Preview Newsletter
Ethicon Media Monitoring 12/6/2017
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Pa. Judge Affirms Jurisdiction On Out-Of-State Mesh Cases
Dec 5, 2017 | Law 360
By Dan Packel
A Pennsylvania state court judge on Tuesday affirmed that the court has jurisdiction over all but one of 71 cases involving out-of-state residents suing Johnson & Johnson subsidiary Ethicon Inc. in Philadelphia’s mass tort program over pelvic mesh injuries. -
Asia Regulatory Roundup: Australia Bans Transvaginal Mesh Products
Dec 5, 2017 | Regulatory Affairs Professional Society
By Nick Paul Taylor
Australia has banned transvaginal mesh products used in the treatment of pelvic organ prolapse. The Therapeutic Goods Administration (TGA) took the action after concluding the risks of the controversial treatment outweigh the benefits. -
What Is Vaginal Mesh Implant? Post-Treatment Sepsis Kills Campaigner Against It
Dec 5, 2017 | International Business Times
By Shreesha Ghosh
A Canadian woman has died reportedly from sepsis after a 4-year struggle with persistent infections stemming from her surgery where she received a pelvic mesh implants that led to painful complications, reports said Monday. -
Health Secretary urged to take ‘decisive’ action on mesh scandal
Dec 5, 2017 | Press Association (In The Evening Express)
MSPs from across the political divide have warned the Health Secretary that she must take “decisive” and “radical” action on Scotland’s mesh scandal. -
The vaginal mesh scandal has claimed its first victim – and she probably won’t be the last
Dec 5, 2017 | The Independent
By Harriet Marsden
So it’s finally happened. A woman has died from complications related to her vaginal mesh implant. -
'A TRULY SPECIAL WOMAN' Chrissy Brajcic dead at 42 – vaginal mesh campaigner and mum-of-two dies of sepsis four years after having the controversial implant
Dec 6, 2017 | The Sun
By Jay Akbar
Tributes have poured in for the 'courageous' campaigner who helped raise awareness of the controversial implant -
Vaginal mesh campaigner dies from sepsis triggered by her implant
Dec 5, 2017 | Metro
By Zoe Drewett
A ‘courageous’ vaginal mesh campaigner has died from sepsis triggered by her own implant after a four-year battle with persistent infections. -
An Ontario Woman Died of Sepsis After Controversial Vaginal Mesh Surgery
Dec 6, 2017 | Vice
By Sarah Berman
A mesh implant meant to support pelvic organs after childbirth comes with some truly nightmarish risks. -
Prominent Vaginal Mesh Campaigner Chrissy Brajcic, Dies From Sepsis
Dec 5, 2017 | Get The Gloss
By Ayesha Muttucumaru
Chrissy Brajcic, a prominent Canadian campaigner against vaginal-mesh implants, has died from sepsis after struggling with numerous infections for years. -
Vaginal mesh campaigner dies in Canada after being hospitalised for sepsis
Dec 6, 2017 | TheJournal.ie
A CAMPAIGNER WHO had worked to highlight complications suffered by women who underwent vaginal mesh operations has died. -
Vaginal mesh campaigner mum dies of sepsis after four years battling infections from controversial operation
Dec 5, 2017 | Daily Record
By Rachael Burford
Chrissy Brajcic documented her final few months online and said she would "never stop fighting" to "advocate for the mesh injured." -
Vaginal Mesh Campaigner Has Died Of Sepsis After Receiving The Scandal-Hit Treatment
Dec 5, 2017 | Refinery 29
By Natalie Gil
A woman who campaigned against vaginal mesh implants has died from complications triggered by her own implant. Christina Brajcic, 42, who was ill with sepsis, is thought to be the first woman to die in what the media has called the vaginal mesh scandal.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
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Pa. Judge Affirms Jurisdiction On Out-Of-State Mesh Cases
Dec 5, 2017 | Law 360
By Dan Packel
Law360, Philadelphia (December 5, 2017, 6:38 PM EST) -- A Pennsylvania state court judge on Tuesday affirmed that the court has jurisdiction over all but one of 71 cases involving out-of-state residents suing Johnson & Johnson subsidiary Ethicon Inc. in Philadelphia’s mass tort program over pelvic mesh injuries.
In a one-page order, Philadelphia Court of Common Pleas Judge Arnold New denied the company’s renewed bid to dismiss the out-of-state cases, but he made an exception for one case in which an out-of-state plaintiff was implanted with Ethicon’s Prolift+M pelvic mesh device.
Although, according to the plaintiffs, the other implants in question were made using a mesh manufactured by Secant Medical Inc. in Pennsylvania, the mesh in Prolift-M was not manufactured by Secant.
“We are heartened by Judge New’s ruling affirming Pennsylvania jurisdiction for all but one of Ethicon transvaginal mesh cases,” attorney Shanin Specter of Kline & Specter PC said in an email. “Now our badly injured clients can continue to have us try their cases, which have been overwhelmingly successful both in Philadelphia and around the country. We will appeal the adverse ruling in the lone other case.”
The judge said in August that he would reconsider a 2015 ruling that kept alive a number of cases brought by non-Pennsylvania litigants.
That announcement, in a one-page order with no explanation, came after Ethicon argued in a June motion that two recent U.S. Supreme Court decisions narrowing the scope of jurisdiction for plaintiffs looking to pursue claims in venues outside either where they were injured or where a defendant is headquartered meant that 91 cases pending in the Philadelphia County Court of Common Pleas needed to be dismissed and refiled elsewhere.
The company previously sought to have claims from out-of-state plaintiffs, whose cases are part of a mass tort program aimed at coordinating litigation over alleged pelvic mesh injuries, dismissed for a lack of jurisdiction, but Judge New rejected its bid in March 2015. Judge New is the coordinating judge of Philadelphia’s Complex Litigation Center, which handles the court’s mass torts.
Renewing its effort, Ethicon pointed to a ruling from the justices in June that found Bristol-Myers Squibb Co. did not have sufficient business contacts in California to confer courts there with jurisdiction over some 600 lawsuits brought by out-of-state plaintiffs over injuries allegedly caused by the blood thinner Plavix.
The 8-1 opinion came just weeks after another ruling from the Supreme Court that found two out-of-state employees couldn’t sue BNSF Railway Co. in Montana given the company’s lack of a bona fide business presence in the state.
Ethicon emphasized that its position as a New Jersey-based business meant that non-Pennsylvanians could not bring their claims in Philadelphia County.
Documents in the litigation show that the original 91 out-of-state cases identified by Ethicon have been whittled down to 71 cases.
“While we have not had an opportunity to review the entire order, we are disappointed and will consider our legal options to have this issue considered further,” Ethicon spokeswoman Kristin Wallace said in an email to Law360.
Six cases in the mass tort program have gone to trial so far in Philadelphia, resulting in five verdicts in favor of plaintiffs against Ethicon and damages now totaling just more than $105 million.
The plaintiffs are represented by Thomas Kline, Shanin Specter, Lee Balefsky and Charles "Chip" Becker of Kline & Specter PC, and Clayton Clark of Clark Love & Houston.
Ethicon is represented by Kenneth Murphy and Melissa Merk of Drinker Biddle & Reath LLP, and Julie Callsen of Tucker Ellis LLP.
The case is In Re: Pelvic Mesh Litigation, case number 140200829, in the Philadelphia County Court of Common Pleas of Philadelphia.
--Additional reporting by Matt Fair. Editing by Stephen Berg.https://www.law360.com/articles/991775/pa-judge-affirms-jurisdiction-on-out-of-state-mesh-cases
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Asia Regulatory Roundup: Australia Bans Transvaginal Mesh Products
Dec 5, 2017 | Regulatory Affairs Professional Society
By Nick Paul Taylor
Australia Bans Transvaginal Mesh Products Following Risk-Benefit ReviewAustralia has banned transvaginal mesh products used in the treatment of pelvic organ prolapse. The Therapeutic Goods Administration (TGA) took the action after concluding the risks of the controversial treatment outweigh the benefits.
Patients and healthcare experts around the world have questioned the use of the medical implants for years, leading to a legal initiatives including a 700-person federal court class action case against Johnson & Johnson and reviews of the device’s risk-benefit profile in the United States and Europe. The United Kingdom’s regulatory agency is reportedly preparing to ban the use of vaginal mesh to treat pelvic organ prolapse, but its peer in Australia has moved first.
On 4 January, TGA will issue notices to remove devices from the Australian Register of Therapeutic Goods (ARTG) or otherwise impose constraints on their use. The notices target transvaginal mesh products used to treat pelvic organ prolapse and single incision mini-slings used to treat stress urinary incontinence. In both cases, TGA thinks the risks outweigh the benefits.
Sponsors affected by the notices have 90 days to ask TGA to review its decision.
The planned ARTG cancellations mark the culmination of a four-year period in which TGA has paid particular attention to the safety of devices designed for urogynecological use. Over that time, the agency has banned 43 devices and prohibited the use of another two products in urogynecological procedures. Many of the actions followed TGA’s 2013-14 review of the safety of the devices.
That review found “little evidence” to support the overall effectiveness of urogynecological mesh implants. However, as TGA saw the data as suggesting certain patients may benefit, it shied away from an outright ban on the use of the devices in the urogynecological context.
TGA’s decision to take a harder line against the implants follows a review of recent international studies and up-to-date clinical evidence. A meta-analysis published in Obstetrics & Gynecology last year found mesh erosion rates, a widely reported complication, ranged from 1.4% to 19%. Those numbers shot up to 3% to 36% when the mesh was implanted in multiple compartments.
The authors behind the meta-analysis, like TGA during its 2013-14 review, noted shortcomings in the quality of the literature. However, with the quality improving over time, TGA now thinks there is sufficient evidence to remove devices from the ARTG.
http://raps.org/Regulatory-Focus/News/2017/12/05/28977/Asia-Regulatory-Roundup-Australia-Bans-Transvaginal-Mesh-Products-5-December-2017/
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What Is Vaginal Mesh Implant? Post-Treatment Sepsis Kills Campaigner Against It
Dec 5, 2017 | International Business Times
By Shreesha Ghosh
A Canadian woman has died reportedly from sepsis after a 4-year struggle with persistent infections stemming from her surgery where she received a pelvic mesh implants that led to painful complications, reports said Monday.
The 42-year-old Canadian woman’s husband Tony confirmed her death after she set up a campaign to raise awareness of the dangers of mesh implants, which are used to treat organ prolapse and urinary incontinence, reports said.
Christina Lynn Brajcic, 42, had the mesh midurethral sling inserted in 2013 in order to treat stress incontinence after giving birth to her second child, the Sydney Morning Herald reported. She is believed to be the first woman to die from complications arising from the treatment.
Brajcic had already launched a lawsuit against Johnson & Johnson, the company which made her device, joining thousands of other Canadian and American women and 800 in the U.K., who were already involved in litigation against various mesh providers. She also campaigned against the providers by selling ribbons and t-shirts in order to raise awareness and funds for sufferers.
The plastic implants that are placed are said to be used in order to support organs such as the vagina, uterus, bowel, bladder or urethra which have prolapsed during childbirth or due to several other complications.
However, they can shrink, twist and cut through internal tissue and have already left many women in unbearable pain.
Brajcic’s death comes just a week after the UK-based National Institute for Health and Care Excellence (NICE) recommended the vaginal mesh be banned as a routine treatment for prolapse.
Professor Carl Heneghan, an expert in medical device regulation, at the time said that it essentially amounted to a "backdoor-ban" — however, it had come too late to help the thousands of women whose lives have already been irreparably damaged, according to the Independent.
"Surgical mesh is a medical device that is used to provide extra support when repairing weakened or damaged tissue. Most surgical mesh devices are made from synthetic materials or animal tissue," as explained by Mayo Clinic.
Urogynaecological meshes, which are also often known as transvaginal meshes are used to treat stress incontinence, a condition, which can lead to women leaking from their bladder when doing impact activities such as running and jumping, or even sneezing or coughing.
This condition is said to be very common in women around the world after childbirth and at the menopause. The meshes are also offered as treatment to women suffering from pelvic organ prolapse, which can happen when pelvic floor muscles, tissue and ligaments that hold the organs in place get weak or damaged.
"A vaginal mesh is purely a synthetic net material used in the placement of a weak connective tissue or ligaments, suspending the vagina and uterus," consultant gynecologist and obstetrician Dr. Amed Ismail, from Queensway Gynecology Clinic, told the Huffington Post U.K.
The mesh is placed to provide permanent support to the weakened organs and to repair damaged tissue. The surgery can be performed through the abdomen (transabdominal) or it can also be done through the vagina (transvaginal).
According to Dr. Ismail, complications are usually caused by the mesh implant by eroding, breaking down into smaller pieces which potentially move.
"The vagina area being stitched up is a weak point of the vaginal wall," he said.
"The mesh can find its own way through this weak point and protrude outside the vagina." He added that women can be aware of the erosion when they feel discomfort during intercourse or if their partner can feel the mesh while having sex.
Women who experience such erosion would require another surgery in order to remove the mesh or get it fixed. Dr. Ismail claimed that around 10 percent of women who go through the treatment experience erosion of the vaginal mesh, the Huffington Post reported.
http://www.ibtimes.com/what-vaginal-mesh-implant-post-treatment-sepsis-kills-campaigner-against-it-2623812
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Health Secretary urged to take ‘decisive’ action on mesh scandal
Dec 5, 2017 | Press Association (In The Evening Express)
MSPs from across the political divide have warned the Health Secretary that she must take “decisive” and “radical” action on Scotland’s mesh scandal.
The Scottish Conservatives said Shona Robison was in “last chance saloon territory” to deliver justice for women who have suffered as a result of mesh procedures – branding it as “the 21st-century’s thalidomide”.
Scottish Labour urged her to set up a judge-led inquiry into the issue while others, including former health secretary Alex Neil, also pressed for the government to go further by revisiting the findings of a review group.
Synthetic transvaginal tapes and meshes are used in the treatment of pelvic organ prolapse (POP) and stress urinary incontinence (SUI).
Thousands of women in Scotland have been treated using the implants but some have suffered painful and debilitating complications.
In 2014, Mr Neil – the then health secretary – called for the suspension of such procedures and an independent review group was set up to look at safety issues.
Its final report, published earlier this year, was branded a “whitewash” by mesh survivors, who stated many of the experts involved were too close to mesh manufacturers.
The government accepted the group’s findings, including a recommendation that mesh implants must not be offered “routinely” to women with pelvic organ prolapse.
The suspension remains in place while its findings are implemented and an oversight group is currently being established to review data and scrutinise adverse event reporting.
Ms Robison has also commissioned a further review by Alison Britton, a professor of healthcare and medical law, into the process by which the review group came to its conclusions.
Speaking during a debate at Holyrood, Tory Jackson Carlaw said the review group’s findings should be opened up to public consultation too.
“There must be no interruption to the current suspension ban, there must be a full public consultation on the content of the review which took place, to be published alongside the procedural review led by professor Britton,” he said.
Mr Carlaw warned his party would unite with others on the issue if action was not taken, adding: “The hourglass has run. I want Scotland to lead again. I want us to prevent mesh destroying more lives ahead.”
Mr Neil said: “I honestly think that as well as reviewing the process, the contents of this report are now so disrespected that we need to review the contents itself, b ecause quite frankly there isn’t universal agreement to accept the contents as it stands.”
Green MSP Alison Johnstone said she also believed that the findings of the report “must also be revisited”.
Labour’s Neil Findlay, who called for a judge-led inquiry, said: ” The review was compromised from the outset. The Government have let down mesh victims.
“This is the last chance to make radical changes to the way forward or we will bring political motions that seek to unite the opposition on this issue.”
Ms Robison said: “The request to suspend remains in place and will do so until the Chief Medical Officer is satisfied that all the recommendations (of the review group) have been implemented, including all upcoming changes to guidance and necessary safeguards are in place.
“What we all want to see is a change in the whole approach to this condition.
“The Scottish Government takes this issue very seriously and, indeed, we have made progress since the publication of the independent review report.”
https://www.eveningexpress.co.uk/news/scotland/health-secretary-urged-to-take-decisive-action-on-mesh-scandal/
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The vaginal mesh scandal has claimed its first victim – and she probably won’t be the last
Dec 5, 2017 | The Independent
By Harriet Marsden
Chrissy's death was so completely and utterly avoidable. But the male reluctance to acknowledge a women’s pain and to misattribute female health issues is as ancient as medicine itself
So it’s finally happened. A woman has died from complications related to her vaginal mesh implant.
Mesh implant, severe complications, partial removal, repeated infections, antibiotic resistance, sepsis, organ failure. She was just 42.
But Chrissy Brajcic is only the first we know of to lose her life in what has become known as the vaginal mesh scandal, or “the new thalidomide”. Her death would not have even made the news just a few short years ago, before the scandal broke.
Consider how many women have received a mesh implant to treat prolapse, incontinence or hernias: an estimated 10,000 a year in the UK alone, and this procedure has been performed around the world for more than twenty years. And it’s still being performed – despite recent healthcare watchdog NICE’s recommendations – since Parliament rejected cross-party calls for a suspension just last month.
Consider that credible estimates of severe side effects of the treatment range from 10 per cent (government reports and leading mesh experts like urogynaecologist Dr Sohier “Suzy” Elneil) to 40 per cent (the FDA, all the way back in 2008). And not just talking chronic pain and loss of sex life – we’re talking organ erosion, perforation, implants slicing into vaginal walls, debilitating infections and loss of the ability to walk or even stand.
Consider also that many side effects either do not manifest themselves for years, or go unreported by sufferers due to ignorance or even embarrassment. Or the estimated two-thirds of surgeons that don’t report mesh removals to the MHRA, since it’s not mandatory to do so.
Consider, more devastatingly, those who are dismissed by medical professionals. Chrissy posted this message on Facebook shortly before she died: “Funny how after going septic and almost dying, now I’m getting respect and being treated well by doctors.”
She joins thousands of women online sharing stories of being sent away, ignored, or having a doctor joke that they should try anal sex or blow jobs instead. The word that comes up most frequently is “hysterical”.
Hysterical woman. What historical resonance that epithet holds. Once a common medical diagnosis with devastating consequences, the male reluctance to acknowledge a women’s pain and to misattribute female health issues is as ancient as medicine itself.
And with all our modern medical advancement, we’re still living in a cultural and medical milieu that has consistently dismissed endometriosis as heavy periods, chronic pain as mere complaining, and female sexuality as simply unimportant. That’s not to mention the persistent ignorance of so many medical professionals (and the public) when it comes to the vagina.
So Chrissy may well not be the first to die. And until things change – until the issue starts to receive the international attention that similar men‘s health scandal undoubtedly would – she probably won’t be the last.
Many women, like Chrissy, are becoming resistant to the antibiotics prescribed for recurrent infections and chronic complications. That means they’ll run the risk of dying from treatable conditions in the future.
The mesh removal surgery, increasingly in demand as the scandal begins to gain a foothold on the national news agenda – is not at all the “simple, quick and easy” procedure that the original implant was touted to be.
Dr Elneil tells me that the surgery, which she now performs regularly, carries high risks of infection, trauma to major organs, voiding dysfunction, deep vein thrombosis, and a 10 per cent-occurrence of lifelong chronic pain. Because the plastic netting devices are designed to be permanent, the removal is often not even fully successful, and has been described as “trying to remove hair from chewing gum” due to disintegration and contamination.
More and more women are seeking the surgery anyway, as a viable alternative to a life of chronic pain, complications and sexual dysfunction. And as awareness of the dangers of mesh implants grow, so will the number of women risking the reversal.
With a little luck, the increasing international scrutiny – and calls for a full ban all over the English-speaking world, in the UK, America and Australia – will discourage women from opting for the device in the first place: a device that most of them don’t even need.
Because that’s the worst part: Chrissy’s death was so completely and utterly avoidable. She suffered from minor stress incontinence following the birth of her second child: a common complication that many believe could be alleviated, even cured, with pelvic physiotherapy. Mesh implants are, for the most part, not the best treatment available, nor are they usually prescribed for life-threatening conditions.
So how can we make her death mean something? As Chrissy wrote, so presciently and so poignantly just days before her heart stopped: “All it took was dying to get better care and better pain management. I will take it... it’s better than fighting for my care.”
We can carry on her fight: campaigning, raising money and awareness of mesh risks and the stories of sufferers. We can continue to challenge a criminally negligent medical device regulatory system that prioritises fiscal wellbeing over physical. We can call out a patriarchal society and medical community that dismisses and delegitimises a woman’s pain, and encourages them to do so themselves.
We can publicise Chrissy’s story in the hope that it might prevent further deaths. But for so many women, whose lives have been utterly and needlessly destroyed, it may already too late.
https://www.independent.co.uk/voices/vaginal-mesh-scandal-sling-tvt-risks-death-procedure-womens-health-gynaecology-feminism-sexist-a8093071.html
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Dec 6, 2017 | The Sun
By Jay Akbar
Tributes have poured in for the 'courageous' campaigner who helped raise awareness of the controversial implant
A PROMINENT vaginal mesh campaigner has died after her a four year battle with sepsis allegedly brought about by the controversial implant.
Chrissy Brajcic, 42, suffered from persistent infections after being fitted with a TVT mesh fitted to cure the mild stress incontinence she suffered after the birth of her two sons.
The scandal-hit devices which are said to cause crippling pain by twisting and cutting through internal tissue are blamed for ruining thousands of women's lives.
Her husband Tony announced her death on her Facebook page, Chrissy's Surgical Mesh Survival Story, where she chronicled her struggle with constant infections in heart-wrenching videos.
He wrote: "It's clear by all of your messages that Chrissy was truly a special woman and touched the lives of many people.
"We have been overwhelmed by your expressions of interest in attending her memorial service."
Christina, 42, suffered from persistent infections after being fitted with a TVT mesh
The interior designer from Ontario, Canada, passed away on November 30, according to a crowd-funding page which has raised more than £1,000 for her sons Ben and Jake.
It says the 'catastrophic chain of events which led to her death' began in 2013, when she was fitted with the mesh.
The once fit and active woman was put on strong medication to suppress the debilitating pain which saw her in A&E at least once a month.
Health officials in the UK and Australia have led calls to ban vaginal mesh, which was developed 20 years ago as the quick and easy alternative to complex surgery for incontinence and prolapse.
The NHS is expected to follow guidance from its healthcare adviser, Nice, following the release of a damning three-year-long investigation in September.Doctors in Britain called for an inquiry into the procedure after the NHS tried to dodge reporting of the implants which left hundreds of women in agony.
At least 800 women were said to be suing the NHS and mesh manufacturers at the time.
Though it is still seen by some as a viable option, Australia has banned its use for prolapse after a study found "the benefits do not outweigh the risks".
Health officials in the UK and Australia have led calls to ban vaginal mesh
to the toilet
Chrissy told her thousands of fans that she was feeling "a little more stable" in her final Facebook post on November 19.
There was an outpouring of love in the comments section underneath the post, a throwback to her first video chronicling her battle with sepsis.
"Rest in Peace lovely lady!" wrote Shelley Zettler. "You fought such a brave fight! We will remember you always!"
Leisa Tilley said: "I'm so sorry to all of her loved ones. This is a tragedy that could have been avoided!"
While Karyn Finley wrote: "Thanks for everything you have done for all of us. You are a true hero."
https://www.thesun.co.uk/news/5069046/chrissy-brajcic-dead-42-vaginal-mesh-campaigner-sepsis/
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Vaginal mesh campaigner dies from sepsis triggered by her implant
Dec 5, 2017 | Metro
By Zoe Drewett
A ‘courageous’ vaginal mesh campaigner has died from sepsis triggered by her own implant after a four-year battle with persistent infections.
Chrissy Brajcic’s death was confirmed by her husband Tony on her Facebook page – where she had posted an array of videos documenting her struggle in the months leading up to her death.
The 42-year-old, from Ontario, Canada, had set up a campaign to raise awareness of the dangers of the mesh – used to treat organ prolapse and urinary incontinence.
The plastic implants are used to support the vagina, uterus, bowel, bladder or urethra if they have prolapsed during childbirth.
But they can shrink, twist and cut through internal tissue and have left many women in unbearable pain.
Chrissy was given the mesh after she suffered mild stress incontinence after the birth of her sons Ben and Jake.
In one of her final online posts, she vowed to ‘never stop fighting’ for her cause and added: ‘This is a life or death issue.’
Tributes flooded in for the ‘courageous’ interior designer, who helped to raise awareness of the ‘catastrophic’ mesh, which are used on thousands of women each year.
Her husband wrote: ‘It’s clear by all of your messages that Chrissy was truly a special woman and touched the lives of many people.’
Earlier this year Professor Carl Heneghan, who specialises in evidence-based medicine, warned against the implants and said some of the devices had not been clinically tested.
He likened the impact of the mesh to the Thalidomide scandal – which was used in the late 1950s and early 1960s to combat morning sickness, but led to children being born without limbs.
‘Unlike in the Thalidomide scandal, you are unable to see the extent of the women’s injuries,’ he said.
Women affected have been left unable to walk with some reporting organ erosion, nerve damage and loss of sexual function.
Chrissy had her polypropylene mesh TVT (tension-free vaginal tape) implanted four years ago after she gave birth.
The type of mesh is the most commonly prescribed in the UK to treat mild incontinence.
But the mum-of-two suffered nerve damage as a result and was in constant pain following the procedure.
After an operation to remove the device a year later, she was back in hospital being treated for urinary tract infections, eventually becoming resistant to antibiotics.
She was readmitted to hospital suffering from sepsis in October.
In one of her final posts, Mrs Brajcic wrote: ‘Funny how after going septic and almost dying now I’m getting respect and being treated well by doctors.
‘All it took was dying to get better care and better pain management. I will take it, it’s better than fighting for my care.’
Kath Sansom, founder of the Sling The Mesh campaign, has created a JustGiving page to raise funds to send to Ms Brajcic’s young sons. So far, it has raised more than £1,000.
Writing on the post, Ms Sansom, 49, said: ‘Chrissy was a courageous woman who, despite her suffering, remained, calm, strong and beautiful.
‘Let her death not be in vain.’ Ms Sansom also described her as ‘determined to spread the message to stop other women suffering’.
Sling The Mesh has almost quadrupled in members in recent months. Nearly 4,600, mostly sufferers, now support the cause to ban vaginal mesh implants.
The death comes a week after the National Institute for Health and Care Excellence (Nice) recommended banning mesh procedures in the UK, which are used on thousands of women each year.
It is expected that the NHS will follow the guidance from Nice, the government’s healthcare adviser – despite not being obligated to do so.
The scandal came to light in April, with senior doctors calling for a public inquiry into the controversial mesh.
At the time, it was reported that at least 800 women were suing the NHS and device manufacturers. However, it is unsure how many women are now looking to take action in Britain.
Scottish officials asked for it to be suspended in Scotland in 2014 pending a similar review, but hundreds of women are still believed to be having the surgery.
More than 10,000 women a year are believed to be fitted with the mesh.
This fundraising page for Chrissy Brajcic’s family will run until New Year’s Day 2018. You can find it here.
http://metro.co.uk/2017/12/05/vaginal-mesh-campaigner-dies-from-sepsis-triggered-by-her-implant-7132687/
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An Ontario Woman Died of Sepsis After Controversial Vaginal Mesh Surgery
Dec 6, 2017 | Vice
By Sarah Berman
A mesh implant meant to support pelvic organs after childbirth comes with some truly nightmarish risks.
A 42-year-old Ontario woman has died of sepsis after years of recurring infections linked to a controversial vaginal surgery.
Christina Lynn Brajcic suffered severe complications after a transvaginal mesh surgery in 2013, a procedure she said ruined her life and left her unable to walk or have sex.
Doctors recommended a mesh implant to address Brajcic’s urinary incontinence after childbirth. (It’s fairly common for new moms to pee a little when they cough or sneeze.) The procedure permanently inserts plastic netting doctors say acts as a “hammock” keeping pelvic organs in place when surrounding tissue has been stretched or damaged.
Brajcic claimed her surgery quickly turned into a nightmare. Last year she told CTV her mesh implant was immediately painful, like “barbed wire” in her abdomen. According to a GoFundMe page for the family, her body rejected the mesh, causing “infection after infection.”
The Windsor mom devoted years of her life to advocating for women injured by transvaginal mesh. Brajcic petitioned regulators to take mesh off the marketuntil more long-term studies proved them safe. She wrote that a near-death experience last month convinced her to “never stop fighting” for what she called “a life or death issue.”
Brajcic’s husband confirmed her death on her Facebook page Sunday night.
According to a recent CTV investigation, tens of thousands of Canadians have similar procedures every year. The surgery has spiked in popularity over the last decade, and is considered less invasive than alternatives. The surgery is widely recommended in cases of vaginal prolapse, also associated with childbirth.
Brajcic’s death has brought new attention to the truly horrific side effects some women endure, sometimes for years after surgery. It’s also added fuel to thousands of ongoing lawsuits against the makers of mesh products in Canada, the US, the UK and Australia.
According to lawsuits filed by thousands of patients, mesh implants can cause blinding pain, bleeding, organ erosion and perforation. Once pelvic tissue has grown around the mesh, it’s very hard to remove.
One woman in Philadelphia was awarded $57 million earlier this year after a mesh implant produced by Johnson & Johnson “mangled” her urethra. Three corrective surgeries reportedly couldn’t get all the plastic out.
After Brajcic had her mesh implant surgically removed in 2015, she remained in a lot of pain, and grew resistant to the antibiotics used to treat her infections. She documented her trips to the emergency room to warn others of the risks. “I don’t want this to happen to anybody,” she said in a recent Facebook video. “This is insane.”
Brajcic claimed her pain wasn’t always taken seriously by doctors, and finding one who would help her get rid of the mesh was a struggle. “Funny how after going septic and almost dying now I'm getting respect and being treated well by doctors,” she recently wrote on Facebook. “All it took was dying to get better care and better pain management. I will take it...it’s better then (sic) fighting for my care.”
The global medical community stands behind mesh implants as a treatment for incontinence, but depending who you ask, doctors say anywhere from one to 30 percent of patients suffer serious complications. Critics say the surgery is overused, doctors aren’t properly trained, and there hasn’t been enough long-term study.
Most importantly, according to Brajcic, patients aren’t properly informed about the serious risks. Back in 2011 the US Food and Drug Administration reclassified pelvic mesh as “high risk” and confirmed complications are “not rare.” Yet hundreds of thousands of mesh implants have been inserted since.
“It’s not being reported and it’s not being taken seriously,” Brajcic told CTV in September.
Brajcic’s death comes days after Australian regulators banned pelvic mesh products in many cases, and as UK politicians are pushing for a similar ban. The Australian regulator released a statement on November 29 saying “the benefits of using transvaginal mesh products in the treatment of pelvic organ prolapse do not outweigh the risks these products pose to patients.”
It’s a sign public opinion might be shifting, and Brajcic’s supporters are sharing the news alongside tributes to her activism.
“She was a gentle soul who stayed positive to the end,” British anti-mesh campaigner Kath Sansom wrote on Facebook. “Her legacy is raising awareness to stop other women suffering as she did.”
A memorial for Brajcic will be held in Windsor this Friday.
https://www.vice.com/en_ca/article/d3xvpy/an-ontario-woman-died-of-sepsis-after-controversial-vaginal-mesh-surgery
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Prominent Vaginal Mesh Campaigner Chrissy Brajcic, Dies From Sepsis
Dec 5, 2017 | Get The Gloss
By Ayesha Muttucumaru
THE MOTHER OF TWO HAD SUFFERED FROM NUMEROUS INFECTIONS SINCE BEING FITTED WITH THE SCANDAL-HIT MESH AFTER CHILDBIRTH. HER BATTLE IS ONE THAT MANY UK WOMEN WILL RELATE TO ACCORDING TO RECENT STATS AND HOPEFULLY NEW NICE GUIDELINES WILL LEAD TO BETTER REGULATION
Chrissy Brajcic, a prominent Canadian campaigner against vaginal-mesh implants, has died from sepsis after struggling with numerous infections for years.
The mother of two had been fitted with a polypropylene mesh TVT (tension-free vaginal tape) four years ago after she had given birth. Usually used to address mild stress incontinence, she suffered nerve damage and constant pain after her operation and, despite having had the device removed a year later, was back in hospital for the treatment of urinary tract infections and became resistant to antibiotics. In October, she was readmitted to hospital with sepsis and while her family awaits the results of a toxicology exam, they believe that her death can be directly connected to her mesh - and so is thought to be the first woman to die as a result of the widely reported scandal.
The devices have come under intense scrutiny in recent times. In April, it was reported that more than 800 women in the UK were taking legal action against the NHS and various vaginal-mesh manufacturers due to a range of problems experienced. Ms Brajcic herself had also launched a lawsuit against Johnson & Johnson, joining thousands of Canadian and American women taking similar actions. Used to treat organ prolapse and urinary incontinence suffered as a result of childbirth, there has been increased pressure on the NHS to make changes to how and when they’re used due to the problems that they can cause which include shrinking, moving, organ erosion, nerve damage and cutting through internal tissue to leave those affected in terrible pain and unable to work, have sex and even walk as a result.
Sufferers and experts alike have voiced concerns as to whether the benefits of them outweigh the risks. Earlier this year, Professor Carl Heneghan, who specialises in evidence-based medicine, stated that some of the devices are not clinically tested and drew attention to how large scale the problem could be, due to the number of women who have undergone the procedure. "I think this is the worst one [scandal] that we'll ever see in my lifetime because of the scale of the number of women affected,” he said. According to NHS data, more than 75,000 women in England had the TVT procedure between 2006 and 2016.
Additionally, it’s been reported that draft guidelines by UK health watchdog NICE (National Institute for Health and Care Excellence) set to be published next month, will be recommending that the mesh should no longer be used to treat prolapse. It doesn’t address its use for urinary incontinence though.
While the NHS isn’t obligated to take up its recommendations, the guidelines serve as a strong push towards better regulation of the device. Hopefully this will go some way in helping women in the UK who feel that their concerns and suffering have been overlooked. Kath Sansom, founder of Sling the Mesh, a UK campaign group who greatly respected Ms Brajcic, told The Independent: “Chrissy must not die in vain. Her death has shocked and upset women around the world. She only had a mild stress incontinence problem from childbirth and physio probably could have fixed it. Now she has lost her life. This is wrong in every way. This is shocking.”
Ms Sansom has created a JustGiving page to raise money to send to Ms Brajcic's young sons. You can donate to it here.
https://www.getthegloss.com/news/prominent-vaginal-mesh-campaigner-chrissy-brajcic-dies-from-sepsis
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Vaginal mesh campaigner dies in Canada after being hospitalised for sepsis
Dec 6, 2017 | TheJournal.ie
A CAMPAIGNER WHO had worked to highlight complications suffered by women who underwent vaginal mesh operations has died.
42-year-old Chrissy Brajcic, from Ontario, Canada, had an operation four years ago to treat urinary incontinence after the birth of her second child. She underwent a procedure that involved the use of a mesh implant called a mid-urethral sling to support her bladder.
After the operation, she experienced severe pain and was left in a wheelchair. She eventually had the implant removed. Her pain continued, however, and she suffered recurrent infections.
She launched a campaign to highlight her story and raise awareness of the problems suffered by other women who have undergone this procedure. The mother-of-two also featured had in a Canadian documentary about mesh implants earlier this year.
In recent years there has been international scrutiny surrounding these devices, which are made from a type of plastic called polypropylene.
They are used in surgeries to treat two conditions women can develop following natural childbirth: stress urinary incontinence and pelvic organ prolapse. These procedures have been carried out on women in Ireland since the late 90s and are still performed today.
However The Department of Health’s Chief Medical Officer is currently compiling a report on the use of transvaginal mesh implants in Ireland, after the stories of a number of Irish women who had these implants were highlighted.
‘A life or death issue’
Chrissy Brajcic became resistant to antibiotics and was hospitalised in October this year suffering from sepsis. She died last Wednesday. Last week her husband Tony told CTV Newsthat her heart had stopped.
The coroner has not yet confirmed her cause of death and her family is awaiting the results of a toxicology examination.
In one of her final posts on Facebook, the 42-year-old had said:After my near death experience a few weeks ago with sepsis from drug resistant infections from surgical mesh, I feel now more than ever I need to advocate for the mesh injured. I will never stop fighting. Please share and raise awareness…this is a life or death issue.
Tony Brajcic this week thanked all of the people who had supported his wife over the last four years.
“It’s clear by all of your messages that Chrissy was truly a special woman and touched the lives of many people,” he said in a Facebook post on the campaign page.
https://www.thejournal.ie/vaginal-mesh-campaigner-dies-3732672-Dec2017/
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Dec 5, 2017 | Daily Record
By Rachael Burford
Chrissy Brajcic documented her final few months online and said she would "never stop fighting" to "advocate for the mesh injured."
A campaigner against the use of controversial vaginal mesh has died after a four-year battle with persistent infections.
Chrissy Brajcic's husband Tony confirmed her death on Facebook on Sunday night.
It is thought the mum-of-two was killed by sepsis , which she had been struggling with for several months.
The 42-year-old was a prominent campaigner against the plastic implants, often used to treat vagina, uterus, bowel, bladder or urethra prolapse after childbirth and incontinence.
The Canadian had her implant installed in 2013 having suffered mild stress incontinence after the birth of her sons Ben and Jake.
She said doctor's assured her the vaginal mesh, also known as a tension free vaginal tape, was completely safe.
But Mrs Brajcic, a former interior designer from Ontario, said she was unaware that the device can twist and cut through internal tissue.
Many women have reported unbearable pain after the 20-minute operation , which is completed on thousands of patients in the UK every year.
During her final months, Mrs Brajcic kept a Facebook video diary detailing her struggle with the device and attracting thousands of viewers.
In one of her final posts she wrote: "After my near death experience a few weeks ago with sepsis from drug resistant infections from surgical mesh.
"I feel now more then ever I need to advocate for the mesh injured. I will never stop fighting."
Mrs Brajcic's death comes just a week after the National Institute for Health and Care Excellence recommended banning the device in the UK.
Confirming his wife's death on her Facebook page, Mr Brajcic wrote: "It's clear by all of your messages that Chrissy was truly a special woman and touched the lives of many people.
"We have been overwhelmed by your expressions of interest in attending her memorial service.
"Again thank you so much on behalf of the family. We wish everyone the best in managing any health conditions that you face."
http://www.dailyrecord.co.uk/news/health/vaginal-mesh-campaigner-mum-dies-11641411
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Vaginal Mesh Campaigner Has Died Of Sepsis After Receiving The Scandal-Hit Treatment
Dec 5, 2017 | Refinery 29
By Natalie Gil
A woman who campaigned against vaginal mesh implants has died from complications triggered by her own implant. Christina Brajcic, 42, who was ill with sepsis, is thought to be the first woman to die in what the media has called the vaginal mesh scandal.
Her death comes just a week after the UK's National Institute for Health and Care Excellence (NICE) called for a ban on vaginal mesh operations to treat organ prolapse in England.
Brajcic, from Ontario, Canada, was implanted with a plastic mesh device to treat mild incontinence after her second son was born four years ago. She suffered serious complications and claimed the operation had ruined her life, leaving her unable to walk, urinate or have sex. The pain became unbearable, she told CTV W5, "and finally it was like my insides were ripping out.”
Brajcic was left bedridden and also suffered nerve damage from the implant, which she had to have removed in a complicated five-hour operation the following year. She then had to be treated in hospital monthly for urinary tract infections, became resistant to her antibiotics and eventually contracted sepsis, a life-threatening condition that can result in organ failure and death.
For years before her tragic death, Brajcic had spent years campaigning to raise awareness of the dangers arising from the implants, selling t-shirts, ribbons and stickers and giving the money raised back to sufferers.
“Funny how after going septic and almost dying now I’m getting respect and being treated well by doctors," she wrote on Facebook on 15th November. "All it took was dying to get better care and better pain management. I will take it...its better then fighting for my care.”
Following Brajcic's death, a Just Giving page has been set up to raise money for her two children, Ben and Jake. "Chrissy was a courageous woman who, despite her suffering, remained, calm, strong and beautiful and determined to spread the message to stop other women suffering as she did," the page reads.
In the UK, the government recently rejected calls from Labour and campaigners for an inquiryand ban on vaginal mesh implants after MPs debated the issue in the House of Commons. Labour MP Emma Hardy said she was “incredibly disappointed” by the outcome. “The lives of women and their families have been turned upside down ... The devastation has been appalling," she told the Independent.
“The government will not be able to undo suffering, but a suspension will go a long way to make sure nothing like this happens again.”
http://www.refinery29.uk/2017/12/183940/vaginal-mesh-scandal-campaigner-dies
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