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Ethicon Media Monitoring 9/26/2018
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The Truth Behind The New York Times’ Transvaginal Mesh Coverage
Sep 26, 2018 | Periscope Group
The New York Times has published a handful of articles this year focusing primarily on a woman out of Arkansas who underwent a transvaginal mesh (“TVM”) kit implant, a surgical finance company who approached her about having the kit removed, a law firm allegedly working in cahoots with the surgical finance company, and a series of lawsuits that this woman filed as a result. -
NZ can’t dismiss calls for surgical mesh inquiry
Sep 26, 2018 | Newsroom
By Teuila Fuatai
Thirty years on from the Cartwright Inquiry and the changes it spurred, Teuila Fuatai assesses how far the doctor-patient relationship has really advanced.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
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The Truth Behind The New York Times’ Transvaginal Mesh Coverage
Sep 26, 2018 | Periscope Group
The New York Times has published a handful of articles this year focusing primarily on a woman out of Arkansas who underwent a transvaginal mesh (“TVM”) kit implant, a surgical finance company who approached her about having the kit removed, a law firm allegedly working in cahoots with the surgical finance company, and a series of lawsuits that this woman filed as a result.
The most recent article on Ms. Jerri Plummer’s situation was published on September 11, 2018, titled: “Prosecutors Are Said to Issue Subpoenas Over Pelvic-Mesh Surgery Financing”. https://www.nytimes.com/2018/09/11/business/vaginal-mesh-surgery-lawsuits-financing.html
What initially caught my attention were buzzwords such as “prosecutors” “subpoenas” and “pelvic-mesh surgery financing.” But, after reading the article, I was disappointed to find the story digressed into a condescending commentary and overgeneralization of the entire TVM litigation.
Descriptions like “lured women,” “tricked,” “unnecessary surgery,” “pressured into getting the implants removed to improve their odds of winning large cash settlements” are dangerous ways to inaccurately portray the real harm hundreds of thousands of women who are not Ms. Plummer suffer every day. And they continue to suffer while desperately seeking medical help in the form of a corrective surgery to remove the mesh.
I highly doubt that the majority of women who have undergone a TVM implant were told the following by their implanting doctor prior to surgery:These TVM kits were not tested in one woman or one human being before being placed on the marketThere is no database or registry to capture failure rates and complications in an accurate and up-to-date manner, so nobody knows how safe these kits really areThe manufacturer of the polypropylene material used to make some of these mesh kits warned “do not use this Chevron Phillips Chemical Company LP material in medical applications involving permanent implantation in the human body or permanent contact with internal body fluids or tissues”Once implanted, these meshes are impossible to remove – in fact, Dr. Tom Margolis, a pelvic surgeon in California, has described it the following way: “trying to get mesh out of the vagina is like taking rebar out of a sidewalk and leaving the sidewalk intact.”There is no plan for removing the mesh and the doctor implanting it likely lacked the skillset and expertise to address and treat any post-implantation TVM complications experienced.
The New York Times chose words like “lured women” “tricked” or “unnecessary surgery” to describe those who have undergone a surgery that was secured by a loan, but are those really fair descriptions for every one of those women out there?
It would be interesting to ask women who have undergone a TVM implant if they would use the New York Time’s exact language to describe the circumstances surrounding their decision to undergo an implant in the first place. In fact, the argument could be made that some women who underwent a TVM kit implant were “pressured into getting the implants” to improve the odds of their OBGYN getting a Lamborghini by the end of the year.
Globally, between 2005 to 2013 there were 3,668,400 TVM kits sold for the treatment of stress urinary incontinence and 848,201 TVM kits sold for the treatment of pelvic organ prolapse. Despite over four million TVM kits being sold over the past decade, there remain only a very small handful of skilled surgeons in the United States, and abroad, who possess the ability to effectively perform mesh removal surgeries.
Because there are few skilled surgeons in the United States to perform corrective surgery treatment, the majority of women who have had a TVM implant cannot get corrective treatment. This often spirals to where they lose their job because they cannot take the physical demands any longer, which leads to a loss of health insurance that they had through their employer, and from there these women are often left struggling to pay their bills while exploring any and all treatment options they have available for the pain and injuries they continue to suffer every day.
Last year, The Guardian used NHS data to show that the number of serious complications from vaginal mesh was much higher than the one (1) to two (2) percent failure rate suggested by the TVM device manufacturers. The Guardian numbers showed that about 1 in every 15 women with vaginal mesh were having to undergo surgery for partial or complete removal of the mesh.
In April, the NHS confirmed the Guardian’s report about the U.K., saying that about 500 women per year were having revision surgery there. In June, the NHS announced it was suspending vaginal mesh implants to avoid further risk of “life-changing injuries” to women. The wait list in the U.K. for corrective TVM surgery repair now goes through May of 2019.
Doctors are now taking out more TVM than they are putting in. “The recent trend of mesh revision is notable with a much faster rate of increase than mesh insertion.” Changes in pelvic organ prolapse surgery in the last decade among United States urologists.
There are an astronomical number of women who are not being “lured” or “tricked” and need a surgery that is absolutely NECESSARY in order to remove the mesh in their vaginas that has left them crippled since the implant. And with respect to accessibility to obtain a corrective surgery? The Guardian points out that overseas there are waiting lists lasting upwards of nine to ten months due to the lack of surgeons available who have the knowledge and expertise to perform corrective surgery.
The New York Times describes Ms. Plummer’s situation as one where she took out a loan that she did not want, in order to undergo a corrective surgery she did not need, after which, Ms. Plummer filed a lawsuit against Boston Scientific in 2016 that she did not want to file, which was resolved, but that led to another lawsuit Ms. Plummer filed in Saline County, Arkansas in 2018, this time for fraud and against her revision surgeon in Florida and TVM attorneys in Minnesota, but also naming Boston Scientific as one of the defendants. In her 2018 lawsuit Ms. Plummer told the court she “believes that the Boston Scientific tape that was implanted in her was defectively designed, but causing her little harm . . . ”
What makes Ms. Plummer’s situation unique, and one that is a poor choice by the New York Times to use as a recent commentary on the entire litigation, is that Ms. Plummer is one of the few women in the United States that suffered only “little harm” post implant.
In 2015, Robert F. Kennedy spoke with former Minnesota Governor Jesse Ventura on an episode of “Off the Grid” where he revealed that 70% of ad revenue for major news networks comes from big pharmaceutical companies. Interestingly, these TVM kits were marketed, sold, and distributed by some of the largest of the big pharmaceutical companies on the globe.
Outside the recent work done by The Guardian over the past year to spotlight the true problems women are having with TVM implants, there has been little if any coverage by major media sources in the United States on what’s really happening. There have been articles discussing some of the complications women are suffering, but as afterthoughts to the bigger piece being discussed, which seems to focus on the unsavory actions of unethical businesses trying to prey on the less fortunate. The focus needs to be on how these TVM kits ever got on the market and why we refuse to take them off the shelves in the United States?
I have spoken with hundreds of women over the past six years who have undergone a TVM implant. Every woman I have spoken with has lived with horrific injuries since undergoing the implant and the majority are desperately trying to find a surgeon with the skill set and expertise to remove the mesh.
The New York Times has clearly focused itself on an issue that is not unique to the TVM litigation but has lost sight of the bigger problem and bigger picture. These medical device companies, the executives who work there, and the sales representatives who were charged with getting these TVM kits into as many hands and vaginas as possible, are the real cast of unsavory characters that New York prosecutors should be issuing subpoenas for and going after.
https://www.periscopegroup.com/transvaginal-mesh/nyt-tvm-truth
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NZ can’t dismiss calls for surgical mesh inquiry
Sep 26, 2018 | Newsroom
By Teuila Fuatai
Thirty years on from the Cartwright Inquiry and the changes it spurred, Teuila Fuatai assesses how far the doctor-patient relationship has really advanced.
The sentiment that ‘doctor knows best’ has persisted through numerous medical botch-ups and poor decision-making over the years. Having the skills to fix people, developed over years of intense training and long hours, gives you a natural standing afforded to only a select few professions by the public.
But when does professional knowledge start to become a barrier for those who trust you with it?
Just a month after the 30th anniversary of the ground-breaking Cartwright Report, which spurred a major shift towards healthcare focused on patient rights, the answer still isn’t clear - at least in the case of surgical mesh implants for urogynaecological procedures.
This ongoing medical saga, spanning more than a decade, has unmistakable parallels to problems identified by the Cartwright inquiry and the 1987 Metro magazine expose which led to it.
Both the inquiry and media investigation showed how National Women’s Hospital doctors Herbert Green and Dennis Bonham chose to abstain from properly treating women with early signs of cervical cancer. The pair also withheld information about the severity of the cancer in their patients, blocking any real discussion on possible treatment options. Green and Bonham believed their behaviour was justified because they were studying how carcinoma in situ - the precursor to cervical cancer - progressed, and whether less invasive forms of treatment would work on it.
At the expense of their patients, the pair proved themselves wrong. Their research methods were also labelled highly unethical.
Fast forward nearly half-a-century and key aspects of how Green and Bonham conducted themselves seem to be replicated in the treatment of women implanted with surgical mesh for incontinence and pelvic organ prolapse.
Just yesterday, “strict new safeguards” overseeing the use of the plastic product in urogynaecological procedures were announced by the Government.
Bear in mind, it's been 10 years since the first surgical mesh injuries were flagged with health authorities. These procedures have also taken place in New Zealand since at least the early 2000s.
The new safeguards included:
“Assessing surgeons undertaking urogynaecological surgical mesh work against credentialing guidance developed by the Australian Commission on Safety and Quality in Health Care.
“Ensuring rigorous informed consent processes that include understandings of the associated risk.”
Acting Associate Health Minister James Shaw also clarified that “only senior medical practitioners with the appropriate training, qualifications, experience and fitness to practice will be able to continue using surgical mesh in these surgeries”.
Shaw's announcement followed a similar letter from Dr Ashley Bloomfield, director general at the Health Ministry, to district health boards. Bloomfield covered suspensions of urogynaecological procedures involving surgical mesh in England and Scotland, and had a stern message to DHBs about surgeons being up-to-scratch:
“If you are not satisfied that your services or surgeons meet these standards, surgeries involving surgical mesh should not take place,” he said.
In the Cartwright report, similar failings from Green and Bonham were articulated through recommendations around informed consent, as well as standard “treatment protocols for gynaecological disease”.
“Treatment protocols for gynaecological disease should be developed and maintained. These protocols will provide the basis for communicating information to various health professionals and for verbal communication with patients," the report said.
For hundreds of women living with debilitating surgical mesh injuries (latest ACC figures show 1018 surgical mesh claims had been decided since 2005), last month’s apology from the Auckland District Health Board for the “events that led to the Cartwright Inquiry” - combined with the most recent round of announcements from those in charge of healthcare - will seem very close to home.
“Judge [Silvia] Cartwright identified long-standing failures in the ethical values and practices used by clinicians who were conducting research at the hospital, operated by the Auckland Hospital Board (now the Auckland District Health Board).
One of the most profound errors was the failure to respect patient consent, to respect the right all patients have to make informed choices about their medical treatment.On the occasion of this anniversary, as Chair of Auckland District Health Board, I formally apologise to the women whose lives were affected by these failures, which for many resulted in an early death.
These patients, including mothers, sisters, partners, daughters, friends and colleagues, whaea and tamahine, were failed by people they trusted to care for their health and wellbeing. We apologise to the women affected for these wrongs.
And to those who have been with them, their whānau, supporters and communities, we also apologise.
To learn from the mistakes of the past it is critical that we remember all aspects of our history, including this serious failure in our care.”
While any advance on the current status quo for New Zealand’s surgical mesh situation is heartening, ongoing problems around the informed consent process and properly qualified surgeons is a huge concern.
It shows that for all the years since the Cartwright Inquiry - and the then-revolutionary changes it led to like the appointment of the Health and Disability Commissioner - there are still major gaps in how patients are treated by doctors.
Calls to revisit just how true New Zealand has held to those 30-year-old recommendations in the form of an inquiry into surgical mesh should not be dismissed by authorities, and users of the health system - for it is obvious that within the medical fraternity, despite the roundtable efforts and announcements, understanding of fundamental principles like informed consent is still lacking.
https://www.newsroom.co.nz/2018/09/25/252406/how-far-is-too-far-to-trust-your-doctor
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