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Ethicon Media Monitoring 8/30/2017
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Ebaugh Trial Continues as J&J Defends TVT-SECUR
Aug 29, 2017 | Mesh Medical Device Newsdesk
As the Ebaugh trial continues in Philadelphia, the sixth pelvic mesh case to be tried in the Philadelphia Court of Common Pleas, it may be close to wrapping up, as early as this Friday. -
No, Anal Sex Is Not the Solution for This Medical Problem
Aug 30, 2017 | SheKnows
By Elizabeth Yuko
Today in medical misogyny, French gynecologists have reportedly instructed women with complications from faulty pelvic mesh to try anal sex instead of painful vaginal penetration. -
Fury, as doctors suggest ‘sodomy’ for victims of faulty implants
Aug 29, 2017 | Punch
Women in Australia who were left in chronic pain from vaginal mesh implants have reacted angrily after doctors suggested that anal sex could be a solution to their problem. -
Pelvic Mesh Implant Class Action Incriminates Misogynistic Doctor Advice
Aug 30, 2017 | Apex Tribune
Many Australian women have to live with the consequences of a faulty pelvic mesh implant. -
Why Aren’t We Talking More About One Of Australia’s Greatest Medical Scandals?
Aug 29, 2017 | The Daily Telegraph
By Jane Marwick
HOW would you feel if your specialist advised you and your partner to “try anal sex” if vaginal intercourse was too painful? -
‘It’s totally barbaric and needs to be stopped’: Mum-of-two opens her heart about vaginal mesh implant “nightmare”
Aug 30, 2017 | Daily Echo
By Tara Russell
A MUM-OF-TWO has revealed she has been suicidal after a ‘barbaric’ vaginal mesh implant has left her unable to work, walk or have sex. -
Ethicon Faces Sixth Transvaginal Mesh Lawsuit Trial in Pennsylvania
Aug 30, 2017 | RX Injury Help (blog)
By Sandy Liebhard
A Pennsylvania jury has been convened to hear yet another transvaginal mesh lawsuit involving a device manufactured by Ethicon, Inc.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
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Ebaugh Trial Continues as J&J Defends TVT-SECUR
Aug 29, 2017 | Mesh Medical Device Newsdesk
Mesh Medical Device News Desk, August 29, 2017 ~ As the Ebaugh trial continues in Philadelphia, the sixth pelvic mesh case to be tried in the Philadelphia Court of Common Pleas, it may be close to wrapping up, as early as this Friday.
It will be an interesting outcome for this latest transvaginal mesh trial in this venue and the third putting the TVT-SECUR on trial. It has been found defectively designed twice before.
This is the first time that a plaintiff has two meshes, made by defendant, Johnson & Johnson and its division, Ethicon.
At age 39, Pennsylvania resident, Ella Ebaugh, had a TVT- SECUR, implanted on May 31, 2007 at Apple Hill Surgical Center in York, PA by Paul Douglass, MD. She went in to treat occasional incontinence. Her doctor reasoned since she was so young and had a very active lifestyle, it was the most minimally-invasive procedure that would allow her to get back to doing sports.
Today Ms. Ebaugh is 51-years-old, but her legal team says her urethra is mangled from the implants surgeries and the implants she has endured.
Ebaugh is represented by Kline and Specter law firm of Philadelphia. Kila Baldwin is her attorney. The Ebaugh trial began July 31 in the Philadelphia Court of Common Pleas where there have been four jury awards in the plaintiffs’ favor totaling $48 million.
Last June 9, plaintiff Kimberly Adkins was the first in this Philadelphia court to lose her pelvic mesh trial against Johnson & Johnson/ Ethicon on the issue of causation – whether or not the defective mesh, a TVT-SECUR, caused her injuries.
This was an unprecedented jury decision since the jury found the TVT-SECUR was defectively designed. The judge will allow another hearing in the case limited to damages and whether they were caused by the TVT-SECUR mesh.
See Mesh News Desk story here.
Defense Opening
The trial transcript from the opening day of Ebaugh v. Ethicon August 4, Case no 130700866, show that attorney, W. Curt Webb, delivered the opening statement to the 12 jurors in the afternoon after the plaintiffs open by Kila Baldwin of Kline Specter.
Mr. Webb representing Ethicon/ J&J said that one in three women will get incontinence, the other side of the story from Ms. Baldwin told you.
It’s not just a few drops of urine. Ms. Ebaugh had stress and urge incontinence (SUI). Stress is when you put pressure on the bladder from coughing or sneezing or athletic movements and a little urine leaks. Urge incontinence is when you suddenly have to go and don’t make it.
“None of the TVT products have anything to do with urge incontinence” said Mr. Webb. For urge incontinence you use medications, he said, to treat overactive bladder and bladder spasms. Stress urinary incontinence (SUI) is the only thing that the TVT will cure and treat, not urge incontinence.
“A lot of what Mrs. Ebaugh complains about now is that she has to stay close to the bathroom, that she doesn’t have any warning. It’s two separate things….She’s got stress urinary incontinence and she’s got urge incontinence. They’re two different things…..And the reason that’s important is because you’re going to have every doctor who testifies in here is going to tell you that the stress urinary incontinence is what the TVT products are supposed to cure, and the urge incontinence is completely different and none of them, none of the TVT products have anything to do with urge incontinence.” ~ W. Curt Webb, Defense attny.
Dr Douglass, professor at the University of Pennsylvania, trained under preceptor/consultant, Dr. Vincent Lucente, in TVT and TVT-Secur implantation.
Dr. Douglass no longer trained on the Burch and MMK after the TVTs came out.
“And by the way, Dr. Douglass was not paid a penny by Ethicon or Johnson & Johnson. He’s not one of these doctors that either trained other doctors – all he did is buy the products or his hospital bought the products. He just used the products with his patients.”~ W. C. Webb
He said he told her the TVT-Secur had a higher rate of failure but it was less invasive and better for someone who was younger and active. Dr. Douglass put it in in 2007. The TVT-Secur didn’t work. So he came back and has a third discussion about risks and benefits-erosion into the bladder, erosion of the urethra, bleeding, infection, perforation of major blood vessels, perforation of the bladder, possibility of having to wear a catheter for a week or so.
TVT-Secur had problems in Australia, according to three doctors, Mr. Webb says in his opening statement. That’s why the defense brought in Dr. Jamie Sepulveda as an expert witness, who has a lot of experience with TVT-S and he’s not happy it’s no longer on the market. He liked the product, said Webb. He had huge success with it. It was minimally evasive.
These are Mr. Webbs’ words:
When she had problems in 2011, Dr. Douglass was no longer around so she sees Dr. Mirsky. Ms. Ebaugh underwent surgery to remove what eroded into the urethra and he takes out 98%. She had a mid-urethral erosion. Dr. Mirsky still uses the mid-urethral sling today.
One year later she still had erosion and tape particles. She goes to Dr. Chai at University of MD, he’s now up at Yale. He sees some of the mesh up in the bladder. He found strands in the urethra not the bladder. More problems she sees Dr. Wright.
No doctors say the TVT products are defective. Erosion in the urethra is very rare, “it happens in one tenth to one percent of the women that are treated with these mid-urethral slings.”“Just because Mrs. Ebaugh’s TVT-Secur didn’t work doesn’t necessarily mean that it’s defective.”
Her occurrence was one in a thousand. Then Mr. Webb suggested an outcome the company might live with, (verbatim trial transcript):
”But it comes out at the end of it you’re sitting there saying it’s a 50/50, they haven’t met their burden of proof. They’ve got to prove by a preponderance of the credible evidence that, in fact, there was a defect in the TVT-Secur, defect in the TVT, or that we were negligent, Ethicon and J&J, the way that we tested and marked this product.”
He then apologized that Mrs. Ebaugh did not have a good result.
“But we can’t guarantee a result, a good result, every time…The fact that you may had, that you may have a very rare occurrence that happens, one in a thousand, we wish that it didn’t happen at all…And we’re sorry for that, but it doesn’t mean we had a defective product and it doesn’t mean we’re a bad company.” ###
LEARN MORE:
Philadelphia Court of Common Pleas
Philadelphia Court of Common Pleas
$2.16 million – Sharon Beltz, Prolift mesh, no punitive damages
https://www.meshmedicaldevicenewsdesk.com/beltz-case-jj-jury/$12.5 million – Patricia Hammons including $7 million in punitive damages over Prolift mesh. Defective design,https://www.meshmedicaldevicenewsdesk.com/philadelphia-prolift-mesh-case-yields-12-5-million-verdict-for-plaintiff/
$13.5 million – Sharon Carlino including $10 million in punitive damages, TVT mesh
https://www.meshmedicaldevicenewsdesk.com/just-in-carlino-pelvic-mesh-found-defective-awards-13-5-million-against-jj/$20 million – Peggy Engleman, includes $17.5 million in punitive damages. TVT-SECUR
https://www.meshmedicaldevicenewsdesk.com/14521-2/$0 – Kimberly Adkins, TVT-SECUR, defective design but did not cause her complications
https://www.meshmedicaldevicenewsdesk.com/jj-wins-first-pelvic-mesh-trial-philadelphia/https://www.meshmedicaldevicenewsdesk.com/ebaugh-trial-continues-jj-defends-tvt-secur/
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No, Anal Sex Is Not the Solution for This Medical Problem
Aug 30, 2017 | SheKnows
By Elizabeth Yuko
Did doctors really suggest anal sex as a solution for women having this problem?
Today in medical misogyny, French gynecologists have reportedly instructed women with complications from faulty pelvic mesh to try anal sex instead of painful vaginal penetration.
Wait, what? How did we even get to this point? Let’s back up a bit.
Complications with pelvic mesh is unfortunately an all-too-common experience for women with pelvic health issues. As we age — and after childbirth — our pelvic floors weaken, sometimes leading to pelvic organ prolapse, when an organ in your pelvis (like your bladder) can no longer be supported by your pelvic floor muscles and drops so it’s up against the wall of your vagina.
Treating pelvic floor disorders, including prolapse, is tricky, and usually involves some sort of device or material that tries to mimic the pelvic floor muscles to keep the organs in place. One such material is pelvic mesh — which is also used to treat stress urinary incontinence (loss of bladder control after movement, sneezing, laughing, etc.). The problem is, pelvic mesh comes with some pretty serious side effects for many women, including pain, infection, bleeding, damage to nearby organs and painful vaginal sex.
Which brings us to the unsolicited anal sex advice. These reported comments surfaced in emails between French gynecologists and a Johnson & Johnson marketing manager referenced during a class-action lawsuit against the pharmaceutical giant, which manufactures the faulty pelvic mesh in question. The lawsuit was initiated by Australian women who claim to be experiencing “chronic and debilitating pain” as a result of the device.
The emails reference the doctors’ unease about discussing sexual matters with middle-aged women, including alternatives to painful vaginal penetration.
“It is no less true that sodomy could be a good alternative!” one doctor wrote.
Another doctor wrote about trying to psych himself into having conversations with his patients about their sexual well-being.
“I said to myself, there you go, for your next prolapse [patient], you talk to her about orgasms. OK! But also about fellatio, sodomy, the clitoris with or without G-spot etc,” he wrote. “I am sure of one thing: that I would very quickly be treated like some kind of sex maniac (which, perhaps, I am) or a pervert, or an unhealthily curious person.”
Doctors not taking the sexual fulfillment of middle-aged women seriously is hardly news, but when the Australian women affected by the faulty pelvic mesh read the contents of these emails, they spoke out about why this attitude toward their sexual health is so troubling. In fact, many women (speaking anonymously) reported to Guardian Australia that they had heard similar comments — including suggestions to switch to anal sex — from their own doctors.
“Our vaginas have been abused by mesh and now doctors are suggesting our anus be abused. Despicable! Only a misogynist could think this way,” one told Guardian Australia.
A second woman said that she was “gobsmacked” by the sexual advice from her doctor, noting that she finds the suggestion that anal sex “is supposed to make the pain and complications from the mesh go away” disgusting.
This attitude toward women’s bodies devalues a woman’s right to an active sex life as a fulfilled participant, reinforcing the idea that we’re “nothing more than a receptacle to satisfy men and that ‘any hole will do,’” a third woman remarked. Amen, sister.
Another woman told ABC Australia that her doctor’s reaction to her complaining about painful vaginal sex as a result of the pelvic mesh was, “There’s more than one way to skin a cat.”
Look, there’s certainly nothing wrong with anal sex — many women enjoy it. That’s not the issue here. The problem is the pervasive notion that women’s pain isn’t a big deal and just part of our lot in life and that our sexual satisfaction comes second to that of men.
If men required the equivalent of pelvic mesh, you’d better believe that by 2017, someone would have come up with a material that not only effectively treats the condition, but has no negative impact on their sex lives. But we’re dealing with women here, so both pain and having a fulfilling sex life are trivialized.
We need to take a page out of the Australian women’s playbook and speak out about these disparities and allegedly “uncomfortable” subjects until our pelvic health — including sexual satisfaction — is taken seriously.
http://www.sheknows.com/health-and-wellness/articles/1135857/pelvic-mesh-sex
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Fury, as doctors suggest ‘sodomy’ for victims of faulty implants
Aug 29, 2017 | Punch
Women in Australia who were left in chronic pain from vaginal mesh implants have reacted angrily after doctors suggested that anal sex could be a solution to their problem.
The trans-vaginal mesh is a net-like implant used to treat pelvic organ prolapse and stress urinary incontinence in women.
Scores of Australian women have launched legal action against manufactures Johnson & Johnson after claiming the implants left them in debilitating pain and ruined their sex lives.
In a series of emails released as part of the on-going court case, doctors discussed the possible solutions offered to women or couples – with one suggesting “sodomy could be a good alternative” to intercourse.
ABC News reported that, in the email thread, gynaecologists associated with the pharmaceutical company also spoke of feeling uncomfortable discussing sexual acts with women who came to them for help post-surgery.
The comments sparked fury among members of the Australian Pelvic Mesh Support Group who contacted Guardian Australia with their responses.
One woman said she and her husband were “gobsmacked” after being advised to try anal sex as a less painful alternative, another accused it of being a kind of abuse.
She said: “Despicable! Only a misogynist could think this way.”
And one woman added: “The suggestion that women who are unable to have vaginal intercourse should practise anal sex instead completely devalues a woman’s right to a full and healthy sex life as an active, empowered and fulfilled participant. It suggests that a woman is nothing more than a receptacle to satisfy men.”
The mesh implants – known as trans-vaginal tape – are a common treatment for post-childbirth complications such as prolapse or urinary incontinence. But the routine procedure has left some women unable to walk or have sex and requiring invasive removal surgery.
Last week it emerged that one in 15 women in the UK had to undergo surgery to remove the implants after they were left in agony.
But Johnson & Johnson have maintained that women suffering with mesh complications remain a “small minority” of patients. The case continues in Australian federal courts.
http://punchng.com/fury-as-doctors-suggest-sodomy-for-victims-of-faulty-implants/
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Pelvic Mesh Implant Class Action Incriminates Misogynistic Doctor Advice
Aug 30, 2017 | Apex Tribune
Many Australian women have to live with the consequences of a faulty pelvic mesh implant. At least that is the advice their doctors gave to them. As victims of failed operation reported unbearable pain during their sex lives, doctors suggested them to have only anal intercourse for the rest of their lives.
JOHNSON & JOHNSON GYNECOLOGISTS SENT HARROWING EMAILS TO THEIR FEMALE PATIENTS DIRECTING THEM TOWARDS UNHEALTHY SEX LIVES
At the beginning of this month, hundreds of women brought horrifying evidence in their class action against doctors. All of them suffered painful complications due to their implants that have the purpose of treating common childbirth side effects at the level of the pelvic region.
Pharmaceutical giant Johnson & Johnson is the manufacturer of these products. However, they caused debilitating and chronic pain, especially during intercourse.
As of recently, the plaintiffs brought to the attention of the court several emails between French gynecologists that work for Johnson & Johnson and the affected women. According to these texts, doctors offer their advice to women who cannot enjoy sexual experiences due to painful implants. However, these guidelines limited victims to a lifetime with just sodomy instead of intercourse.
“It is no less true that sodomy could be a good alternative!”
However, the affected women did not receive these suggestions well. On the contrary, they found them misogynistic. Such recommendations coming from experts condemned women to a lifetime without healthy sexual life. Instead, they were downgraded to mere instruments that offer men pleasure and nothing else.
WOMEN DESCRIBE THE PAIN OF FAULTY PELVIC MESH IMPLANT AS LIKE HAVING AN INNER CHEESE GRATER
A Greens Senator, Rachel Siewert, has been vocal about these findings even though she is part of the chair commission that leads the inquiry into such pelvic mesh implant. Siewert stated that there is enough evidence to uncover an unhealthy trend of shallow practices and poor advice. These unprofessional demeanors led to women having to readjust their lives in resignation.
Several reviews indicate that one in eight women will develop ugly side effects due to their mesh implants in the pelvic region. Some women described the pain as having a cheese grater inside them. Australia is among the few countries that still allow such surgery. Other nations have long banned it while U.S. recorded 120,000 pending lawsuits regarding this practice.
https://www.apextribune.com/pelvic-mesh-implant-misogynistic/218687/
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Why Aren’t We Talking More About One Of Australia’s Greatest Medical Scandals?
Aug 29, 2017 | The Daily Telegraph
By Jane Marwick
HOW would you feel if your specialist advised you and your partner to “try anal sex” if vaginal intercourse was too painful?
A doctor at a senate inquiry in Perth on Friday said that she was “aghast” that a medical practitioner would make such a suggestion, but the women behind her, some so injured they were unable to sit, were not shocked, because they’d heard it all before and so had senators Derryn Hinch and Rachel Siewert.
The inquiry into transvaginal mesh implants in Australia, spearheaded by Derryn Hinch has heard horrific, disturbing and heartbreaking testimony from women who sought surgery to correct prolapse and stress incontinence.
Prolapse occurs if pelvic muscles are weakened after giving birth or hysterectomy, when the uterus, bladder or rectum slip out of place either protruding into the vagina or the vaginal wall.
The women sharing their stories, some sobbing as they spoke, were implanted with mesh designed to permanently fix prolapse by supporting organs, but a staggering 95 per cent surveyed are adamant that didn’t know that polypropylene mesh was being used in their surgery.
Instead they were handed brochures of smiling women and told that they’d quickly be up and about, better, brighter and healthier than they’d been in years.
The accounts mirror each other: agony after what the patient is told will be a simple day procedure, painful sex, inability to sit, pass urine, infection, chronic pain, a worsening of symptoms and most hurtful of all, doctors who don’t believe them.
When things go wrong with this mesh, the results can be catastrophic. It hardens, causing tissue erosion, infection, sepsis and even the loss of organs like the bowel and bladder.
For mesh-injured women the pain is chronic and excruciating.
We don’t tend to talk about prolapse or incontinence, it’s one of the last taboos in a society given to over-sharing.
Perhaps that is why the devastating stories of what has happened to an estimated 10,000 Australian women has remained largely untold.
Record keeping has been haphazard, so it’s difficult to know exactly how many women have had this surgery, but the best guess is that it’s in the range of 100,000. Of that number, 10 to 12 per cent report serious complications, with some so bad that sufferers consider suicide their only option.
Marriages have broken down, relationships destroyed, and children left with mothers whose lives are ruined.
So why isn’t this story front page news? Is it because it’s about something so private that we don’t wish to discuss it? Is it because it’s seen as a women’s issue?
It isn’t a women’s issue, it affects families and communities.
And it is a news story because it involves our health system, politics and money.
Why has it taken the resolve of a hardy group of damaged women, who banded together to form the Australian Pelvic Mesh Support Group to bring this to our attention?
They contacted politicians, including a federal health minister whose assistant told them to go to the Therapeutic Goods Administration. The very organisation that approved the mesh in the first place. The AMA in WA was the exclusive agent for one of the mesh devices. Where is the outcry?
Derryn Hinch was the only politician who responded to their pleas for help. He put it best when he said the women have been “treated like mushrooms … kept in the dark and fed bullshit by doctors, hospital administrators, the drug companies, even the TGA …”
It was humbling to watch these brave women conquer physical and emotional barriers as each took her turn to speak at the hearing. Some, so upset they broke down when asked to state their name, told the hearing consultants had scoffed, mocked, and humiliated them, and that negative stories about mesh were “media hype”.
The divorce rate among mesh-injured women is around 30%, but there were some stoic men supporting wives, friends and mums on Friday. Men who can no longer share physical intimacy with the women they love, some have themselves been injured while having intercourse because the hardened mesh has pierced the vaginal wall, like a spear.
They too have long forgotten the niceties about not mentioning vaginas and rectums.
Derryn Hinch has done what those who pledge to do no harm have thus far failed to do.
He has given mesh-injured women a voice and restored their dignity.
Now it’s up to us.
These women are our friends, our sisters, our daughter, our mothers, our wives and our grandmothers. They are our women.
http://www.dailytelegraph.com.au/rendezview/why-arent-we-talking-more-about-one-of-australias-greatest-medical-scandals/news-story/92f4cb833ba105f6e86eefd82404afe1
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Aug 30, 2017 | Daily Echo
By Tara Russell
A MUM-OF-TWO has revealed she has been suicidal after a ‘barbaric’ vaginal mesh implant has left her unable to work, walk or have sex.
Lesley Elder, from Poole, hoped the routine gynaecology procedure would mean she could return to her active lifestyle.
However the implant has cut into her causing her chronic pain and is now embedded in her body.
The 50-year-old is now disabled, her marriage ended because she cannot have sex, she cannot work and is battling depression and post-traumatic stress disorder.
Lesley says she has endured 13 operations to try to end the pain to remove the mesh but like other women it is too embedded.
Vaginal mesh implants are offered to women with incontinence or prolapse after childbirth yet but hundreds are suing the NHS and the implants manufacturers after suffering crippling pain.
The plastic meshes are made of polypropylene - the same material used to make certain drinks bottles - and manufactured by many different companies.
Lesley, who has joined the Sling the Mesh campaign which is calling for the procedure branded by some medical professionals as ‘the biggest health scandal of our time’ to be suspended in the UK, said: “It’s been horrendous. I don’t feel like a woman anymore. I feel everything has gone out of my life.
“I’ve been back and forwards to hospital constantly.
“It is totally barbaric and people should know about it because this needs to be stopped.
“My life has not even been worth living anymore. It’s a nightmare it really is.”
Lesley explained before the controversial operation she enjoyed socialising, netball, running and going to the gym but had a type of mesh known as TOT fitted in December 2010 to cure her incontinence and her life turned upside down.
She explained: “The surgeon said it was a simple and fast operation to fix my bladder and that it would change my life.
“It certainly did change my life.
“I woke up in crucifying pain and I thought I was a man because that’s how swollen I was down there. I have never seen anything like it.
“I was in agony screaming and was rushed back into surgery bleeding. I had a haematoma. It was hell.”
Lesley discovered her implant had cut into her vagina causing her severe discomfort.
“My body is just wrecked. It feels like a barbed wire fence inside you. It’s been infection after infection after infection. I have to self-catheterise as it’s ruined all my bladder. Sometimes if I don’t do that I’m still wetting myself. ”
Lesley said the implant led to the breakdown of her marriage as she found intercourse too painful and her partner had even been injured by the mesh during sex.
“I tried a couple of years ago to have intercourse but it is just too painful so it’s been about seven years I’ve been without it but I have tried. I'm now single because nobody really wants to be in a relationship with someone who can't have sex.
"It’s just like glass down there. It’s like you sitting in your private area with broken glass with it burnt and you can’t shut your legs.
“Some days my mobility is fine but other days it really isn’t. It is a living nightmare.
“My dogs have been my life saviours.”
Today Lesley is recovering from her 13th operation at University College London Hospital with removal specialist Sohier Elneil.
Lesley, who has to walk aided with a stick, said: “It is still there. It’s stuck on my pubic bones at the moment.
"They couldn’t find the mesh because it is so embedded and it has also caused scar tissue so my bowels and bladder are stuck together. It’s like getting chewing gum out of your hair. It just doesn’t come out.
“It is a living nightmare. My life has been absolutely wrecked and I just want to get my life back and make others aware how dangerous this can be.”
A spokesman for Medicines and Healthcare products Regulatory Agency said: "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, or via gov.uk/report-problem-medicine-medical-device.”
http://www.bournemouthecho.co.uk/news/15502854.___It___s_totally_barbaric_and_needs_to_be_stopped_____Mum_of_two_opens_her_heart_about_vaginal_mesh_implant____nightmare___/
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Ethicon Faces Sixth Transvaginal Mesh Lawsuit Trial in Pennsylvania
Aug 30, 2017 | RX Injury Help (blog)
By Sandy Liebhard
Sandy Liebhard is an Senior Partner at Bernstein Liebhard LLP
A Pennsylvania jury has been convened to hear yet another transvaginal mesh lawsuit involving a device manufactured by Ethicon, Inc.
According to her complaint, Ella Ebaugh was implanted with Ethicon’s TVT-Secur sling in 2007, at the age of 39, to treat stress urinary incontinence. In July 2007, she underwent corrective surgery due to mid-urethral erosion, at which time she was implanted with a different TVT product. (Case No. # 130700866)
Ebaugh was forced to undergo another corrective surgery due to complications in June 2011. She underwent a third corrective procedure the following March, at which time several strands of mesh were removed from her urethra.
Ebaugh says she continued to experience complications, forcing her to undergo a fifth surgery just last year.
Like other women pursuing transvaginal mesh lawsuits, she alleges that Ethicon’s TVT devices were defectively designed, and claims that the company failed to warn doctors and patients about their potential risks.
“These defective products have literally mangled Ella Ebaugh’s urethra,” the plaintiff’s attorney told jurors during August 4th opening statements in the Philadelphia Court of Common Pleas. “Pain, incontinence will cause her to suffer with this for the rest of her life.”Philadelphia a Favorable Venue for Transvaginal Mesh Plaintiffs
Transvaginal mesh implants are intended to treat women suffering from pelvic organ prolapse and stress urinary incontinence. However, reports linking the devices to thousands of serious injuries and complications have prompted the U.S. Food & Drug Administration (FDA) to issue several warnings regarding their use. Following years of investigation, the agency finally decided to reclassify transvaginal mesh intended for prolapse repair as a high-risk medical device.
More than 55,000 transvaginal mesh lawsuits have been filed nationwide on behalf of women who allegedly suffered severe and life-changing complications due to Ethicon’s products. Trials have been convened in various states, with plaintiffs and the defendants each scoring victories, while a small number of cases have settled outside of court.
The Philadelphia Court of Common Pleas has been especially favorable to Ethicon transvaginal mesh plaintiffs, as four previous juries have ordered the company to pay damages ranging from $2.16 million to $20 million.
Ethicon’s sole victory came in June, when another TVT-Secur plaintiff was denied damages after the jury hearing the case determined that the implant was not responsible for her injuries. However, they did find that the transvaginal mesh device was defectively design. Ethicon’s win could be short-lived, however, as the court agreed to grant the plaintiff a new damages hearing after she filed a post-trial motion arguing that the jury’s verdict was inconsistent with the evidence.
In 2012, Ethicon announced it would end sales of TVT-Secur mesh and three other transvaginal mesh devices, citing commercial concerns rather than safety reasons. However, the FDA had previously ordered Ethicon and other vaginal mesh manufacturers to conduct further research into the risks associated with their products.
http://www.rxinjuryhelp.com/news/2017/08/29/sixth-ethicon-transvaginal-mesh-lawsuit-currently-at-trial-in-pennsylvania/
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