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Ethicon Media Monitoring 5/3/2019
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Wilkinson to step down as MHRA medical device chief
May 2, 2019 | MedTech Dive
By Nick Paul Taylor
John Wilkinson is set to step down as director of devices at the U.K. Medicines and Healthcare products Regulatory Agency in October. -
Treating Chronic Pain – A Success Story
May 3, 2019 | National Pain Report
By Judie Plumley
...Originally, I am a “Mesh Sister”, one of the first women who was implanted with transvaginal mesh in 2002. Over the years it did terrible damage to my female organs, and I am a mess. -
GPs 'dismiss' symptoms of pelvic organ prolapse, study finds
May 2, 2019 | The National
Shame and embarrassment stop some women seeking health help – but GPs "dismiss" symptoms of pelvic organ prolapse, new research has found. -
'No reason in logic' why Ethicon pelvic mash class should not be expanded, judge says
May 2, 2019 | Lawyerly
By Cat Fredenburgh
A judge has signed off on the lead applicants' bid to expand the current group definition in a class action against Johnson & Johnson unit... -
Bard Hernia Mesh Litigation Continues in Federal and State Courts
May 2, 2019 | The National Law Review
By Stefanie Colella-Walsh and Martin P. Schrama
On April 17, 2019, Judge Sargus, who is overseeing the Bard Hernia Mesh MDL in the Southern District of Ohio, held a Case Management Conference.
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Wilkinson to step down as MHRA medical device chief
May 2, 2019 | MedTech Dive
By Nick Paul Taylor
Dive Brief:John Wilkinson is set to step down as director of devices at the U.K. Medicines and Healthcare products Regulatory Agency in October.
Wilkinson joined MHRA in 2012 when its response to the Poly Implant Prothèse (PIP) breast implant scandal was in the spotlight, and will depart against a backdrop of criticism about its handling of adverse events linked to vaginal mesh devices.
Over his seven years at the agency, Wilkinson helped to shape European device regulations and tried to make improvements at MHRA in response to criticism that predated his appointment.Dive Insight:
Wilkinson was involved in multiple initiatives during his time at MHRA, from the establishment of the agency’s position on medical apps to the development of European Union regulations about devices and in vitro diagnostics.
To an extent, Wilkinson’s areas of focus were defined by the criticisms of MHRA that preceded his arrival. While a government report largely exonerated MHRA over the PIP scandal, others took a very different view. The scandal led to a further assessment of the agency and recommendations about how it could improve, including a call for it to "take devices as seriously as medicines."
Under Wilkinson, MHRA sought to implement the recommendations, for example by hiring clinical staff and working with the U.K. Foreign & Commonwealth Office in Brussels to push for regulations that would strengthen oversight of medical devices across the EU.
MHRA also initiated activities intended to improve its relationships with patients and the public, which had been strained early in Wilkinson’s tenure by the agency’s handling of reports about vaginal mesh implants. Elaine Holmes, of the Scottish Mesh Survivors campaign group, summed up the source of the grievances of patients in comments to the Scottish Parliament in 2014.
"The agency is not an effective watchdog. It does not take our concerns seriously. We have written to it a number of times and telephoned it, but we get standard copy-and-paste replies. The agency does not listen to us,” Holmes said.
MHRA has also faced criticism from politicians over its handling of vaginal mesh devices.
"I include the MHRA in my criticisms. When the public petitions committee took evidence from it, we learned that its detailed analysis amounted to three postgraduate students doing a desktop exercise for two weeks at a cost of £20,000 ($26,000)," Jackson Carlaw, a Scottish politician, said during a parliamentary debate in 2016. Another exchange involving Carlaw suggests MHRA spent £40,000.
The revelation led to strong criticism of MHRA, with one politician describing it as evidence that the way the agency reviews devices is "not fit for purpose" and "completely inadequate." MHRA commissioned the report around the time of Wilkinson’s appointment in 2012 and cited it to support the positions it took up over the following years.
In the wake of the criticism, MHRA has promised to take a "more structured approach to proactive patient engagement and improved safety messaging." However, Wilkinson’s as-yet-unidentified successor may be pressured to make other, more significant changes once an independent report into MHRA’s handling of scandals including vaginal mesh safety delivers its findings.
https://www.medtechdive.com/news/wilkinson-to-step-down-as-mhra-medical-device-chief/553922/
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Treating Chronic Pain – A Success Story
May 3, 2019 | National Pain Report
By Judie Plumley
All through the month of April, I had been in more pain than usual. I was trying to build up my muscles against the day my back would no longer carry me. Six years ago, I had contracted MRSA in a dirty OR. It liquefied my back.
Originally, I am a “Mesh Sister”, one of the first women who was implanted with transvaginal mesh in 2002. Over the years it did terrible damage to my female organs, and I am a mess.
For the first decade after mesh, our doctors did not believe us. They scoffed at our pain, they called us liars, drug seekers. I went to one doctor who said if I could stand a pelvic, there was no reason I couldn’t have sex. Really? I cried for days.
Then lawsuits started popping up, and with them, closed groups on Facebook of thousands and thousands of women who had been injured. For me, that is where it all started.
In 2012, there were only 4 doctors in the US who could successfully remove mesh. Your tissue grows through it. It hardens inside you and poisons your tissues. Early in 2013, I was lucky enough to find my doctor in Atlanta, Dr. Miklos, who took excellent care of me, removed most of the mesh, and did some reconstruction. Yet, I did not get better.
By September, I knew something else was wrong; I had an MRI and required a spinal fusion. Within 2 weeks, I had HA-MRSA, “an acceptable risk of surgery” that very nearly killed me.
I battled the infection for a year, having more surgeries, but every time, the infection came back and then the little hospital I was in sent me home to die, and my family took me to Emory in Atlanta.
I was way too sick to remember much, but I do know they saved my life in 2014.
It would be so nice, if when you are sick, all you have to do is concentrate on getting better, but the Opiate Epidemic has made that impossible for pain patients. We all know this. Most of us still play the game though and we get cheated. I wasn’t a game player and I was very afraid I was going have to pay for that decision.
I knew there was a lot of damage done to my body from the mesh and the MRSA, and I would spend the rest of my life in pain. I knew they had put one last ditch effort to save my back, and I was no longer a candidate for surgery. In July, 2015, I lost my COBRA. It was a year after that I was finally awarded Disability benefits. Due to circumstances beyond my control, I had to taper myself off all my pain medications. I couldn’t go to a pain clinic without insurance.
I did see a pain doctor once, but he got a false positive for THC in my urine screen, and refused to see me after that. The $1600 lab test they did prove I had done nothing wrong, but I thought I was black balled.
I researched my options, found kratom and CBD and made do. As time went on, I became less trustful of the Medical Community and what was happening to pain patients. I have severe PTSD from the pain I suffered, and I have declined all medical care for the last 5 years.
I rarely leave my house. I am very active in the kratom community the Chronic Pain Communities and the Global Mesh Alliance. But I stay home. It hurts too much to go out.
The week before Easter, it had gotten to the point I could no longer walk. I felt it was important to go get an X ray just to see what might be wrong.
I told my doctor it took an act of God to get me in his office. Obviously, I wasn’t too far off. The rods holding my fusion were broken.
There is no way to make you understand the terror that went through my soul as I looked at my X-Ray. I thought about hospitals who no longer use opiates, I thought of the horror stories in my closed groups of people who had been refused proper treatment. I thought of Pain Clinics, the CDC, the FDA, the guide lines of 2016, the suicides, and now I had to go back into that hell. I had chosen kratom and CBD, not the mainstream medical care. How were my panic attacks ever going to let me deal with this but I had no choice!
I called the surgeon who had done my surgery 5 years before. I told Dr. Refai’s nurse what had happened. I was still in shock, still thinking it was a mistake. That was Tuesday before Easter.
On Thursday I was admitted to Emory, just like that. All the sudden, there was nothing left to worry about.
My doctor popped his head in, said not to worry about a thing, they had this covered. He would do tests over the weekend, he would do surgery to replace the rods on Monday, and rebuild the parts that did not fuse in the beginning. He went through my back on Monday, then through the front the next Thursday, even though all the scar tissue of the mesh. These were my 29th and 30th surgeries.
They of course took my history; knew I had not seen a doctor in 5 years.
They did not berate my decisions of kratom and CBD. There was not one person who I came in contact with at Emory who was not helpful and kind. Most importantly, I was always given proper pain control, I was always treated with respect, and even my panic attacks, which got really bad at on point, were taken seriously. I was treated the way every person should be treated while ill. It made me believe in healthcare again. The day after the first surgery, I was up walking around with no nerve pain!
Thursday was just a little harder, yet I was able to graduate from PT and IT on Friday. I got home yesterday and I just had to share with you.
Emory has a commercial on its channels that comments on the technology of healthcare today. We have more advances now than we ever have, but it’s going to be up to the hospitals to bring technology and care to the people. The Government is not going to do it, and we need to fix the Healthcare system. It’s going to be up to us. This is a true Easter miracle.
http://nationalpainreport.com/treating-chronic-pain-a-success-story-8839729.html
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GPs 'dismiss' symptoms of pelvic organ prolapse, study finds
May 2, 2019 | The National
Shame and embarrassment stop some women seeking health help – but GPs "dismiss" symptoms of pelvic organ prolapse, new research has found.
The health condition affects around 40% of women over the age of 40 and occurs when the bladder, bowel or womb descend into the vagina, causing pain, incontinence, sexual difficulties and psychological distress.
Treatments have included the use of mesh surgical tapes, which themselves caused serious complications for patients, leaving some with chronic pain and mobility problems. The Scottish Government will reveal new guidelines for improving care later this year, following a campaign spearheaded by patients including Olive McIlroy, from Renfrew, and Elaine Holmes of Newton Mearns.
Now new research by Stirling University's Dr Purva Abhyankar reveals how many women hold off on seeking medical help for pelvic organ prolapse through feelings of shame and embarrassment.
And those who do turn to GPs are "not taken seriously", with doctors dismissing symptoms as "not too bad".
This is despite the body of evidence that lack of early treatment – such as physiotherapy – exacerbates the problem, increasing the need for surgeries.
Abhyankar said: “We found that women’s own confusion and lack of awareness around prolapse symptoms, coupled with feelings of shame and embarrassment, prevented them from seeking early help for symptoms.
“Even when they did seek assistance from their local doctor, symptoms were often dismissed as being ‘not too bad’.
"Women reported that they were ‘not taken seriously’ until their symptoms became more severe. By the time prolapse was suspected and a specialist referral made, the condition had progressed to the extent that surgery was the only viable option left.”
She continued: “The study highlights a need for greater awareness and education among women, as well as healthcare professionals about prolapse and its treatment.
"Women presenting with prolapse symptoms need to be listened to by healthcare professionals, offered better information about treatment choices, and supported to make a decision that is right for them.
“We hope our research will provide a foundation for designing and improving health services in the UK and internationally.”
https://www.thenational.scot/news/17614893.gps-dismiss-symptoms-of-pelvic-organ-prolapse-study-finds/
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'No reason in logic' why Ethicon pelvic mash class should not be expanded, judge says
May 2, 2019 | Lawyerly
By Cat Fredenburgh
A judge has signed off on the lead applicants' bid to expand the current group definition in a class action against Johnson & Johnson unit...
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Story can be found here: https://www.lawyerly.com.au/no-reason-in-logic-why-ethicon-pelvic-mesh-class-should-not-be-expanded-judge-says/
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Bard Hernia Mesh Litigation Continues in Federal and State Courts
May 2, 2019 | The National Law Review
By Stefanie Colella-Walsh and Martin P. Schrama
On April 17, 2019, Judge Sargus, who is overseeing the Bard Hernia Mesh MDL in the Southern District of Ohio, held a Case Management Conference. At the time of the conference, the Court noted that there were just over 1,700 cases filed in the MDL, with approximately 80-100 new cases being filed each week. The parties advised that the protocol and schedule for conducting various depositions were still being discussed, including the depositions of the treating physicians, corporate designees, and company witnesses. Paper discovery from defendants is also still being produced and reviewed by Plaintiffs’ leadership. Another conference is scheduled for early June.
This April conference comes less than a month after Judge Sargus issued Case Management Order No. 15 in which he approved the Bellwether Discovery Pool Plaintiffs. As previously mentioned, the bellwether process allows for an efficient and streamlined judicial approach to potentially resolving many cases that involve common questions or similar sets of facts. As part of the bellwether selection process in the Bard MDL, each party proposed six cases, for a total of twelve cases. Once Core Discovery is completed on the twelve cases selected, each party will then select three cases for trial consideration, for a total of six cases. The Court will then select three cases for bellwether trials by February 14, 2020.
The first bellwether trial in the MDL is currently scheduled to begin on or about May 8, 2020; the second trial will begin on or about July 13, 2020; and the third bellwether trial will begin on or about September 14, 2020. Meanwhile, trials are also being prepared in the Bard hernia mesh state litigation, which is venued in Rhode Island. Multiple trials are currently scheduled to begin in Rhode Island between July 2019 and April 2020.
https://www.natlawreview.com/article/bard-hernia-mesh-litigation-continues-federal-and-state-courts
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