Mesh


July 20, 2017  FiDA highlight

* The world’s biggest healthcare group has quietly cut its exposure to victims in its vaginal mesh class-action lawsuit.
* Seven Johnson and Johnson subsidiaries are in breach of the Corporations Act.
* With no explanation, J&J and its auditor PwC reduced accounting disclosures and transparency.
The 700 women suing Johnson and Johnson for faulty vaginal mesh implants will not be pleased to hear that the healthcare giant has quietly reduced its exposure to medical negligence lawsuits.
Buried in Johnson and Johnson’s disclosures to the corporate regulator is a letter from the group’s lawyers King & Wood Malleson to the corporate regulator which shows a Deed of Cross Guarantee between seven of the group’s subsidiaries has lapsed. By allowing the Deed to lapse, the company has effectively reduced the pool of assets which creditors can access in a legal claim.
Previously, this Deed had ensured that the seven Johnson and Johnson companies had, until this year, guaranteed each others’ debts. This no longer appears to be the case. In the event therefore of a successful class action lawsuit, a claim potentially worth hundreds of millions of dollars, the 700 women may have less access to the assets of the world’s biggest healthcare company.
The company, whose market value in the US is $US370 billion, refused to respond to questions for this story. Communications director Meshlin Khouri claimed, “We are endeavouring to respond to your questions in the timeframe that you’ve requested …”.
We extended the timeframe and Khouri failed to respond to all questions. Gavin Fox-Smith, managing director of Johnson and Johnson Medical Australia/NZ was approached for comment but also declined to respond.
Johnson and Johnson is being sued in a class action lawsuit in the Federal Court. The plaintiffs claim faulty pelvic implants have caused them debilitating pain and that Johnson and Johnson failed to properly test the devices. The case is expected to run for six months. It follows a successful class lawsuit last year in which a $250 million settlement was struck with victims of faulty Johnson and Johnson hip implants.
An analysis of ten years of Johnson and Johnson financial statements shows a swathe of irregularities. Unlike its Big Pharma peers Abbvie and Gilead, Johnson and Johnson pays a reasonable amount of tax. Over ten years, the company racked up $12 billion in revenues and paid $238 million in income tax. In comparison to aggressive transfer pricing culprits Gilead and Abbvie, Johnson and Johnson showed gross margins of 40 per cent in Australia over the period; an indication that it is not pillaging the Australian tax base quite as aggressively as its peers.
However, enshrining the trend towards increasingly shoddy accounting and poor financial disclosure by multinational companies and their Big Four auditors – PwC, Deloitte, KPMG and EY – the financial statements of Johnson and Johnson are littered with faults.
For a start, its seven subsidiaries which had been covered by the aforementioned Deed of Guarantee, have failed to file accounts and are now two and a half months late. We can safely assume that the Australian Securities & Investments Commission (ASIC) has failed to fine the company for these myriad breaches.
Without any explanation by its directors or by its auditor PwC, Johnson and Johnson quietly changed from lodging General Purpose financial statements to the inadequate and skimpy Special Purpose variety in 2009.
Here is a company therefore which deems there are no other “users” of its financial statements than its parent company in New Jersey. Here is a company, the world’s largest healthcare group, an institution which has attracted billions of dollars in taxpayer support from Australia’s Pharmaceutical Benefits Scheme, but which deems that no other party apart from its parent company could be interested in its financial statements.
That is, directors and their auditors at PwC deem the victims of Johnson and Johnson lawsuits, the company’s staff, its creditors and the taxpaying public which subsidises the PBS – none of these stakeholders are deemed to have any interest in its financial statements.
PwC, which cooly picked up $6.6 million over the decade for audit and tax advice can’t even get its numbers straight. According to its “Auditors’ Remuneration” note, PwC earned $1.07 billion in audit fees over the past two years, rather than $1.07 million.
Moreover the accounts are larded with completely spurious information about accounting policies relating to items which don’t exist. All this mirrors a systemic failure: a failure of the Australian Accounting Standards Board (AASB) a failure of successive governments and their Ministers for Finance, a failure of accounting peak bodies, a failure of ASIC to police the sector and above all a failure of the global accounting firms to which all these governments, agencies and peak bodies kow-tow.
If the government really had the backbone to fix this problem it could instruct ASIC to issue a guidance note requiring all foreign multinational companies to lodge General Purpose financial statements. This damaging failure of accountants to be accountable could be fixed in a week. Instead, the world’s largest companies operating in Australia, jagging billions in taxpayer subsidies, file inadequate financial statements which allow them to hide critical information and avoid tax.

michaelwest.com.au has been sponsored by GetUp! and the Tax Justice Network to conduct an investigation into the financial statements and tax affairs of 20 multinational companies. 
https://www.michaelwest.com.au/exposed-how-johnson-johnson-cut-its-risk-in-vaginal-mesh-lawsuit/