Preview Newsletter
Ethicon Media Monitoring 1/25/2018
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Johnson & Johnson withdraws pelvic mesh implant from Australian market
Jan 25, 2018 | ABC News
On RN Breakfast we have been looking into the controversy surrounding pelvic mesh implants for women. -
Pharma giant withdraws mesh implant from Aussie market
Jan 24, 2018 | 9News
US medical giant Johnson and Johnson has withdrawn its supply of a vaginal mesh implant that is the subject of a federal court class action. -
Dáil hears call for audit over transvaginal mesh implants
Jan 24, 2018 | RTE
Sinn Féin's health spokesperson has called for a "central approach" for women who are suffering from the side-effects of transvaginal mesh implants. -
'It was cutting my husband during sex': Women with vaginal mesh complications take fight to the Dáil
Jan 24, 2018 | thejournal.ie
THEY STOOD IN the cold outside Leinster House, huddled together with the rain pelting down on them. For many of the members of Mesh Survivors Ireland, the road to the Dáil has been a long one and on the way they have suffered pain and stress, been brushed aside and ignored. -
'It’s not ideal telling my story like this. It’s my private life... but this has taken my soul' - mum-of-two (39) left in excruciating pain after vaginal mesh op
Jan 25, 2018 | Independent.ie Newsdesk
Two Irish women who underwent a 20-minute procedure in hospital to cure incontinence after pregnancy and childbirth have described how the surgery has had a devastating effect on their lives. -
Study: Revision Surgery Rate for Metal-on-Metal Hips on Rise
Jan 24, 2018 | Drugwatch
... In 2016, Ethicon withdrew certain brands of its Physiomesh Composite Hernia Mesh from the world market after higher than average complication rates showed up in a pair of European hernia registries.
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Johnson & Johnson withdraws pelvic mesh implant from Australian market
Jan 25, 2018 | ABC News
On RN Breakfast we have been looking into the controversy surrounding pelvic mesh implants for women.
For years, doctors have been implanting the devices as a treatment for a range of issues affecting women — including incontinence and pelvic prolapse.
But a growing number of women say the implants have caused excruciating pain and even permanently damaged their body.
Now, pharmaceutical giant Johnson & Johnson has withdrawn from sale in Australia a type of pelvic mesh implant, known as mid-urethral vaginal sling, which is currently the subject of a class action before the Federal Court.
http://www.abc.net.au/radionational/programs/breakfast/pelvic/9360050
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Pharma giant withdraws mesh implant from Aussie market
Jan 24, 2018 | 9News
US medical giant Johnson and Johnson has withdrawn its supply of a vaginal mesh implant that is the subject of a federal court class action.
A Therapeutic Goods Administration spokeswoman told 9news.com.au Johnson and Johnson had withdrawn its supply of mid-urethral sling devices "to enable them to consider their options in response to TGA’s request to update the Instructions for Use of their products".
"The Johnson and Johnson devices remain currently on ARTG (Australian Register of Therapeutic Goods, but from 17 January 2018, Johnson and Johnson had decided to withdraw supply," the spokeswoman said.
"Use of devices supplied prior to the 17 January date is at the discretion of the medical practitioner and the individual patient."
The TGA's request for updated instructions would have pushed manufacturers to including information about the risks of pain and injury.
A list of products with updated instructions has been made available on the TGA's website.
In November, the TGA removed from its register all transvaginal mesh products used to treat pelvic organ prolapse via implantation.
Doctors backed the Johnson and Johnson devices at a Senate inquiry, but women who claim to have suffered chronic pain and infections after being implanted with a Johnson and Johnson mesh product hailed the withdrawal from the market, the Herald Sun reported.
The Johnson and Johnson implant became the subject of a class action in Australia last year, with 700 women alleging that faulty implants caused them debilitating pain.
Similar class actions are underway in the UK and US.
Shine Lawyers, who brought the class action in Australia, have alleged Johnson and Johnson failed to properly test the devices and downplayed the risks of their use.
A Current Affair investigated the issue last year after the class action was launched.
Mother Joanne Mannion received an implant after giving birth, and said the pain she was left with felt like being "cut and doused with petrol".
"I can't exercise, I can't pick things up," she said.
"I thought it would be safe."
https://www.9news.com.au/national/2018/01/24/15/46/johnson-and-johnson-withdraw-urethral-mesh-from-australia
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Dáil hears call for audit over transvaginal mesh implants
Jan 24, 2018 | RTE
Sinn Féin's health spokesperson has called for a "central approach" for women who are suffering from the side-effects of transvaginal mesh implants.
The surgery is the implantation of a device to help counter stress urinary incontinence.
Speaking in the Dáil, Louise O'Reilly also called for a retrospective audit of those with the mesh device in Ireland.
RTÉ’s Prime Time reported on women who are suffering from side-effects as a result of the implants.
Today, a group of women called for a suspension of the use of transvaginal mesh and an inquiry into its effects.
Leslee Ann Stevens, 39, and from Carlow, said she is now walking with a stick and unable to drive as a result of issues caused by the procedure.
Melanie Power of Powers Solicitors said more than 100 women have contacted her about complications they have suffered as a result of the transvaginal mesh.
The group met TDs to highlight their concerns and were joined by a doctor from the UK's National Health Service who is calling for the suspension of the use of the device.
Dr Wael Agur said several countries have already banned or reduced their use of the procedure, and that cases of complications are not limited to Ireland.
The HSE said more than 700 women were discharged from hospitals in Ireland last year after having a sling procedure for stress incontinence, but it is not possible to say how many of these had the transvaginal mesh implanted.
There were 29 reports of problems with the device made to the Health Products Regulatory Authority (HPRA).
Taoiseach Leo Varadkar expressed sympathy and concern "with any patient who have any complications as a result of an operation or a procedure in the past".
He said he had not seen last night's Prime Time programme, but had read "something about the issue" in the papers and in the media. However, he said he was not an expert on the subject.
Mr Varadkar said he would be guided by the best medical advice from obstetricians and gynecologists in the area, adding it was not up to the Government but the HPRA to approve medical devices.
Ms O'Reilly said she raised the matter with Minister for Health Simon Harris previously, who said he was not aware of the issue until he saw it in the media.
She described the response by Mr Harris as "odd" and expressed concern that his officials did not brief him on the matter.
The Taoiseach said he could not answer for the Minister for Health directly. However, he said the HSE and the Department of Health would consider the matter based on domestic and international evidence.
He said any response from the Government, the HSE or the Department of Health will be "compassionate, understanding and respectful".
Today, Mr Harris said he wanted to ensure that the use of the devices and the clinical management of women who have had them fitted were in line with international best practice.
He has asked the Chief Medical Officer to report on the issue and that work is now under way.
https://www.rte.ie/news/politics/2018/0124/935703-dail-transvaginal-mesh-implants/
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'It was cutting my husband during sex': Women with vaginal mesh complications take fight to the Dáil
Jan 24, 2018 | thejournal.ie
THEY STOOD IN the cold outside Leinster House, huddled together with the rain pelting down on them. For many of the members of Mesh Survivors Ireland, the road to the Dáil has been a long one and on the way they have suffered pain and stress, been brushed aside and ignored.
Thousands of women across the world have suffered complications after having a vaginal mesh device implanted. These devices, made with polypropylene – a type of plastic – are used in surgeries to address stress urinary incontinence and pelvic prolapse, conditions women can suffer after natural childbirth.
Each of the women in the support group, which was established in October last year, believed they were the only ones who had suffered in this way after these procedures until they saw the global media coverage as the scandal broke in the US, Australia, New Zealand and then the UK. TheJournal.ie began an investigation into the scale of the problem in Ireland in September last year and now over 100 women have come forward.
Protesting outside, accompanied by her husband Darren, Lesley-Anne Stephens told TheJournal.ie she was just 36 when she had her operation, which was to address stress incontinence. Now, at 39 she has to use a walking stick for support.
Her incontinence was so bad she said she would “drench” herself when she got out of her car, but if she could go back she still would not get the procedure.
“As it is I’m incontinent and in pain,” she explained. “We were told this was my fix, that this was going to change my life for the better.”
She has had two partial removal procedures, but still has some of the mesh tape inside her. The device is designed in such a way that the tissue around it grows into the tape so it can act as a support for the bladder wall.
This, however, makes it extremely difficult to fully remove without causing damage to the internal tissue and other organs around it.
“There is another piece of mesh sticking out through my skin – I can feel it. I can’t spend any time with my husband, I can’t lift our girls, I can’t walk very far. I can’t drink at all – it goes straight through me.
“I know it sounds silly, but I had cereal one morning with a small bit of milk on it and I went to the toilet 56 times between nine in the morning and three in the day and I was exhausted. You can’t go anywhere if you’re going to take a little drink.”
“It’s very difficult to hear a five-year-old making comments about where we should and shouldn’t go,” her husband Darren added.Things that we would have done in the past automatically, to hear your five-year-old say ‘We can’t go there because there’s lots of steps and it’ll be difficult for Mam”, that’s very difficult. It’s had an impact on every aspect of Lesley-Anne’s life and her family life, her friends, every aspect of who she is.
‘Suffering in silence’
After the protest, inside Leinster House, TDs were given a chance to learn about the issue.
They heard from Sinn Féin’s Louise O’Reilly, who had earlier raised the topic with the Taoiseach, Melanie Power, a solicitor representing many of the women affected, and Margaret Byrne, who suffered complications after her surgery, as well as two experts.
Power, who set up the support group Mesh Survivors Ireland said women who experienced complications have “suffered in silence for far too long”. More than 100 Irish woman who consider themselves as being mesh injured have contacted her and she said they had been “butchered” by the device, adding that she did not use that term lightly.
The Chief Medical Officer is currently compiling a report on the issue, but Power said the HSE needs to conduct an audit to make it clear how many women have had these procedures and how many have experienced complications.
She said the reality for some of these women now is a reliance on disability allowance, a cocktail of medication, the loss of their sex life, relationship breakdowns, depression, isolation and suicide attempts.
‘Traumatic’
Margaret Byrne, who shared her story with TheJournal.ie last year, spoke at the presentation. She underwent one of these operations in 2000 as a treatment for stress incontinence.
She told TDs that she first realised something had gone wrong with the operation when she and her husband resumed sexual relations.
There was an audible gasp from those listening to Byrne when she told them there was “something sticking there, cutting my husband” and that it “had a sharp edge”.
She eventually had a procedure to remove the device, but she went through three years of procedures before that, which she said she found traumatic.
“I can still see the lights overhead in the theatre.”
One woman told TDs she had been a private patient and had to pay €40,000 for two procedures to remove the mesh.
Another woman from Belfast said she had been examined a number of times in Northern Ireland and doctors had found no issue, but when she had the same examination in London, she was told she had significant vaginal scarring.
In testimonies from other women, read out by Melanie Power, they reported chronic urinary tract infections, chronic pain and erosion into their bladders, urethras and vaginal walls. One woman said she was on so many opiates for the pain she became addicted at the age of 64.
Another, similar to Margaret Byrne, said her husband had been “physically injured by the device” during intercourse.
‘Pressure from industry’
The striking personal stories were followed up by presentations from two experts. The first was a consultant from Scotland called Dr Wael Agur who himself had done mesh procedures over a five-year period. He stopped in 2014 due to concerns he had about the risks, which he believes outweigh the benefits.
He told TDs he had a junior doctor conduct research about all of the patients he had worked on between 2009 and 2014 and showed them an email on the screen that this doctor sent him halfway through.
She told him the patients either had no complications or “neverending ones”.
Agur believes there was “huge pressure from industry” to move away from the old standard of procedures, which did not involve the use of any devices and therefore did not make any money for manufacturers.
In Scotland, the number of operations for stress incontinence doubled after the use of mesh tape became the gold standard.
This, he said, was not as a result of more women suffering stress incontinence – surgeons started offering the procedure to women who had mild incontinence or just urinary urgency.
Agur said many doctors who performed these procedures did not link up complications afterwards such as chronic pain or issues with sexual intercourse after the surgeries because the instructions from manufacturers did not list them as risks.
He finished by telling TDs he could understand why clinicians did not want to be seen to take a step backwards by reverting back to the old procedures. However, he said there is “always something you can do” if the patient has complications with non-mesh operations.
“With mesh, it can be irreversible and there is little we can do.”
Trinity College Professor David Taylor was the second expert to speak on the issue. He has been researching these procedures and he said one study, which looked at outcomes from over 11,000 patients who had operations for prolapse found there was a failure rate of 10%.
He believes there may be as many as 1,000 women in Ireland suffering from mesh erosion issues.
Taylor said he can not find any piece of research where someone has taken a piece of mesh that has failed and been removed from a patient to test it. There are strict procedures around medical devices that fail, he said, and he said the HSE should be enforcing these.
Sympathy and concern
Speaking in the Dáil on the issue today, Taoiseach Leo Varadkar said his “sympathy and concern” goes to any patient suffering from complications.
“I absolutely expect that the HSE and the Department of Health will consider this matter based on evidence and not just evidence from this State. As is the norm in any kind of medical issue, one examines peer-reviewed international evidence as well as domestic evidence and take them together,” he said in response to a question from Sinn Féin’s Louise O’Reilly.In health care, one will always find evidence going one way and then evidence going the other way. It is therefore necessary to take all the evidence together to see which of it is peer-reviewed and strongest and make a judgment based on that.
“Any response from the Government, the HSE and the Department of Health will be compassionate and understanding and respectful of the pain and suffering of anyone who is enduring complications as a result of an operation. Further, any actions taken by government will have to be guided by best clinical advice from the experts in the field and it will have to be evidence-based.”
https://www.thejournal.ie/vaginal-mesh-leinster-house-3815029-Jan2018/
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Jan 25, 2018 | Independent.ie Newsdesk
Two Irish women who underwent a 20-minute procedure in hospital to cure incontinence after pregnancy and childbirth have described how the surgery has had a devastating effect on their lives.
Lesley-Anne Stephens (39) and Janet Roche (48) told Prime Time on Tuesday night that they had a vaginal mesh inserted to cure their stress incontinence.
The mesh is like a sling, which is inserted into the walls of the vagina to treat incontinence and prolapse – common side effects following childbirth.
In Ireland, almost 7,000 public patients and thousands more private patients have undergone a procedure in the last ten years to treat urinary stress incontinence. The condition affects 30pc of women over 50, mainly as a result of pregnancy or childbirth.
Mother-of-two Lesley Anne Stevens (39) from Carlow decided to have the procedure after suffering incontinence after her pregnancies.
“I noticed that doing things like coughing, sneezing, bending over to pick something up, I would wet myself. It had got so bad that when I was driving and getting out of the car, I would wet and I would destroy myself.”
“So I went to my GP and she referred me to a gynaecologist who told me I had stress incontinence, and that he had a fix.”
Lesley-Anne had the mesh inserted in 2016. As soon as she woke up, she says, she was in excruciating pain
“I had severe pain in my groin, it was excruciating. I’d take more medication and I’d walk the floor in agony. I went back down to the gynaecologist, I told him the way I was and he told me that there was a piece of the mesh sticking through my skin, sticking through my vagina wall.”
“It has got to the point now where I can’t drive. I use a crutch to walk any distance at all. With the [her daughters] I have to use a crutch. I bleed a lot. I have a lot of internal infections. It’s debilitating.”
“To tell a seven and five year old when they sit on your knee, just mind mammy’s tummy, you know, that’s not fair, because they become little carers of you.”
Lesley-Anne says she is lucky to have the support of her husband Darren.
“I’m extremely lucky… [Darren] is my rock. He really, really is. And we’re very lucky that we have that deep love. Because even though we can’t spend time together, it doesn’t matter.”
“It’s not ideal telling my story like this. It’s my private life. We’re very private people. But I don’t think it’s fair that as we speak now, somebody else is in having that done, and there will be people in the very same situation as myself.”
“There needs to be something done before more people are destroyed with it.”
“I would love to think, and I hold out hope, that the day I’m mesh-free will be the day that my life can start again.”
“It’s something that has taken my soul… it has completely taken who I am away from me, because I can’t be there as a wife for Darren, I can’t be there as a mother for the girls in the way you should be.”
Today in Dublin, dozens of Irish women who’ve been affected by the vaginal mesh will march on the Dáil to highlight their situation.
Janet Roche (48) had the same procedure done eight years ago and is now on an invalidity pension.
“Within a couple of weeks after the procedure, I was in terrible pain. I couldn’t get off the couch. I was in agony, and I put it down to everything’s tightening up, and they had told me the operation had gone well so I just kind of thought it was just after-pains.”
“I would be in so much pain that I wouldn’t be able to speak. It used to terrify the kids.”
“I was actually convinced that they had left something inside me, because the pain would hit it would be like a knife. It was like somebody had cheese wire and they were just slashing at my insides.”
Janet, like Lesley-Anne, has had the mesh partially removed. Removing the entire mesh is a complicated procedure. Janet now attends a pain management clinic.
“It’s a bigger operation to have it all removed, so I have some still inside me which was too close to an artery.”
“I’ve been told that I’ll have a chronic pain condition for the rest of my life. They can’t cure that. It’s nerve damage.”
Janet, too say her relationship with her husband Will has changed as a result of the complications from the mesh.
“He’s like my carer now. We can’t have any kind of an intimate relationship and we haven’t been able to for years.”
Dr Wael Agur, Consultant Urogynaecologist, at the NHS in Scotland acknowledged the complications which have arisen as a result of the vaginal mesh.
“Some women have developed problems immediately after the insertion of the device, while some women, the adverse events of the chronic pain can reveal itself years after.”
He said the mesh device itself is difficult to remove because it embeds itself into the tissues, making it very difficult to separate them without causing “significant destruction”.
But Dr Suzanne O’Sullivan , from Cork University Maternity Hospital, told Prime Time: “Whilst it’s a procedure that has complications and problems like every other procedure does, calling for a ban on these procedures is not going to be helpful, and is not fair on the desperate women who are suffering on a daily basis.”
27 Irish women have complained to the health products regulatory authority about the vaginal mesh.
In a statement to Prime Time, health minister Simon Harris says he wants to ensure that we are in line, here in Ireland, with international best practice and emerging evidence.
He also added that the Chief Medical Officer is preparing a report at his request on the issues involved, and that if any woman is concerned she should contact her GP or contact the hospital where she had the implant fitted.
https://www.independent.ie/life/health-wellbeing/health-features/its-not-ideal-telling-my-story-like-this-its-my-private-life-but-this-has-taken-my-soul-mumoftwo-39-left-in-excruciating-pain-after-vaginal-mesh-op-36524886.html
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Study: Revision Surgery Rate for Metal-on-Metal Hips on Rise
Jan 24, 2018 | Drugwatch
A new study finds the rates of revision surgery involving metal-on-metal (MoM) hips “significantly increased” in the U.K. since 2007. The study also suggests patients with metal-on-metal hips are receiving treatment for serious complications sooner than patients in the past.
Researchers analyzed records from more than 24,500 patients who received metal-on-metal hips between 2003 and 2012.
“The five-year revision rates were significantly increased for all primary MoM [total hip arthroplasties] undertaken from 2007 onwards,” researchers concluded in their study published in The Bone & Joint Journal.Greater Awareness of Metal-on-Metal Hip Replacement Risks
The researchers believe the trend shows health care providers are more aware of MoM hip complications and are more carefully monitoring patients who received the devices.
“The increased number of metal-on-metal hip implant patients undergoing further surgery in recent years is likely explained by changes made in how this group of patients are managed,” study author Gulraj Matharu of the University of Oxford told the U.K.’s National Joint Registry. “Our study findings are most likely attributable to the increase in regular patient follow-up combined with many surgeons now acting earlier to perform revision surgery.”
Wear between the metallic parts in a hip implant can release microscopic amounts of cobalt, chromium and other metals into a patient’s body. This can lead to a condition called metallosis. It can destroy muscle and other tissue near the implant, cause the device to loosen and lead to other complications.
Health care professionals recommend patients with metal-on-metal hips undergo regular medical checkups, blood tests and imaging to monitor for metallosis.Study Compared Pinnacle Hip Replacements to Competitors
Researchers set out to compare the DePuy Pinnacle hip system to others metal-on-metal hips.
DePuy’s Pinnacle hip implant is blamed in more than 9,000 lawsuits in the U.S. for causing serious complications, including revision surgery.
Researchers found the increased revision surgery rates were seen with all MoM hip replacements, not just the Pinnacle.
They concluded the reason all brands studied saw higher revision rates was likely because of “increased surveillance and recent lowering of the threshold for revision.”National Joint Registry Data Exposed Trends in Hip Revisions
Researchers were able to tap into data from the U.K.’s National Joint Registry (NRJ) to look for trends.
The registry has tracked joint replacements and their follow ups in the U.K. since 2002. It is the largest registry of its kind in the world.
The U.S. Food and Drug Administration relied on the U.K. and Australian joint registries when it examined the effectiveness of metal-on-metal hip implants in 2012.
Ashley Blom of the University of Bristol and head of the NRJ’s data analysis team says the registry has cultivated relationships with regulators and professional medical associations to improve patient care.
“This has resulted in increased awareness of potential problems and increased surgical experience for hip revision surgery performed for abnormal reactions to metal,” Blom said on the registry’s website.
Data from medical device registries can show important trends among medical devices and alert regulators and health care providers about potential problems with devices.
In 2016, Ethicon withdrew certain brands of its Physiomesh Composite Hernia Mesh from the world market after higher than average complication rates showed up in a pair of European hernia registries.
The idea of establishing joint and other medical device registries in the U.S. has lagged behind European efforts.
The American Academy of Orthopaedic Surgeons began work on the American Joint Replacement Registry (AJRR) in 2009. The Centers for Medicare and Medicaid Services recognized it as a Qualified Clinical Data Registry in 2014. More than 1,000 hospitals and 8,900 surgeons currently participate in the registry.
https://www.drugwatch.com/2018/01/24/study-revision-surgery-rate-metal-metal-hips-rise/
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