60 Minutes, Boston Scientific, China and pelvic surgical mesh harm

https://www.cbsnews.com/news/boston-scientific-gynecological-mesh-the-medical-device-that-has-100000-women-suing/

Surgical Mesh Scandal: Worse Than Thalidomide. Truth.

Vaginal mesh 'disaster' could be 'worse than Thalidomide', experts warn

Compensation could "run into the billions of pounds" according to a lawyer, making it one of the largest medical cases in history.

16:40, UK,

Saturday 30 September 2017

The vaginal mesh that was fitted to tens of thousands of women, leading some to suffer pain

By Charlotte Lomas, Sky News Correspondent and Aubrey Allegretti, News Reporter

An operation to treat incontinence performed on tens of thousands of women across the UK could be hiding a scandal worse than Thalidomide, a leading expert has warned.

Professor Carl Heneghan, who specialises in evidence-based medicine, said some of the devices used in vaginal mesh implants had not been clinically tested and, "unlike in the Thalidomide scandal, you are unable to see the extent of the women's injuries".

Speaking about the scale of the scandal, he said: "I think this is the worst one that we'll ever see in my lifetime because of the scale of the number of women affected."

More than 75,000 women in England had the procedure - known as TVT - between 2006 and 2016, according to NHS data.

One in 15 have had the implant removed.

The 20-minute operation is used to treat stress incontinence and also prolapse, mainly caused after childbirth, by inserting a plastic mesh, made out of polypropylene, into the vagina to support the bladder.

While for many the procedure can be quick and successful, for others it can have dire consequences, leaving patients in chronic pain and unable to walk, work and have sex.

The mesh is supposed to be flexible, but when inside the body can stiffen, erode and slice through organs, including the bladder.

Lesley Elder, 49, had the mesh fitted in 2010 after having two children, and has had 13 subsequent operations to repair the catastrophic damage.

She is now registered disabled, is in chronic pain and survives on benefits.

Image:

Lesley Elder has had 13 operations to repair damage caused by the fitting of the mesh

"I'm not the woman I used to be," she told Sky News. "I feel like a helpless no-hoper. I think I'd be better off dead; I don't want to live like this. I want my old life back."

Professor Heneghan, from the University of Oxford, said Lesley's case is not unique, and warned that the UK is heading for a "major disaster".

"Every young woman I have talked to has not been told about the adverse consequences," he told Sky News.

Professor Heneghan said the NHS was not offering the operation to patients based on "need" but on what manufacturers with a commercial interest wanted.

The mentality, he said, was: "Get people through the system - in and out."

Image:

Ms Elder says she has to take a cocktail of drugs after having the procedure

One manufacturer of TVT is Ethicon, a subsidiary of Johnson & Johnson.

Up to 300 women in the UK are taking part in legal action against Johnson & Johnson, claiming the implants they were fitted with are not fit for purpose.

David Golten, a solicitor at Wedlake Bell LLP, which is representing the women, said it was a "significant" medical case.

Total compensation, he claimed, could "run into the billions of pounds, which would make it the largest medical case in UK history".

A spokesperson for Johnson & Johnson told Sky News implantable mesh was "backed by years of clinical research" and that "Ethicon is confident in its products".

They said the use of pelvic mesh devices is "supported by medical experts around the world".

The spokesperson added: "Ethicon is defending lawsuits concerning the use of our pelvic mesh products.

"We are confident the evidence will show that Ethicon acted appropriately and responsibly in the research, development and marketing of its pelvic mesh products."

http://news.sky.com/story/vaginal-mesh-legal-action-could-be-bigger-than-thalidomide-11060083

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

Transvaginal Mesh Settlement News: Endo ENDP Agrees to Resolve “Virtually All” Remaining Pelvic Mesh Claims, Sets Aside Additional $775 Million

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

John George

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.

J&J Pelvic Mesh Inventor: Dr. Bernard Jacquetin email exposed in court document.

“I would not want my wife to undergo this procedure”: pelvic mesh inventor

Joanne McCarthy

4 Jul 2017, 12:04 p.m

LANDMARK CASE: Gai Thompson, lawyer Rebecca Jancauskas and Jo Manion outside the federal court on Tuesday. Picture: Joanne McCarthy

A FRENCH doctor who invented a Johnson & Johnson pelvic mesh device told another doctor in 2005 that "I would not want my wife to undergo this procedure", the federal court in Sydney was told today.

Dr Bernard Jacquetin made the comment in an email to another doctor in the same year his Johnson & Johnson Prolift device was cleared for use in Australia.

The comment, revealed in a Johnson & Johnson internal document on the first day of a landmark class action by more than 700 Australian women, drew gasps from some of the women sitting in the public gallery at the federal court.

Tony Bannon SC, for the women, told Justice Anna Katzmann that Dr Jacquetin, who was part of a Johnson & Johnson transvaginal mesh evaulation team, concluded his comment about not wanting to have his wife to have a mesh procedure by saying "and I don't think I'm alone in that".

Mr Bannon told the court the comments' message was "those of us who were in the know".

"Once one understands what is really involved with this you wouldn't want your wife, your sister, your mother to undergo this, except in extreme circumstances," Mr Bannon said.

The landmark case, which has attracted international media attention, is expected to take six months.

Mr Bannon told the court each of the 700 women had suffered continuous, frequent and often unbearable pain.

"Their enjoyment of life has been seriously compromised,” he said.

"Their lives have been dramatically altered for the worse.”

Up to 100,000 Johnson & Johnson pelvic mesh devices for incontinence or pelvic organ prolapse were implanted in Australian women.

The three lead complainants in the case were seeking substantial damages in the hundreds of thousands of dollars, Mr Bannon told the court.

The court heard evidence from another internal Johnson & Johnson document from May 2010 which described the kind of doctor the mesh devices were aimed at.

They were doctors who could "do" a Johnson & Johnson TVT mesh device in eight minutes.

Johnson & Johnson envisaged these doctor-clients as the kind who would see the devices helping enhance their reputations and revenues.

They were more likely "mid-career doctors" who saw their practices as businesses.

The court heard the internal Johnson & Johnson document pictured doctors who would use the product as the type who would also enjoy holidays in St Moritz and Lamborghinis.

The document quoted one of the imagined doctor-clients as saying "that makes four (mesh surgeries) before lunch, that works for me".

Mr Bannon told the court the document exhibited the internal approach of Johnson & Johnson to the mesh devices.

He said there was a valuable market to be gained out there by emphasising the speed of the mesh surgery.

The court will also hear of the lack of evidence supporting the safety and efficacy of pelvic mesh devices.

One of the women implanted with a pelvic mesh device, Jo Manion, left the courtroom after Mr Bannon read the internal Johnson & Johnson documents.

Ms Manion was visibly upset through some of the evidence.

The hearing continues.

http://www.theherald.com.au/story/4769832/i-would-not-want-my-wife-to-undergo-this-procedure-pelvic-mesh-inventor/?cs=305

4/27/2017 ACTION: Johnson & Johnson Annual Shareholders Meeting

Who: Device and Drug Harmed Patients/Advocates:  

Pelvic Surgical Mesh, Breast Implants, Hernia Mesh, Power Morcellators, Hip Replacements  Risperdal, Levaquin,  Motrin, etc.

What: MAM Rally & Patient Safety Peaceful Protest with Award-winning Documentary Filmmaker
When:  Thursday, April 27th 2017, 8 am - 1pm EDT
Where:

State Theatre
15 Livingston Avenue
New Brunswick, NJ 08901

J&J Headquarters
1 Johnson and Johnson Plaza (Intersection of Albany & Neilson)
New Brunswick, NJ  08901-1241

RSVP to organizers on the official Facebook Event Page:  https://www.facebook.com/events/1190677214382644/

Meet & Greet
Wednesday Evening, April 26th, 6pm
Carrabba's Italian Grill
335 NJ-18, East Brunswick, NJ 08816
(732) 432-8054

Video of 2014 action:  

https://vimeo.com/92990332

What the shareholders are told: http://www.investor.jnj.com/events.cfm

$1Billion verdict J&J DePuy Pinnacle metal-on-metal hips (December 2016)
https://www.law360.com/articles/867121/3rd-j-j-hip-implant-bellwether-delivers-1b-verdict
$2 Billion settlement - Risperdal (2013)
http://articles.latimes.com/2013/nov/04/science/la-sci-drugmaker-settlement-antipsychotic-20131104
Levaquin antibiotic  http://www.fiercepharma.com/regulatory/levaquin-users-slap-j-j-800m-rico-suit-claiming-pharma-giant-hid-serious-side-effects
https://www.drugwatch.com/manufacturer/johnson-and-johnson/

Research must be carried on, innovative programs developed and mistakes paid for. 
The Johnson & Johnson credo

Hotel:  
Holiday Inn Express & Suites Tower Center New Brunswick
4 Tower Center Blvd
East Brunswick, New Jersey 08816
800-315-2621 or 732.247.6800
www.ihg.com/holidayinnexpress/hotels/us/en/east-brunswick/ebknj/hoteldetail

$99 discount rate - code: MAM(complimentary breakfast is included)

Airport:  
Newark (airport code EWR)
20 miles from hotel
or
LGA(LaGuardia airport) via hired car to NYC Penn Station/Manhattan to NJTransit/New Brunswick Station $14/1 hour

Contributions:
Encourage your supporters to participate financially:
GoFundMe to help with expenses and to help pay for hotel costs for those in need.  
https://www.gofundme.com/jj-mesh-rally-fund

J&J relies on European registries for recall data: FDA fails to protect US citizens.

J&J’s Ethicon recalls Physiomesh flexible composite hernia mesh

JUNE 20, 2016 BY BRAD PERRIELLO   FiDA highlight

Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon last month recalled 1 of its surgical mesh products after studies showed higher revision rates after a type of minimally invasive hernia repair using its Physiomesh flexible composite mesh.

In a May 25 letter to healthcare providers, Ethicon said it’s pulling the mesh after a review of unpublished data from a pair of European registries revealed the discrepancy between Physiomesh flexible composite and the other meshes in the registries after laparoscopic ventral hernia repair.

West Somerville, N.J.-based Ethicon said it believes the higher revision rates are due to a “multifactorial issue,” possibly including “product characteristics, operative and patient factors,” but hasn’t been able to pin down a cause.

“Consequently, Ethicon [has] not been able at this time to issue further instructions to surgeons that might lead to a reduction in the recurrence rate and [has] decided to recall Ethicon Physiomesh composite mesh from the global market,” according to the letter. “Ethicon will not return theEthicon Physiomesh composite mesh product to the market worldwide.”

Patients already implanted with the product should be followed as usual, the company said. The recall does not involve any other Ethicon meshes, including the Physiomesh Open flexible composite mesh, it said.

“Ethicon recognizes the voluntary product recall of the Ethicon Physiomesh composite mesh may be disruptive to your facility and apologizes for any inconvenience this may cause,” the company wrote. A list of the affected product codes can be found here.

http://www.massdevice.com/jjs-ethicon-recalls-physiomesh-flexible-composite-hernia-mesh/

AU "living nightmare" with J&J Prolift pelvic mesh!

'We've lost so much': Senate urged to act on failures over mesh device implants

April 13, 2016 - 8:15PM

Joanne McCarthy (FiDA highlights)

EXCLUSIVE

Five years ago Gai Thompson warned Australia's peak health bodies of a looming disaster involving women receiving mesh device implants to treat common problems after pregnancy, birth and hysterectomies.

This week Mrs Thompson and others are speaking publicly for the first time as they plan a rally in Canberra and call for a formal inquiry into the health regulators and medical bodies they say have failed them.

They are the women who, in many cases, can no longer have sex, have lost their jobs, have had to mortgage or sell their homes, have travelled overseas for surgery to remove the mesh, have suffered excruciating chronic pain, are resistant to some antibiotics because of chronic infections, and have suffered in isolation and silence – often for years.

"We've lost so much that I can't believe in this day and age this can happen to women, that our lives are being destroyed and no one cares," Mrs Thompson said.

In America tens of thousands of mesh victims have taken manufacturers and doctors to court and been awarded damages of up to $12.5 million. In Australia the response from women has been slower because of fewer numbers and isolation, but it is growing, says Australian Pelvic Mesh Support Group founder Caz Chisholm.

A planned rally by her group in Canberra in late May will target one of Australia's peak health regulators, the Therapeutic Goods Administration (TGA), which approved the first of more than 40 different mesh devices for transvaginal (through the vagina) surgery to treat prolapse in 2005. Prolapse is where pelvic muscles and ligaments are weakened after pregnancy, birth or hysterectomy.

The TGA approved the devices despite no evidence of their safe use in prolapse cases and clear warnings in 2003 of the need for controlled trials on related mesh devices.

Eleven years later, in a letter to a patient advocate in 2014, the TGA conceded its assessment process for mesh devices had not been "mature" and lacked "rigour". The letter coincided with belated TGA action requiring clinical evidence from manufacturers of the safety and efficacy of transvaginal mesh devices.

Mrs Thompson's life after mesh surgery in February, 2008, is reduced to a one-page incident report on the TGA website.

She is the woman whose adverse event report to the TGA in October, 2011 about the Johnson & Johnson Prolift mesh device, noted she could no longer have sex and her life after February, 2008 had become "a living nightmare".

The report noted multiple urinary tract infections leaving her resistant to some antibiotics, chronic and severe pelvic pain, chronic bowel problems, incontinence, multiple areas where the mesh had eroded into her vagina, and that she was unable to stand for any length of time, suffered constant fatigue and stress, and had needed successive surgeries and treatments.

She was unable to work and as a consequence she and her husband had been forced to sell their home, Mrs Thompson said.

It took almost exactly three years for the TGA to complete its investigation of Mrs Thompson's October, 2011 complaint, until it placed her adverse event report on its website in October, 2014.

This week she said she first contacted the TGA by phone in 2010, after two years of seeing different medical specialists to deal with the consequences of the surgery.

"You don't know where to complain when something like this happens. When I first phoned the TGA they said they'd had no other complaints. I kept ringing them. I kept saying to them 'What else have I got to do to get you to do something'?" she said.

"They just kept saying sorry, but I was the only complaint they had."

A Senate inquiry into Australia's health care complaints processes will consider a submission by a patient advocate arguing the complaints process has spectacularly failed women given transvaginal mesh devices to treat prolapse surgery.

While it is mandatory for manufacturers to report adverse events to the TGA, they have to be made aware of any adverse events experienced by women. The TGA has confirmed it is not mandatory for doctors to report adverse events experienced by patients.

Ms Chisholm and Mrs Thompson say the majority of women were completely unaware they could complain to the TGA, or even that mesh was classed as a "device" that came under the TGA.

When Mrs Thompson was told three or four years ago that she had irreversible nerve damage in her pelvis because of the mesh, she was advised she could try morphine patches to cope with the pain.

She rejected the idea. Her life is about managing pain and the stress that flows from it.

"I can't get up and down steps. I can't go out for a walk. I feel like I have barbed wire in my pelvis and every time I move it causes me pain," she said.

"To have one day pain free, when you've had years and years of chronic pain, is something I can't even imagine now."

The Therapeutic Goods Administration said it started monitoring urogynaecological meshes in 2008, with a review in 2010 that found complications were closely linked to the skill and training of surgeons.

By August 2014 after a clinical review it reassessed the clinical evidence for devices and took action against some manufacturers, including the cancellation of devices.

In a statement to the Newcastle Herald the TGA said it had strengthened its oversight of new applications for mesh approvals, including conducting its own clinical assessment of the evidence rather than relying solely on European approvals as the basis for approval in Australia.

Johnson & Johnson was contacted for comment.

Newcastle Herald

http://www.smh.com.au/federal-politics/political-news/weve-lost-so-much-senate-urged-to-act-on-failures-over-mesh-device-implants-20160413-go5obe.html

Read more: http://www.smh.com.au/federal-politics/political-news/weve-lost-so-much-senate-urged-to-act-on-failures-over-mesh-device-implants-20160413-go5obe.html#ixzz45hzjwkUb 

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