Australian Inquiry: Pelvic Mesh Causes Catastrophic Harm

A Melbourne Senate inquiry hearing was told up to 3000 women left with serious mesh injuries

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/

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

Exposed: how Johnson & Johnson cut its risk in vaginal mesh lawsuit.

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/

Johnson & Johnson Pelvic Mesh: Sell, Sell, Sell !!!! Profit over Safety.

Court told how Johnson & Johnson conducted 'tidal wave of promotion'

By Hannah Sinclair

Nine years ago Gai Thompson had a mesh implant that she said changed her life forever.

“The mesh destroys lives, it destroys you physically and emotionally,” Ms Thompson told reporters outside the court in Sydney.

Ms Thompson is one of the seven hundred women involved in one of the country's largest product liability class actions, taking on Johnson & Johnson and its subsidiary Ethicon.

“Today is their chance to be heard and seek justice for what was lost,” Shine Lawyers’ Rebecca Jancauskas said.

“This is about accountability and ensuring this never happens again.”

The mesh is used to treat common complications after childbirth, such as prolapse and incontinence.

Shine’s Barrister Tony Bannon SC told the court many of the women now live in excruciating pain due to inflammation and infection.

Some are unable to work or be intimate with partners, meaning their "enjoyment of life had been seriously compromised and dramatically altered for the worse."

The court heard Johnson & Johnson conducted an aggressive "tidal wave of promotion" towards surgeons, spruiking the procedure without conducting appropriate clinical trials.

Lawyers for the claimants say removing the implant is near impossible and "is a highly complex, life threatening surgery. Even if removed the pain and disability will continue."

The court heard patients weren't properly advised of the risks involved with the surgery, and that if they were they never would have gone ahead with it.

More than 100,000 women have started legal action against the pharmaceutical giant in the US, the UK and Canada.

Some of the products involved in the suit are still available to purchase.

“There’s too many women who are injured,” implant victim Joanne Maninon said.

“The pain, the complication, the autoimmune diseases. It’s lifelong. You don’t just have the mesh removed and then recover and go on with life. You’re damaged for life.”

Johnson & Johnson says the products were developed in consultation with specialist surgeons and the majority of women had a positive result.

A statement from Johnson & Johnson said: “We have sold over 100,000 mesh products in the Australian market.

“We have been notified of fewer than 200 total product events. 67 of these product events were assessed as reportable to the TGA and Medsafe, in line with their requirements.

“It is always a concern to us when a patient doesn’t get the outcome they had hoped for, or believes they have experienced an adverse event.

“However it is important to remember that the majority of women who have undergone this surgery have had a positive result, and it has improved their quality of life.”

Their lawyers will give evidence next week.

http://www.sbs.com.au/news/article/2017/07/04/court-told-how-johnson-johnson-conducted-tidal-wave-promotion

Medical device industry: "rotting from the inside out".

‘I’m rotting from the inside out’: woman tells of vaginal implant gone wrong

September 5, 2015 9:00am

Rhian DeutromThe Sunday Mail (Qld)

A BRISBANE woman whose body rejected a controversial pelvic implant at the centre of a class action has spent the past decade in agony.

Dee Nelson, 46, has been fighting for specialists around the country to address severe complications caused by a common vaginal implant.

While the mother-of-two looks perfectly healthy, she believes the tension-free vaginal tape sling, distributed by Johnson & Johnson Australia, is slowly killing her.

Ms Nelson received the implant in 2005 for weak pelvic muscles following the birth of her daughter. Two weeks later, she was rushed to the emergency department with heavy bleeding and a high fever.

According to Ms Nelson, her body rejected the implant but no one would believe her. Doctors told the mother her symptoms were “all in her head”, and at one point, a psychiatric assessment was suggested.

“I knew what the problem was, as did millions of other women across the world, but no one would listen,” Ms Nelson said.

“These people were playing with my life, but if I went back and said there was something wrong, they just wiped their hands of me.

“I have been handed around the system from one specialist to another, and in the meantime, women are dying from these foreign objects inside them.”

For the next 10 years, Ms Nelson’s health rapidly deteriorated as her nerves and muscles grew through the plastic implant, wreaking havoc with her confidence.

“I have aged so much, and I’m in constant pain,” she said.

“I can’t hold down a job, eat during the day or stand up for long periods … I feel like I’m 90 years old. It’s horrific.”

Surgeons around the country have refused to remove her implant as it has been inside her for too long.

Ms Nelson said the side effects have taken a significant toll on her family as well.

“When my children were young and needed me, I couldn’t be there for them because I was in agony,” she said.

“They have had to watch me deteriorate … it’s devastating.”

For Ms Nelson, even the thought of having sex with her husband was painful.

“I have a beautiful partner who I have been married to since I was 16 years old, but I can’t love him and he can’t love me,” she said.

“To go through life without love and not be a woman isn’t right.”

Ms Nelson is one of about 40,000 Australian women who received mesh implants before they were withdrawn from sale in 2012. Shine Lawyers’ class actions solicitor Bridget Cook told The Courier-Mail a lawsuit was filed against distributor Johnson & Johnson Australia and manufacturer Ethicon in 2012 on behalf of 400 women who suffered the devastating side effects.

“We allege the products were introduced without any pre-market testing … the implants were not fit for their purpose,” Ms Cook said.

A spokeswoman for Johnson & Johnson Australia said the company was “always concerned when a patient experiences adverse medical events”.

She said Ethicon is “vigorously defending” all lawsuits concerning the allegedly faulty implants.

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

“We have made patient safety a top priority, and will continue to do so,” the spokeswoman said.

While the lawsuit inches closer to a trial, Ms Nelson remains housebound, praying to regain control of her life. Her only hope is to travel to the US to undergo $40,000 surgery to finally have the mesh removed.

“Knowing what I know now, I would never have gone through with it … It’s rotting me from the inside out,” she said.

http://www.couriermail.com.au/news/queensland/im-rotting-from-the-inside-out-woman-tells-of-vaginal-implant-gone-wrong/story-fnihsrf2-1227514296507

Boston Scientific follows product failure with belated $1 million clinical study

Vaginal Mesh Effectiveness Target of New Boston Scientific Study

By: Austin Kirk | Published: June 10th, 2013  (FiDA highlight)

Boston Scientific announced last week that it is working with the Pelvic Floor Disorders Network (PFDN) to study the effectiveness of treating uterine prolapse with vaginal mesh compared to traditional surgery.  

The company is contributing more than $1 million to the study, which will look at one form of pelvic organ prolapse (POP) and the available treatment options.

The announcement comes two years after the FDA found that there was no evidence that transvaginal mesh provides any additional benefits when compared to traditional surgery, yet it appears to carry a risk of serious complications.

Concerns about the safety of surgical mesh for treatment of pelvic organ prolapse and female stress urinary incontinence gained widespread attention in July 2011, when the FDA indicated that nearly 3,000 reports of problems with vaginal mesh were received by the agency between January 2008 and December 2010, including cases where the mesh eroded through the vagina, caused infections and other debilitating injuries.

In early 2012, the FDA sent a letter to several manufacturers of these products, ordering that they conduct additional studies and trials to evaluate the safety of transvaginal mesh products, looking for additional information to establish whether they pose an unreasonable risk of injury for women.

Concerns Over Safety and Effectiveness of Vaginal Mesh

The main manufacturers of vaginal mesh products sold in the United States are Boston Scientific, American Medical Systems (AMS), C.R. Bard, Johnson & Johnson’s Ethicon and Gynecare subsidiaries, Coloplast Corp. and Cook Medical.

Many of these products were approved through the FDA’s controversial 510(k) system, which allowed the manufacturers to begin selling the devices without conducting rigorous pre-market studies. Products were approved by the agency as long as the manufacturer could indicate that it was “substantially equivalent” to other products on the market.

As concerns have surfaced over the safety and effectiveness of vaginal mesh, many of the manufacturers have elected to cease marketing their products in an effort to avoid conducting the required studies.

The new study announced last week by Boston Scientific, the SUPeR clinical trial, is expected to enroll 180 women considering surgery to treat uterine prolapse who do not plan to have any more children. The women will either be implanted with the Boston Scientific Uphold LITE Vaginal Support System or they will be treated with more traditional surgery, including a vaginal hysterectomy.

The test subjects will be evaluated every six months for up to five years. Researchers will look at the safety, success, cost-effectiveness and other factors resulting from the surgery. The final results are expected in 2018.

Vaginal Mesh Lawsuits

About 20,000 women throughout the U.S. are currently pursuing a vaginal mesh lawsuit against the makers of these products, alleging that transvaginal surgical mesh is unreasonably dangerous and defective, carrying a severe risk of painful and debilitating health problems for women that outweighs any potential benefits.

The U.S. Judicial Panel on Multidistrict Litigation (JPML) has established separate consolidated proceedings in the federal court system for cases involving different manufacturers, with five Multidistrict Litigations (MDLs) centralized before U.S. District Judge Joseph Goodwin in the Southern District of West Virginia.

According to an updated case list (PDF) released on May 15, Judge Goodwin is currently presiding over at least 2,938 Bard Avaulta lawsuits, 6,028 AMS vaginal mesh lawsuits, 3,557 Boston Scientific pelvic mesh lawsuits, 5,763 Ethicon Gynecare mesh lawsuits and 320 Coloplast bladder slings lawsuits.

Several cases pending in state courts throughout the country have already gone to trial, with a California court awarding $5.5 million in damages to a woman who experienced complications with a Bard Avaulta mesh in July 2012, and a New Jersey state court jury awarded $11.1 million in damages in February, including both compensatory and punitive damages for problems with Ethicon’s Gynecare Prolift mesh.

In the federal court system, the first vaginal mesh trials are scheduled to begin next month, with a series of lawsuits involving the Bard Avaulta mesh set to begin on July 6. Later this year and early next year, a series of at least three additional trials will be held involving AMS mesh, Boston Scientific mesh and Ethicon mesh.

These early trial dates are designed to help the parties gauge how juries are likely to respond to certain evidence and testimony that may be offered throughout the vaginal mesh litigation. The preparation and any outcomes may help facilitate negotiations to reach vaginal mesh settlements in other cases.

Knowingly implant a failed medical device for profit.

New York Times     EDITORIAL

What a Company Knew About Its Metal Hips

Published: February 10, 2013   FiDA Highlight

                                   

All-metal hip replacements have failed at a high rate and harmed many patients in recent years. Now there is evidence that a major manufacturer was aware of a serious problem with one of its models yet failed to alert patients or doctors and continued to market it aggressively.

The all-metal hips, in which a ball and a cup component are both made of metal, were thought to be superior in some respects to traditional hip replacements made of plastic and metal. Some 500,000 people in this country received all-metal devices over the past decade. They were not adequately tested because of regulatory loopholes the Food and Drug Administration is now moving to close, and began failing not long after implantation.

Thousands of patients have had to replace them in painful operations; hundreds more have suffered internal damage. Court documents now show that a major manufacturer, the DePuy Orthopaedics division of Johnson & Johnson, buried the bad news about a model known as the Articular Surface Replacement, the most failure-prone of the implants. The implants were recalled in 2010, but the documents show that as early as 2008 DePuy executives were told by a number of surgeons, including its own consultants, that the device appeared flawed. That was never disclosed to doctors who were putting the device into patients, nor were other unfavorable internal studies. By the time of the recall, the device had been implanted in about 93,000 patients around the world.

Surgeons have largely stopped using the device; even so, the company is facing more than 10,000 lawsuits in this country related to past implantations. Though the company says the evidence will ultimately show that it acted appropriately, it clearly has a lot of explaining t