Preview Newsletter
Ethicon Media Monitoring 8/18/2017
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Gynecologist admits he would never allow his wife to have a vaginal mesh implant as medics joke women whose sex lives have been destroyed by the procedure should have intercourse with ANIMALS
Aug 17, 2017 | The Daily Mail
By Alexandra Thompson And Stephen Matthews
A gynecologist has revealed he would never allow his wife to have a controversial vaginal mesh implant fitted - a procedure that has left thousands of women in crippling pain and unable to walk or have sex. -
MESH HELL Mum-of-two left ‘a broken woman’ after botched vaginal mesh op left her homeless, jobless and unable to have sex
Aug 17, 2017 | The Sun
By Hayley Richardson and Tracy Gayton
At her lowest point, Lisa Woodrow, 53, from Thetford, Norfolk, was in a wheelchair for 18 months and couldn't walk after having a TVT mesh sling inserted -
1 in 15 women have vaginal mesh devices removed
Aug 17, 2017 | Medical Plastics News
By Reece Armstrong
NHS figures obtained by The Guardian have revealed that thousands of women have undergone surgery to have vaginal mesh implants removed. -
"I have pain every day, every hour, every minute. It never goes away” What it’s like to live with surgical mesh
Aug 18, 2017 | ITV
Women have been speaking to ITV Wales about the chronic pain they are suffering after having surgical mesh as fresh calls are made for it to be banned. -
Pelvic mesh victims demand meeting with minister over 'alleged cover-up'
Aug 18, 2017 | WA Today
By Joanne McCarthy
Two pelvic mesh victims are demanding a meeting with Health Minister Roger Cook to allege a cover-up of trials involving women – but not disclosed to them – in Western Australian public hospitals after failed attempts to locate surgical records. -
Corrections and clarifications
Aug 17, 2017 | The Guardian
An article about women having to undergo surgery to remove vaginal mesh implants said that in Scotland “the use of mesh devices was suspended in 2014 pending a review”. -
Over 80 Lawsuits Already Pending in Consolidated Physiomesh Litigation
Aug 17, 2017 | The Legal Examiner
By Roopal Luhana
On June 2, 2017, the U.S. Judicial Panel on Multidistrict Litigation (JPML) consolidated all federally filed Ethicon Physiomesh lawsuits into the Northern District of Georgia. Since then, more cases have joined the litigation. There are now over 80 pending in that court, with more expected to be filed over the coming months. -
Alabama Physiomesh Lawsuit Claims “Unreasonably Dangerous” Multi-Layer Design Led to Severe Hernia Complications
Aug 17, 2017 | RX Injury Help (blog)
By Sandy Liebhard
An Alabama man has filed a Physiomesh lawsuit against Ethicon, Inc., claiming he suffered severe hernia complications due to its “unreasonably dangerous” multi-layer design.Plaintiff: Physiomesh Warnings Inadequate
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
Full Text of Stories Below
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Aug 17, 2017 | The Daily Mail
By Alexandra Thompson And Stephen Matthews
· Email exchanged between doctor and Johnson & Johnson marketing manager
· One suggests 'sodomy' for women who are longer able to have sex with partners
· A doctor expresses his reluctance to discuss 'fellatio' or 'clitoris' with sufferers
· More than 800 women are suing the NHS, saying they are now unable to walk
· Pressure is mounting for a UK ban of the 'gold-standard' incontinence treatment
A gynecologist has revealed he would never allow his wife to have a controversial vaginal mesh implant fitted - a procedure that has left thousands of women in crippling pain and unable to walk or have sex.
And rather than be sympathetic to the plight of such patients', a doctor ridiculed their suffering, suggesting they have sex with an animal if they are no longer able to have intercourse with their partner.
The comments came to light during an Australian court case of mesh-suffering women against implant manufacturer Johnson & Johnson when an email exchange between gynaecologists and the pharma giant was revealed.
Pressure is also mounting for a UK ban of the 'gold-standard' treatment for urinary stress incontinence and pelvic organ prolapse.
More than 800 women are suing the NHS and the implants' manufacturers after allegedly suffering crippling pain.
The NHS has even been accused of sweeping such complications under the carpet in an effort to dodge media attention.
'Sodomy could be a good alternative!'
Used as evidence of the implants' poor safety, an email exchange between a gynaecologist and a marketing manager at Johnson & Johnson was presented in the trial.
The unnamed doctor wrote that he 'would not like my wife to undergo this procedure', ABC News reported.
Johnson & Johnson did not respond to a request for comment.
In the same correspondence between two unnamed French doctors, one mockingly suggests patients who now find intercourse with their partners too painful resort to having sex with animals.
He wrote: 'It is no less true that sodomy could be a good alternative!'
Sodomy is defined as 'unnatural sexual intercourse' including bestiality, or oral or anal sex.
One of the gynecologists continues to describe his reluctance to talk to vaginal mesh sufferers about 'fellatio' and 'the clitoris with or without g-spot'.
'I'VE BEEN ON THE BRINK OF SUICIDE. MY KIDS KEPT ME GOING'
A mother-of-three has revealed she was on the brink of suicide after suffering agonising pain from a vaginal mesh implant she had fitted.
Janette Nelson, 43, from Newtownards, Northern Ireland, said the only think that kept her going was her children, but she still battles guilt every day as she depends on them to help her wash, dress and even catheterise after the procedure left her unable to control her bladder.
The former hairdresser also blames her implant for the breakdown of her relationship as her boyfriend left her when the pain was too severe for her to have sex.
Unable to work, her career has also been destroyed.
'My children lost their mummy'
Ms Nelson had the most common type of mesh, known as TVT, fitted in March 2012 in an attempt to cure her urinary stress incontinence.
She said: ‘Immediately once my tape was fitted I woke up with excruciating pain in my groin; its indescribable.’
Just one week later, Ms Nelson wet herself while out with her children and now relies on her eldest daughter to help her catheterise every day.
Due to the excruciating pain of the mesh, Ms Nelson has been forced to rely on her mother and sister to help her raise her children.
She said: ‘My children lost their mummy. I’ve been on the brink of suicide.
‘My kids kept me going. I was useless as a mum but I’m still their mum. It’s all been about me for the past few years.’
'My boyfriend left me because of it'
As well as affecting her as a parent, Ms Nelson also blames the implant for the loss of her love life and career.
She said: ‘I had a boyfriend when this started but the sex was excruciating, neither of us could cope with it. My boyfriend left me because of it.
‘I used to work as a hairdresser; always on my feet, always very confident, but now I can hardly walk and I can’t control my bladder so I can't work. It’s really knocked my confidence.'
'Total disregard for a woman's wellbeing'
Kath Samson, who had the procedure in 2015 and leads 'Sling The Mesh', a campaign group seeking to have the implant banned in the UK, told MailOnline: 'This misogynistic approach to a woman's sex life is appalling.
'It shows a total disregard for a woman's wellbeing and is treated as some sort of joke.
'If a simple operation was ruining men's sex lives I can guarantee you it would have been stopped years ago.
'For most women this is a really embarrassing thing to talk about - so for years this insidious risk of mesh has been left unspoken.'
This comes after accusations against doctors that they accept benefits to encourage women to have vaginal mesh implants fitted.
One manufacturer of the mesh paid doctors more than $4million in 2016 alone to fund their travels, consultancy fees, and even food and drink, according to the Centers for Medicare and Medicaid Services' Open Payment database.
It has also been claimed that many of the studies that reveal a benefit from having an implant were sponsored by mesh manufacturers - leading to fears of a risk of bias and conflicts of interest.
http://www.dailymail.co.uk/health/article-4796388/Doctor-doesn-t-want-wife-mesh-implant.html -
Aug 17, 2017 | The Sun
By Hayley Richardson and Tracy Gayton
At her lowest point, Lisa Woodrow, 53, from Thetford, Norfolk, was in a wheelchair for 18 months and couldn't walk after having a TVT mesh sling inserted
A MUM-OF-TWO was left a "broken woman" after a botched vaginal mesh operation left her homeless, jobless and unable to have sex.
Lisa Woodrow had hoped the routine gynaecology procedure would make a "new woman" out of her, but afterwards she suffered chronic pain and spent 18 months in a wheelchair unable to walk.
Unable to work, she lost her job and had to sell her house, leaving her homeless, while her relationship also fell apart.
In October 2016, Lisa had NHS surgery to remove it. But although her symptoms improved, she has yet to return to full health.
She has since joined the Sling the Mesh campaign which is calling for the procedure to be suspended in the UK.
Lisa said: "I was a fun loving party girl before a transvaginal mesh implant (TVT) robbed me of the life I once knew."
The former sales and marketing executive underwent the 20-minute surgery in November 2012.
She explained: "Before the mesh operation, I was excited and optimistic.
"I thought it would resolve my long-running problems of uterus prolapse and mild urine incontinence, which had gradually developed after the birth of my two sons, now 31 and 32.
"I even joked to my partner at the time that this operation was going to make me feel like a new woman.
"It certainly did that. I haven’t been the same since."
Immediately after her surgery, Lisa found using the toilet difficult, had recurrent urine infections and couldn't sit down without cushions underneath her.
She also found it painful to have sex.
Lisa raised concerns at a three-month check-up but was told the operation had been a success and the problems were due to scar tissue.
She recalled: "My consultant told me scar tissue could take a long time to heal.
"But then I started to get painful nerve spasms in my legs and my GP was fearful it might be MS.
"After seeing a neurologist I was given the all-clear. But still I got the spasms, then I started to get pain radiating through my hip and groin area.”
For a long time, Lisa felt she had no choice but to put up with her symptoms.
But in May 2015, things suddenly took a turn for the worse.
"I woke after a restless night with pain - but when I went to get out of bed, I couldn’t stand up or support myself any more," she said.
"My partner dialled 999 and called an ambulance."
After six weeks in hospital, Lisa was told she had slipped a disk or that her lower spine had narrowed, although this later proved to be an incorrect diagnosis.
She said: "Every time I tried to walk, my legs shook so that I could only shuffle a few steps.
"It felt like there was barbed wire inside my groin and leg. I had to start using a walking frame and wheelchair to get about."
When her dad Jack visited her in hospital, he told her of a woman he'd seen on TV complaining of similar symptoms, caused by her TVT mesh.
Fearing her operation was to blame for her plight, too, Lisa begged doctors to send her to a gynaecologist specialising in mesh.
But medics were reluctant to make a referral, so she spent her life savings to privately see a gynaecologist who discovered the mesh had torn through her urethra and vagina wall.
In February 2016, on the NHS, Lisa saw removal specialist Dr Sohier Elneil in London and was told her mesh had been incorrectly inserted and had since eroded.
She had it removed that October, but she's been left in permanent nerve pain, which can flare up and keep her in bed for days.
Lisa said: "My legs still shake badly and I need a stick to support me.
“I’ve had to learn to walk again with a heel-toe step, but I can only manage a little way and must use a wheelchair for longer distances.
“I'm now waiting for further surgery to remove the remnants of the mesh from behind my pubic bone, then I’ll have a colposuspension – the traditional surgical fix for incontinence – as I've become fully urine incontinent.
“Ironically, the mesh never helped very much with my incontinence- the reason I had it done in the first place.
"I’ve gone from loving dancing, doing karate, swimming and taking long walks to a shell of the woman I once was.
"I had to give up my successful business supplying hotels with accessories and sell my house.
"Now I live in rented accommodation on benefits. I’m registered disabled, a broken woman.
"The pain is so bad I’m on the highest dose of daily pain-relieving drugs - I’m a legal drug addict. I take 22 tablets a day.
“If it hadn’t been for the support of (Sling the Mesh founder) Kath Sansom and other women on the Sling the Mesh Facebook group, I don’t believe I’d ever have got the operation to remove the mesh, that I so needed.
"Because of how I was treated by my GP, in particular, I’d almost started to believe the pain must be in my head."
Recently Lisa has been to parliament to lobby against the surgery and has joined a legal case.
MPs will be meeting to discuss a public enquiry and there are plans for an all-party parliamentary group to look into the allegations.
In March we told how a mum was left with a "deadly vagina" that "BIT" her partnerduring sex after surgery for stress incontinence went wrong.
In June we reported how a biker's botched vagina op destroyed her sex life – and left her jobless and disabled.
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.
· 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 ordered a temporary suspension of TVT 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.
https://www.thesun.co.uk/living/4262779/mum-tvt-mesh-botched-op/
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1 in 15 women have vaginal mesh devices removed
Aug 17, 2017 | Medical Plastics News
By Reece Armstrong
NHS figures obtained by The Guardian have revealed that thousands of women have undergone surgery to have vaginal mesh implants removed.
The figures show that around one in 15 women fitted with trans-vaginal tape (TVT) implants have had the device removed due to complications. Between 2006 and 2016, over 75,000 women had the implants fitted, but during the same period over 4,900 women (6.5%) had the implant removed.
TVT implants are the most common type for treating pelvic organ prolapse and incontinence following childbirth. However, 44,000 women were also treated with a second type of mesh called transobturator tape (TVT-O), The Guardian reported.
Johnson & Johnson is a well-known producer of the devices. The company’s subsidiary Ethicon has been taken to court over the mesh implants, with thousands of women in Australia claiming that the devices have ruined their lives.
The Guardian spoke to Carl Heneghan, a professor at the University of Oxford. Heneghan told The Guardian that the “very high rates of removal…are only likely to get worse. It only suggests that one in 15 women will need a removal at some point”.
A consultant urogynaecological surgeon at University College Hospital, London, told The Guardian that the high number of removal procedures was a “scandal”.
In response to the Mesh Oversight Group report released by the NHS, the Medicines and Healthcare products Regulatory Agency (MHRA) released a statement saying: “Patient safety is our highest priority and we sympathise with women who have suffered complications after surgery.
We are committed to helping address the serious concerns raised by some patients. We have undertaken work to assess the 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 continue to see is that evidence supports the use of these devices in the UK for treatment of the distressing conditions of incontinence and organ prolapse in appropriate circumstances. This is supported by the greater proportion of the clinical community and patients.
In common with other medical device regulators worldwide, none of whom have removed these devices from the market, we are not aware of a robust body of evidence which would lead to the conclusion these devices are unsafe if used as intended.
We actively encourage patients and healthcare professionals to report complications associated with these implants through the Yellow Card Scheme.”
http://www.medicalplasticsnews.com/news/medical-devices/1-in-15-women/
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Aug 18, 2017 | ITV
Women have been speaking to ITV Wales about the chronic pain they are suffering after having surgical mesh as fresh calls are made for it to be banned.
Karen's Story:
I had vaginal mesh surgery in 2014 after suffering with stress incontinence after having a big 10lb baby.
They offered me a TVT operation, said I'd be in hospital just one day, I ended up being in for 8 days, the pain after surgery was instant.
Before this operation I was happy, enjoyed exercise, had fun with the kids.
Now, I'm very limited to what I can do. Pain is constant in my hip and thigh area and my groin and pelvis.
I take more than 20 tablets over the course of the day for nerve pain, depression and some to counteract the effects of the pain killers.
You get really bad shooting pains, you don't know when they're going to come and it's like being sliced with cheese wire. I have pain intimately, it's constant, every day, every hour, every minute, it never goes away.– KAREN PREATER
Rhian's Story:
In May I had a hernia fixed with a mesh . Since that day I have been left in severe pain. I'm on morphine but the pain is chronic. It's seriously affecting my life and my mobility, my relationship, it swells, it hurts.
It's stopped me from being able to do the things I used to do, I can't walk far, I can't sleep , I can't lie on my left side , I have lost any intimate relationship with my husband, I can't play with my children.
I'm on constant morphine- I have begged them to take it out but I just feel they are not taking it as serious as they should be.
Physically, I can't walk, I can't bend, I can't sleep at night, I wake up in severe pain even with morphine. I'm getting my 8 year old son to put my socks on because I'm in so much pain, I can't dress myself, it's awful, it's not fair.– RHIAN DOYLE
What is surgical mesh?
Surgical mesh is made of polypropylene plastic - the same material used to make plastic bottles. It can shrink, twist, degrade and cut or erode into nearby tissues and organs, causing chronic pain.
What's it used for?
It is used to treat incontinence, prolapse and hernias.
Why is it used?
It is popular as it is a cheap and quick fix and takes less surgical skill than traditional, native tissue repairs. It is also strong and provides a longer term solution.
Find out more:
ARGUMENT FOR MESH TO BE BANNED
Doctor Sohier Elneil specialises in vaginal mesh removals.
She completes up to six removals a week.
She feels medical mesh should be temporarily withheld from any surgical procedure until we know more about it.
BENEFITS OF MESH
However, Chief medical officer in Wales, Dr Frank Atherton says benefits of mesh treatment can’t be ignored.
Mesh has helped many women. I don’t think a temporary ban would be appropriate. What’s important is that people in Wales have access to good quality information and are aware of benefits and risks of these treatments.– DR FRANK ATHERTON, CHIEF MEDICAL OFFICER FOR WALES
The Welsh Government say they are aware of concerns over mesh surgery and are working with clinicians and patients to determine what to do next.
http://www.itv.com/news/wales/2017-08-18/i-have-pain-every-day-every-hour-every-minute-it-never-goes-away-what-its-like-to-live-with-surgical-mesh/
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Pelvic mesh victims demand meeting with minister over 'alleged cover-up'
Aug 18, 2017 | WA Today
By Joanne McCarthy
Two pelvic mesh victims are demanding a meeting with Health Minister Roger Cook to allege a cover-up of trials involving women – but not disclosed to them – in Western Australian public hospitals after failed attempts to locate surgical records.
The call has been backed by Health Consumers Council chief executive Pip Brennan and comes after documents show WA Health paid a secret settlement to a woman in 2013 after pelvic mesh surgery at the Bentley public hospital in December, 2003.
The woman alleged she suffered serious injuries after she was implanted with a device developed in Western Australia that used anchors embedded in her body.
Ms Brennan said Mr Cook needed to "sit down with the women and hear what they've been through" because "it seems to me there's been a real slowness to understand the impact and depth of this issue".
"He needs to understand the scale of this mesh disaster and WA Health's direct involvement with it," she said.
The device leading to the 2013 compensation – which research papers by two WA doctors say was used in Royal Perth and Armadale hospital trials - was implanted in Perth women Jeanette McKinnon and Sue Turner. They will tell a Senate inquiry hearing in Perth on August 25 that they have suffered catastrophic injuries because of the mesh surgery.
"When my doctor showed me what was in my body, I nearly vomited," said Mrs McKinnon, who only discovered this month that she was implanted with two different Western Australian-developed mesh devices in 2004 and 2005, and whose hospital records cannot be located despite extensive searches.
"I was just inconsolable. I was in such a state. What happens if they haven't got those records? How do I prove that they did this to me?" she said.
A screenshot of a hospital electronic record, which provided confirmation of one of the four operations she had in 2004 and 2005, showed the inventor of both Western Australian-developed devices attended the operating theatre along with her surgeon. Both doctors' names appear on research papers from 2005 saying trials of one of the devices at WA public hospitals had ethics committee approval.
WA Health advised Fairfax Media there are no records of research approvals for trials using the device.
"I'm disgusted. I'm horrified that the public health system can do this to us. How did it ever get like this?" Mrs McKinnon said.
"I have no faith whatsoever in the public health system. I was an experiment. I felt it at the time. Something happened to me that was serious. Something very serious went wrong.
"I absolutely feel WA Health is hiding things from us and there's a cover-up because of the experiments. What happened to me will haunt me until the day I die."
Perth urogynaecologist Dr Michelle Atherton said she was concerned Mrs McKinnon's patient notes at the Bentley Hospital could not be located, despite concerted efforts by medical records staff since a freedom of information application in late June.
"If the notes cannot be found in the next few days I will ask the hospital executive to look further into this," Dr Atherton said.
"Lack of previous operation reports impacts on the treating specialist's ability to manage problems after pelvic surgery, particularly after mesh surgery or revisions."
Mrs McKinnon sobbed while talking about using her sick and annual leave to deal with mesh complications, reducing her hours and eventually having to stop work.
"When there's problems with a car and there's a recall, there's publicity and the owners are advised. They have to do that with cars so why not with a human being? I've got mesh in me that's cancelled and I'm on my own. They just toss you on the heap but people knew what was going on. They know what happened to us," Mrs McKinnon said.
Ms Brennan, who contacted Mr Cook's office on the women's behalf on Wednesday, said she wanted to see appropriate medical and psychological support for women affected by the growing mesh scandal, "and they shouldn't have to pay for it".
"There needs to be a register of every single device in every single woman. If we have harmed women we need to make amends," she said.
Mr Cook's office referred questions to WA Health.
Questions about the device trials in WA public hospitals, put to WA Health on July 21, remain unanswered.
http://www.watoday.com.au/wa-news/pelvic-mesh-victims-demand-meeting-with-minister-over-alleged-coverup-20170817-gxyjkd.html
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Corrections and clarifications
Aug 17, 2017 | The Guardian
An article about women having to undergo surgery to remove vaginal mesh implants said that in Scotland “the use of mesh devices was suspended in 2014 pending a review”. In fact the Scottish health secretary wrote to health boards requesting the suspension of mesh devices in 2014, though some hospitals in Scotland still use mesh implants (NHS figures reveal vaginal mesh ‘scandal’, 16 August, page 7).
• The caption to a photograph of a moth with red and black wings misidentified it when referring to the photographer’s love of cinnabar moths. As many readers have said, it was of a similarly coloured but differently marked moth, a six-spot burnet (Colour my world, 15 August, page 28).
https://www.theguardian.com/news/2017/aug/17/corrections-and-clarifications
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Over 80 Lawsuits Already Pending in Consolidated Physiomesh Litigation
Aug 17, 2017 | The Legal Examiner
By Roopal Luhana
⦁ Roopal Luhana is an attorney with Chaffin Luhana LLP
On June 2, 2017, the U.S. Judicial Panel on Multidistrict Litigation (JPML) consolidated all federally filed Ethicon Physiomesh lawsuits into the Northern District of Georgia. Since then, more cases have joined the litigation. There are now over 80 pending in that court, with more expected to be filed over the coming months.
Plaintiffs claim that after being implanted with Physiomesh hernia patches, which have since been recalled, they suffered from serious injuries including adhesions, infections, mesh erosions, and other complications. The court held its first status conference on August 1, 2017.Ethicon Recalls Physiomesh After Six Years on the Market
Manufacturer Ethicon, a subsidiary of Johnson & Johnson (J&J), released an urgent field safety notice on May 25, 2016, alerting hospitals and doctors to the fact that it was initiating a voluntary recall of its Physiomesh product. The company noted that an analysis of data from two large hernia registries showed recurrence and reoperation rates after laparoscopic hernia repair using Physiomesh were “higher than the average rates of the comparator set of meshes among patients in these registries.”
Physiomesh was on the market for only six years prior to this recall, having been FDA-approved for the repair of ventral (abdominal) hernias in April 2010. The manufacturer did not have to submit clinical trials on their device to gain approval, however. Instead, they went through the FDA’s fast-track 510(k) approval system, which only required that they prove their product was significantly similar to one already on the market.
Physiomesh was designed differently than other similar mesh products. It was made with five distinct layers: two layers of “Monocryl” film covering two underlying layers of PDS, which in turn, coat a polypropylene mesh. This design separates Physiomesh from other similar hernia repair meshes, and was something that the manufacturers advertised as being superior when they first released the product.
The multi-layer coating was supposed to prevent or minimize adhesion and inflammation, and encourage incorporation of the mesh into the body. Plaintiffs claim, however, that it does the opposite, and instead causes an intense inflammatory reaction, creates pockets of fluid buildup, slows healing of the surgical area, and attracts bacterial infections.Physiomesh More Likely to Cause Problems Than Other Types of Mesh
Plaintiffs who have filed lawsuits in the consolidated litigation report extremely painful and lasting complications stemming from their Physiomesh implantations. Doctors use hernia mesh to help support stretched and protruding muscles and tissues. But plaintiffs claim Physiomesh has caused more harm, including internal infections, bleeding, organ perforation, tissue damage and death, and chronic, debilitating pain, often requiring multiple corrective surgeries.
Many times the damage is so severe and the mesh so embedded in the body that doctors are unable to remove it, and must leave some behind.
In support of their claims, plaintiffs refer to scientific studies showing that Physiomesh was more likely to cause complications than other hernia mesh products. In 2016, for example, researchers compared Physiomesh with Ventralight, another type of hernia mesh.
They observed 20 percent hernia recurrences in the Physiomesh group in the first 6 months after implantation, and none in the Ventralight group. They also observed a significantly higher rate of pain in the Physiomesh group after three months.
http://newyork.legalexaminer.com/medical-devices-implants/over-80-lawsuits-already-pending-in-consolidated-physiomesh-litigation/
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Aug 17, 2017 | RX Injury Help (blog)
By Sandy Liebhard
Sandy Liebhard is an Senior Partner at Bernstein Liebhard LLP
An Alabama man has filed a Physiomesh lawsuit against Ethicon, Inc., claiming he suffered severe hernia complications due to its “unreasonably dangerous” multi-layer design.Plaintiff: Physiomesh Warnings Inadequate
According to his August 15th filing in the U.S. District Court, Southern District of Alabama, Bill Tedford was implanted with an Ethicon Physiomesh Composite mesh patch (Catalog/Reference No. PHY1520V) in December 2013 to repair a hernia. He later required additional invasive procedures due to complications allegedly associated with Physiomesh’s unique, multi-layer design.
That design is supposed to helps the hernia mesh incorporate into the body and reduce inflammation. However, Tedford alleges that it actually causes a number of problems, including chronic pain; recurrence of hernia; foreign body response; rejection; infection; inadequate or failure of incorporation/ingrowth; migration; scarification; deformation of mesh; improper wound healing; excessive and chronic inflammation; adhesions to internal organs; erosion; abscess; fistula formation; granulomatous response; seroma formation; nerve damage; tissue damage; and even death.
“Plaintiff’s severe adverse reaction, and the accompanying medical treatments which were required, directly and proximately resulted from the defective and dangerous condition of the Defective Device and Defendants’ defective and inadequate warnings about the risks associated with the Defective Device, and the frequency, severity and duration of such risks,” Tedford’s lawsuit alleges. “Plaintiff has suffered, and will continue to suffer, both physical injury and pain and mental anguish, permanent and severe scarring and disfigurement, lost wages and earning capacity, and has incurred substantial medical bills and other expenses, resulting from the defective and dangerous condition of the Defective Device and from Defendants’ defective and inadequate warnings about the risks associated with Physiomesh.”Physiomesh Market Withdrawal
Ethicon announced it was withdrawing Physiomesh Flexible Composite Mesh from the worldwide market in May 2016, after unpublished data from two European hernia registries suggested that the product was associated with higher average recurrence and revision rates compared to other meshes used in laparoscopic ventral hernia repair. Because Ethicon was unable to determine the reason for these issues or identify a solution, the company stopped selling the affect Physiomesh product and has indicated it will not be returning those devices to the market.
Earlier this year, the U.S. Judicial Panel on Multidistrict Litigation (JPML) centralized all federally-filed Physiomesh lawsuits in the U.S. District Court, Northern District of Georgia, for the purpose of coordinated pretrial proceedings. The litigation convened its Initial Conference on August 1st, and has grown include more than 100 hernia mesh cases.
http://www.rxinjuryhelp.com/news/2017/08/17/alabama-physiomesh-lawsuit-claims-unreasonably-dangerous-multi-layer-design-led-to-severe-hernia-complications/
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