Preview Newsletter
Ethicon Media Monitoring 6/5/2017
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Georgia Judge to Handle Hernia Mesh MDL
Jun 2, 2017 | The Daily Report
By R. Robin McDonald,
Nationally-watched litigation prompted by complications arising from a medical mesh implant used to treat hernias has been consolidated as multidistrict litigation and will be adjudicated in the Northern District of Georgia. -
A Lawyer Who Won $20 Million For His Client Says We Are Facing "The Greatest Women's Health Crisis Of Our Generation"
Jun 4, 2017 | Buzfeed
By Gina Rushton
"Even just a few months after the operation I was raw with pain and I had this feeling that my urine was absolutely hot and scalding." -
Australian Pelvic Mesh Support Group says all pelvic mesh devices should be banned.
Jun 3, 2017 | Newcastle Herald
By Joanne McCarthy
AUSTRALIA’S college of gynaecologists and obstetricians has backed the use of traditional pelvic mesh “slings” for incontinence in women despite conceding failure can lead to “intractable” and permanent complications and have “severe effects” on quality of life. -
Patients who say surgical mesh has made their lives a 'living hell' question why it's still being used
Jun 4, 2017 | Stuff
By Cate Broughton And Michelle Duff
"My husband has been really good about it," says Blucher, fighting back tears. "It's painful for me, which makes it painful for him, so we stopped eight years ago." -
Four mesh deaths but government drags heels on inquiry: 'Mum always put on a brave face for us'
Jun 4, 2017 | Stuff
By Cate Broughton
The family of a Kiwi mother-of-two who died following complications caused by surgical mesh is calling for a large-scale inquiry into the controversial medical device's use. -
Gynecologist urges women to seek help for incontinence
Jun 5, 2017 | The Courier
By Jessica Black
A Ballarat gynecologist is urging women to distinguish vaginal mesh implants – which are the subject of an ongoing Senate Inquiry – from life-changing surgery. -
Call for women to complete online survey about mesh implants
Jun 4, 2017 | The Border Mail
By Janet Howie
BORDER and North East women have been asked to share their experiences of a medical procedure some people say has ruined their lives. -
Bellwether Cook blood-clot-filter case heads to trial
Jun 3, 2017 | Indianapolis Business Journal
By John Russell
... Earlier this decade, more than 60,000 patients sued makers of transvaginal mesh, including Johnson & Johnson, C.R. Bard, Coloplast and American Medical Systems.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
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Georgia Judge to Handle Hernia Mesh MDL
Jun 2, 2017 | The Daily Report
By R. Robin McDonald,
Nationally-watched litigation prompted by complications arising from a medical mesh implant used to treat hernias has been consolidated as multidistrict litigation and will be adjudicated in the Northern District of Georgia.
The U.S. Judicial Panel on Multidistrict Litigation issued the transfer order in In Re: Ethicon Physiomesh Flexible Composite Hernia Mesh on Friday, assigning the case to U.S. District Judge Richard Story.
Story, who has not previously handled multidistrict litigation, will preside over about 50 product liability cases pending against Johnson & Johnson and its corporate subsidiary Ethicon.
The MDL panel has made a concerted effort to broaden the roster of federal judges with experience managing MDL dockets, and Story is a natural choice. A nearly 20-year veteran of the federal bench and former chief superior court judge of the Northeastern Judicial Circuit in Gainesville, he's presided over several sprawling class actions since he was appointed to the bench by President Bill Clinton in 1998. Among them are a landmark race discrimination case against The Coca-Cola Co. that involved more than 2,000 class members and eventually settled for $192 million; nearly two-dozen suits by Mirant Corp. shareholders claiming that the gas energy marketer illegally manipulated California energy prices in 2000 and 2001 that Story dismissed with prejudice after six years of litigation; ongoing litigation against SunTrust Banks over its 401(k) savings plan involving a class of about 50,000 individuals; a class action against Wells Fargo that resulted in a $30 million settlement last year, and a class action—settled in 2015—on behalf of Georgia's deaf citizens against the state of Georgia over its failure to provide equal access to mental health services to those who were both death and developmentally disabled. Story also presided over former Atlanta Mayor Bill Campbell's racketeering trial in 2006.
At least three of Story's colleagues have MDL experience. U.S. District Chief Judge Thomas Thrash has four pending MDLs and recently signed off on settlements involving Home Depot's 2015 massive data breach that affected an estimated 56 million customers. U.S. District Judge Timothy Batten earlier this year closed eight years of litigation in an antitrust MDL against Delta Air Lines and AirTran Airways over passenger baggage fees. U.S. District Judge William Duffey presided over multidistrict product liability litigation over defective hip implants that last year settled for $240 million.
Attorney Henry Garrard III of Blasingame, Burch, Garrard & Ashley who is spearheading the Physiomesh litigation, said Friday that defense counsel first suggested the Northern District of Georgia as a venue and recommended that the litigation be assigned either Story or Batten. Garrard said he agreed to both the Georgia venue and to assigning the cases to Story. William Gage of the Jackson Mississippi office of Atlanta's Butler Snow represents Ethicon.
"Both sides recognized he is a very experienced judge," Garrard said. "And, at the end of the day, both sides are desirous of fair treatment, and we believe that will occur in the Northern District of Georgia."
http://www.dailyreportonline.com/recent-news/id=1202788276874/Georgia-Judge-to-Handle-Hernia-Mesh-MDL?mcode=1202616187678&curindex=1&slreturn=20170505020445
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Jun 4, 2017 | Buzfeed
By Gina Rushton
"Even just a few months after the operation I was raw with pain and I had this feeling that my urine was absolutely hot and scalding."
It was supposed to be a 50th birthday present to herself.
But the urogynaecological surgical mesh - sometimes called a bladder sling - that Janelle had inserted in September 2014 left the Brisbane mother-of-two in excruciating and life-defining pain.
She can't wear underwear. She can't have sex. She can't fall asleep without a handful of painkillers and a pillow propped between her legs.
"Sometimes it is so aggravating that it is teeth clenching," Janelle, who asked to be identified by her first name only, told BuzzFeed News.
The 53-year-old is one of more than 700 Australian women registered for a class action against the maker of the mesh, Ethicon (a subsidiary of Johnson & Johnson), which will go to trial on July 4.
The polypropylene implant was inserted by her gynaecologist to treat stress urinary incontinence (poor bladder control).
"[The doctor] suggested they put the bladder sling in at the same time as my hysterectomy, so it was a gift to myself to change my life so I didn't have to wear pads or worry about [the urinary incontinence]."
Urogynaecological meshes, sometimes known as transvaginal meshes, are inserted into women as a treatment option for urinary incontinence or pelvic organ prolapse – when the connective tissue securing the vagina and uterus to the pelvis gives way after childbirth.
In the latter case the mesh - which is non-absorbable and acts as a permanent implant - is inserted under the urethra (the tube that empties urine from the bladder).
The pain began straight after the operation.
"Even just a few months after the operation I was raw with pain and I had this feeling that my urine was absolutely hot and scalding," Janelle said."The pain in my groin was like someone had belted me with a cricket bat."
She said she was passed between specialists who refused to take her pain seriously.
"Every doctor just looked at me like 'it can't be that bad' while I was weeping."
Eventually, she was told the implant had eroded through her vaginal wall, so she had surgery to partially remove the device.
The pain continued through another treatment suggestion – cortisone injections into her pubic area.
Today, it hurts Janelle too much to even wipe after urinating, and she is unable to have sex.
"The nerve damage just shoots down your leg from your groin to your ankle." she said.
"My lower back sometimes feels like it is in labour. Bending down to get washing or stepping over something is like being ripped in half."
Janelle is determined to continue working most days as she doesn't want her husband to be "smothered with the financial burden".
"I just have to suck it up and take it one day at a time... I'm just not the person I used to be, but the old me is still stuck in there somewhere."
Many Australian women have flown to St. Louis, Missouri, to see obstetrician-gynecologist Dionysios Veronikis and have their implants partially removed.
Veronikis said he has performed more than 1,000 mesh removal surgeries since 1994, and seen a rapid increase in patients over the past five years.
"I can't afford that because it would be upwards of $30,000," Janelle said.
She didn't think any legal recourse would be available until she joined the class action with Shine Lawyers.
In the statement of claim, supplied to BuzzFeed News, patients have listed a raft of symptoms and complications following the insertion of nine different Ethicon mesh devices.
Chronic and constant vaginal pain, visceral pain with bowel movements, dyspareunia (pain during sex), vaginal bleeding, the granulation of vaginal tissue, pain through the glutes, inflammatory reactions, "offensive discharge", incontinence, leg weakness, haemorrhages.Many women listed subsequent mental health issues as well as repeated erosions through the vaginal wall or rectum.
Janelle lives in fear of another perforation into one of her organs.
"The unknown is the most terrifying part... I am worried it will perforate into the bowel."Shine Lawyers has said there could be upwards of 8,000 Australian women who have been implanted with one of the nine devices and suffererd complications that may be entitled to join the action.
Shine Lawyers principal Jan Saddler said her clients had suffered complications with their mesh implants and those complications had had a "severe and extreme impact on their daily lives".
"These complications range from erosion into the tissues of the body through to pain during intercourse, infections, chronic pain," Saddler told BuzzFeed News.
"These issues arose because there was no adequate testing and evaluation of the products."
Almost all (95%) of her clients in this class action had had revision surgery – operations to try and assist with the complications, or to partially remove the mesh.
"We have ladies who have had seven or eight revision surgeries and there is no compensation scheme in place."
Saddler estimated "up to 100,000" of the nine products had been implanted in Australian women.
"It is really heartbreaking to hear stories day in and day out of marriages breaking down and careers being thrown away, and women who can't enjoy a normal life with their children."
Saddler is confident she can win compensation for her clients.
Bloomberg estimated there were more than 54,000 lawsuits pending over Johnson & Johnson's vaginal mesh inserts. The company has lost at least five jury awards to the tune of US$35 million over the devices since 2014.
Ohio lawyer Ben Anderson was the lead plaintiff's attorney on a case where last month Johnson & Johnson was ordered to pay US$20 million to a New Jersey woman who blamed the company's TVT-Secur mesh for her chronic and unresolved pain.
"The vagina, rectum and bladder are flexible organs that need to be able to move and stretch and you can't do that with a bunch of hardened fishing lines around your organs," Anderson, who has liaised with Shine Lawyers to help its case, told BuzzFeed News."This is the greatest women's health crisis of our generation.
"A theme that runs through these pelvic mesh lawsuits is that these companies knew there were complications, and they failed to tell doctors and patients because it would hurt their precious profits."
An Australian Johnson & Johnson spokeswoman told BuzzFeed News the company was "always concerned" when a patient believed they had experienced an unexpected or undesirable outcome.
"Our priority is and always has been patient safety, and pelvic mesh is backed by years of medical research," she said.
"This is a complex court case. We are confident the evidence will show that Ethicon acted responsibly and appropriately."
In a defence filed to the Federal Court, Johnson & Johnson has outlined its defence for the upcoming July case.
On June 4, 2012, Ethicon announced that four versions of transvaginal mesh would be withdrawn from the market including that embedded in Anderson's client, the Gynecare TVT Secur System.
Anderson said there were two main points he had to prove to win the case.
"I had to prove that the product was defective in design, which I did... the mesh itself caused too much scarring and inflammation and because it was too short and sharp it was just cutting through tissue.
"I also had to prove that Johnson & Johnson had failed to warn the doctors and their medical directors testified under oath that they knew before they sold the product of this list of horrible and chronic lifelong permanent injuries like pain, painful intercourse, erosions and the need for multiple surgeries.
"Not only was I able to prove a 'failure to warn' claim but we showed malicious intent."
Johnson & Johnson will appeal the decision.
Anderson warned the looming Australian case would be tough on any women asked to give evidence and described the experience of his lead plaintiff Margaret Engleman.
"If someone testifies she has to talk about painful sex and wetting herself and foecal incontinence and putting her fingers in her vagina as a splint to defecate properly in front of a courtroom and I understand that women don't want to do that.
"But I have tens of thousands of clients and these women want to be heard and that was more important than any dollar sign.
"Twelve jurors said, 'we believe you; we believe that you were injured; we believe that this company was wrong and this company should be punished'."
But unlike in the US, class actions cases are not heard by a jury in Australia, so Shine Lawyers will be trying to convince a judge.
It is easier to commence and maintain a class action in Australia than in the US, but because the unsuccessful party has to bear the cost of the proceedings here – in the United States each party pays its own fees regardless of outcome – "speculative litigation" is deterred, a recent paper published by leading Australian law firm Allens found.
Anderson said settlement payments could take years to be distributed to patients.
"You can't give someone back their life and you can't take away the pain, but money is the only language these corporations understand."
An Australian Senate inquiry launched in February will hear from women affected by the implants and doctors, and will also examine the Therapeutic Goods Administration's "knowledge of women suffering from health problems after having transvaginal mesh implants".
Submissions to the inquiry close at the end of the month and the committee will report in November this year.
Another 300 Australian women have registered with Shine Lawyers for a second class action against American Medical Systems over 10 of its different mesh implants. Shine said the group may eventually exceed ,2000 women.
https://www.buzzfeed.com/ginarushton/hundreds-of-women-are-taking-a-pharmaceutical-to-court-over?utm_term=.wrEz4a2y3#.evWPyzdNx
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Australian Pelvic Mesh Support Group says all pelvic mesh devices should be banned.
Jun 3, 2017 | Newcastle Herald
By Joanne McCarthy
AUSTRALIA’S college of gynaecologists and obstetricians has backed the use of traditional pelvic mesh “slings” for incontinence in women despite conceding failure can lead to “intractable” and permanent complications and have “severe effects” on quality of life.
In response the Australian Pelvic Mesh Support Group said all mesh devices should be banned.
The Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG) backed traditional midurethral “slings”, such as the Tension-free Vaginal Tape (TVT), in a position statement this week after growing global outrage from women about pelvic mesh surgery for both incontinence and prolapse.
The statement was released a month before the expected start of a landmark class action by 450 Australian women who experienced serious complications after they were implanted with Johnson & Johnson pelvic mesh devices, including the TVT midurethral sling for incontinence.
RANZCOG conceded more recent single incision incontinence mesh slings – many already withdrawn from the Australian market after women experienced serious complications - should only be performed “within a properly-conducted clinical trial”.
In some women these long term adverse outcomes have had severe effects on everyday activities and their quality of life.- Royal Australian and New Zealand College of Obstetricians and Gynaecologists
But it blamed “media attention” on mesh use for pelvic organ prolapse for causing “unnecessary confusion and fear” in women. This is despite Brisbane gynaecologist and obstetrician Professor Chris Maher, among others, criticising the college for remaining largely silent about growing alarm over prolapse and incontinence pelvic mesh devices for a decade from 2003.
It is also despite the Australian device regulator, the Therapeutic Goods Administration, TGA, continuing to classify all pelvic mesh devices as medium to high risk.
In a paper in February Professor Maher said women questioned “the competence and trustworthiness of us as clinicians” because pelvic mesh devices were used to treat prolapse and incontinence without evidence they were safe and beneficial.
“It is imperative that pelvic floor surgeons take a leadership role that ensures the mistakes of the past are not revisited,” Professor Maher said.
The mesh is a permanent material that can result in mesh exposure and infection which may occur soon after surgery or many years later. This can result in the need for mesh removal which may be difficult, may have complications and may not completely resolve chronic pain or other adverse symptoms.- RANZCOG
In its position statement RANZCOG outlined known complications of even traditional midurethral sling pelvic mesh surgery, and said surgeons “must discuss” the complications with women so they could give informed consent.
“Discussion must include bleeding, damage to the bladder and urethra, bowel and major vessel perforation and voiding difficulties which may require catheterisation, loosening or even division of the sling at a later stage,” RANZCOG said.
Midurethral sling pelvic surgery for incontinence, even using traditional slings like TVT that are regarded as the “gold standard”, could cause pain and painful sexual intercourse, RANZCOG said.
“This is usually short lived but may become intractable. In some women these long term adverse outcomes have had severe effects on everyday activities and their quality of life.
“The mesh is a permanent material that can result in mesh exposure and infection which may occur soon after surgery or many years later. This can result in the need for mesh removal which may be difficult, may have complications and may not completely resolve chronic pain or other adverse symptoms.”
Australian Pelvic Mesh Support Group founder Caz Chisholm, who successfully campaigned for a Senate inquiry into the devices that will start public hearings in the next two months, slammed RANZCOG and said all pelvic mesh devices and slings should be banned because of the severity of complications some women experienced.
A group poll of 85 members found more than half had complications from the midurethral sling, and another 20 per cent had complications from a combination of prolapse mesh and midurethral sling treatment.
If it is safe and highly effective, why do they need the trials? Why have the trials not already been done prior to implanting the midurethral sling? This means women are still guinea pigs.- Australian Pelvic Mesh Support Group founder Caz Chisholm
“I believe the complication rates of the midurethral sling are higher because this mesh is now the most popular choice for surgeons because of the withdrawal of some prolapse meshes,” Ms Chisholm said.
She slammed RANZCOG for saying even the traditional “gold standard” mesh slings needed to be removed because “who and where are these full-removal surgeons and what training have they had to fully remove them?”
“Surgeons have said that full removal is not possible when it comes to the transobturator mesh, yet in the same sentence they say they can remove mesh. How about they film their evidence of removing it all and take photos as well?” Ms Chisholm said.
“Many, many women in the group are having partial removals and revision surgeries but none of their surgeons are removing their mesh.
“How can they say they are safe when they also suggest in the same position statement that they need clinical trials for outcomes?
“If it is safe and highly effective, why do they need the trials? Why have the trials not already been done prior to implanting the midurethral sling? This means women are still guinea pigs.”
http://www.theherald.com.au/story/4704976/college-slammed-for-backing-pelvic-slings/
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Jun 4, 2017 | Stuff
By Cate Broughton And Michelle Duff
It's been eight years since Lyn Blucher has had sex.
"My husband has been really good about it," says Blucher, fighting back tears. "It's painful for me, which makes it painful for him, so we stopped eight years ago."
There are other things she's stopped, too. Blucher, 68, has no control over her bowel or bladder; she can never make it to the toilet in time.
"We had to sell our business, because it involved me driving and I just couldn't do it, so we retired early. We had plans to travel, but I did one flight to Singapore and it was awful – it was so embarrassing and I had to change almost constantly," the Whangaparaoa grandmother says.
Some days, she's too ashamed to leave the house. Instead, the formerly active business owner spends hours each day on chat rooms, speaking to other women worldwide who are suffering similar complications from operations involving surgical mesh.
Severe pain and bleeding. Constant bladder infections. Nausea. The frustration of having no doctors believe them, or being told they are hypochondriacs. Ongoing, expensive attempts to remove the mesh.
Blucher is one of an untold number of women in New Zealand who have suffered catastrophic injuries from the insertion of surgical mesh to treat pelvic organ prolapse and urinary incontinence – common effects of pregnancy, childbirth, and ageing.
There are 367 victims in the New Zealand support group she's part of, Mesh Down Under, which also includes some women and men who have suffered complications as a result of surgical mesh used in hernia repair.
ACC have received 780 claims for mesh injuries since 2005, at a cost of $12 million to the taxpayer.
But an investigation shows the true extent of injury is likely much higher. It found:
* Four New Zealanders have died from complications after mesh surgery;
* Government agencies do not know how many surgeries are being done, and what the outcomes are;
* Select committee recommendations last year have gone largely unheeded;
* Calls are mounting for a Commission of Inquiry, like the Australian senate inquiry that is underway;
* It's understood a mesh manufacturer has paid secret compensation to one group of victims.Surgeons say mesh is very effective for thousands of people, and that patients are warned it comes with complications just like any other surgery.
But Blucher, who has been left in debilitating pain after her surgery to treat a minor bladder problem eight years ago, wants to know when the toll will be high enough for concerns to be taken seriously.
WHAT IS SURGICAL MESH?
Thousands of patients are having mesh implanted for hernia repair, pelvic prolapse and urinary incontinence every week.
For most, the procedures are successful but for others – statistics vary, but up to one in 10 who undergo these surgeries – the results are devastating.
Hernia repair for defects in the stomach wall is one of the most common surgical procedures in New Zealand.
The Association of General Surgeons doesn't know how many are completed each year but president Andrew Moot said it would be "many thousands".
Most hernia repair in New Zealand is done with mesh during keyhole surgery: mesh replaces tissue and reinforces muscle to stabilise the stomach wall.
But there are detractors within the surgical community.
A large Danish study of more than 3000 incisional hernia patients published in February found major complications for hernia mesh repairs were much higher than for non-mesh repairs. Up to five per cent of mesh patients had major complications compared to less than one per cent of non-mesh patients.
Given a choice, Gerald Young, an Auckland GP with a specialist interest in the surgery, would opt for non-mesh over mesh for himself.
"Why take the risk of ongoing groin pain if you don't have to?"
When it comes to transvaginal mesh (through the vagina mesh ), researchers now say the life-altering complications that arise when it goes wrong mean using it should not be the first choice.
After widespread use from the late 1990s, it has now been established the mesh products were not backed by clinical trials, were not regulated, and required no specific training.
Pelvic organ prolapse is a common condition affecting hundreds of thousands of women worldwide. About half of all women who have had a child have some level of prolapse, and one in five women will need to seek medical help.
Outcomes of mesh complications for affected women in Medsafe reports include rectal damage, infection, holes in the bladder and urethra, vaginal wounds, fecal incontinence, leg, bowel, and pelvic pain, and ongoing pain, nausea, bleeding and discharge. The mesh is difficult to remove, and this does not always work. "Severe pain and bleeding following intimacy," one unknown woman told Medsafe in 2014. "Erosion causing pain, discharge, infection," report after report states.
In Australia, an inquiry is underway after Victorian Senator Derryn Hinch told Federal Parliament that transvaginal mesh devices rivalled Thalidomide as one of Australia's worst health scandals. Court action includes one of the largest medical civil cases in Australia, starting in July and expected to run for six months, brought by 450 women against global pharmaceutical giant Johnson & Johnson.
While some doctors say it is not used as frequently in New Zealand as it was in the past, there is no real record of the extent of mesh use – and the scale of the problem.
HOW HIGH IS THE TOLL?
In New Zealand, treatment injury claims to ACC for mesh complications have doubled in the past three years – with 301 claims accepted since 2014 and a further 138 declined. The majority of these were for vaginal repair and surgery.
Around 20 per cent are declined. ACC admit this data is likely incomplete, as mesh injuries are not specifically coded.
Regulation of mesh implants include adverse event reporting to Medsafe, but it is not mandatory.
The Government regulator has 131 reports on record since 2005. Only three of these have been made by manufacturers, three by healthcare professionals, and 26 by suppliers. The rest are from patients and ACC. The majority were for transvaginal implants.
Further investigations revealed Medsafe has allowed more than 56,000 devices to be supplied on the New Zealand market since 2005, without requiring any proof of clinical safety or efficacy.
The Ministry of Health admits it has no idea how many people are having mesh implanted nationwide, because they do not collect this data. Some District Health Boards record it, but this is not consistent.
Royal Australasian College of Gynaecology and Obstetrics New Zealand committee chair Ian Page says there is a 15 per cent risk of complications from pelvic organ prolapse mesh procedures compared with about 5 per cent for urinary incontinence surgery.
Non-mesh prolapse surgery involved using sutures, or stitching, but had a higher rate of recurrence, Page says.
"Unfortunately the reality is all treatments have the potential for causing problems and there's no escaping that."
Patients should be fully informed by surgeons about the risks of mesh, Page says, but he can't be totally confident this is happening because he does not personally monitor their consultations.
The College provides clear guidance and advice for surgeons on informed consent, he adds. In their guidelines, the Royal Australian and New Zealand College of Obstetricians and Gynaecologists have warned against the use of transvaginal mesh for prolapse, because of insufficient testing and concerns of injury and long-term safety.
In an editorial last year, Auckland gynaecologist Professor Cindy Farquhar said the gynaecological and surgical communities needed to learn from the experience of mesh harm and make sure patients were protected in future.
WHAT IS BEING DONE TO PROTECT PATIENTS FROM HARM?
A Health Select Committee inquiry in 2014 produced seven recommendations, endorsed by Minister of Health Jonathan Coleman in August last year.
None of them required mandatory action but instead committed to "encourage", "discuss" , "investigate" and "suggest" improvements to monitoring, coding, training and reporting for mesh procedures and complications.
Setting up of a registry and prior approval of medical devices have been put on hold until the government progresses a wider review of therapeutic goods legislation late this year, a Ministry of Health spokeswoman says.
Government representatives have met with medical colleges on three occasions to discuss informed consent, setting up a registry and ongoing education, Medsafe general manager Chris James says.
James says improved adverse event reporting forms have now been developed and are available on the Medsafe website.
The gynaecologists' association is backing the call for a registry but Royal Australasian College of Surgeons New Zealand executive director Richard Lander says this will be expensive.
No government funding has been "sought or allocated" for any of the recommendations including the establishment of a registry, James adds.
'AN INSULT TO MESH SURVIVORS'
Two-and-half-years after they launched a petition for an independent inquiry, founders of supporters group Mesh Down Under, Carmel Berry and Charlotte Korte are deeply disappointed.
The select committee's recommendations, which emerged from their petition, were "weak" – and for them to be ignored is an insult to mesh survivors, they say.
"Very little has been achieved," Korte says. "We relied on the government to take the mesh issue seriously which, going by this response, they didn't."
They say it should be mandatory for ACC, surgeons, GPs and manufacturers to report adverse events, there should be an implant register for all mesh products, and more stringent safety regulations.
Their calls are echoed by Wellington's Wakefield Hospital gynaecologist Hanifa Koya, who sees dozens of women a year for transvaginal mesh removal surgery. Not only should a registry have been set up long ago, but surgeons needed to be supporting all claims, she says.
"I just feel so gutted that even after the Cartwright Enquiry we are still letting these women down."
Auckland Women's Health Council advocate Lynda Williams has been taking phone calls from those whose life has been irreversibly changed for more than ten years. "This is yet another women's health issue which is downplayed and dismissed."
"There's a tsunami of cases."
At 68, Lyn Blucher will never get back the years of her life she has lost to mesh.
But she says she won't stop fighting until surgeons stop using the mesh. "It's just ruined my life. It's made my life hell."
She just hopes the government may take action to save other women from the same misery.
- Sunday Star Times
http://www.stuff.co.nz/national/health/92633100/Patients-who-say-surgical-mesh-has-made-their-lives-a-living-hell-question-why-its-still-being-used
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Four mesh deaths but government drags heels on inquiry: 'Mum always put on a brave face for us'
Jun 4, 2017 | Stuff
By Cate Broughton
The family of a Kiwi mother-of-two who died following complications caused by surgical mesh is calling for a large-scale inquiry into the controversial medical device's use.
Stuff can reveal four people have died in New Zealand after mesh complications, according to ACC, and hundreds more are living in severe pain with what they describe as a "cheese grater" ripping them up internally. The numbers of New Zealanders suffering from mesh are much higher than previously realised.
After a long-running investigation by this newspaper, the calls for an inquiry are now being backed by doctors and international experts. They say the "catastrophic" side-effects of the implants are leaving hundreds of people in agony.
In the Australian Senate and several other countries, inquiries are underway into the numbers of people injured by mesh implants; in Scotland, mesh was banned entirely for three years. But in New Zealand, the government and health authorities have been slow to respond.
"It's pathetic," Auckland Women's Health Council advocate Lynda Williams says. "There needs to be a bigger inquiry, and these people need to be confident that the doctor they go to to take it out can do so without causing further damage."
Gore grandmother Karyn Freer died alone in Southern Cross Hospital, Invercargill, three years ago today, while recovering from surgery to remove mesh implanted for a hernia repair.
The use of mesh for hernia repair is strongly supported by the surgeons and is used routinely for thousands of procedures in New Zealand each year.
But internationally there is growing evidence the risk of complications including infection, severe chronic pain, and death are higher for procedures using mesh.
Sharleen Greer said after having surgery for a hernia procedure, her mother was left in constant pain. She would hunch over, clutching her stomach in agony. She lost feeling in her legs and was prescribed opioid pain-killers. "She always put on a brave face for us," Sharleen said.
Eventually her GP ordered a scan, and a large sheet of mesh the size of "a big bit of bacon" was found to be jabbing into her organs. A treatment injury claim to ACC was accepted and arrangements were finally made to have the mesh removed.
On June 3, Karyn went into hospital. Sharleen spoke to her that night. It would be the last time she talked to her mother.
"I rang her and she was laughing away ... and I said I'll ring you in the morning, just give me a text when you're awake and that was it, it was 'love you, talk soon'.
At 3.50am, nurses found Karyn unresponsive. A coroner's report found she died from cardiac arrest and polypharmacy.
The family said she had been prescribed pain medicines after an earlier back surgery and these were increased significantly following the hernia operation.
But they say their loved one's death could have been avoided if not for the mesh being implanted in the first place. "If it hadn't been used she'd still be here today," daughter Sheree Freer said.
And Sharleen questioned whether using the mesh was worth it, if people were left in agony.
"Some people have it and it doesn't affect them. But there's a large number that have it and their lives are buggered.
"They've gone from healthy people to very limited. There are better ways."
The first New Zealand death from mesh complications was in 2010: Geoff Mehrtens, 54, of Hokitika. His widow Heather threatened to call in police as she battled for justice for her husband.
A Health Select Committee inquiry, in response to a petition from mesh campaigners Charlotte Korte and Carmel Berry, was held into surgical mesh in 2014. The government accepted its recommendations last year – but has done nothing.
The Sunday Star-Times found none of the recommendations mandated better regulation of mesh. And a national registry to track surgeries and victims has been put on hold for consideration as part of legislative review late this year.
The recording of mesh surgeries and associated injury is not mandatory.
That is despite Official Information Act requests showing ACC treatment injury claims have doubled in the past three years. Since 2005 there have been 265 treatment injury claims to ACC for mesh hernia repairs, 403 for vaginal repair and 112 for other surgeries – at a cost to the taxpayer of $12 million.
The New Zealand Association of General Surgeons president Andrew Moot said use of mesh for hernia repair was not controversial and complications were rare.
The benefits of a faster recovery through keyhole mesh procedures for thousands of patients outweighed a small number of those left with chronic pain, Moot said.
But gynaecologist Hanifa Koya said the government and the medical community had failed patients harmed by mesh and a national inquiry was long overdue. "The bottom line is the medical profession hasn't taken responsibility ... to do the right thing."
Emeritus Professor Don Wilson, a urogynaecologist, has called for a register of mesh implants, and for all surgeons using mesh to be trained and credentialled.
Yesterday he said: "I wrote my submission asking for a register three years ago. It's frustrating that there's not been more action taken."
He said patients should ask doctors to provide their surgical complication rates.
WHAT IS SURGICAL MESH?
* A device used when providing additional support for pelvic organs and hernia repair.
* Can be absorbable or, if it is a permanent implant, non-absorbable.
* Despite complaints about mesh no recalls have been undertaken as regulators conclude the risks are minimised when product is used by surgeons with the correct training.
* MedSafe is monitoring reports relating to surgical mesh implants but has for now concluded that it is safe when used correctly.
* Surgical mesh remains approved for use by international regulators.
http://www.stuff.co.nz/national/health/93268557/four-mesh-deaths-but-government-drags-heels-on-inquiry-mum-always-put-on-a-brave-face-for-us
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Gynecologist urges women to seek help for incontinence
Jun 5, 2017 | The Courier
By Jessica Black
A Ballarat gynecologist is urging women to distinguish vaginal mesh implants – which are the subject of an ongoing Senate Inquiry – from life-changing surgery.
Dr Deepika Monga, who spoke at a sold out women’s health forum on Wednesday, said about two-thirds of women she saw had some problem with incontinence, but rarely came to discuss the issue directly.
The UFS-organised event, which was attended by 280 women, raised $1400 for WRISC Family Violence Support.
“Women need to understand the distinction and that there are the options available to improve quality of life. Not everyone sees me has an incontinence problem but every second women I see would say ‘I have a little bit of that’.
“Sometimes they think it’s a way of life they just have to accept.”
Dr Monga said women often asked whether remedies for incontinence – which range from pelvic floor exercises to non-invasive surgery – were the same as the vaginal mesh implant, which has been used to treat vaginal prolapse.
“With all the bad press that has been given to the mesh and its complications, it’s really important to make that distinction because the mesh is used for a prolapse repair,” she said.
Ballarat is proving a hot-spot for women who have suffered ill effects from the mesh implants, which range from incontinence, severe chronic pain, problems walking, painful intercourse and relationship breakdown.
One Ballarat woman told The Courier the implant had caused chronic pain and had eroded multiple spots on her vaginal wall.
http://www.thecourier.com.au/story/4703978/women-urged-to-seek-remedy/
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Call for women to complete online survey about mesh implants
Jun 4, 2017 | The Border Mail
By Janet Howie
BORDER and North East women have been asked to share their experiences of a medical procedure some people say has ruined their lives.
Transvaginal mesh implants, used to treat prolapse, is the subject of an anonymous online survey by Health Issues Centre, a consumer advocate group. About 2000 women nationally have completed the questionnaire to date, at least six from the Wangaratta and Albury regions.
Health Issues Centre chief executive Danny Vadasz said while 25 per cent of respondents were happy with results, about half reported ongoing adverse effects such as incontinence and abdominal pain.
“Twenty-five per cent of respondents said it led to their marriages ending,” Mr Vadasz said.
He quoted one woman who wrote “I am left with no husband, permanent incontinence, permanent pain and no chance of a financial settlement to pay for the products I need for the rest of my life”.
Another said “every day of my life is filled with pain and every doctor I have seen just passes the buck”.
Therapeutic Goods Administration has been monitoring surgical implants since 2008 and received 99 adverse events reports between July 2012 and June 2016.
Mr Vadasz said the centre’s survey indicated numbers were much higher, with many doctors not linking symptoms with implants and women not being informed fully about the procedure.
“But the main reason it’s been under-reported, I believe, is the stories are so painful and intimate,” he said.
Women who have had an implant or believe they may have can complete the survey via the Health Issues Centre website or Facebook page.
http://www.bordermail.com.au/story/4705797/survey-reveals-daily-pain-after-implants/
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Bellwether Cook blood-clot-filter case heads to trial
Jun 3, 2017 | Indianapolis Business Journal
By John Russell
The lawsuits continue to pile up, dozens a month, against Cook Group from patients who say the company’s blood-clot filters malfunctioned, sometimes piercing organs and blood vessels, requiring surgeons to remove them.
Now, the first bellwether case is headed for trial this fall in Indianapolis, setting the stage for about 2,000 such lawsuits that have piled up against Bloomington-based Cook.
Bellwether cases are small groups of lawsuits that are tried first and serve as a litmus test for how the remaining cases might be tried and decided.
So far, Cook has refused to settle any of the cases, saying it will “vigorously defend these products because we believe in their ability to save lives.”
Still, a federal magistrate has scheduled three settlement conferences starting July 26; last year, the two sides failed to reach a settlement following similar discussions. The lawsuits have been consolidated in U.S. District Court in Indianapolis.
The magistrate, Tim A. Baker, ordered each side to file a confidential settlement statement, giving a candid assessment of strengths and weaknesses of the litigation and a proposed settlement framework, “to determine whether a settlement can be achieved.”
“Unrealistic assessments, including posturing, will be of no value and should be avoided,” Baker wrote in his order.
Cook declined to say what it might include in its settlement statement. A company spokeswoman said President Pete Yonkman was unavailable for an interview.
“Cook has no present plans to resolve the claims,” the spokeswoman, Marsha Lovejoy, wrote in an email to IBJ.
The company makes more than 16,000 products, from stents to catheter balloons. It has annual sales of $2 billion and a global workforce of 12,000.
Cook’s blood-clot filters are tiny, cage-like devices inserted into blood vessels to prevent clots from reaching the lungs, which could lead to pulmonary embolism, or blockage of an artery in the lungs.
Nationally, 100,000 people die each year from pulmonary embolism, according to the Centers for Disease Control and Prevention.
About 200,000 blood-clot filters—also known as inferior vena cava filters, or IVC filters, for short—are implanted nationwide each year. The market for IVC filters is $435 million, according to market research firm Axis Research Mind.
Cook, which is privately owned and rarely discloses sales information, did not disclose how many of its blood-clot filters are implanted each year. It said in a statement that “only a very small percentage of our IVC filters placed worldwide are subject to litigation.”
About 1,930 patients have filed lawsuits against Cook for its IVC filters, according to a May 15 report by the U.S. Judicial Panel on Multidistrict Litigation. Dozens of additional lawsuits have been filed since then, according to U.S. District Court in Indianapolis, pushing the total to about 2,000.
Some plaintiffs’ attorneys said they felt optimistic they would prevail, either in winning a jury award or getting a settlement for their clients, based on what they say is the harm the filters have caused.
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“These are pretty simple cases to understand,” said Randy Roberts, a personal-injury lawyer from Tyler, Texas, east of Dallas, who is representing several patients. “I don’t think a jury will have much trouble following the facts.”
In recent years, several other medical-device makers have settled large numbers of lawsuits. In 2014, Biomet Inc. in Warsaw agreed to settle for more than $100 million a group of cases involving the company’s implanted hip replacement devices. More than 950 patients around the nation claimed they were harmed by the metal-on-metal ball-and-socket parts.
Earlier this decade, more than 60,000 patients sued makers of transvaginal mesh, including Johnson & Johnson, C.R. Bard, Coloplast and American Medical Systems.
Whether the plaintiffs have a strong case against Cook will not be known until the bellwether cases go to trial.
The first case, set to begin Oct. 2, involves a Florida woman who had a temporary filter known as the Celect Cava implanted in 2010. The filter had four anchoring struts and eight secondary struts to help trap clots.
Four months later, the woman went back to her doctor to have the filter removed. According to her complaint, all attempts to remove the filter were unsuccessful. The woman subsequently developed gastrointestinal symptoms, fatigue, diarrhea, vomiting and abdominal pain. She later underwent an endoscopy procedure, where it was determined the filter had pierced a large blood vessel and small intestine. She was transferred to another hospital where the filter was removed.
The complaint said the filter was unable to withstand the normal anatomical and physiological demands, “causing the filter to tilt, migrate, perforate [and] fracture.”
The complaint also alleges Cook knew the filter’s design was defective, but the complaint did not appear to offer any evidence to support that allegation. The woman’s attorney, Joseph Johnson of West Palm Beach, Florida, did not return several calls from IBJ.
The second bellwether case, set for trial April 2, involves a Chicago-area patient who claims he was injured after being implanted with a Cook Gunther-Tulip filter. The plaintiff had a history of pulmonary embolisms, which caused him to be admitted to a hospital in 2011. The next day, doctors implanted the filter.
Soon afterward, the complaint said, the patient “began experiencing extreme chest pain and shortness of breath.” Doctors later told him the filter had perforated his vena cava blood vessel “and could not be removed due to such a high risk of death during the procedure.”
The third bellwether case, set for trial in August 2018, involves a Georgia woman who had a Cook Celect Cava filter inserted in 2011, before spinal-fusion surgery. Several months after the filter was inserted, the woman discovered a “painful region” on the inside of her right thigh, which grew to a 5-inch area.
One day, she pressed on the protrusion that had developed on her thigh, and a piece of metal wire about 1-1/2 inches long popped out, which was later determined to be one of the struts of the filter.
X-rays revealed that a second strut had broken off and migrated near her spine. She underwent an operation, “but after several unsuccessful attempts to remove the filter during this surgery, the procedure was halted,” the complaint said.
Cook said in a statement to IBJ that “filter implantation is a serious procedure intended to help prevent life-threatening pulmonary embolisms.”
The company added: “Physicians choose to use IVC filters based on each patient’s need, knowing that every patient’s situation is different and individual factors and risks must be considered when deciding on treatment options.”•
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