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Ethicon 10/13/17
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SLING THE MESH It’s barbaric and ruins women’s lives… Mum who could barely walk after vaginal mesh implant calls for the ‘disgusting’ procedure to be banned
Oct 12, 2017 | The Sun
By Hayley Richardson
Sling the Mesh campaigner Kath Sansom, 49, who had a mesh implant inserted in March 2015 to help with mild incontinence and later had it removed after a painful seven months, told how the 'disgusting' surgery has left some women on the brink of suicide -
Living with incontinence
Oct 12, 2017 | Choice
By Uta Mihm
Three weeks after having a baby, Alice sneezed while taking her washing off the line and "I felt it running down my leg". -
Vaginal mesh implants: Parliament set to debate the use of controversial vaginal mesh implants
Oct 12, 2017 | Lexology
By Maeve Keenan
Parliament has announced it is set to debate the use of controversial vaginal mesh implants next week, following mounting pressure to reassess the risks associated with the devices. -
Recent Hernia Mesh Lawsuit Filings Include Claims Against Ethicon, C.R. Bard
Oct 12, 2017 | RX Injury Help
By Laurie Villanueva
Two new hernia mesh lawsuits have been filed on behalf of plaintiffs who allegedly suffered serious complications following implantation of Ethicon, Inc.’s Physiomesh product and C.R. Bard, Inc.’s Ventralex ST device.Bard Ventralex ST Hernia Mesh Blamed for Hernia Recurrence
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Oct 12, 2017 | The Sun
By Hayley Richardson
Sling the Mesh campaigner Kath Sansom, 49, who had a mesh implant inserted in March 2015 to help with mild incontinence and later had it removed after a painful seven months, told how the 'disgusting' surgery has left some women on the brink of suicide
A MUM-OF-TWO who is calling for vaginal mesh procedures to be banned has blasted the practice, calling it "barbaric" and accusing it of driving some women to the brink of suicide.
Journalist Kath Sansom, 49, said it's "fantastic" that the issue is finally being debated by MPs in parliament next week, but called it a "tragedy" that it's taken 10 years of campaigning to get to this point.
She said: "That’s 10 years of women being maimed with unnecessary, life-changing injuries that have been ignored, which is so upsetting.
"Finally we get a chance to hopefully make MPs listen and realise that there are studies out there, there are growing numbers of women out there who are suffering, and morally this is so wrong – they can't ignore us anymore.
Kath founded Sling the Mesh, a campaign group warning women of the dangers of transvaginal tape, after her vaginal mesh implant, which she had inserted in March 2015 to cure mild incontinence following the birth of her second child, left her barely able to walk.
She explained: "I’d heard about this operation so I went to my GP and was referred to my local hospital, and it was very much sold as it is to all of us, it’s a simple, 20-minute fix. So why not go for it?
"Afterwards I knew instantly that something was very wrong.
"As the days went by the pain got worse and worse. I had a deep, intense, tooth ache-like pain in my legs and groin, and my feet didn’t feel like they were attached to my legs.
"It felt like someone had slashed my feet with a knife. The pain was so bad that I would feel sick, it was horrible.
"As the weeks went by I started to get burning pains in my vagina. I described it as - imagine a hedgehog covered in chilli sauce.
"Thankfully my GP believed me and straight away referred me to a removal specialist, so seven months later I got this mesh implant removed in Oxford."
Following the removal, the pain in her vagina cleared within a week and she got her sex life back.
Kath, formerly a keen high board diver and mountain biker, considers herself one of the "lucky ones", despite the fact she can never enjoy her beloved sports again.
She said: "Bear in mind I was training to cycle up Snowdon – I cycled about one mile two weeks ago and it took me two weeks to recover and I was back on pain medication.
“I can’t even run to the car from Tesco when it’s raining because the impact hurts my legs.
"It’s a new normal; I will never go back to the woman I was.
"The saddest part of my story is, I’m probably one of the best mesh recovered women globally. I feel so lucky, but even my life’s messed up."
What are transvaginal tape (TVT) implants?
· Transvaginal mesh implants, commonly known as TVT implants, are medical devices used by surgeons to treat women for pelvic organ prolapse and incontinence, which commonly occur after childbirth.
· The mesh, usually made from a synthetic polypropylene, is intended to repair damaged or weakened tissue.
· Mesh implants have been used successfully in many other parts of the body, but may react differently when inserted in the abdomen, where they can cut into into surrounding tissue and nerves, causing severe discomfort.
· Throughout the past decade, more than 100,000 women in the UK have been fitted with the implants.
· Some women reported severe and constant abdominal and vaginal pain following the surgery. Others have claimed they can no longer have sex, experienced infections and bleeding. Many have said their original incontinence wasn’t improved by the surgery.
· In 2014 the Scottish government called for a suspension in the use of mesh implants by the NHS in Scotland, after members of Scottish Mesh Survivors told of life-changing side effects they’d suffered. The surgery was reinstated in March 2017, amid claims the independent review was a whitewash.
· Campaigners have also claimed a cover-up by UK regulatory body, the Medicines and Healthcare Products Regulatory Agency (MHRA), which allegedly attempted to divert attention away from recording adverse incidents.
· Consultant urogynaecologist Dr Sohier Elneil is one of few surgeons in the UK who can remove the mesh implant, once it's been fitted. She has seen an increase in patients, admitting: "I used to see five women a week, now it's more like 15. Many women are getting the procedure without full information about the risks."
· There are growing calls for TVT mesh to be suspended, with some medical professionals describing it as “the biggest health scandal of our time”.
· The UK-wide MHRA has said it believes up to three per cent of women having the procedure for stress urinary incontinence and up to six per cent who receive an implant for pelvic prolapse suffer complications. But campaigners believe the problem is affecting many more women than that.
· Next week parliament will discuss the risks associated with the implants.
Kath told how the number of women in her campaign group has risen from 1,100 to 3,400 in six months.
She explained: "There’s women in the group who walk with sticks, their legs shake with every step, they’re in crippling pain and have had to give up work.
"One used to work as a paramedic. She ran 5km every day – after having a mesh inserted in February she can now barely walk and she’ll probably never work as a paramedic again.
"I was at work last week when a Facebook message came through from this poor woman, she had this mesh at 26, she’s now 33, she said, ‘Kath, I’m in so much pain.'
"The pain is so chronic that she’s gone to a bridge three times to throw herself off because she can’t cope with the pain. The only thing that stops her killing herself is her little boys.
"There’s a women whose life is in tatters and nobody cares. It ruins peoples’ lives. It is barbaric.
"The thing that’s really hard to get across is, some people just think that the operation hasn’t worked. No, no, no; it isn’t that the operation hasn’t worked, it’s completely decimated a woman’s quality of life.
"Not only does it destroy the woman’s life – we get a lot of people in our group with depression, PTSD, anxiety - but that has a knock-on effect for their children and their family, who are having to support them.
"Even my kids, with my good recovery, they say it makes them every so sad that I can’t do all the high adrenaline sports that I used to. They see me sometimes in pain and it’s upsetting. It affects the whole family."
More and more injured women are taking legal action against mesh procedures...
Robert Rose, partner and head of the clinical and medical negligence team at Lime Solicitors, said: "New figures have revealed that one in 15 women fitted with the most common type of mesh are later found to have needed surgery to remove it.
"The critical issue is whether these women were warned of the possible complications of this procedure before the meshes were inserted.
"Were the medical profession aware of these complications, and if they were not, then why not?
Many injured women are now considering taking legal action against both the NHS Trusts (for failing to obtain proper pre-operation consent, as well as inadequate surgical technique) and the manufacturers of the mesh itself (based on a product liability claim).
Kath reckons health professionals across the UK are panicking about the prospect of mesh procedures being banned as it's been pushed so hard over the past 10 years that young surgeons are not getting proper training in how to do the traditional alternatives.
"All they know is mesh," she said.
"If mesh is banned, they’ve got a whole army of surgeons across the NHS and the UK who can’t do anything else. But that’s not a reason to not stop it. That’s actually disgusting."
She added: "Can you imagine men putting up with this? This has been going on for 20 years – if men were losing their sex lives in the way that this is doing to women, this would have been stopped 19-and-a-half years ago.
"Honestly, this would not be allowed to happen to men. Women are dismissed with this, and that’s a really cruel part of it.
"Finally it really feels like it’s starting to come to a head now."
In August we told how a mum-of-two was left a "broken woman" after a botched vaginal mesh operation left her homeless, jobless and unable to have sex.
Meanwhile another mum said the op left her vagina with “teeth” that “bit” her partner’s penis.
https://www.thesun.co.uk/fabulous/4670109/mum-calls-for-vaginal-mesh-implants-ban/
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Oct 12, 2017 | Choice
By Uta Mihm
Three weeks after having a baby, Alice sneezed while taking her washing off the line and "I felt it running down my leg".
Alice is not alone as pregnancy and childbirth, along with menopause, are key risk factors for urinary incontinence. It's estimated that up to 37% of women experience bladder accidents at least occasionally. Thirteen percent of men are also affected, with prostate problems a key risk factor.
Incontinence can also be associated with constipation, obesity, reduced mobility and dementia, and is more common the older you get. But incontinence is not normal or even inevitable, and it can be helped and in many cases cured.
In this article:Types of incontinenceLoss of quality of lifeSuffering in silenceWhat you can doSurgical optionsFinancial assistance
It's important to seek an individual assessment and treatment. Improvements often involve simple changes such as:a healthy diet with lots of fibre and plenty of fluids and good lifestyle habitsmaintaining a healthy weightregular exercisevisiting a physio to learn the correct way to train your pelvic floor muscles.
And it's important to do something about it sooner rather than later, as older people with severe incontinence are at risk of losing their independence. After dementia and reduced mobility, incontinence is a major factor for getting moved from living on your own to a nursing home, which can mean a loss of quality of life, privacy and control.Types of incontinence
Bladder problems are more common than bowel problems and often people who have faecal incontinence also leak urine; around 8% of females and 3% of males are affected by both conditions.
The five main types of incontinence are:stress incontinenceurge incontinenceoverflow incontinencefunctional incontinencefaecal (bowel) incontinence.
Alice suffered from stress incontinence which is the most common type of incontinence in women.
Stress incontinence is when weakened pelvic floor muscles can't hold back urine, and a leak occurs when you cough, sneeze, laugh, walk, lift or play sport. The main causes are changes to women's bodies that weaken pelvic floor muscles during pregnancy, childbirth and menopause. Men often experience stress incontinence after prostate surgery, which usually takes six to 12 months to resolve.
Urge incontinence is associated with a sudden and strong need to urinate, which may be caused by an overactive bladder and can result in leaks on the way to the toilet. Other associated symptoms are waking several times a night to go to the toilet and frequent toilet visits during the daytime. In an overactive bladder, the bladder muscle contracts too early, whereas in a normal bladder, the muscle stays relaxed as it gradually fills up.
Overflow incontinence is when the bladder does not fully empty when going to the toilet, which leads to the chronic retention of urine and, as a result, there are frequent small leaks. There are a number of possible causes, including nerve damage of the bladder, prolapse of pelvic organs, an enlarged prostate and some medications. Overflow incontinence most often affects men.
Functional incontinence can happen because of dementia, poor eyesight, poor mobility or poor dexterity, which makes it difficult to remove clothing. It means you either don't recognise you need to go to the toilet or cannot find and use the toilet in time and therefore have an accident.
Faecal incontinence or bowel mishaps could be caused by a number of health issues including constipation, diabetes and some medications and can also include excessive wind. In many cases, it can be prevented or cured by diet and lifestyle changes.Loss of quality of life
Alice realised she had a problem after experiencing another accident about six weeks after giving birth: "We were having a big weekend away and both my husband and I were in the bridal party. It was the first time I'd had a couple of champagnes for more than nine months, and while we were busting out some dance moves, I accidentally busted out a little bit of wee," says Alice.
Often, incontinence can lead to a loss of quality of life: "People stop exercising which has ramifications for their general health and wellbeing," says Director of Women's & Men's Health Physiotherapy Shan Morrison. She also encountered severe psychological consequences for her patients, "they stop socialising and isolate themselves," says Morrison.
The effects might even be more severe for older or disabled people who need care; they can experience rejection, loss of control and problems with their body image. And if you care for someone with incontinence and it's not treated, it could cause a lot of stress for you.
Incontinence can also have a major financial impact. According to Deloitte Access Economics, loss of earnings for carers in 2010 was estimated at $2.7 billion per year.
And for people who suffer from incontinence, their issues can be a major distraction at work, and it can be harder for them to find employment.Suffering in silence
Alice is herself a pelvic floor physiotherapist and knew that incontinence is a common problem for new mothers and immediately sought treatment. "I love running and I wasn't prepared to give that up. That would have changed who I am and really affected my mental health," she says.
National Continence Helpline Manager Sue Blinman says many others think incontinence is normal and don't seek help. The Continence Foundation of Australia (CFA) works against the stigma of incontinence, encouraging people to seek treatment. "They perceive they're the only one with a problem. Quite often they've had it for a long time and have been too embarrassed to talk about it even with their doctor."
Recently 1000 women who experience incontinence were asked what happened when incontinence was mentioned in a social setting. They said that 70% of the time, the issue was not seriously discussed but just laughed off. In the vast majority of cases, they reported bladder accidents being seen as a normal part of having babies or ageing.
Blinman confirms that: "We normalise it within our own community, immediate family and friends," she says.What you can do
Morrison says that people often don't know that there's effective treatment available. In her practice, "almost everyone will get some improvement: 75 to 80% of our patients will get enough improvement that they don't need to do anything else – 50% will get cured."
If you think you might be suffering from incontinence, your first step is to talk to your GP. They can exclude issues like urinary tract infections and start an assessment of the type and severity of incontinence that affects you.
The least invasive treatment option is an assessment and individual plan set up by a continence nurse advisor, a registered nurse with extensive training in continence care, or a physiotherapist with specific training in incontinence and pelvic floor rehabilitation. For both women and men, incontinence can normally be improved or cured by training your pelvic floor muscles.
But this is easier said than done, as pelvic floor muscles are complicated and can be hard to isolate – doing it wrong can do more harm than good. Research shows that only half the women trying to learn pelvic floor muscle training from a pamphlet get the technique right.
Depending on your condition, your GP may be able to set up a chronic disease management plan, which often enables you to access up to five Medicare rebated physiotherapy sessions in a calendar year. Extras health insurance can also help with the cost of physiotherapy.
After starting treatment at a specialised physiotherapy clinic, Alice was able to go running again within two months. She still performs exercises every day to keep her pelvic floor muscles in shape.What if I need surgery?
In severe cases, surgery may be recommended to you. Surgery is a last resort if less invasive options such as exercises, lifestyle changes and a better diet have failed. Surgery can be an effective treatment but there are risks involved. For stress incontinence, surgical mesh slings or mid-urethral slings (MUS) sometimes called "tape" are often inserted to support the pelvic organs.
MUS should not be confused with transvaginal mesh repair often used for pelvic organ prolapse (POP) and associated incontinence. Thousands of women have reported devastating complications as a consequence of this type of POP surgery and there are currently class actions underway in Australia against two manufacturers of these devices.
According to CFA in its submission in the current Senate inquiry into mesh, while MUS surgery can cause complications, they're "infrequent and less severe and rarely require follow-up surgery".
If surgery is suggested to you, ask:Are there any less invasive options that could be explored first such as medication?What type of surgery is recommended?What training and experience does your surgeon have in this procedure?What are the risks and potential side effects?How high is the rate of complications in the surgeries your doctor has performed?Financial assistance
Managing incontinence on a long-term basis with costs from 12c to $2.33 for continence aids like pads or pull-ups can become expensive, especially if you consider the cost of additional equipment like bedding protection or catheters. There are a number of financial assistance schemes, though there may be various criteria such as a health care or similar concession card and a prescription by a health professional. For information, contact the National Continence Helpline of the CFA on 1800 33 00 66.
https://www.choice.com.au/health-and-body/conditions/general-health/articles/living-with-incontinence
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Vaginal mesh implants: Parliament set to debate the use of controversial vaginal mesh implants
Oct 12, 2017 | Lexology
By Maeve Keenan
Maeve Keenan is an attorney with Kingsley Napley
Parliament has announced it is set to debate the use of controversial vaginal mesh implants next week, following mounting pressure to reassess the risks associated with the devices. MPs will discuss the procedure which has destroyed the lives of thousands of women, leaving some unable to walk, work or have sex as a result of the treatment. The debate is seen by many as long overdue, as the scandal has already seen over 800 women in the UK sue the NHS after suffering serious health complications.
Back in April the BBC’s Victoria Derbyshire program ran an exclusive feature on the legal action, sharing the stories of many women that have been left in permanent, debilitating pain. As clinical negligence solicitors, we find it extremely encouraging to see high profile coverage of this important issue. It not only spreads awareness of the dangers of mesh implants to a wider audience, but we hope talking about these issues will help dispel the stigma surrounding injuries of this kind.
So, what is a vaginal mesh implant?
A vaginal mesh is a purely synthetic net material used in the placement of a weak connective tissue or ligaments, suspending the vagina and the uterus. The treatment is common in the UK, with more than 92,000 women receiving a vaginal mesh between April 2007 and March 2015 in England alone. The implants are used by surgeons to treat pelvic organ prolapse and incontinence in women, two conditions which commonly occur after childbirth.
As discussed in our previous blog on ‘Stopping the Stigma of Childbirth injuries,’ many women find it difficult to talk about the injuries they incur in childbirth and complications with vaginal meshing is no different. Many can feel too uncomfortable or embarrassed to find out what might be causing their symptoms.
Unfortunately, even those who did seek help from medical professionals found that they were not being listened to. One sufferer, who began to experience pain three years after giving birth to her first child, had her womb removed at the age of 39 after doctors believed it to be the source of her pain. When she went back to her GP after the operation with continuing pain, she was told she was ‘imagining it.’ The severity of the pain, coupled with the lack of understanding and support, resulted in the woman having suicidal thoughts. She told the BBC “This stuff breaks up marriages. I wouldn’t at all be surprised if there are mesh-injured women that have taken their own lives and didn’t know what the problem was.”
Despite data collected by the Medicines and Healthcare products Regulatory Agency (MHRA) showing more than 1,000 adverse incidents related to the mesh had been reported in the last five years, the regulator continued to say that ‘the figures did not necessarily indicate a fault with any device.’ While they claimed to ‘sympathise’ with women who had suffered complications, none of the 100 different types of vagina mesh implants available on the NHS have been recalled.
Lawsuits in the US have seen around £2 billion being paid out to women affected by vaginal mesh implants. If the women in the UK are successful in their legal action, experts have anticipated the NHS could have to pay out tens of millions of pounds of compensation. However, this alone will not address the issue and cannot reverse the pain and suffering that so many women have gone through. Many women remain unsure what symptoms to expect after the procedure, it is vital that women are aware of the risks and should not hesitate to seek help if they experience any pain or discomfort.
https://www.lexology.com/library/detail.aspx?g=7b00b66c-e25a-49d9-ba36-f0043c7e6b89
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Recent Hernia Mesh Lawsuit Filings Include Claims Against Ethicon, C.R. Bard
Oct 12, 2017 | RX Injury Help
By Laurie Villanueva
Laurie Villanueva is an attorney with Bernstein Liebhard LRX Injury Help
Two new hernia mesh lawsuits have been filed on behalf of plaintiffs who allegedly suffered serious complications following implantation of Ethicon, Inc.’s Physiomesh product and C.R. Bard, Inc.’s Ventralex ST device.Bard Ventralex ST Hernia Mesh Blamed for Hernia Recurrence
According to a complaint filed in the U.S. District Court, Eastern District of Louisiana, on September 29th, Richard Stipelcovich was implanted with C.R. Bard’s Ventralex ST implant in October 2016.
By April 2017, he was forced to undergo hernia revision surgery, due to excruciating abdominal pain and hernia recurrence.
The complaint alleges that Stipelcovich continues to suffer permanent injures due to the defective nature of Ventralex ST hernia mesh.
“Before Plaintiff suffered the injuries complained of herein, Defendants were on notice of numerous bodily injuries caused by the Product, and based thereon, Defendants knew or should have known that the Product caused an unreasonably high rate of infection, extrusion, perforation, chronic pain and/or abscess in people implanted with the Product,” the complaint states.
“Even through Defendants had known or should have known that the Product created a foreseeable, unreasonable risk of harm to those patients into whom they were implanted, Defendants continued to market the Product in the United States. Defendants have sold thousands of Product in the United States.”Ethicon Physiomesh Lawsuit Faults Multilayer Design, Polypropylene Mesh
Amy Flood’s Ebard hernia mesh lawsuit ethicon hernia mesh lawsuithttps://www.rxinjuryhelp.com/wp-content/uploads/bard-hernia-mesh-lawsuit.pdf was filed October 9th in the U.S. District Court, Eastern District of Texas, just two years after she was laparoscopically implanted with Physiomesh Composite mesh, catalog number PHY1015V, to treat an incisional hernia.
According to Flood’s complaint, the allegedly defective nature of that device resulted in hernia recurrence, as well as severe physical pain and mental anguish that continues to this day. Flood further claims that her complications were the result of Physiomesh’s unique multi-layer design, as well as the polypropylene used in the hernia mesh.
“The degradation of this multi-layer coating caused or exacerbated an intense inflammatory and foreign body reaction. Once exposed to the viscera, the polypropylene mesh will inevitably adhere to the viscera, initiating a cascade of adverse consequences,” the complaint states. “Any purported beneficial purpose of the multi-layer coating (to prevent adhesion to the internal viscera and organs) was non-existent; the product provided no benefit while substantially increasing the risks to the patient.”
Flood also points out that Ethicon conducted a worldwide market withdrawal of all Physiomesh Flexible Composite products in May 2016, after data suggested that the devices were associated with high rates of recurrence and revision surgery, issuing an “Urgent Field Safety Notice” overseas that characterized the action as a “voluntary product recall.”
“However, in the United States, Defendants failed to issue a nationwide recall, opting instead to simply remove the product from shelves and cease further sales within the United States,” the lawsuit states. “This notice was not sent to patients implanted with the device, nor were physicians instructed to immediately remove the device. Instead, the recall instructed health care practitioners to “continue to follow those patients in the usual manner.”
https://www.rxinjuryhelp.com/news/2017/10/12/recent-hernia-mesh-lawsuit-filings-include-claims-against-ethicon-c-r-bard/
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