Preview Newsletter
Ethicon Media Monitoring 12/4/2017
-
Australia Bans ‘Risky’ Transvaginal Mesh Implants
Dec 1, 2017 | Drugwatch
By Michelle Llamas
Australia has become the first country to ban use of transvaginal mesh implants, finding the benefits of using the surgical implants to treat pelvic organ prolapse and urinary incontinence do not outweigh the risks for patients. -
Canadian woman Christina Lynn Brajcic dies after receiving pelvic mesh implant
Dec 4, 2017 | The Sydney Morning Herald
By Joanne McCarthy
It is the Facebook post on October 29 that shocked women around the world, pelvic mesh campaigner Christina Lynn Brajcic in a hospital bed saying: "This is insane. To almost be on your death bed at only 42 because of mesh. It's not right." -
Mum Of Two Dies Four Years After Receiving Pelvic Mesh Implant
Dec 4, 2017 | Honey
By Kahla Preston
A Canadian mother of two has died four years after receiving a pelvic mesh implant that left her with painful complications. -
Mum-Of-Two Dies 4 Years After Being Given A Pelvic Mesh Implant
Dec 4, 2017 | Marie Claire
By Marie Claire
A Canadian mother-of-two has died four years after being given a pelvic mesh implant and one month after posting a viral Facebook video from hospital. -
Canadian advocate for patients harmed by surgical mesh dies in hospital
Dec 4, 2017 | CTV
Chrissy Brajcic, a patient who battled chronic, debilitating infections after receiving surgical mesh to treat incontinence, has died in a Windsor, Ont. hospital. -
Surgical Mesh Products Lost On New Government
Dec 3, 2017 | Newsroom
By Teuila Fuata
In one month, it will be illegal to use surgical mesh products to treat pelvic organ prolapse in Australia. -
Surgeon Says Vaginal Mesh Patients' Complications Were 'Ignored' By Doctors
Dec 2, 2017 | thejournal.ie
A CONSULTANT IN the UK has said complications women suffered following surgeries which used vaginal mesh implants were often ignored by their doctors. -
Group urge government to ban surgical mesh
Dec 2, 2017 | Newstalk ZB
By Jordan Bond
The Government's being urged to ban surgical mesh for women's pelvic prolapses after an Australian regulator banned them from being used. -
‘We had the chance to lead the world in banning mesh and protecting patients. We did not take it’
Dec 3, 2017 | The Sunday Post
By Marion Scott
THE Scottish Government had a chance to lead the world in protecting women from controversial mesh implants but blew it, according to a renowned expert. -
INCONTINENCE SURGERY What are vaginal mesh implants, why are they used for treating incontinence and are they safe?
Dec 1, 2017 | The Sun
By Amanda Devlin
BOTCHED vaginal mesh implants have left hundreds of women suffering from the after effects, it has been revealed. -
A mum of three who had a mesh implant has been left in so much pain she now needs 20 tablets a day
Dec 2, 2017 | Wales Online
By Amy Coles
When mum-of-three Karen Preater began suffering with urinary incontinence after her son was born weighing 10b 1oz she was told it was a common problem that was easily fixed.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
-
Australia Bans ‘Risky’ Transvaginal Mesh Implants
Dec 1, 2017 | Drugwatch
By Michelle Llamas
Australia has become the first country to ban use of transvaginal mesh implants, finding the benefits of using the surgical implants to treat pelvic organ prolapse and urinary incontinence do not outweigh the risks for patients. Doctors and patient advocates in the U.S. praise Australian regulators for their decision and are urging the U.S. Food and Drug Administration to do the same.
“I do believe the FDA is watching what happened with the vaginal mesh implant ban in Australia,” Orlando-based urogynecologist and Drugwatch expert Dr. Christopher Walker said. “I support a ban on these products and hope they are banned in the U.S. as well.”
The Therapeutic Goods Administration — the Australian equivalent to the U.S. Food and Drug Administration — announced this week its decision “to remove transvaginal mesh products whose sole use is the treatment of pelvic organ prolapse via transvaginal implantation from the Australian Register of Therapeutic Goods.” Transvaginal mesh implants remain available in the U.S., despite pleas from local doctors and patient advocates to have the products banned.
“The [Australian agency] is of the belief that the benefits of using transvaginal mesh products in the treatment of pelvic organ prolapse do not outweigh the risks these products pose to patients,” the agency said in its Nov. 28, 2017 alert.
The ban includes single incision mini-slings, small mesh strips used to treat urinary incontinence. It also includes mesh products from Boston Scientific and Coloplast, two companies involved in transvaginal mesh lawsuits in the U.S.
“When you place this foreign object into the vagina, you are placing bacteria into the tissue where the mesh is placed, causing chronic inflammation and other problems,” said Walker, who has treated a large number of women for complications from mesh implants, often with multiple surgeries.
However, not all pelvic mesh implants are covered by the ban. According the Australian agency, devices not used to treat pelvic organ prolapse via transvaginal approach — implanting the device through the vagina — will remain available for use.
“I’m not sure the ban goes far enough yet, but it is a good first step,” Amada Dykeman, an American medical device safety advocate told Drugwatch. “The materials used in mesh are highly controversial and long term data proving its safety simply does not exist to my knowledge. Australia has made a very wise decision to ban it.”
Australian regulators began monitoring mesh in 2008. The Therapeutic Goods Administration launched a formal review in 2013 after receiving reports of serious complications linked to the device. Mesh complications include infection, bleeding, severe pelvic pain, painful sex, organ perforation and recurring incontinence and prolapse.
Since the review, the agency has removed 45 devices from urogynecological use and cancelled 43 from the Australian Register of Therapeutic Goods, according to the agency. The ban will take effect Jan. 4, 2018.
For some women, the ban is not extensive enough, nor did it come soon enough.
“The mesh ban doesn’t include the one that poisoned me,” said Justine Watson, an Australian resident who had to travel to the U.S. to have her mesh removed. “I was sold a defective product and implanted by a poorly trained surgeon. It ruined seven years of my life and cost me my career.”
New Zealand’s Medsafe agency says it will follow Australia’s lead. But experts in the U.S. are skeptical the FDA will take a similar stance.Transvaginal Mesh Controversy Continues in the U.S.
In the U.S., more than 40,000 federal transvaginal mesh injury lawsuits are pending in West Virginia, and about 8,500 more are pending in New Jersey.
At one time, federal cases numbered over 100,000.
Elizabeth Hrymoc’s trial against Johnson & Johnson’s Ethicon subsidiary is currently underway in New Jersey. Hyrmoc had two mesh devices implanted for incontinence and had multiple surgeries to remove the device after complications.
American juries have already handed plaintiffs in pelvic mesh lawsuits millions in verdicts, and mesh manufacturers have settled more than 50,000 lawsuits.
Patient advocates and mesh-injured American women continue to hold rallies and protest on social media, hoping to get the device banned.
Yet, despite the legal uproar, the FDA has not banned any mesh products in the U.S.
The FDA allowed the majority of mesh products on the market through the controversial 510(k) clearance program. Manufacturers were allowed to sell their devices without clinical trials or testing if they were “substantially equivalent” to devices already on the market.
After adverse event reports continued to rise, the agency reclassified vaginal mesh for prolapse as a Class III, high-risk device in 2016. Unlike devices cleared through the 510(k), high-risk devices are subject to premarket approval, which requires more data on safety.
Despite this action, experts say the reclassification hasn’t improved device safety and allows manufacturers to hide complication reports.
“Two years ago, I would’ve said that the FDA would deem transvaginal mesh risks to outweigh benefits,” Device Events CEO and founder Madris Tomes told Drugwatch. “But, since the FDA reclassified mesh as high risk, they have still continued to allow manufacturers to use reporting that is summarized and redacted.”U.S. Experts: FDA Unlikely to Follow Australian Lead
U.S. advocates and doctors support the Australian ban, and urge the FDA to follow suit. But, not all are confident the agency will do so.
Cardiologist and outspoken women’s health advocate Dr. Hooman Noorchashm told Drugwatch the FDA won’t ban the product because it is acting more like a marketing agency for device companies than a public health agency.
“Kudos to the Aussies. They are clearly taking a leadership role in protecting citizens and women, and I think the FDA and the U.S. should learn from them,” Noorchashm said. “The reason why the FDA is unable to do what TGA is doing is that there is a lot of pressure from industry for FDA not to give in. And FDA is buying this concept that industry is an equal stakeholder to patients, and that’s not right.”
Patient advocates like Dykeman feel the FDA’s system is flawed, especially when it comes to protecting patients after a drug or medical device hits the market.
“The FDA has consistently reiterated the importance of keeping up with the rest of the world when it comes to medical device innovation and technology by fast tracking the approval process of life-saving drugs and medical devices, but they lack resources and fall short when it comes to post-market surveillance,” she said.U.K.’s NICE to Ban Mesh
Although it seems to be business as usual in the U.S., the U.K.’s National Center for Health Care and Excellence has recommended a ban.
NICE’s Interventional Procedure Committee is due to publish its guidance on Dec. 20, the BMJ reported, adding that the draft says mesh should not be used to treat prolapse because of “serious but well recognized safety concerns.”
Patient advocate and journalist Kath Sansom of Sling the Mesh and other mesh-injured women in the U.K. have staged rallies and Twitter campaigns to get the government’s attention.
“The [Therapeutic Goods Administration] announcement is proof of the growing realization of the global scandal of surgical mesh implants,” she said in a statement. “NICE has given what I deem is a back door ban on transvaginal prolapse mesh. I hope we follow suit and suspend all transvaginal and transabdominal pelvic mesh as the risks are grave and life altering.”
There will be more to come from NICE on transabdominal and incontinence meshes in 2019, Sansom said.
https://www.drugwatch.com/2017/12/01/australia-bans-risky-transvaginal-mesh-implants/
-
Canadian woman Christina Lynn Brajcic dies after receiving pelvic mesh implant
Dec 4, 2017 | The Sydney Morning Herald
By Joanne McCarthy
It is the Facebook post on October 29 that shocked women around the world, pelvic mesh campaigner Christina Lynn Brajcic in a hospital bed saying: "This is insane. To almost be on your death bed at only 42 because of mesh. It's not right."
One month later, the outspoken Canadian and mother of two was dead.
Australian pelvic mesh campaigner Caz Chisholm advised the Therapeutic Goods Administration on Friday of Mrs Brajcic's death, in an email demanding it extend last week's targeted ban of some pelvic mesh and sling devices to become a total ban on all pelvic mesh devices, even those regarded as "gold standard" for stress incontinence.
"Chrissy was sick for many years," Ms Chisholm told TGA deputy secretary John Skerritt. "She fought hard. She was 42 years old and leaves behind two very young sons and a husband. It was a Johnson & Johnson stress incontinence midurethral sling that destroyed her life and finally took it forever.
"Women who are permanently injured by these devices do not consider them to be the gold standard. How can they be when the risks can be so catastrophic?"
Danny Vadasz, of consumer health group Health Issues Centre, said there were "ample reasons" to support a total ban on all pelvic mesh devices. He was scathing of a system that accepted permanent and incapacitating injuries to a minority of women because the devices helped treat some women's incontinence.
"What does it have to take before the penny drops, before we treat this seriously enough?" Mr Vadasz asked.
Mrs Brajcic's death – which is not the first recorded death of a woman experiencing pelvic mesh complications – was "way beyond the discomfort and inconvenience" that some doctors referred to when questioned about mesh risks, he said.
"How many deaths before the regulators and other health bodies are shamed into doing their jobs?" Mr Vadasz asked.
Mrs Brajcic died in hospital on Thursday, Sydney time, after emergency treatment in late October for sepsis, a life-threatening response to infection that can lead to organ failure. Her husband Tony said "her heart stopped", but the coroner is yet to provide a formal cause of death. In Facebook posts in November, she described some days as "really bad".
Mrs Brajcic was implanted with a mesh midurethral sling in 2013 for incontinence after the birth of her youngest son. Versions of the midurethral sling remain on the market in Australia, despite the TGA's targeted ban of all transvaginal – surgery via the vagina rather than the abdomen – prolapse mesh devices, and a group of incontinence mesh slings.
Mrs Brajcic experienced immediate severe pain after the 2013 surgery that only worsened with time. In a Canadian news report in September, she said her surgeon dismissed her complications as the mesh settling in.
The formerly vibrant and active interior designer had the mesh removed after searching for surgeons who would do the risky procedure, but spent much of the past four years confined to a wheelchair and on constant antibiotics, painkillers and anti-nausea medications.
Her death prompted an outpouring of grief from mesh-injured women around the world, including many in Australia who had regular contact with her via Facebook.
"Everyone in the mesh world knew her," Ms Chisholm said. "No one can believe she's gone. She helped all of us and now she's dead. It's just so shocking. She was so unwell but now it's happened. It's really happened."
Sydney mesh campaigner Gai Thompson, who had a different Johnson & Johnson transvaginal mesh device in 2008 that Australian surgeons have told her cannot be removed, said Mrs Brajcic "drew attention to the cause because she wanted to get this stuff banned".
"Doctors talk about the thousands of women who've had mesh without complaint but they don't talk about the women who are left with this crap in them that destroys their lives, and that's what people don't understand," Mrs Thompson said.
In a complaint to the TGA in 2011, Mrs Thompson said she was "living a nightmare", with constant urinary tract infections leaving her resistant to some antibiotics, chronic and severe pelvic pain, chronic bowel problems, incontinence and multiple areas where the mesh had eroded into her vagina. She was unable to have sex with her husband, unable to work and the couple had been forced to sell their home.
"I've still got all my mesh in and I've got constant infections I can't get rid of," she said. "I'm on the strongest antibiotics I can be on and it's doing nothing. It's been in there for nearly 10 years. The long-term consequences of putting polypropylene mesh into women's bodies is unknown, and yet doctors, manufacturers and the TGA say it's all OK."
In one of her final posts, which echoed evidence by Australian women at recent Senate public hearings in Perth, Sydney, Canberra and Melbourne, Mrs Brajcic said she experienced "anger that my life was taken away from me".
"I feel neglected by the medical system," Mrs Brajcic said. "That we have to fight so hard to get even an ounce of help is just not right."
In her October 29 Facebook post from a Canadian hospital bed after she was transferred from an intensive care unit, Mrs Brajcic told supporters: "How do I go from an infection to heart failure? I'm 42. It was the scariest experience of my life. I'm so lucky to be alive."
In a Facebook post circulated to mesh groups in Australia, the United States, New Zealand, England, Scotland, Ireland and Europe, Mr Brajcic said his wife was "a very strong fighter right up to the very end".
On November 28, the TGA moved on a final eight transvaginal prolapse mesh devices and certain incontinence slings on the Australian market, ordering their cancellation or that they not be implanted via the vagina.
It followed a review that found the risks outweighed the benefits of the prolapse devices and there was a lack of adequate scientific evidence backing the incontinence slings. Since 2013, the TGA has cancelled 43 mesh devices and their multiple variants.
In October, the TGA moved to upgrade the classification of all implantable pelvic mesh devices to high risk.
In a statement on the "gold standard" midurethral slings, where there is accepted research supporting their use, the Royal Australian and New Zealand College of Obstetricians and Gynaecologists in May acknowledged complications "may become intractable".
"In some women, these long-term adverse outcomes have had severe effects on everyday activities and their quality of life," the RANZCOG 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."
http://www.smh.com.au/national/health/canadian-woman-christina-lynn-brajcic-dies-after-receiving-pelvic-mesh-implant-20171203-gzxsl1.html
-
Mum Of Two Dies Four Years After Receiving Pelvic Mesh Implant
Dec 4, 2017 | Honey
By Kahla Preston
A Canadian mother of two has died four years after receiving a pelvic mesh implant that left her with painful complications.
Christina Lynn Brajcic, 42, had the mesh midurethral sling inserted in 2013 to treat stress incontinence following the birth of her second child, the Sydney Morning Herald reports.
Within hours of the procedure, Brajcic found herself in severe pain that only intensified with time.“The pain got worse ... and finally it was like my insides were ripping out, I couldn't pee hardly at all,” she told Canadian media outlet CTV W5.
Yet when she shared her complaints with a surgeon, they dismissed the pain as a side-effect of the device “settling in”.
While the interior designer found a surgeon skilled enough to remove the mesh a year after its insertion, complications persisted over the next four years.
Brajcic required a wheelchair and constant antibiotics, painkillers and anti-nausea medications, and was in and out of hospital with infections and pain from nerve damage."I can’t walk, I can’t take my kids to the park. Every little thing I do is such a huge ordeal to even get myself out of the house,” she told CTV W5.
Her case received widespread attention in October when she was rushed to hospital for sepsis resulting from a life-threatening infection.
"This is insane, to almost be on your deathbed at only 42 because of mesh," the 'mesh warrior' told her followers in a Facebook video recorded from her hospital bed.
Brajcic died in hospital on Thursday, leaving behind her husband and two sons.
According to the Herald, hers is not the first recorded death of a woman suffering complications from a urogynaecological mesh.Home 9Honey NewsMum of two dies four years after receiving pelvic mesh implantBy Kahla Preston 7 hours agoPelvic mesh advocate dies due to her implantsFSharePPin itTTweetBMailA Canadian mother of two has died four years after receiving a pelvic mesh implant that left her with painful complications.
Christina Lynn Brajcic, 42, had the mesh midurethral sling inserted in 2013 to treat stress incontinence following the birth of her second child, the Sydney Morning Herald reports.
Within hours of the procedure, Brajcic found herself in severe pain that only intensified with time.“The pain got worse ... and finally it was like my insides were ripping out, I couldn't pee hardly at all,” she told Canadian media outlet CTV W5.
Christina Lynn Brajcic received a pelvic mesh implant four years ago. (Image: Facebook)
Yet when she shared her complaints with a surgeon, they dismissed the pain as a side-effect of the device “settling in”.
While the interior designer found a surgeon skilled enough to remove the mesh a year after its insertion, complications persisted over the next four years.
Brajcic required a wheelchair and constant antibiotics, painkillers and anti-nausea medications, and was in and out of hospital with infections and pain from nerve damage."I can’t walk, I can’t take my kids to the park. Every little thing I do is such a huge ordeal to even get myself out of the house,” she told CTV W5.recommendsARTICLE CONTINUES BELOWPolice buy car seat instead of giving mum speeding fineHoneyPink is raising her children gender neutralHoneyKim Kardashian's Christmas countdown is the cutest thing everHoneyRonnie and Georgia explain what happenedHomes powered by plista
Her case received widespread attention in October when she was rushed to hospital for sepsis resulting from a life-threatening infection.
"This is insane, to almost be on your deathbed at only 42 because of mesh," the 'mesh warrior' told her followers in a Facebook video recorded from her hospital bed.
Brajcic died in hospital on Thursday, leaving behind her husband and two sons.
According to the Herald, hers is not the first recorded death of a woman suffering complications from a urogynaecological mesh.WATCH: Victims share the debilitating complications they've suffered from pelvic mesh implants.
The net-like devices are used to address issues that typically result from childbirth, namely stress incontinence and pelvic organ prolapse.
They are intended to provide permanent support for weakened organs including the bladder, rectum or uterus, and repair tissue damage.
However, numerous women have come forward to share the debilitating injuries they’ve suffered after receiving mesh implants.In August, more than 700 women launched a class action against manufacturer Johnson & Johnson, seeking compensation for complications including organ damage, recurring infections and inability to have sex.
Last week, the Therapeutic Goods Administration announced vaginal mesh implants for use in pelvic organ prolapse, and single incision mini-slings, will be removed from the Australian Register of Therapeutic Goods.
“The TGA is of the belief that the benefits ... do not outweigh the risks these products pose to patients,” a statement read.https://honey.nine.com.au/2017/12/04/11/05/pelvic-mesh-implant-death
-
Mum-Of-Two Dies 4 Years After Being Given A Pelvic Mesh Implant
Dec 4, 2017 | Marie Claire
By Marie Claire
A Canadian mother-of-two has died four years after being given a pelvic mesh implant and one month after posting a viral Facebook video from hospital.
Christina Lynn Brajcic experienced severe pain immediately after having the mesh implanted in 2013 following the birth of her second son, Sydney Morning Herald reports.
Her surgeon dismissed the complications as side-effects of the mesh "settling in" to her body, but the pain only worsened with time.
Christina eventually had the mesh removed, but spent much of the past four years confined to a wheelchair and on constant antibiotics and painkillers.
"How did I go from having an infection to heart failure? At 42? Dang mesh," the mesh campaigner said in a Facebook live video from her hospital bed only weeks ago.
"I don't want this to happen to anybody. This is insane," she continued.
"To... almost be on your death bed at 42 because of mesh, it's not right. I'm terrified at what we all go through and I never want another woman or man dealing with mesh to go through this."
Christina's died in hospital on Thursday after emergency treatment in late October for sepsis, a life-threatening response to infection that can lead to organ failure. Her death has prompted outcry from women all over the world who are suffering from mesh implants.
Just last week, pelvic mesh implants were banned from Australia.
https://www.marieclaire.com.au/women-dies-pelvic-mesh-implant-christina-brajcic
-
Canadian advocate for patients harmed by surgical mesh dies in hospital
Dec 4, 2017 | CTV
Chrissy Brajcic, a patient who battled chronic, debilitating infections after receiving surgical mesh to treat incontinence, has died in a Windsor, Ont. hospital.
Brajcic's story was featured on CTV's W5 in September.
Four years ago, after the birth of her second child, she was implanted with polypropylene mesh, a type of plastic used to treat stress urinary incontinence (SUI).
However, she said the treatment left her in severe pain and bedridden.
Her pain persisted, even after a five-hour operation to remove the implant, and she was often in and out of hospital seeking help for infections.
"I'm in a terrifying place," she told CTV News, adding her goal was to get all pelvic mesh off the market until further studies are done.
In November, she entered hospital again for sepsis – a life-threatening response to infection that can cause organ failure. Her Instagram account states: "Fighting for my life battling complications from TVT #Mesh. I now advocate for the mesh injured."
She died on Wednesday. Her husband Tony told CTV News that, "her heart stopped." However, the coroner has not confirmed her cause of death. Her family is awaiting the results of a toxicology examination. It is unclear if her death is related to her surgical mesh implant.
News of her death has devastated the close-knit community of mesh patients who were in contact with Brajcic through social media.
Kath Sansom, who launched the U.K. patient support group Sling the Mesh, wrote in an email to CTV, "The news has hit the mesh community hard. Chrissy was very popular… Despite her pain and suffering she remained serene, stoical and determined to spread the word on mesh... Her courage and positivity in the face of such adversity was admired by everybody in the mesh campaign."
There are thousands of lawsuits against the makers of surgical mesh in Canada the U.S. the U.K. and Australia. They allege the polypropelene mesh can trigger pain, and infections in some women. There are also reports the mesh can break, and migrate into other parts of the body. Some women in Canada have settled with mesh-makers quietly. The exact terms of settlements were not publicly disclosed.
In Australia, the country's medical device regulator recently banned the use of mesh for another pelvic condition – pelvic organ prolapse (POP) – where the muscles that hold pelvic organs in place become weak from childbirth or age. In a statement, the Therapeutic Goods Administration called the device too risky.
"Based on this new information, and since the publication by the TGA of the results of review into urogynaecological surgical mesh implants, the TGA is of the belief that the benefits of using transvaginal mesh products in the treatment of pelvic organ prolapse do not outweigh the risks these products pose to patients," a statement from the TGA said.
"The TGA also considers that there is a lack of adequate scientific evidence for it to be satisfied that the risks to patients associated with the use of mesh products as single incision mini-slings for the treatment of stress urinary incontinence are outweighed by their benefits."
Mesh products for urinary incontinence, like the one used to treat Brajcic, are not included in the ban.
In the U.K., the National Institute for Health and Care Excellence, also recommended vaginal mesh operations to treat prolapse should be banned as a routine treatment. An Australian Senate inquiry into use of transvaginal mesh products is issuing a report in the coming months.
Meanwhile, Sansom has set up an online donation page for Brajcic's children Ben and Jake which has already exceeded its target in a few hours.
"We are all determined that Chrissy did not die in vain - that her legacy is one of awareness," she said.
http://www.ctvnews.ca/health/canadian-advocate-for-patients-harmed-by-surgical-mesh-dies-in-hospital-1.3703710
-
Surgical Mesh Products Lost On New Government
Dec 3, 2017 | Newsroom
By Teuila Fuata
In one month, it will be illegal to use surgical mesh products to treat pelvic organ prolapse in Australia. In New Zealand, the Labour-led Government - which supported stricter mesh regulations during its opposition years - have yet to offer any real solutions to the problem. Teuila Fuatai reports.
Members of patient advocate group Mesh Down Under last week watched their counterparts across the Tasman celebrate a regulatory ban on transvaginal mesh products used for pelvic organ prolapse injury surgery.
It was a bitter-sweet victory for the 500-strong group. Changes in the Australian jurisdiction, controlled by Therapeutic Goods Administration (TGA), are monitored closely by New Zealand's Medsafe - which relies on information from overseas regulatory bodies like the TGA and the United States' Food and Drug Administration to inform its own decision-making.
In response to the Australian announcement, Ministry of Health Medsafe spokesman Chris James said the agency had been aware of the TGA's four-year review that had led to the product ban. It had also been "anticipating the outcome", he said.
Despite this, and the litany of problems associated with surgical mesh products in New Zealand - which have cost at least $13 million in ACC injury claims over the past 12 years - James and others in charge remain hesitant about enforcing change.
"Medsafe has asked TGA for the detailed information on which it made its decisions and will carefully assess this," James said.
"As the products available on either side of the Tasman can differ, Medsafe has been enquiring about the status in New Zealand with suppliers. This is ongoing."
In response to the Australian announcement, Health Minister David Clark said he had requested to be briefed about the TGA ban from his officials.
Clark, who had promised during the election campaign to immediately begin work on a surgical mesh registry if elected to office, was asked by Newsroom whether he would call for a registry in light of ban.
Clark, who also told MDU before the election he would do just that "when the opportunity presents", sent an old written statement in response to Newsroom's question.
"Now that I've become Health Minister, I look forward to being briefed more fully by health officials about this issue and ways to better respond to it, alongside my colleague, ACC Minister Iain Lees-Galloway.
"I'm pleased that the Ministry held a positive meeting recently with people injured by surgical mesh. As an initial response, it has committed to looking at a cost-benefit analysis for a pelvic surgical mesh registry."
That meeting Clark referred to happened on October 20. Furthermore, the development of a national surgical mesh registry was proposed a year ago as part of a raft of health select committee recommendations following a two-year inquiry into surgical mesh products.
After a month of non-action following the October meeting, MDU wrote to Clark requesting he overlook the cost-benefit analysis due to the urgency of the situation.
MDU-co founder Carmel Berry, who presented before the health select committee in 2014, also recalled a previous statement made to the group from Clark regarding a registry:
"Hopefully we will be in government in September and then we can bypass campaigning and just set about fixing things," Clark had said before the election.
"There has been no further progress in regards to the health select committee recommendations that we have been made aware of," Berry said at the weekend.
"We have written to the Minister asking him to bypass the cost-benefit analysis and make funding available to get on with the job of creating a registry. All parties at that October 20 meeting supported the implementation of the registry except the Ministry of Health, which had cost concerns," she said.
The Minister is yet to respond to MDU's letter and request.
Berry also highlighted seemingly unnecessary delays from the Ministry - which has cited the need to consider an upcoming UK publication on further guidance of the gynaecological use of surgical mesh, due December 20.
"I have the NICE [National Institute for Health and Care Excellence] draft report and have offered it to the Ministry of Health," Berry said.
"They just need to do this urgently and take action urgently - just as we have been urging them to do since 2014."
Meanwhile, Helen Clark also weighed in on the issue - urging New Zealand to act on the recent TGA ban announcement, and on the UK NICE draft report.
"UK Health watchdog NICE is reported to be set to recommend banning of vaginal mesh operations for treating organ prolapse. Many women around world have suffered greatly from these. Hope NZ will follow suit," she said in a tweet at the weekend.
Another tweet read:
"UK health advocates call for ban on vaginal mesh implants to extend more widely to include a ban on implantation to treat incontinence. Hope NZ Govt will also act. NZers are among those badly injured by these "treatments".
The former Prime Minister tagged both David Clark and his associate health minister Jenny Salesa in the tweets.
Last week, the Government also came under fire for refusing to release a document with directives for new ministers, despite previously promising it would be made public. Labour had promised in its supply and confidence agreement with the Greens to "strengthen New Zealand's democracy by increasing public participation, openness, and transparency around official information".
https://www.newsroom.co.nz/2017/12/03/65032/surgical-mesh-products-lost-in-new-government
-
Surgeon Says Vaginal Mesh Patients' Complications Were 'Ignored' By Doctors
Dec 2, 2017 | thejournal.ie
A CONSULTANT IN the UK has said complications women suffered following surgeries which used vaginal mesh implants were often ignored by their doctors.
Sohier Elneil is a consultant urogynaecological surgeon at University Hospital, London.
She has carried out hundreds of vaginal mesh removal procedures on women who have suffered debilitating complications, including a small number of Irish women.
There is international scrutiny now 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.
The HSE’s Chief Medical Officer is currently compiling a report on the use of transvaginal mesh implants in Ireland.
Speaking to TheJournal.ie, Elneil said complications she has come across in patients she has treated include chronic pain, urinary tract infections and bladder overactivity.
“With lots of patients this has been ignored, not because [medical] colleagues didn’t care necessarily, they just didn’t think there was a connection,” she said.
TheJournal.ie has previously highlighted issues experienced by a number of Irish women who have had these procedures. One woman, 65-year-old Margaret Byrne, described how the vaginal tape had “cut through” her vagina.
Banned in the UK and Australia
Elneil’s comments come as The Guardian this week revealed new draft guidelines from a UK health watchdog recommend that one of the vaginal mesh implant operations to treat prolapse should be banned.
The leaked draft guidelines from the National Institute for Health and Clinical Excellence (NICE), state that implants for prolapse should only be used in the context of research. They do not address the use of mesh implants for incontinence.
Products used to treat pelvic organ prolapse were also banned by Australia’s devices regulator. This week the Therapeutic Goods Administration said the move followed a review of the latest international studies and an examination of the clinical evidence for each product supplied in the country.
It said it believes the benefits of using these products to treat prolapse “do not outweigh the risks”.
It also said it considers that there is a lack of adequate evidence for it to be satisfied that the risks to patients are outweighed by the benefits of certain mesh procedures to address stress urinary incontinence.
However, the Australian regulator is not removing mid-urethral slings – the most commonly used devices in Ireland – from the market.
Gold standard“I think the trouble is this sort of therapy became the gold standard for many people. It became difficult for people [surgeons] to offer anything else because they were told this is the way forward,” Elneil said.“I think that’s why we’ve had a difficulty in getting people to stop using it, because people didn’t have alternatives to offer. In the old days you would have alternatives.”
She said many surgeons in the UK have not had full training and so are unable to offer the older alternatives.
For example, urinary stress incontinence in the UK – and in Ireland – was previously treated with a surgery called colposuspension, which involves the use of sutures to attach tissue on the site of the urethra to a supportive tissue behind the public bone.
This procedure has a similar success rate (70-85%) to the mesh sling operation. It also has similar complications afterwards and a longer recovery time.
When asked if she believed colposuspension was a safer procedure than the mid urethral sling procedure (which uses mesh), Elneil said it is “safer in that you’re not leaving a piece of prosthetic plastic in the vaginal area”.
“As the complications have become clear, we know now that we have to go back to the old days. It’s sad in a way, but that’s the way it is,” she said.
Removal
Although the mesh procedures, particularly the mid-urethral sling operation to address incontinence, is a quick procedure with minimal recovery time, the surgery to remove the mesh when a woman suffers complications is considerably more invasive and risky.
The mesh devices are designed to be permanent and so natural tissue grows into them. Removal is a complex procedure – sometimes multiple procedures – and it can sometimes be too dangerous to take it all out.
There is also a risk that other organs can be damaged if nearby tissue has become embedded in the mesh. In Irishwoman Margaret Byrne’s case, she suffered a perforated bladder during her removal surgery.
Elneil has carried out hundreds of these surgeries.
“I’ve had quite a few Irish women over the last few years, I have around five or six that are on the books that I have looked after,” she said.
In response to recent parliamentary questions from Sinn Féin TD Louise O’Reilly, the HSE said a “small number of subspecialisturogynaecologists” in Ireland have experience in removing mesh and dealing with complications, and “have been doing so for several years”.
When questioned by O’Reilly in the Dail on the issue last month, Health Minister Simon Harris said he had asked his Chief Medical Officer to examine the use of transvaginal mesh devices.
“I very much take extraordinarily seriously if there’s anybody in this country who is experiencing any pain or suffering or difficulty as a result of a procedure that they’ve had here or indeed abroad.”
He asked that any women who have experienced issues with these devices come forward, adding “no woman should be suffering or left in pain”.
https://www.thejournal.ie/vaginal-mesh-3-3728179-Dec2017/
-
Group urge government to ban surgical mesh
Dec 2, 2017 | Newstalk ZB
By Jordan Bond
The Government's being urged to ban surgical mesh for women's pelvic prolapses after an Australian regulator banned them from being used.
Kiwi group, Mesh Down Under, is a group of women who've been injured by the controversial medical material which can cause serious pain.
Spokesperson Carmel Berry says now that the Australia medical regulator has banned it, Medsafe should seriously review their own policy.
Ms Berry said the group has petitioned the Health Select Committees for years, but now they've got a very authoritative voice on their side.
"They didn't have the evidence from another regulator [so] they just couldn't act on it. So yeah, it's a game changer".
Berry said regulators here should follow their counterparts.
"It's exciting news for the women of the world who've suffered so greatly and for validating something that we've been saying for years, it's now being recognised by a regulator"
http://www.newstalkzb.co.nz/news/health/group-urge-government-to-ban-surgical-mesh/
-
‘We had the chance to lead the world in banning mesh and protecting patients. We did not take it’
Dec 3, 2017 | The Sunday Post
By Marion Scott
THE Scottish Government had a chance to lead the world in protecting women from controversial mesh implants but blew it, according to a renowned expert.
Dr Wael Agur fears our hospitals are now lagging “dangerously behind” other countries as the risks of the procedures are exposed around the globe.
He spoke out days after health watchdogs in England announced plans to ban many of the vaginal mesh implants, used to treat organ prolapse, after they were blamed for inflicting crippling and permanent injuries. Australia is going even further.
A leading urogynaecologist, Dr Agur, said: “From leading the world, we are lagging dangerously behind.”
Three years ago, Scotland became the first country to suspend the use of mesh as the then Health Secretary Alex Neil ordered a safety review.
However, the two-year review was later branded a “whitewash” by campaigners who highlighted payments from mesh manufacturers to many of the experts interviewed. Some health boards have stopped using mesh completely but hundreds of operations are still being performed each year.
Health secretary Shona Robison defended the review and said it was not the government’s role to ban mesh.
Dr Agur said: “After Scotland’s controversial review, women here are still at risk.”
The surgeon, who resigned from the inquiry, accusing it of ignoring vital evidence, added: “I was incredibly proud to be part of something which was taking steps to protect women.”
Mesh implants have injured hundreds of thousands of women worldwide, including hundreds of Scots, many of whom are taking legal action against the NHS and manufacturers.
In the US, manufacturers have already paid £3 billion to victims.
Dr Agur, who is based in Ayrshire, no longer uses mesh because he believes risks outweigh benefits, and he praised Alex Neil for recognising that three years ago.
He said: “Mr Neil did the right thing ordering a mesh suspension.”
But he accused the Scottish Government of backtracking, and while Mr Neil’s suspension officially remains, hundreds of women are still being implanted with mesh for bladder ailments.
He added: “Scotland failed to live up to expectations.
“Today, a single surgeon in Scotland can make the decision to use a mesh device that will soon no longer to be available in England.
“The recommendations in England do apply here but usually we follow their example. In this case, we have not done so.”
As controversy over mesh sweeps the world, Dr Agur called on the Scottish Government to open up the earlier review to public consultation. The first step in that process could take place on Tuesday when a parliamentary debate on mesh will take place at Holyrood.
Dr Agur added: “We have an opportunity to protect women.
“More surgeons are training to use patient tissue instead of polypropylene mesh, and there is an increased awareness of injury thanks to the campaign by the Scottish Mesh Survivors.”
Campaigner Elaine Holmes said: “We have high hopes that Tuesday’s debate will be a new beginning and we can turn around the review debacle.”
England’s National Institute for Health and Care Excellence (NICE) plan to ban mesh used to treat pelvic organ prolapse (POP) while Australia is also banning single incision mesh tape used to treat bladder problems.
Former Health Secretary Alex Neil is calling for a global mesh summit in Scotland, to share information and co-ordinate action against companies “responsible for this scandal”.
Mr Neil added: “The decision by NICE to no longer recommend the use POP mesh is a giant step.
“But we all still have much more to do to guarantee that no woman ever again becomes a victim.
“What we need is an overhaul of our medical watchdogs which have behaved abominably throughout this sorry saga, failing women throughout the UK.”
Scottish Labour health spokesman Neil Findlay said: “We are seeing the gradual exposure of the global mesh scandal. Scotland had the opportunity to lead the world but after five years of women campaigning, the Scottish Government flunked it.”
Scottish Conservative MSP Jackson Carlaw added: “Scotland needs to regain its international leadership role, initiate and lead a full investigation and give justice to those caught up in it.”
https://www.sundaypost.com/fp/we-had-the-chance-to-lead-the-world-in-banning-mesh-and-protecting-patients-we-did-not-take-it/
-
Dec 1, 2017 | The Sun
By Amanda Devlin
BOTCHED vaginal mesh implants have left hundreds of women suffering from the after effects, it has been revealed.
The controversial implants are set to be banned, officials are expected to recommend.
But what exactly are they?What are vaginal mesh implants?
Vaginal mesh implants is a common treatment in the UK for women who experience pelvic organ prolapse and incontinence.
This means they suffer from leaking urine when they cough or sneeze, or have difficulty having sex.
Typically those who seek treatment for this are over the age of 50 who have had several children, are overweight or suffered a vaginal tear.
Around 1.500 people undergo vaginal mesh implants every year in the UK.Why are vaginal mesh implants used to treat incontinence?
Younger people suffering from incontinence are told to complete pelvic floor exercises to help tighten up.
But if this unsuccessful, doctors will recommend an implant to support the vaginal wall.
The mesh is a synthetic and biological material inserted to support the vaginal wall and/or internal organs.
By securing the mesh inside the vagina at an angle between the urethra and bladder, it allows for better shape to allow the woman to be continent.What are the complications?
Complications associated with vaginal meshes have been reported to the Medicines & Healthcare products Regulatory Agency (MHRA).
Complaints include persistent pain, sexual problems, mesh exposure through vaginal tissues and occasionally injury to nearby organs, such as the bladder or bowel.
Problems are usually caused by the mesh eroding and breaking down into smaller pieces which move.
It's normally felt during sex by the woman or her partner.
Dr Ismail told HuffPost: “The vagina area being stitched up is a weak point of the vaginal wall.
“The mesh can find it’s own way through this weak point and protrude outside the vagina.
“Anyone reading the news might think 90% of the women have the complication and 10% get better, but it’s the other way around.
"Anyone concerned after receiving a vaginal mesh implant should visit their GP or a healthcare professional."
Earlier this year, around 800 women allegedly sought legal action against botched vaginal mesh implants which left them unable to walk or have sex without being in severe pain.
Thousands more were reportedly forced to have their implants removed because of complications.
A statement from MHRA said: “We have undertaken a great deal of work to continuously assess findings of studies undertaken by the clinical community over many years, as well as considering the feedback from all sources in that time.
“What we have seen, and continue to see, is that evidence supports and the greater proportion of the clinical community and patients support the use of these devices in the UK for treatment of the distressing conditions of incontinence and organ prolapse in appropriate circumstances.
“We encourage anyone who suspects they have had a complication after having a mesh device implanted to discuss this with their clinician and report to us via the Yellow Card scheme regardless of how long ago the implant was inserted.”Call for ban
Draft guidelines from health watchdog Nice say the implants should not be used for routine operations.
They can cut into the vagina and women have described constant and horrific pain, leaving them unable to walk, work or have sex.
Now, Nice are expected to recommend they are only used for research and not routine surgery, the BBC's Victoria Derbyshire show revealed.
The official guidance is due to be published next month.
One expert said he expects the NHS will take up those guidelines, after top doctors warned the vaginal mesh scandal is "bigger than Thalidomide".
https://www.thesun.co.uk/fabulous/4710046/vaginal-mesh-implants-incontinence-treatment-cures/
-
A mum of three who had a mesh implant has been left in so much pain she now needs 20 tablets a day
Dec 2, 2017 | Wales Online
By Amy Coles
When mum-of-three Karen Preater began suffering with urinary incontinence after her son was born weighing 10b 1oz she was told it was a common problem that was easily fixed.
Doctors reassured her a operation to insert a vaginal mesh implant was straight forward and would only require a general anaesthetic and an overnight stay in hospital.
But she awoke from the procedure in agonising pain and unable to walk – and nearly four years later still relies on up to 20 tablets a day to numb the pain she says “never stops”.
The 41-year-old, who walks with a stick thanks to the pain in her hip and left thigh, said: “There has not been a day that I’ve not been in pain.
“It’s every minute of every day. It can get worse but it never stops.
“I feel as old as my gran. I did not expect my life at 41 to be like this.
“I feel like I have just been handed the ‘grow old before your time’ card and my kids see it as well.
Karen was given tension-free vaginal tape (TVT) – a type of mesh sling used to treat stress incontinence by keeping the urethra in the right position.
But the routine operation instantly left her in “excruciating” pain and it wasn’t until Karen read about other women living with complications from mesh implants that she realised what was the cause. Talking about the procedure she said: “I was told: ‘You will only be in the hospital overnight and you can get back to your kids’.
“So I thought: ‘This is your best option.’ I just believed what they said.
“I came round and was in a massive amount of pain. Initially I didn’t think anything of it.
“But they were struggling with what to give me for the pain. I couldn’t wee at all and was given a catheter.
“After eight days in hospital I was given a big bag of painkillers and left to get on with it. I was left needing crutches.
“I was led to believe it was the best and only option. I didn’t have a choice and I took the option that has changed my life.”
Karen, who lives in Rhyl, has to self-catheterise five to six times a day and takes seven different medications for pain and depression.
The pain is so debilitating she was forced to give up her job in sales and take voluntary redundancy and says it has impacted on her relationship with her partner.
She is now waiting to see a specialist in Manchester to see if she can get the tape removed.
She said: “I don’t like having that amount of medication but it’s something I can’t not have.
“The procedure itself is saving them money but in the long term it’s costing them a whole lot more.”
Any operation to remove mesh carries lots of risks and can only be done by an experienced doctor.
The British Society of Urogynaecology has compiled a list of UK hospital units with experience in treating mesh complications.
Here they can scan to see how much damage the mesh is causing and can safely remove the device, which can become embedded into the flesh.
There are none of these centres in Wales.
Karen says she struggled to get referred out of Wales on the NHS to see a mesh removal specialist and fears other women are being prevented from doing the same.
She said: “I do not think that is right. There needs to be specialist care in Wales or they need to refer us out.
“It’s major surgery having it removed. I know the risks of having it removed and kids are at an age where they still need me to do everything for them.
“It’s something I struggle to think about without getting anxious over it.”
She added: “If I had known all the risks involved in the first place I would have asked for other options.
“Sometimes you just don’t want to get out of bed in the morning. But I have kids and I have to.”
http://www.walesonline.co.uk/news/wales-news/mum-three-who-mesh-implant-13981729
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
Add recipients
Suggested