Preview Newsletter
Ethicon Media Monitoring 3/20/2018
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Mother, 51, claims her partner dumped her because her vaginal mesh implant sliced his PENIS during sex (and she says the scandal-hit procedure has also left her suffering from PTSD)
Mar 19, 2018 | The Daily Mail
By Stephen Matthews
A 51-year-old mother claims that her partner dumped her because her controversial vaginal mesh implant sliced his penis during sex. -
Woman plans to sue hospital trust over mesh ‘trauma’
Mar 19, 2018 | Eastbourne Herald
A mum is planning on suing the hospital that fitted her with a surgical mesh - because it left her unable to work and suffering from Post-traumatic Stress Disorder. -
Senator says doctors could need 'expertise' to identify gender issues raised in mesh inquiry
Mar 20, 2018 | Newcastle Herald
By Joanne McCarthy
A PELVIC mesh scandal that has left Australian women with serious, permanent and disabling injuries is a wake-up call for the medical profession that some doctors might have a problem with women, said Senator Rachel Siewert as a Senate committee prepares to release a report on the scandal. -
Co. Did Not Warn Of Mesh Product Risks, NJ Jury Told
Mar 20, 2018 | Law 360
By Bill Wichert
Counsel for a woman suing C.R. Bard Inc. over pelvic mesh products told a New Jersey state jury Monday that the business knew the devices were unsafe and failed to warn doctors about potential risks, but a company attorney countered that they were safe and that adequate warnings had been provided.
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Mar 19, 2018 | The Daily Mail
By Stephen Matthews
· Theresa Bartram, from East Sussex, is one of thousands of 'meshed up' women
· She experienced repeated infections and agony after mesh was fitted in 2007
· It even cut through her vaginal wall - slicing into her partner's penis during sex
· Like hundreds of others, she claims she was told the agony was all in her head
· She now plans on suing Brighton and Sussex University Hospitals NHS Trust
A 51-year-old mother claims that her partner dumped her because her controversial vaginal mesh implant sliced his penis during sex.
Theresa Bartram, from East Sussex, had the scandal-hit device removed following the incident - only to end up single two months later.
The former health worker has been left battling post-traumatic stress disorder and unable to work after undergoing the 'barbaric' procedure.
She is one of thousands of women who have been tainted by vaginal mesh. Many have been on the brink of suicide or left in wheelchairs.
Before the decision for the removal of the brittle plastic, which can curl, twist and cut through tissue, she also experienced unbearable pain and infections.
Like hundreds of other victims, she claims she was told the agony was all in her head and was offered anti-psychotic drugs. Her own family dismissed her concerns.
She is now planning on suing Brighton and Sussex University Hospitals NHS Trust, where she was fitted with a TVT sling in 2007. It was removed three years ago.
Relentless fights by campaigners have led to the Government announcing an audit into the 'barbaric' procedure and banning one type of mesh completely.
Ms Bartram, who is now barely able to walk, is the latest in a chain of 'meshed up' women to speak about their horrific ordeal.
She said: 'I had the sling put in because I had a mild prolapse while giving birth standing up, and was told that it was the "gold standard" for women like me.
'The doctor said the risks were minimal, it was fantastic, and there was only a one per cent chance of infection - I had no idea at all that it could cut through me.
'In 2010, it cut my partner during sex because it had perforated my vaginal walls after three years.
'I blew up - I was hugely swollen and looked eight months pregnant - so I went to A&E, but they said I was fine and to go home.'
Ms Bartram revealed that bungling doctor actually looked at someone else's blood results - meaning they failed to sport her liver and pancreas problems.
She added: 'I felt so sick, I kept falling asleep in conversations and on the phone and was sleeping for 18 hours a day.
'I had swollen up all over and I spent five-and-a-half years going from doctor to doctor and they all told me I wanted to be ill and it was all in my head - they tried to give me anti-psychotic medication.
'Eventually in summer 2015, I was able to see a gynecologist, who admitted that the mesh was cutting through my vaginal wall.
'It smelt like I had leg ulcers and I didn’t know what was going on, it was only later that the penny dropped with the doctors that it was the mesh.
'I had been screaming it from the rooftops and no one listened - even my own family.'
Ms Bartram finally had the sling removed at Eastbourne District General Hospital in November 2015, in a three-hour operation, described as ‘very violent'.
It took five months for the wound to heal, and she has even developed an allergy to five antibiotics since the mesh’s removal, meaning she struggles with any infection.
Ms Bartram, whose partner left her two months after the penis-slicing incident, added: 'I can’t work because of all the pain I’m in.
'I have a constant low level electrical buzz all over my body, I’m sore all over, with shooting pains in both ankles and my left elbow.
'Because my pelvic floor has been cut through, holding my body up is a struggle and I’m constantly incontinent.
'I’ve had sepsis even after the mesh was removed, which you don’t expect, and still now I’m having treatment for PTSD - which is difficult, because I’m still living in this trauma.'
Ms Bartram is now hoping to take legal action against the hospital and the tape manufacturers, Johnson & Johnson.
A 51-year-old woman in the US was awarded £42.5 million by the pharmaceuticals company last September.
Her case revealed that the implant was launched without a clinical trial, and then marketed for five years despite the company discovering it had a higher failure rate than two similar devices.
Ms Bartram wants to instruct a solicitor, but is unable to access legal aid and is currently on benefits.
She said: 'I’m going to get legal advice, but I have no money.'
Brighton and Sussex University Hospitals NHS Trust refused to comment on her individual case. However, a spokesperson said her consultant no longer works there.
They added that vaginal mesh is 'no longer being inserted at the Trust for vaginal wall prolapse'. But added it remains an option of urinary stress incontinence.
The spokesperson said they have conducted eight vaginal wall prolapse treatments since March 2018 - but no patient reported pain and none needed a removal.
NHS England estimates 100,000 women have undergone the procedure since it was introduced for surgeons to treat incontinence and prolapse in the 1990s.
Chiefs have remained adamant that only three per cent of patients will experience complications of vaginal mesh, which can curl, twist and cut through tissue.
However, an array of trials into mesh - made of brittle plastic - have revealed the true rate of serious side effects is likely to be nearer the 10 per cent figure.
At least 4,800 women have suffered lacerations and nerve damage from the mesh in England, but only 1,000 have reported it to the MHRA.
However, campaigners stress these are just the tip of the iceberg and that actually there are thousands more - but they have been kept silent.
http://www.dailymail.co.uk/health/article-5518691/Mother-51-claims-left-PTSD-vaginal-mesh.html
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Woman plans to sue hospital trust over mesh ‘trauma’
Mar 19, 2018 | Eastbourne Herald
A mum is planning on suing the hospital that fitted her with a surgical mesh - because it left her unable to work and suffering from Post-traumatic Stress Disorder.
Theresa Bartram, 51, said she suffered so badly after having a trans-vaginal tape put in to lift her prolapsed bladder that she has been left with repeated infections, fibromyalgia and PTSD - usually seen in ex-servicemen.
The mum-of-one from Peacehaven, East Sussex, said she had been suffering from stress incontinence after having a baby when she had the Gynecare TVT sling fitted in 2007.
But the former health worker was forced to have it removed in 2015 after the device cut through her vaginal wall - slicing into her partner’s penis while they had sex.
Theresa, who is now barely able to walk, said: “I had the sling put in because I had a mild prolapse while giving birth standing up, and was told that it was the ‘gold standard’ for women like me.
“The doctor said the risks were minimal, it was fantastic, and there was only a one per cent chance of infection - I had no idea at all that it could cut through me.
“In 2010, it cut my partner during sex because it had perforated my vaginal walls after three years.
“I blew up - I was hugely swollen and looked eight months pregnant - so I went to A&E, but they said I was fine and to go home.
“Eventually it was found that they’d looked at someone else’s blood results and I had liver and pancreas problems, because my body was reacting so violently to the mesh.
“I felt so sick, I kept falling asleep in conversations and on the phone and was sleeping for 18 hours a day.
“I had swollen up all over and I spent five-and-a-half years going from doctor to doctor and they all told me I wanted to be ill and it was all in my head - they tried to give me anti-psychotic medication.
“Eventually in summer 2015, I was able to see a gynecologist, who admitted that the mesh was cutting through my vaginal wall.
“It smelt like I had leg ulcers and I didn’t know what was going on, it was only later that the penny dropped with the doctors that it was the mesh.
“I had been screaming it from the rooftops and no one listened - even my own family.”
Theresa finally had the sling removed at Eastbourne District General Hospital in November 2015, in a three-hour ‘very violent surgery’.
She says it took five months for the wound to heal, and she has even developed an allergy to five antibiotics since the mesh’s removal, meaning she struggles with any infection.
Theresa added: “I can’t work because of all the pain I’m in - I have a constant low level electrical buzz all over my body, I’m sore all over, with shooting pains in both ankles and my left elbow.
“Because my pelvic floor has been cut through, holding my body up is a struggle and I’m constantly incontinent.
“I’ve had sepsis even after the mesh was removed, which you don’t expect, and still now I’m having treatment for PTSD - which is difficult, because I’m still living in this trauma.”
Theresa, whose partner left her two months after the penis-slicing incident, is now hoping to take legal action against the hospital and the tape manufacturers, Johnson & Johnson.
In September, a 51-year-old woman in the US was awarded £42.5 million by the pharmaceuticals company.
Her case revealed that the implant was launched without a clinical trial, and then marketed for five years despite the company discovering it had a higher failure rate than two similar devices.
Theresa wants to instruct a solicitor, but is unable to access legal aid and is currently on benefits.
She said: “I’m going to get legal advice, but I have no money.”
Brighton and Sussex University Hospitals NHS Trust refused to comment on Theresa’s individual case.
A spokesperson said: “Ms Bartram’s consultant is no longer at BSUH.
“NICE issued new guidance on the use of vaginally inserted mesh for vaginal wall prolapse in December 2017.
“This was followed by a statement from the Royal College of Obstetricians and Gynaecologists and the British Society of Urogynaecology.
“The main change is that vaginal mesh is no longer being inserted at the Trust for vaginal wall prolapse.
“Since March 2016, we conducted eight vaginal wall prolapse treatments, for which one patient had recurrent prolapse and no patient had pain, infection or exposure. No mesh required removal.
“The guidelines do not apply to abdominally-inserted mesh, which has a much lower complication rate.
“The NICE guidelines also don’t apply to tapes used for urinary stress incontinence.
“The new National Institute for Health and Clinical Excellence (NICE) guideline on the management of urinary incontinence in women is due for release in March 2018.
“Mid-urethral tape slings remain the most commonly used surgical procedure for stress incontinence in the United Kingdom.
“Our data shows that our rate of mid-urethral tape slings removal for complications is around 2.4 per cent.
“Without being able to comment directly on Ms Bartram’s circumstances, we can’t really say much beyond offering the assurance that we are following the latest guidelines, all patients are followed up after prolapse surgery and assessed and if there are any patients who are not satisfied with the care provided, they can request a follow up assessment.”
https://www.eastbourneherald.co.uk/news/health/woman-plans-to-sue-hospital-trust-over-mesh-trauma-1-8422162
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Senator says doctors could need 'expertise' to identify gender issues raised in mesh inquiry
Mar 20, 2018 | Newcastle Herald
By Joanne McCarthy
A PELVIC mesh scandal that has left Australian women with serious, permanent and disabling injuries is a wake-up call for the medical profession that some doctors might have a problem with women, said Senator Rachel Siewert as a Senate committee prepares to release a report on the scandal.
“The medical profession need to look at themselves about how something like this could have happened. If it wasn’t for the women’s tenacity this still wouldn’t have come to light,” said Senator Rachel Siewert after evidence women were patronised, dismissed, told their problems were "all in their heads”, isolated and silenced by doctors for years after pelvic mesh implants.
A Senate inquiry heard evidence some doctors did not tell women they were being implanted with the devices, or that they had a financial relationship with the manufacturer. At least one woman told the inquiry her doctor suggested anal sex after she was unable to have vaginal sex for the rest of her life following failed mesh surgery.
Senator Siewert, who chaired the inquiry, said she hoped obstetricians and gynaecologists had the capacity to acknowledge and address the underlying gender issues repeatedly raised by women during the inquiry but “maybe they need to get in some expertise about how you do a review, how do you change your practices”.
“It was really clear from the women that they weren’t listened to for a long time,” she said.
Australian Pelvic Mesh Support Group founder Caz Chisholm, who campaigned for the Senate inquiry, said it featured men representing manufacturers defending the devices and male surgeons also defending the devices.
It was really clear from the women that they weren’t listened to for a long time.Senator Rachel Siewert
“It was men making decisions about women’s bodies,” Ms Chisholm said.
”To the women who have been injured by these devices it feels like abuse. It feels like a violation. Mesh injury is traumatic and takes the core of a woman’s femininity away from her, and the industry is dominated by males.”
Australian Medical Association president and Western Australian obstetrician Dr Michael Gannon said he had “heard stories of yesteryear and there may have been a cultural problem in the past” by largely male obstetricians and gynaecologists towards women, but rejected it as a contemporary problem.
“If I reflect on my contemporaries I have to say the male obstetricians/gynaecologists were really, without exception, gentlemen who cared about the women they looked after,” Dr Gannon said.
Asked to comment on whether evidence to the inquiry of women being patronised, dismissed and told their mesh complications were “all in their heads” showed respect by doctors for women, Dr Gannon said he did not dispute their evidence.
“There’s evidence to suggest there was a problem,” he said.
“I have no doubt at all that there are women, a significant number of women, that this is not just their perception, it’s the reality.
“I’ve met individual women who have been caught up in this mess. This is not a great story for medical practice and for gynaecological practice.”
Senator Siewert said it was distressing knowing some women were in so much pain even years after pelvic mesh surgery that they could not sit for very long during the Senate hearings.
She declined to comment on whether the Royal Australian and New Zealand College of Obstetricians and Gynaecologists had responded adequately to concerns raised about some pelvic mesh devices from at least a decade before legal action by women and the first warnings by the American Food and Drug Administration.
She was surprised that even in 2017 there was no formal credentialing process for surgeons using the devices, despite warnings from regulators nearly a decade earlier about the need for skilled, experienced surgeons when performing mesh surgery.
Despite days of public hearings across Australia and hundreds of submissions, there was more to be known about how pelvic mesh devices were approved for the Australian market and remained on the market despite many women reporting serious complications to doctors, Senator Siewert said.
The inquiry revealed there was not enough information about devices and doctors for women to make informed choices when dealing with incontinence or prolapse problems after childbirth, she said.
Senator Siewert said she was saddened but not surprised to hear of the suicide of NSW woman Alison Blake in 2015, only two weeks after a doctor told her nothing could be done to ease her pain or address the devastating consequences of pelvic mesh device surgery.
“Women have spoken about feeling suicidal and it doesn’t surprise me that somebody has. Women have spoken about the agony, the impact on every aspect of their lives,” Senator Siewert said.
She hoped the Senate report, which was due for release on Tuesday but will now be released next week, would help the thousands of women dealing with serious, permanent and incapacitating complications know that their evidence had been heard and “the community now knows this is a real issue”.
“The women don’t have to keep battling for people to recognise they’ve been left with extremely serious and lifelong impacts after mesh surgery. Now it’s a question of how we deal with that,” she said.
The Royal Australian and New Zealand College of Obstetricians and Gynaecologists did not respond to a request for comment.
http://www.theherald.com.au/story/5290477/doctors-warned-of-women-problem-after-pelvic-mesh-scandal/
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Co. Did Not Warn Of Mesh Product Risks, NJ Jury Told
Mar 20, 2018 | Law 360
By Bill Wichert
Law360, Hackensack, N.J. (March 19, 2018, 10:01 PM EDT) -- Counsel for a woman suing C.R. Bard Inc. over pelvic mesh products told a New Jersey state jury Monday that the business knew the devices were unsafe and failed to warn doctors about potential risks, but a company attorney countered that they were safe and that adequate warnings had been provided.
Adam Slater of Mazie Slater Katz & Freeman LLC, representing plaintiff Mary McGinnis, said Bard went through “stoplights” related to alleged defects with the Avaulta Solo Support System and the Align Trans-Obturator Urethral Support System in the global medical device company's pursuit of sales.
Those products caused McGinnis to suffer debilitating pain and made her unable to have sexual relations with her husband, Slater said. A surgeon has said she would not have implanted the devices in McGinnis if Bard had warned the physician about certain risks, according to Slater.
Slater said that Bard did not perform clinical studies on the devices and asserted that internal company documents would show that “Bard knew that there were unsafe aspects of these products.”
“Yet they kept selling them,” Slater told jurors in the Hackensack, New Jersey, courtroom. “Yet they were telling doctors they were safe.”
Displaying images from one of the revision surgeries McGinnis underwent following the initial procedure, Slater later added: “This is unsafe. They knew this was gonna happen and it sure as heck wasn't warned about.”
But Bard attorney Lori G. Cohen of Greenberg Traurig LLP said in her opening statement that the products were “safe and effective” and stressed that they met all requisite standards and requirements to be sold on the market.
Saying there were “significant, substantial mountains of data,” Cohen said the company relied on information related to similar devices and, given that trove of research, new clinical studies were neither needed nor required. Bard also conducted extensive testing of the Avaulta Solo and the Align, Cohen said.
Cohen went over McGinnis' medical history and said preexisting conditions were a potential cause of her medical problems, not the Bard devices.
Cohen cited an informed consent document signed by McGinnis before the initial procedure and asserted that she was notified by the surgeon — following warnings provided by Bard — about the risks of medical issues that McGinnis is now attributing to the company's products.
“She obviously knew this information and warned the patient of exactly the things they are now complaining about,” Cohen said, referring to the surgeon.
Bard also disagreed with the plaintiffs' assertion that the devices were too heavy and the pore sizes in the mesh were too small, Cohen said, adding that the products are “appropriate in terms of balancing to do the work that they need to do and to do it safely and properly and they met the requirements to be on the market to do that.”
McGinnis, who filed the lawsuit in 2011 along with her husband, Thomas, had the devices implanted in March 2009. She underwent the Avaulta Solo procedure to support her bladder, and the Align system was designed to treat stress urinary incontinence, court documents state.
Before McGinnis' procedure, however, Bard knew about problems with the devices, Slater told the jury, citing a Sept. 2, 2008, memo from Bard executive Bobby Orr. The memo refers to a “hypothesis” dealing with mesh design, but Slater said Orr's comments about existing mesh products are “not hypothetical."
“This is the problem they know they have,” Slater said.
The memo stated that “mesh products designed to date are over engineered with regard to strength for the biologic requirement,” and that “the pore size results in formation of a scar plate that is rigid and does not integrate well over time with the host tissue.” Orr proposed the development and testing of “a light weight, large pore mesh for vaginal repair.”
“Mesh construction requires optimization so that integration within the host tissue results in a more natural repair where the resulting scar plate is reduced and is more elastic to meet biologic requirements,” Orr wrote in the memo.
Referring to that passage, Slater said of Bard: “They know they have this need and they keep selling the product.”
But Cohen later countered that a subsequent study disproved Orr's hypothesis about larger pore sizes.
“Nobody is trying to squelch his research. It's great. He was looking at it, thinking about it, thinking ahead,” said Cohen. “Nobody is critical of him for trying to do this.”
The two attorneys also clashed Monday over a material safety data sheet issued by the supplier of the raw material used in the mesh devices.
That sheet stated: “Do not use this Phillips Sumika Polypropylene Company material in medical applications involving permanent implantation in the human body or permanent contact with internal body fluids or tissues,” court documents state.
“No one is gonna dispute that that was the material safety data sheet. No one's going to dispute it was added in 2004, five years before it went in Mary's body, and no one's going to dispute that Bard had this and knew it,” Slater said.
Cohen argued that that warning has nothing to do with the devices ultimately sold by Bard.
“They're talking about a material safety data sheet related to ... the pellets, the raw material. That's where it comes into play,” Cohen said. “This MSDS has nothing to do with the finished product. Zero.”
Mary and Thomas McGinnis are represented by Adam Slater and Cheryll A. Calderon of Mazie Slater Katz & Freeman LLC.
Bard is represented by Lori G. Cohen and Cliff Merrell of Greenberg Traurig LLP and Melissa A. Geist of Reed Smith LLP.
The case is Mary McGinnis et al. v. C.R. Bard Inc. et al., case number L-17543-14, in the Superior Court of New Jersey, County of Bergen.https://www.law360.com/articles/1023473/co-did-not-warn-of-mesh-product-risks-nj-jury-told
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