Preview Newsletter
Ethicon Media Monitoring 6/6/2018
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Cross-Appeals to 7th Cir. Filed in Ethicon TVT-Obturator Transvaginal Mesh Case
Jun 5, 2018 | Harris Martin Publishing
The parties in a Gynecare TVT Obturator transvaginal mesh device case that resulted in a $55,000 verdict plan to appeal the Illinois federal court’s rulings, according to recent filings. -
Transvaginal and Hernia Mesh Still Used Today – What You Should Ask?
Jun 5, 2018 | Mesh Medical Device News Desk
By Jane Akre
Your editor of Mesh News Desk is hearing from newly mesh-implanted women who are being told the same thing. -
Woman's mesh implant felt like a chemical burn and cheese wire inside her body
Jun 5, 2018 | DevonLive
By Anita Merritt
This year Susan Morgan has set herself the challenge of accepting the shell of a woman she has become after sustaining horrific life changing injuries from vaginal mesh surgery. -
'Not all vaginal implants are a problem': Doctor says women are refusing to seek treatment for incontinence after hundreds claimed mesh left them in pain and ruined their sex lives
Jun 6, 2018 | Mail Online
By Sheree Mutton
There has been a sharp drop in the number of women seeking treatment for incontinence and doctors say it's because they're fearful of vaginal mesh.
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Cross-Appeals to 7th Cir. Filed in Ethicon TVT-Obturator Transvaginal Mesh Case
Jun 5, 2018 | Harris Martin Publishing
The parties in a Gynecare TVT Obturator transvaginal mesh device case that resulted in a $55,000 verdict plan to appeal the Illinois federal court’s rulings, according to recent filings.
In their May 2 notice of appeal, Ethicon and J&J say they will appeal to the 7th Circuit U.S. Court of Appeals the trial court’s denial of their motion for judgment as a matter of law and granting in part Herrera’s bill of costs.
In addition, defendants are challenging an order excluding the opinions of defense expert Timothy Ulatowski; an order permitting evidence of changes to TVT-O’s labeling; rulings ...
Access to full text unavailable – subscription required.
Story can be found here: https://harrismartin.com/article/23536/cross-appeals-to-7th-cir-filed-in-ethicon-tvt-obturator-transvaginal-mesh-case/
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Transvaginal and Hernia Mesh Still Used Today – What You Should Ask?
Jun 5, 2018 | Mesh Medical Device News Desk
By Jane Akre
Your editor of Mesh News Desk is hearing from newly mesh-implanted women who are being told the same thing. (Talking points carefully crafted by public relations professionals?) That is – this is a “New Mesh” not the same mesh you’ve heard about in the lawsuits. That ultimately is the only way to “sell” a product or to continue selling mesh use on the public as a first line defense against incontinence or pelvic organ prolapse. But is it true?
Image: Creative Commons, Serena Wong
NEW MESH OR NEW NARRATIVE?
By now, most people have heard that there are a high number of product liability lawsuits filed against mesh manufacturers. Johnson & Johnson and its Ethicon division, Boston Scientific, C.R. Bard, American Medical Systems, Coloplast, Cook Medical and Neomedic are the focus of more than 104,000 cases filed in one federal court in West Virginia. And the verdicts have been generally favorable to the plaintiff, ranging from $1 million to $100 million.
A recent 60 Minutes story on Boston Scientific and its shady methods to secure new raw polypropylene put a dark stain on the company and caused industry-wide reaction. Generally that comes in the form of hiring public relations professionals to “craft” a new narrative and issue “Talking Points” to quiet the public concerns.
Though MND has not yet seen those talking points (please sent them) this is the MO of corporate crisis counseling. Regardless, women are reporting they are being told that the mesh today is “New Mesh” and not that same stuff the lawsuits are about.
There have been too many report to disregard this as random narrative and not corporate re-branding. So if you have stress urinary incontinence(SUI), urge incontinence, pelvic organ prolapse (POP) or a hernia, and your doctor is suggesting mesh:
WHAT DO YOU ASK?
While its true the major mesh manufacturers are playing around with the weight of the mesh and the pore size, basically most mesh is still made of polypropylene (PP) a cheap plastic woven from raw PP resin. So some suggested questions you might want to ask your doctor. Make sure he/she answers the questions:
What is the mesh you use made of? (Answer: polypropylene, biologic or composite or coated is what’s on the market. Even biologic ( pig, cow or cadaver) or coated generally merge with a PP base)
How is it new? (Answer: He/She may say its entirely different, get an answer – How is it new? Your doctor may be following the guidance of medical societies that favor using mesh as a first-line defense.)
Is it polypropylene? (Answer: Pay attention to this answer. Your medical provider may not even know, though he/she should know. PP is a polymer plastic sourced from the petroleum industry. It is also used for Tic Tac box tops and indoor outdoor carpet).
What is the brand name of the product you use? Who makes it? How long have you been using it? (Answer: See how honest and up front the provider is).
Are there any alternatives to using mesh? (Answer: Unless you have had a mesh repair previously and it has failed, unless you are obese and a smoker, there are generally alternatives to starting off with a mesh repair. We’ve learned from litigation that it may not be the best choice for a first line defense against SUI and POP).
Am I a candidate for a non-mesh repair and can you do one? (Answer: This is important. Many newer doctors have not been trained in doing anything but using mesh to treat SUI and POP. Ask if they can do a suture only repair).
Can you do a native tissue repair? (Answer: This involves harvesting fascia from your body and using it as a “sling” so your body does not reject it. This also involves more surgical skill and takes longer and ultimately may not be as profitable for your provider as a 20 minute sling procedure. If your doctor cannot do this type of repair, why not? Isn’t going conservatively the best way to start? Does he understand the most experienced docs are not using mesh for slings?)
How many native tissue repairs have you done? (Answer: Will you become an experiment? You want to chose a provider who understands this method).
If needed, can you remove my mesh if it causes complications? (Answer: Pay careful attention here, even the best doctors have trouble removing the arms or anchors that are punctured deep into ligaments, leaving behind lasting pain potentially. If a doctor says he can, ask “How do you know?”)
What is your relationship with the mesh manufacturer? (Answer: Look up Dollars for Doctors prior to your appointment. A database from ProPublica, it has documented the financial relationship between doctors and the manufacturers and might be one factor you want to consider. Can a doctor who has received $1 million from Ethicon be providing unbiased information about Ethicon mesh? You decide.)
If your doctor hasn’t thrown you out of the office by now, you may have found a good one who is willing to have a true informed consent. Good for you for becoming an informed consumer!
https://www.meshmedicaldevicenewsdesk.com/transvaginal-and-hernia-mesh-still-be-used-today-what-you-should-ask/
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Woman's mesh implant felt like a chemical burn and cheese wire inside her body
Jun 5, 2018 | DevonLive
By Anita Merritt
This year Susan Morgan has set herself the challenge of accepting the shell of a woman she has become after sustaining horrific life changing injuries from vaginal mesh surgery.
At the age of 51, Susan was advised a urinary incontinence procedure would achieve her wish of being able to enjoy ballroom dancing.
Instead she left hospital and endured pain so excruciating she thought she was going to die.
She is now virtually a recluse at her home in Brixham because she has no control over her bladder and remains in constant pain from the vaginal mesh trans vaginal tape (TVT), which she says feels like a chemical burn and cheese wire inside her body.
As well as the horrific impact the surgery has had on her health, Susan has lost her successful career, partner and all the other things she took for granted in life.
She is also uncomfortable with any photographs being taken of her.
Like many survivors of mesh surgery which has gone wrong, Susan admits to having felt suicidal on many occasions but says it is her two daughters, now aged 21 and 25, who have got her through her darkest moments.
Since turning 60 last year, Susan has reached a turning point and says she doesn’t want to spend almost another decade grieving for the woman she once was and now has to accept the woman she has become.
Mesh treatment has been offered in cases of pelvic organ prolapse and incontinence after childbirth, but has since sparked controversy after many women said they felt discomfort and had difficulty walking or having sex after undergoing the surgery.
Details of an NHS audit released this month showed 127,500 women have been operated on in a nine-year period. But hundreds a year are having subsequent procedures to remove implants.
Mesh campaigners claim the data published by the NHS was selective and didn’t show the full extent of the problem, and they are calling for all mesh to be banned.
The use of vaginal mesh has been suspended by mesh for stress urinary incontinence (SUI) is still being used.
Guidance from England’s National Institute for Health and Care Excellence in December said that following “serious, but well-recognised safety concerns” vaginal mesh should only be used for research purposes in future.
Devon hospitals no longer use vaginal mesh implants but the controversial material is still being used for the treatment of incontinence.
As the mesh is labelled as tension free vaginal tape (TVT), patients may not be aware it is the same mesh that has been linked to serious complications
Susan, who used to run the Susan Morgan Skin Clinic in Brixham, had her surgery at Torquay’s Mount Stuart Hospital and says she now wishes she had never had it done.
“It’s a 21st century catastrophe for the medicine world and the patients involved, and is just getting into the public arena,” she said.
“I have had lots of women ring me over the years having had similar experiences and I have lost a few through suicide.
“I can understand why as the pain is just unbelievable. It’s far worse than labour pains as it’s hitting the same nerves. It’s like your body wants to dispel this thing stuck to you and your body goes into push overdrive.
“It has caused me to suffer from depression for years because I have lost my career, my bladder, my partner and my sex life.
“Turning 60 was a big landmark for me. It made me realise I had lost my 50s - virtually a decade of my life, along with my youth and womanliness. That hit me hard.”
The feeling of how Susan says she felt after waking up from her urinary incontinence procedure still haunts her today.
She recalled: “I woke up after the surgery and thought I was going to die. The shock was so immense that I got into a brain fog. It was quite bizarre.
“I was in hospital for three days instead of 24 hours. I was not able to empty my bladder and had an infection. They struggled to put a catheter in.
“I also had haematomas (a collection of blood outside of a blood vessel) between my legs.
“They sent me home, even though I don’t think I was well enough. Within two hours of being home my catheter was blocked.
“Suddenly I was hit with just the most unbelievable pain. I have given birth to two children so I’m quite tough but I just crawled into a foetal position and screamed in pain.
"It was like the screams were coming from another world and I thought I would never see my children again who back then were aged 16 and 12. I really thought, ‘this is it’.”
Susan claims the Mount Stuart Hospital would not send an ambulance to her home so her brother Paul came and carried her to his car and drove her back to the hospital.
She was diagnosed with an engorged bladder and pelvic hematoma as a result of bleeding lacerations during and after the gynecological surgery.
To ease the pain she was given morphine and had emergency surgery to drain the hematoma.
Susan said: “I thought it had just been a blip but then I had a searing weird pain in my right leg and I constantly suffered from urine infections, passing blood and jugs of puss.”
The next procedure Susan underwent was urethra stretching surgery three months later in the hope of her bladder emptying properly.
Susan recalled: “My legs were swollen so much that I kept falling flat on my face. It looked like I had elephant legs and I ended up in a wheelchair. The pain was ridiculous.”
In 2010, a year after the first surgery Susan made the devastating decision to close her successful business, which she had started 30 years previously, due to her poor mobility and constant pain.
Her partner left her and she was being nursed by her youngest daughter.
Susan said: “I had been in a wonderful new relationship that started six months before the surgery and we were very, very happy.
"Suddenly I went from being a happy, pretty businesswoman to an unhappy woman with vagina and urinary problems which he couldn’t cope with. That was another trauma I had to deal with.”
Due to her constant pain, Susan also found herself not wanting to leave her house.
The first time she was not alone was two years after her surgery when she found a website created by a woman from Bristol who had suffered a similar fate during the same procedure.
It set her on a path of intensive research and says she has since written thousands of letters to raise awareness of mesh complications.
She said: “My local MP Sarah Wollaston has done so much to get the message out there about the agony women are going through due to vaginal mesh implants.
“It has opened the door for people to talk about it, but prior to then I really struggled to find anyone else who it had happened to. I just wanted to know it was not in my imagination
“I feel in my case and in many other cases hospitals have been underhanded in that they have incorrectly promoted the procedure as safe for urinary incontinence, and I think many women didn’t need to have it done at all.
“What’s misleading is surgeons call it tape but it’s still mesh. It fuses into your body and sticks like glue.”
In 2011, Susan had further surgery in London Whipps Cross because she was still unable to empty her bladder and did not want to go back to Mount Stuart.
The surgeon cut either side of the mesh to create more room for her urethra, and then the following year she opted for full mesh removal at another hospital in London in 2012.
Afterwards she was told it was all gone but her health then deteriorated to the point she was almost bedridden for a year and had no control over her bladder.
It wasn’t until four years later, at a different hospital in Leicester, where she had a volume MRI scan and was told there was still a large proportion of mesh inside her body which showed it was misplaced in the wrong place since 2009 in the front of her pubic bone.
It means Susan has been left with an abnormal urethra with continuous pain and has to take antibiotics every day for the rest of her life to ward off infections which could stop her being able to walk.
She said: “The muscles in my bladder won’t ever return and I have refused to have a bladder bag.
“I can feel the mesh burning inside me like a chemical burn and cuts like a cheese wire. The only way of getting it out would be open abdominal surgery, and as far as I know no one is prepared to take it out due to the fact that it is stuck.
“I have now got osteoarthritis in my right hand from the crutches I previously had to use.
“The outcome of both procedures should never have been allowed to happen.”
Susan says she believes she will never get any financial compensation, despite the loss of her business and half of her property.
“I want an apology; I think everyone deserves one who has had the mesh. “Due to my urinary incontinence I now live reclusively and I live for my daughters.
“I do break down and have very dark moments, but it’s my daughters who get me through.
“I have been through real hysterics and have screamed, ‘I can’t live like this’, particularly after the second mesh removal attempt.
“I don’t feel suicidal now. I feel sad for the loss of the woman I was and I have come to terms with the woman I am now. That’s my new goal and it’s not easy.
“I have to accept I’m never getting back what I had and this is now me.
“I feel now like I’ve got to let go. If I can help other women that’s what I would love to do. If anyone wants to talk to me they can.”
The impact of what Susan has been through has also affected the lives of her daughters, as well as her mother who has been devastated watching what she has gone through and her brother who Susan describes as having been the 'man' who has protected her and her daughters for nine years.
Her youngest daughter Natalie said: “Since the summer of 2009 after my mother’s second operation performed to try to correct the mistakes from her earlier surgery, my childhood abruptly ended.
“At the age of only 12, with a father who had left us, I became a sole carer for my mother who was confined to a wheelchair. This period of intense care continued for over two years.
“To have too hear your mother wail in pain day in and day out, and to have to see her on such a reduced personal level, as she was unable to go to the toilet without assistance left me in shock, not only because I felt like I had become a parental figure at such a young age, but also that such derogatory harm could be caused to my wonderful mum.”
Natalie says her mother was never offered the help of carers which is why it fell upon her young shoulders.
She continued: “The operation has injured my mum and ruined her life, mine and also my incredible sister’s.Natalie Morgan
Her youngest daughter Natalie said: “Since the summer of 2009 after my mother’s second operation performed to try to correct the mistakes from her earlier surgery, my childhood abruptly ended.
“At the age of only 12, with a father who had left us, I became a sole carer for my mother who was confined to a wheelchair. This period of intense care continued for over two years.
“To have too hear your mother wail in pain day in and day out, and to have to see her on such a reduced personal level, as she was unable to go to the toilet without assistance left me in shock, not only because I felt like I had become a parental figure at such a young age, but also that such derogatory harm could be caused to my wonderful mum.”
Natalie says her mother was never offered the help of carers which is why it fell upon her young shoulders.
She continued: “The operation has injured my mum and ruined her life, mine and also my incredible sister’s.
“I am now a quiet girl who rarely speaks or voices any opinion, such is the shock I have suffered at seeing my mum hurt.
“At the very least I would expect a written apology to my mum and each and every member of my family, for the utter devastation that has befallen us.”
No one was available from Mount Stuart Hospital for a comment, and it remains unconfirmed whether the hospital still uses TVT mesh for urinary incontinence procedures.
https://www.devonlive.com/news/devon-news/womans-implants-felt-like-chemical-1642291
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Jun 6, 2018 | Mail Online
By Sheree Mutton
There has been a sharp drop in the number of women seeking treatment for incontinence and doctors say it's because they're fearful of vaginal mesh.
The Urogynaecological Society of Australasia (UGSA) has revealed that young women aged between 35-44 are the most likely to put up with incontinence due to concerns over mesh implants, impacting their work, quality of life and mental health.
Figures show there has been a 41 per cent decline in stress incontinence surgery in the age group since peak rates in 2009, and 32 per cent in women aged 25-54.
It comes after UGSA raised serious concerns at the Australian Senate Committee Inquiry recommendation that implantation of all transvaginal mesh products only be undertaken as a 'last resort' by women with urinary incontinence and pelvic floor conditions.
UGSA chair Dr Jenny King said about 150,000 meshes have been used in Australia for prolapse and incontinence, with a 95 per cent success rate.
But she said specialists were now being left with no choice but to perform sub-standard surgery without mesh, as women had been exposed to inaccurate information.
'I think the fall in patients seeking treatment for their incontinence is evidence of the fear generated by adverse publicity, social media and the Senate inquiry,' she said.
'Anecdotally we have all had patients with severe and recurrent prolapse who are simply too anxious to contemplate a mesh repair even though it really is their only chance of a good outcome.
'At the moment I am performing prolapse procedures without mesh which I know have an extremely high chance of failure - simply because of patient anxiety.
'They will then be faced with further, more complex surgery with greater rates of complications. This is poor practice but what else can we do?'
She said the Senate had lumped together incontinence and prolapse devices, considering them all to be ''transvaginal meshes", even though only the prolapse devices were problematic.
Last year, hundreds of Australian women claimed the mesh left them with debilitating, chronic pain and they were unable to have sex again.
The Therapeutic Goods Administration decided in November to remove transvaginal mesh for the sole purpose of pelvic prolapse and single incision mini-slings from the Australian Register of Therapeutic Goods (ARTG).
However, Dr King said those used for incontinence, called mid-urethral slings (MUS), were safe.
A prolapse is when pelvic organs – such as the bladder, bowel or uterus – fall through the vagina.
Stress urinary incontinence is involuntary urine leakage with activity such as sport, coughing or even walking. It affects up to 37 per cent of Australian women, according to the Australian Institute of Health and Welfare.
UGSA states lightweight, minimally invasive mid-urethral slings are the safest and most effective surgical treatment for urinary incontinence, having been used in Australia and New Zealand since 1998.
The US FDA statements on safety concerns over transvaginal mesh do not include mid-urethral slings and the Australian Therapeutic Goods Administration (TGA) has continued to support the inclusion of these products on the Register of Therapeutic Goods.
The Royal Australian and New Zealand College of Obstetricians and Gynaecologists also recommends the MUS as it is highly effective in the short and medium-term, with fewer adverse outcomes than other available major continence surgeries.
'MUS have been clearly shown to be safer and more effective with a lower complication rate than our previous continence procedures,' said Dr King.
'UGSA believes the way forward lies in rigorous safeguards including ongoing audit, long term monitoring, careful surgical training and research with thoughtful patient selection and counselling.'
Dr King said it was important to clarify that the TGA had removed from the register only those transvaginal meshes used for treatment of prolapse.
'The mid-urethral mesh slings have been recognised in Australia and worldwide, by all medical and regulatory agencies, as the appropriate treatment for stress urinary incontinence and these continue to be available.'
'Much work still needs to be done to help those women who have had adverse outcomes but this should not be at the expense of other women who will benefit from these treatments,' she said.
Continence Foundation of Australia CEO Rowan Cockerell said that incontinence was a concern for millions of people.
'Incontinence is a massive problem affecting more than five million adult Australians and costing the Australian economy more than $67 billion a year,' he said.
http://www.dailymail.co.uk/femail/article-5810097/Not-vaginal-implants-problem-Doctor-says.html
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