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Ethicon Media Monitoring 5/15/2017
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A healthy baby isn't the only important outcome of birth. A healthy mother is too
May 13, 2017 | The Sydney Morning Herald
By Clementine Ford
When Stella Channing sought medical help after suffering a pelvic organ prolapse in her late 40s, she was advised of surgery that could easily fix it by the insertion of a transvaginal mesh implant. -
Some women’s mesh implant problems don’t begin until up to seven years later, survey shows
| Wisbech Standard
By Kath Sansom
A worrying number of doctors do not understand mesh implant surgery complications so will not know what to do if a woman presents with problems - which can be years later, according to a survey. -
Punitive Damages Overkill Redux: J&J Hit With Another Massive Disproportionate Punitive Award In Talc Litigation
May 12, 2017 | Mondaq
By Evan M. Tager
Just about a week after suffering its third punitive award in pelvic-mesh litigation, Johnson & Johnson found itself on the wrong end of a $105 million punitive award—close to 20 times the $5.4 million compensatory award—in litigation alleging that its iconic talcum powder causes ovarian cancer in women.
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A healthy baby isn't the only important outcome of birth. A healthy mother is too
May 13, 2017 | The Sydney Morning Herald
By Clementine Ford
When Stella Channing sought medical help after suffering a pelvic organ prolapse in her late 40s, she was advised of surgery that could easily fix it by the insertion of a transvaginal mesh implant. Unfortunately, like most women, Channing was not properly informed of the risks. Her overnight hospital stay turned into an eight day stint and the mesh (which had been grafted into the wall separating her vagina from her rectum) began to erode one week after being discharged. From here, her condition rapidly deteriorated.
Only a few years later, Channing is now mostly confined to her bed. She is now unable to sit down because of the pressure placed on her pelvis, and she suffers chronic bleeding and pain. In her words, the mesh has "continued to erode and shrink, shrinking and hardening [her] rectum, trapping and scarring the pudendal nerves running through the rectum and legs, damaging the flesh and muscles throughout the pelvis." She describes the nerve pain as being "like petrol burning inside me."
Channing is just one of more than 200 women giving evidence to a Senate Inquiry into the "adverse effects" experienced following the insertion of transvaginal mesh implants. Senator Derryn Hinch spearheaded the inquiry, describing the medical intervention as one of the worst mass cases of medical negligence since doctors widely prescribed thalidomide to cure morning sickness. Those adverse events include chronic pain, erosion of the implant, disability, loss of sexual function, constant bleeding and ongoing incontinence. (A recent survey on the Facebook page Understanding pelvic mesh implants & impacts on women in Australia had almost 1500 respondents, but nobody knows overall how many are experiencing these "adverse events" as a result of this surgery.)
Transvaginal mesh implants were approved for use in 2005 by the Therapeutic Drugs Administration, but no clinical trials had been performed. Horrifyingly, the procedure is irreversible.
You might be wondering how thousands of women can have been told that transvaginal mesh implants (branded by Johnson & Johnson) could "fix" pelvic organ prolapse when there was barely any evidence to support the long (or even short) term efficacy. But this disgraceful, widespread medical malpractice is just one extreme example of the general dismissiveness shown towards women's health and particularly the health of postpartum women.
For many of us who have experienced birth, there is immense pressure to remain upbeat and positive about the experience. Veer too closely into territory that's considered "unseemly" and you'll be swiftly reminded that the most important thing is giving birth to a healthy baby. Childbirth, we are frequently reminded (and all too often by people who have never experienced it nor will ever experience it, i.e. cisgender men), isn't that big a deal. Billions of women have done it, and most of them didn't have the luxury of doing it in a hospital. Quit your whining, privileged women! I mean, how hard can it be if mere women can do it?
Torn muscles, postpartum depression, incontinence and pelvic organ prolapse: these are just some of these "no big deal" complications that can arise for women who have given birth. And compounding this showbag of potential various traumas is the narrative that instructs women to remain silent about their postpartum woes and to focus instead on their good fortune and "precious little bundles".
When Leah McLaren wrote about her birth trauma (which included the later discovery of a prolapsed bladder) for the Guardian UK recently, sympathetic comments were interspersed with sneers about "privileged white women" who needed to stop whinging. One man went so far as to compare his own stoicism in the face of surgery with McLaren's comparative self-indulgence, with no respect for the fact that surgery typically aims to fix problems rather than create them and that childbirth is the only medical procedure in which its participants are encouraged to eschew pain relief.
Prolapse – including the kind experienced by Channing, who is not incidentally also the mother of three children – isn't a tiny little thing, nor should the risks of it be downplayed or dismissed when those women affected by it dare to bravely speak up. In fact, pelvic organ prolapse is estimated to affect around half of all people who've had a baby, with around one-fifth of them needing medical help or intervention.
And while some of these prolapses can occur immediately or soon after birth, they are more likely to happen during or after menopause as our hormone levels shift, which means that pelvic floor health is a lifelong goal. Because no matter when a prolapse occurs, the impact it has on a woman's life is devastating. Shame, depression and a sense of isolation are all common, with the prolapse itself affecting any or all of the bladder, the uterus or the bowel. Some women never seek help because of the embarrassment associated, and those who do sometimes need to fight to be taken seriously. (In McLaren's account, albeit one from the UK, she wrote about being palmed off until the point she insisted further investigation be made – it was only after this that her bladder prolapse was discovered.)
Which brings us back to the idea that the trauma of childbirth is somehow reduced solely to a few labour pains and a bit of a sore downstairs. Worse, it's treated like something women should easily bounce back from. I recently began seeing a women's health and fitness specialist who focuses primarily on pelvic floor conditioning. When I told Michelle that I had "just" suffered a second-degree tear during the birth of my child last year, she reminded me that it's hard to think of any other circumstance in which a torn muscle would be downplayed as something minor. And yet, this downplaying seems part and parcel of the cultural expectations that birth be experienced "drug free" and "naturally" in order to somehow imbue it with more meaning and denote a greater maternal strength in the labouring woman. Those people who birth by Caesarean are not infrequently treated as if they cheated – because major abdominal surgery is such a walk in the park, especially when it's immediately followed by the care of a squalling newborn.
This cuts close to the bone for me. I have not suffered a postpartum prolapse (and I hope the pelvic floor conditioning I'm doing now will help to avoid one later on), but I did wear bladder incontinence liners for the first seven months of my child's life. For most of this time, I was too embarrassed to speak out about it. It was only after meeting my trainer, Michelle, that I realised how common these kinds of problems are. Prior to this, (after searching Google for cures and treatments) I read a lot about mesh implants – but nothing about the horrifying risks associated with them.
Giving birth is not a walk in the park. Our ability to come through it relatively unscathed is not testament to our strength and fortitude as humans. Injuries sustained during childbirth are real, and so is the trauma that can come from treating those injuries. Why is it still framed as something in which the only important outcome is the health of the baby and not also the health of the mother? It is one of the most physically dangerous things a person can go through and it needs to be treated as such. The risks posed to our health are lifelong, yet it seems not enough of us are made aware of this.
For women like Stella Channing, that lesson has come with a hefty price. This Senate inquiry and its findings may go some small way to making up for the harm done to Channing and women like her – but it should never have come to this.
http://www.smh.com.au/lifestyle/news-and-views/opinion/a-healthy-baby-isnt-the-only-important-outcome-of-birth-a-healthy-mother-is-too-20170511-gw35ra.html
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Some women’s mesh implant problems don’t begin until up to seven years later, survey shows
| Wisbech Standard
By Kath Sansom
A worrying number of doctors do not understand mesh implant surgery complications so will not know what to do if a woman presents with problems - which can be years later, according to a survey.
Some women said that problems did not start until up to seven years later.
The patient forum survey showed that two in ten GPs didn’t know what the surgery was and almost half did not believe women when they said their problems were mesh implant related.
The survey results come just weeks after MP Paula Sherriff launched the All Party Parliamentary Group (APGG) into women’s health to make sure females were listened to and treated with dignity and respect.
In her group’s launch report Ms Sherriff says: “The group has heard of areas of health care where women receive worse outcomes due to a lack of awareness.
“All too often I have heard of women being marginalised and side-lined when they try to seek help, dismissed and not taken seriously.
“This needs to stop. Women have a right to be heard and they deserve to be treated with dignity and respect at all times.”
A survey of 123 patients on Sling The Mesh forum showed that 20 per cent of doctors did not know about the mesh implant surgery for incontinence or prolapse and a further 45 per cent did not believe a woman’s pain was related to that procedure.
The survey, carried out this month, showed that more than seven out of 10 people (73 per cent) suffered a complication within the first year.
For almost two out of ten (17 per cent) problems started between year one and three.
Some problems did not cut in for some women until seven years later.
Only six out of ten of those people suffering sought medical help in the first year (63 per cent) while two out of ten asked for help between one and three years (20 per cent).
Almost one in ten sought help between one and three years, while 7.5 per cent asked for medical help up to seven years later.
The survey also showed that more than half of those surveyed (56 per cent) had not reported their mesh pain and complications to the Government watchdog body’s MHRA Yellow Card system.
This is the official logging system that lets the Government know how many people have had problems with medical devices, drugs or concerns like e cigarettes.
The under reporting means the figures quoted by the MHRA are only telling half the story.
The MHRA say this surgery carries a risk of one to three per cent but campaigners say this figure is grossly under reported.
• Two reports released in 2015 says mesh degrades in the body. When queried about these reports the MHRA said: “This will contribute to our on-going work in monitoring the safety and performance of these medical devices.
“We note that this study concludes that both physical and chemical aspects of polypropylene degradation need to be studied more extensively for their roles in the development of complications, which we fully agree with.”
• However, the spokesman added: “Any women who are concerned should speak to their doctor or surgeon.”
The same doctors who, as the study suggests, often do not believe mesh has anything to do with a woman’s mesh pain.
• The MHRA spokesman said: “We have listened to and understand the concerns that many women have, for the majority the use of vaginal mesh implants is safe and effective and can greatly help in dealing with upsetting conditions such as urinary stress incontinence and pelvic organ prolapse.
“We undertook extensive analysis of transvaginal tapes and meshes at the request of the Chief Medical Officer for England and our findings show that the benefits continue to outweigh the risks.
• They said: “As with all medical devices we will continue to monitor their safety and performance and we encourage women to report any adverse incidents to us via our Yellow Card scheme.”
The same Yellow Card Scheme that a leaked document shows the MHRA wants to keep out of the media spotlight.
• MP Paula Sherriff concentrated her launch report on endometriosis and fibroids but it is hoped other women’s health conditions will be taken on board as the group gathers momentum. Read her report here.
http://www.wisbechstandard.co.uk/news/some-women-s-mesh-implant-problems-don-t-begin-until-up-to-seven-years-later-survey-shows-1-5016683
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May 12, 2017 | Mondaq
By Evan M. Tager
Just about a week after suffering its third punitive award in pelvic-mesh litigation, Johnson & Johnson found itself on the wrong end of a $105 million punitive award—close to 20 times the $5.4 million compensatory award—in litigation alleging that its iconic talcum powder causes ovarian cancer in women.
As in the pelvic-mesh litigation, this is one of several punitive awards arising out of the same product and claims—including $62 million and $50 million verdicts in the first half of 2016 and a $65 million verdict in October 2016—all imposed by St. Louis, Missouri juries in trials supervised by the same state-court judge.
By this point, what more is there to say beyond what we already have said in prior posts? Only this: Even if a Missouri court can exercise personal jurisdiction over out-of-state companies brought by out-of-state plaintiffs, due process almost surely forbids application of Missouri law to the controversy, including Missouri punitive damages law.
In this particular case, the claim was brought by a Virginia resident against a New Jersey defendant. Virginia has a strict $350,000 cap on punitive damages, while New Jersey caps punitive damages at five times the compensatory damages. If the St. Louis trial judge applies either state's law in resolving the post-trial motions, J&J should, at minimum, see a dramatic reduction of the punitive damages.
Moreover, for reasons my colleagues and I have explained on numerous previous occasions, a ratio of 5:1 in a case like this one would almost certainly be unconstitutionally excessive, because if every plaintiff were to obtain a punitive award in that ratio to the compensatory damages, the aggregate punishment would far exceed any amount that could reasonably be thought necessary to punish and deter.
The appeal from one of the earlier verdicts was argued in the Missouri Court of Appeal on May 10. We will be watching what the appellate court does in that case with great interest.
http://www.mondaq.com/unitedstates/x/593838/trials+appeals+compensation/Punitive+Damages+Overkill+Redux+JJ+Hit+With+Another+Massive+Disproportionate+Punitive+Award+In+Talc+Litigation
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