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Ethicon Media Monitoring 4/28/2017
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Vaginal mesh left me in agony. When will women’s health be taken seriously?
Apr 27, 2017 | The Guardian
By Kath Sansom
In the 21st century it is hard to imagine women being maimed in a surgery with risks that they are not being properly warned about. -
Thousands of women await day in court against J&J
Apr 27, 2017 | NJ.com
By Kathleen O'Brien
Maggie Bednarz longed to join the people planning to picket outside Johnson & Johnson's annual shareholders meeting in New Brunswick today, but knew it would be impossible.
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Vaginal mesh left me in agony. When will women’s health be taken seriously?
Apr 27, 2017 | The Guardian
By Kath Sansom
In the 21st century it is hard to imagine women being maimed in a surgery with risks that they are not being properly warned about.
This, however, is the reality of vaginal mesh. A net-like implant, it is used to treat incontinence or prolapse, conditions that have often, but not always, been caused by childbirth. Between 2006 and 2016, more than 92,000 women in England have been treated with a polypropylene surgical material that is either inserted as a mesh patch or a vaginal tape, known as TVT, TVTO and TOT.
Women are told they are going for a simple, low-risk operation that takes just 20 minutes.More than 800 women sue NHS and manufacturers over vaginal mesh implants
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But there is, in fact, the potential for this operation to leave them using a wheelchair or walking with sticks, with leg pain so bad it feels like intense toothache, constant urinary infections that burn and sting, and having to self-catheterise. Some suffer intense inflammation in sensitive tissues which means they lose their sex lives, and the mesh can slice through vaginal walls, urethras or cut into their bladder.
Problems can emerge quickly, or begin years after implantation.
I set up the support page Sling the Mesh on Facebook two years ago, in June 2015, just 10 weeks after I had a mesh implant to treat incontinence from childbirth. The pain in my legs and feet was so intense, along with burning pains in my vagina – like being cut with a cheese wire – that I knew something was terribly wrong.
When I told my surgeon of the pain I was suffering I was ignored. He told me I must have a slipped disc.
I had walked into the operating theatre as one of the fittest mothers in her 40s you could wish to meet – a keen high-board diver, mountain biker and boxer – and emerged a physical wreck. When I searched online I discovered women worldwide suffering similar problems. All were being ignored, not only by their surgeons but also by the media.
Perhaps this will change now that many women are suing the NHS and manufacturers of the implants. These women have all suffered serious complications, however the government watchdog, the Medicines and Healthcare Products Regulatory Agency (MHRA), still says the benefits of this operation outweigh the risks. We know from leaked minutes of a meeting between the MHRA and NHS England in October last year that they are keen to “avoid media attention” over the scandal. It doesn’t seem to be working. Last week, after I appeared on the Victoria Derbyshire show on the BBC to discuss the issue, 200 women joined Sling the Mesh within 24 hours.
This week I was contacted by a lawyer for advice. His client faces having her leg amputated as a result of her mesh implant migrating and causing repeated infections. On the same day three women joined Sling the Mesh; all had lost their bladder because of a simple operation to fix an embarrassing problem. Yes, you read that correctly. Women on support pages globally are losing bladders and bowels, and I estimate more than half the women on my page have lost their sex life.
The majority are told the symptoms they experience after the implant are a mystery. Without the internet we would never have realised that we were not alone.
Some surgeons deny they are putting in a mesh implant when queried by patients, instead calling it a tape or gauze. Or they deny it is plastic. “It is polypropylene” came the earnest reply from a surgeon to one woman earlier this year. (Polypropylene is, of course, plastic.)
The NHS and MHRA say the risk of complications with these operations is 1-3% but a report in the journal Nature by nine leading medics puts that risk at 15%. In the US the Food and Drug Administration recently released figures that said the trocar hooks used to implant the mesh cause injuries for up to 39% of women having a prolapse mesh and 29% of women having a mesh inserted for incontinence.
These aren’t the only problems. Mesh can be fine for years then suddenly shrink or degrade. This happens because the material is not inert – it can change inside the body. Years after implantation it can shrink, twist, harbour infection, go brittle or degrade. Unlike drugs, which have to go through a strict set of three trials, mesh has been approved for use according to a system called substantial equivalence, which means a product can be passed on the basis that there is already something else like it on the market.
Women tell me time and again about how their surgeon told them the risks were very low. Some risks, such as loss of sex life, had not even been highlighted to them, or if they had it was with a quick nod to the medical word dyspareunia (meaning difficult or painful sexual intercourse) and given no further discussion. This is in spite of a Supreme Court ruling in 2015 which stated all surgeons must give reasonable and transparent information to patients about the risks of any procedure.
It is not mandatory for surgeons to report problems to any database and there is no national register, so in truth nobody knows the true scale of this. All I can see as a patient campaigner is women experiencing chronic pain while in many cases surgeons deny the problem has anything to do with their operation. Some go back and forth for up to 10 years before their problems are properly recognised and addressed.What's your experience of vaginal mesh implants?
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Given the complications, why are so many of these operations still being carried out? One answer seems obvious. Inserting a mesh implant takes 20 minutes as a day procedure under general anaesthetic compared to three hours and up to a four-night stay for traditional surgeries which include the Burch colposuspension (a hitch and stitch) or the autologous sling which uses a piece of muscle from a patient’s stomach wall to make a sling.
It is easy to see that vaginal mesh provides a cost-effective fix.
The traditional fixes have risks, as all surgery does, but the old-fashioned methods do not carry the risk of a piece of plastic shrinking inside the body, cutting into delicate tissues or causing allergic foreign body reactions.
The all-party parliamentary group into women’s health was formed this year to press for women to be treated with dignity and respect. Despite this, some women with the implant feel they are “going mad” after being told there is “nothing wrong”, despite years of painful symptoms, they say. Unlike other devices such as hip or breast implants, mesh embeds into the tissue and is designed to be a permanent implant. Removing it is like trying to get chewing gum out of matted hair.
When undergoing this surgery it is Russian roulette as to whether it will be successful or not. Is that a risk worth taking with a woman’s health?
https://www.theguardian.com/commentisfree/2017/apr/27/vaginal-mesh-women-health-bladders-bowels-sex-lives-nhs-operations
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Thousands of women await day in court against J&J
Apr 27, 2017 | NJ.com
By Kathleen O'Brien
Maggie Bednarz longed to join the people planning to picket outside Johnson & Johnson's annual shareholders meeting in New Brunswick today, but knew it would be impossible.
"I could never go," she said in disappointment. "I can't stand up that long."
Bednarz is one of nearly 55,000 women suing the pharmaceutical giant over the transvaginal surgical mesh implants it sold to help fix bladder leakage or bulges in pelvic organs.
Those lawsuits claim that the mesh shrank, broke into pieces, moved about internally or adhered to bone - making it nearly impossible to remove.
In New Jersey alone, the lawsuits number in the thousands, the list of the women's names running to 181 pages.
They're part of one of the largest mass medical injury cases in the country - one that has lumbered along through the courts for years, with no clear end in sight.
Several smaller companies that also sold transvaginal mesh - including C.R. Bard Inc, which is based in Murray Hill - are included in the some of the litigation as well.
Bednarz, 50, is in the pool of cases that have been consolidated in Bergen County Superior Court. She's hopeful that after nearly seven years of torment, she might see some satisfaction for what she said she has endured: Ten surgeries, with perhaps an 11th coming up. Loss of physical intimacy with her husband. Surgical bone damage affecting her leg.
And pain. Constant pain.
"It feels like there's broken glass in my vagina, and just the slightest move just keeps cutting and crushing me," she said. Mesh implants are netting typically made of a bendable kind of polypropylene plastic specifically formulated for use in medical devices, according to Ethicon, the unit of J&J that developed and sold the medical device.
Ethicon debuted the Gynecare Prolift in 2005. The company had success with surgical mesh in patching abdominal walls after men had hernia surgery, before it marketed it to bolster weakened internal tissue in women. Fashioned into a large "sling," with wing-like extensions to buttress it, the mesh could tackle problems with leaking bladders or prolapsed organs.
Seven years later, though, so many women had reported problems that J&J already faced 1,400 lawsuits and stopped selling the mesh surgical. By that time, it had sold nearly 800,000 surgical kits, according to one lawsuit.
The 2012 decision to withdraw from that market "was not related to the safety or efficacy of the products," an Ethicon spokeswoman said.
The Food and Drug Administration last year switched the medical device to its "high risk" category and required companies to do rigorous safety studies.
The company is also being sued by state attorneys general in Kentucky, California and Washington, who claim J&J misled both women and their surgeons about the implant's true risks.
An Ethicon spokeswoman said the Somerville-based company is prepared to try the upcoming cases.
"We empathize with the medical situation of these patients, and are always concerned when an adverse medical event occurs," said spokewoman Kristen Wallace. "We are confident the evidence shows that Ethicon acted appropriately and responsibly in the research, development and marketing of our pelvic mesh products, and will continue to vigorously defend lawsuits concerning their use.
The other N.J. defendant, C.R. Bard Inc., did not response to requests for a comment.
In giant tort cases like this one, the attorneys typically pick several "bellwether" cases that will help both sides get a sense of how a jury may respond to the evidence. They select cases that represent several levels, or tiers, of injury, from inconvenience all the way to death - thereby giving both sides a rough idea of the financial award each type of plaintiff could expect.
Once there are enough verdicts, the two sides can work out settlements for each tier of cases.
One of the first pelvic mesh verdicts was in Atlantic City, where a North Dakota woman who had required 18 surgeries won an $11.1 million verdict in 2013 - including hefty punitive damages of $7.76 million against J&J for misrepresenting the product in brochures. The trial was held in New Jersey because it is the corporate home of J&J.
Adam Slater, with the Roseland law firm that handled that case, has about 300 mesh cases and has been designated one of the lead attorneys to shepherd the sprawling litigation through to Bergen County court to which it has been assigned.
After months of delay because the cases were twice switched to a new judge, a trial date of Nov. 27 has been set. Eight cases have been submitted for consideration; one of those will ultimately be picked. Bednarz, of Ringwood, who is represented by a different attorney, is not in that group of cases.
Slater has done four mesh trials so far, the first one lasting two months, two others lasting three weeks. Two produced verdicts against J&J's Ethicon, while the other two were settled mid-trial, one after just three days.
"They're embarrassing for the women. They're embarrassing for juries," he said of the trials. "Some potential jurors have been excused because they said the topic would be too awkward for them."
That awkwardness has extended to pre-trial depositions as well, Slater said. He said attorneys for the medical device companies often ask the woman if she can't compensate for her injuries by doing "other things" to satisfy her partner.
"You should see the husbands," Slater said of the reaction to that line of questioning. "They look like they want to jump across the table and wring the guy's neck."
The lawsuits typically seek some damages on behalf of the husband's loss of companionship - but in some cases include actual injuries as well, Slater said, as some male partners have been injured by errant mesh prongs during intercourse.
Working with his clients has given him insights into the emotional impact brought about by the failed medical devices, he said.
"These women are catastrophically injured," he said. "They don't feel like real women anymore. They feel like no man is going to love them."
http://www.nj.com/healthfit/index.ssf/2017/04/massive_jj_pelvic_mesh_lawsuit_gets_autumn_court_d.html
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