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Ethicon Media Monitoring 12/20/2018
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Chronic Pelvic Pain Protocol [Video]
Dec 19, 2018 | Mesh Medical Device News Desk
By Jane Akre
This video is produced by Dr. Greg Vigna and Dr.Michael Hibner concerning the treatment of pudendal neuralgia, or nerve pain following a synthetic vaaginal mesh or sling implant. -
Top 10 Civil Justice Stories for 2018: Part One
Dec 19, 2018 | Legal Examiner
By Richard Shapiro
2018 was a big year for civil justice (and injustice). This top-10 lists highlights massive jury verdicts, including multi-million dollar pending lawsuits and verdicts in the field of personal injury, faulty products, dangerous medical devices, toxic substances, and other civil wrongs involving corporate giants Johnson & Johnson, Monsanto, GM, and other titans of industry. -
Essex mums reveal the horrific side effects of having surgical mesh implants
Dec 19, 2018 | Essexl ive
By Paige Ingram
Thousands of women across the country are suffering the horrific side effects of a surgical mesh which was often implanted to fix problems caused by childbirth. -
The DWP has been under the microscope ahead of a debate in parliament
Dec 19, 2018 | The Canary
By Steve Topple
... I suffer from debilitating pelvic #mesh injuries including nerve damage, severe bladder dysfunction, multiple autoimmune diseases, chronic fatigue, kidney damage, years of chronic infections & biofilms leading to antibiotic resistance. High risk sepsis…
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Chronic Pelvic Pain Protocol [Video]
Dec 19, 2018 | Mesh Medical Device News Desk
By Jane Akre
December 18, 2018 ~ This video is produced by Dr. Greg Vigna and Dr.Michael Hibner concerning the treatment of pudendal neuralgia, or nerve pain following a synthetic vaaginal mesh or sling implant.
Pudendal neuralgia pain may result in a burning sensation or dyspareunia, pelvic pain with sitting, discomfort with tight clothing, problems with the bladder and/or bowel, genital or anal pain.
According to Dr. Hibner, a urogynecologist based in Arizona, when a patient comes in she is first subject to an MRI imaging. On the same day, she receives a physical therapy assessment, all part of diagnosis and initial treatment.
Then if the are pelvic floor muscle spasms, she is scheduled for Botox injections then vaginal suppositories. She will receive Botox injections and wait 2 weeks for it to be effective. If the patient has pain relief after Botox, it’s a pelvic floor muscle spasm as opposed to pudendal neuralgia.
If there is no relief of pain after Botox, the patient is offered three CT Guided Nerve Blocks. The goal is to diagnose pudendal neuralgia and deliver steroid to relieve pain. If a patient receives four, five or six months of pain relief, he will not offer that patient surgery but tell them to return every six months.
Next they proceed with surgical removal of all of the mesh including the arms vaginally and abdominally. He uses a robot in the abdomen to find the arms. If part of the mesh is removed and the arms only remain,removal is much more difficult. Surgery could take six to ten hours which includes a Burch procedure, an anti-incontinence surgery.
https://www.meshmedicaldevicenewsdesk.com/chronic-pelvic-pain-protocol/
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Top 10 Civil Justice Stories for 2018: Part One
Dec 19, 2018 | Legal Examiner
By Richard Shapiro
2018 was a big year for civil justice (and injustice). This top-10 lists highlights massive jury verdicts, including multi-million dollar pending lawsuits and verdicts in the field of personal injury, faulty products, dangerous medical devices, toxic substances, and other civil wrongs involving corporate giants Johnson & Johnson, Monsanto, GM, and other titans of industry. The list also features the most tantalizing civil lawsuits against President Donald Trump, the Trump family & Russia.
This is Legal Examiner’s annual compilation of the 10 most important civil cases of 2018, created by Virginia Beach, VA attorney-author Richard N. (Rick) Shapiro and his research assistants. This year-end compilation has become a tradition and provided by Rick and his team for Legal Examiner since 2012.
In Part I, below, we countdown from 10 through 6 of the top ten civil justice stories.
10. Pelvic Mesh: North Carolina Couple Awarded $68 Million at Trial
· Why It’s Big:
o Thousands of lawsuits have been filed against the manufacturers of pelvic mesh implants devices and juries have often sided with the injured plaintiffs by delivering huge compensatory personal injury awards and demanding large companies pay millions out in punitive damages to punish the wrongdoer.
· What We Learned:
o A husband and wife residing in Raleigh, North Carolina (NC) endured years of pain and hardship from these defective pelvic mesh devices. The wife endured terrible pain from the implanted device, but the husband also had a claim for the interference with their sexual relationship (loss of consortium) due to her ongoing pain. The jury determined that the medical devices were faulty, and that the Raleigh, NC couple was never adequately informed of the risks associated with these devices. This is a big reason why the NC couple received $33 million in faulty medical device compensatory damages and $35 million in punitive damages from the New Jersey jury.
· Dig Deeper:
o https://www.northcarolinaproductliabilitylawyer.com/bard-pelvic-mesh-north-carolina-couple-wins-68-million-jury-award/
9. Monsanto Ordered to Pay $289 Million Due to Cancerous, Toxic Effects of Roundup
· Why It’s Big:
o A jury found, unanimously, that Monsanto’s glyphosate-based Roundup weed killer directly caused a California man’s deadly cancer and that Monsanto failed to warn of this serious health hazard. Furthermore, the jury found that Monsanto acted with “malice, oppression or fraud and should be punished for its conduct.”
· What We Learned:
o During trial, internal company emails were brought to light indicating that Monsanto representatives ghost-wrote portions of scientific articles that would declare there was no link between Roundup’s active ingredient glyphosate and the development of cancer. The jury also found Monsanto knew about Roundup’s carcinogenicity but hid its dangers from the public, which is why they awarded $250 million in punitive damages. One of the “giant slayer” trial attorneys is Timothy Litzenburg, with the Miller Firm, based in Orange, Virginia, a small town with a population under 5,000. “I hope my kids say to me in 20 years, I can’t believe you used that weed spray on your crops, just like how I can’t believe my parents smoked cigarettes on planes,” he said.
· Dig Deeper:
o https://www.courthousenews.com/jurors-defend-289-million-roundup-cancer-verdict/
o https://www.foxbusiness.com/features/meet-the-small-town-attorney-that-took-monsanto-for-298m
8. Settlement Reached in Stryker Hip Replacement Litigation
· Why It’s Big:
o This is another large, multi-district settlement associated with defective hip implant devices. Hip replacements, when working properly, can be life-changing for recipients, and hundreds of millions of dollars are being made by the device manufacturers. But these hip replacement devices have been plagued by defects. This new batch of defective hip replacement devices share many similarities to Stryker’s Rejuvenate modular-neck device, which had product defects that previously resulted in more than $1 billion being paid out in settlements and jury awards to injured claimants.
· What We Learned:
o The devices involved in this settlement relied on cobalt and titanium. Constant wear and tear between these two materials caused fretting and corrosion which produced the release of toxic metal particles into the surrounding tissues of the hip and bodily injury in its users, causing new huge health problems that often eclipsed the original arthritic hip condition for which the defective medical devices were implanted to correct. This settlement amount was not announced, due to a confidentiality agreement, but we assume the manufacturer is paying out hundreds of millions, yet again.
· Dig Deeper:
o https://www.law.com/dailybusinessreview/2018/11/06/stryker-reaches-settlement-in-nationwide-hip-replacement-lawsuits/
7. GM Agrees to Pay $120 Million to Settle Faulty Ignition Switch Claims
· Why It’s Big:
o This continues the massive payout by GM over these faulty ignition switches. GM has already paid more than $2.5 billion in penalties and settlements for the faulty switches.
· What We Learned:
o The consent judgment entered with the State of NY requires GM to instruct its dealers that all recall repairs must be completed before selling a certified, pre-owned vehicle in the United States. The dangerous product defect allowed the ignition switches to move from the “Run” position to the “Accessory” or “Off” position in certain conditions. The State AGs who filed suit against GM alleged that personnel were aware of the faulty ignition switch problem as early as 2004, but they decided it wasn’t a safety concern and GM wrongfully delayed initiating any recalls.
· Dig Deeper:
o http://www.abajournal.com/news/article/gm_agrees_to_pay_120m_to_settle_state_claims_on_faulty_ignition_switches
6. The Trump Trilogy: Three High Profile Civil Cases Pending Against President Trump
· Case No. 1 – New York Claims Trump Foundation Violated the Law
· Why It’s Big:
o The lawsuit not only names President Trump, but two of his children, Ivanka and Eric Trump.
· What We Learned:
o New York filed this lawsuit after a two-year investigation into the Trump Foundation and revelations that President Trump and his family improperly used the charity to settle business disputes and to bolster Trump’s campaign, even implicating the foundation in a 2016 political fund-raiser in Iowa.
· Dig Deeper:
o https://www.nytimes.com/2018/11/23/nyregion/trump-foundation-lawsuit-new-york.html
· Case No. 2 – DNC Takes Legal Action Against Trump’s Family, WikiLeaks, and Russia
· Why It’s Big:
o This New York lawsuit has been hovering under the radar during 2018 but may help bring additional evidence to light concerning the incestuous relationship between members of the Trump 2016 President Campaign, Wikileaks, and the Russian government. Why should the DNC be complaining about illegal hacking of their internal email? Perhaps because they think it may have turned the tide during the 2016 presidential election.
· What We Learned:
o The DNC claims that there is a longstanding relationship between the Trump family and Russia, dating back as early as the 1980s and this long-running relationship provided “fertile ground for a conspiracy.”
· Dig Deeper:
o https://www.courtlistener.com/recap/gov.uscourts.nysd.492363/gov.uscourts.nysd.492363.1.0.pdf
· Case No. 3 – DC and Maryland Take on Trump Over Emoluments Clause of the U.S. Constitution
· Why It’s Big:
o A decision against Trump in this case would provide a clear, irrefutable determination that President Trump has violated the U.S. Constitution by receiving “value” from foreign governments at Trump real estate properties since his election.
· What We Learned:
o The Emoluments Clause of the U.S. Constitution bars any president from personally profiting from his dealings with foreign governments — or even U.S. state governments. The presence of Trump Hotel in Washington, D.C., and the President’s refusal to disassociate and divest himself from his business enterprises, had created a viable legal claim that the President is violating the Constitution.
· Dig Deeper:
o https://www.npr.org/2018/07/25/632300960/federal-lawsuit-against-president-trumps-business-interests-allowed-to-proceed
https://virginiabeach.legalexaminer.com/legal/legal-issues/top-10-civil-justice-stories-for-2018-part-one/
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Essex mums reveal the horrific side effects of having surgical mesh implants
Dec 19, 2018 | Essexl ive
By Paige Ingram
The procedure has had a drastic impact on their lives
Thousands of women across the country are suffering the horrific side effects of a surgical mesh which was often implanted to fix problems caused by childbirth.
The surgical mesh, made of polypropylene plastic, can shrink, twist, degrade and erode into tissue and organs causing chronic pain.
The mesh was most commonly used to treat incontinence, prolapse and hernias.
Following an increase in the number of women experiencing health complications following a mesh implant, NICE guidelines were updated.
In December 2017 the guidelines changed to say vaginal mesh repair “should only be used in the context of research”.
These Essex mums have spoken about the catastrophic impact the procedure has had on their lives
Kirsty Rix's story began in September 2012 after the her youngest son, Ollie, was born two months premature.
He was delivered via cesarean section at Colchester Hospital and after that Kirsty was "in and out of hospital like a yo-yo".
On November 5, 2013 she had a inguinal hernia repaired using the aforementioned mesh.
The 31-year-old from West Bergholt, Colchester, said: "That Christmas my husband had to do everything, look after the kids and me, do the Christmas shopping and go to work himself, my parents also had a stroke at the time; everything went wrong at once.
"I can still hear his exact words, 'you are going to have to have a mesh put in your stomach'.
"Not having a medical degree you just kind of go along with it, but now in hindsight, if I'd have known what I know now I would have said no."'I just want my old life back'
Speaking about how she felt after the procedure, Kirsty said: "It felt like someone was twisting a knife inside me, I couldn't get out of bed, walk or even dress myself, it all fell on my husband.
"It's literally like having a carer 24/7 some days, my husband didn't sign up to look after at the age of 31 and my kids deserve to be out with other kids not sat in a hospital bed eating a packet of crisps while they visit their mum in hospital.
"The hardest thing is putting on a brave face, it's only when the kids are sitting down eating dinner in front of the TV that I come into the kitchen and Mark can see just how bad I am."
Before Kirsty had the mesh implanted she regularly went out with friends socialising, but since the operation she has been unable to go out.
She said: "I have no social life, I am trying to be someone I'm not just to get through day to day life, I just want my old life back, I want to be a normal person again.
"If someone said to me do you want £200,000 or my hernia mesh taken out I would have my mesh taken out any day."
Since being admitted to hospital in March this year with pneumonia, Kirsty has been experiencing severe stomach cramps.
She explained: "I was having trouble going to the toilet and I felt really tired, at first I was just experiencing all the symptoms you get from a wee infection, but then I started to get stomach pains and cramps.
"The stabbing and pulling pains got worse to he point where I was on the floor rocking on all fours screaming because the pain wouldn't stop."
Kirsty was admitted to hospital and was on a morphine drip for four days.
She added: "Yes, it got the pain under control but I would then have the come down off the drug and start shaking, as soon as I got back to normal life it would flair up again and I was back to square one.
"It's not until recently that we have been told its the staples and hernia mesh causing the irritation."'I just hope there is a light at the end of the tunnel'
Kirsty, who married Mark in August this year, said: "What was meant to be the happiest year of my life was so miserable.
"We went to Dubai for our honeymoon and they are so strict on drugs so I some of the honeymoon I enjoyed but some of it I spent in the hotel in pain unable to move.
"If you have a hernia do not have the mesh, I know there are so many women in the same situation as me, I just hope there is a light at the end of the tunnel for us all."Kath's story
In March 2015, Kath Sansom, 50, from Cambridge had a TVT mesh (Tension-free Vaginal Tape) implanted following incontinence problems.
The mum-of-two said: "The pain was instant, so it was obvious it was this operation that caused it.
"It felt as if someone was kicking all down the backs of my legs, and I had a burning in my private parts which meant I could no longer use tampons.
"I could barley walk, the pain was keeping me awake at night. I obviously had a massive reaction to the mesh.
"I tried to hide a lot of the pain because I didn't want my children to see me upset."
Kath, who has two daughters now aged 16 and 21, added: "I used to box twice a week and cycle 20 miles a week, I had the fitness of a 20-year-old when I was in my 40s.
"Overnight I went from a super fit mum of teenagers to a physical wreck who could just about walk my dog round the park.”
In June 2015, just ten weeks after her mesh operation, Kath set up the 'Sling the Mesh Campaign', which has since gained national recgonition.
Kath, who has worked as a journalist since 1990, said: "I just knew I could make a difference and it has been the most important thing I have done in my career.
"It has slowly snowballed and sometimes I forget just how big it is."
The Sling The Mesh Facebook group now has more than 7,000 members who share their individual journeys and advice with others.
Kath is also a formal advisor for the All Party Parliamentary Group (APPG) into mesh, which involves attending debates at both the House of Commons and the House of Lords.
After numerous campaigns, protests and debates in Parliament, the use of mesh has been suspended across the UK until March 2019, for an independent review chaired by Baroness Julia Cumberlege.
In October 2015, Kath had her mesh sling removed by Natalia Price in Oxford and although her quality of life has improved she is adjusting to a new normal.
She explained: "Within one week of having my mesh removed the pain went away, I could go back to using tampons again."'I am not the woman I used to be'
Kath continued: "No woman who has the mesh removed goes back to what they were, it can be a never ending cycle of health problems.
"I haven't boxed for a year and I really miss it, I am not the woman I used to be, but I am better than I was."
Kath is determined to continue helping women across the country experiencing mesh related health problems.
Follow her blog for the latest updates on her battle to ban the mesh.June's story
June Faircloth, from Clacton, had the mesh implant when she was 37 and now, 11 years later, she is finally on the waiting list for an operation to remove it.
June needed the mesh to fix a prolapse which formed following the birth of her two daughters.
Rebecca Lawless, who is now 29, weighed nine pounds 7.5 ounces and Madelaine Stockall, who's now 24, weighed 10 pounds and six ounces.
As a result of having two large babies naturally, June suffered a prolapse of the back passage and the bladder, which were both fixed by the mesh implant in September 2007.
'I was stuck in the Caribbean moaning that I was aching'
June continued: "It was successful, I noticed a change in everything, but two years later I had back surgery, then in 2013 I did a sponsored bike ride for help for Hero's on a tandem with my friend.
"I was really fit I was doing loads of spin classes to get fit for it, but around three weeks after the bike ride I noticed I started going to the toilet more often.
"I went to the doctor for a routine check up and they said I had erosion inside me and I needed my mesh repaired."
In July 2013, June had the mesh repaired and did not notice something was wrong until October when she was on holiday with her friend in Cuba.'The penny dropped'
June said: "I didn't feel right, but I just put it down to the bike ride, I felt guilty that I was stuck in the Caribbean moaning that I was aching.
"If I laid down on a sun bed I couldn't get up or roll over, I couldn't move properly, when I got home I had lots of blood tests done.
"The pain felt like my hips were trying to press through and I've started to notice I'm wobbling when I walk, it's almost like I'm drunk.
"You start to think maybe its just age because I'm not getting any younger, but one day I was watching TV and Sling the Mesh Campaign came up and the penny dropped."'I couldn't get up and dance at my daughter's wedding'
On September 7 this year, June's youngest daughter Madelaine got married.
But sadly June's health meant she could not enjoy the special day to the fullest.
She explained: "I couldn't get up and dance at my daughter's wedding, it was too exhausting.
"It was just a case of getting through the day, I was in bed at quarter to ten that night which is a shame because I love to get on the dance floor and have a boogie."
June is hopeful her operation to remove her mesh implant on December 19 at University College London will be a success and will bring a sense of normality back to her life.
She added: "I'm not so worried about the procedure itself, it's more about the aftercare it is going to be a long battle."Donna's story
Donna McQuire, 54, from Chelmsford, had a TVT mesh implanted in 2012 at the age of 48 to fix her incontinence problems related to stress.
She said: "I was sent home with a catheter because I couldn't pass urine but two days later I was readmitted because I had chronic bleeding.
"I went home again after about a day then I was readmitted four days later with an anal abscess which had to be drained and packed- I ended up having three months off work and then I had MRSA, so it was a catalogue of disasters.
"About 18 months ago the pain was getting so bad and my bladder was ten times worse; it was so embarrassing, I was constantly back and forwards from the doctors.
"I thought maybe I was going through the menopause, sex was really uncomfortable, but I never thought for one minute it was anything to do with my mesh."
Donna, who has been married to her husband Clive for nine years, says her health problems have massively impacted their relationship.
She explained: "It's affected our lives so much, we're not able to have a physical relationship anymore, it's awful because it's horrible for him, it's horrible for me and it's just too painful.
"Clive has been very supportive thought this whole thing, it's put a massive strain on our relationship, we're not a normal couple as such anymore."
Health problems caused by Donna's mesh have also had a huge impact on her career.
She said: "I had a really good high profile job but I wasn't coping well, I was in a lot of pain so I stepped down from regional manager of a medical company to managing a team of just six.
"I can't do my job as effectively as I could ten years ago because of my health, I've lost two jobs because of it and I won't be able to work full time again until I have the mesh removed completely."'I try my best to not let it affect me'
Before Donna had the mesh implanted she used to exercise on a daily basis but since having the mesh she struggles to keep active.
She said: "I never had to worry about my weight, I used to play tennis for a club, I cycled everywhere, I feel like I've gone from a 45-year-old to a 90-year-old in the sense that my mum can walk better than me.
"I am very very positive and strong willed- I try my best to not let it affect me too much."
Donna is due to have her mesh removed early next year.
She said: "The most important thing is to be out of pain, they have to take my mesh out first then they have to look at the bladder then my bowel, so its going to be along process for me
"I would be horrified if they didn't ban it."
In April 2019, the findings of the Independent Review into the use of mesh will be published, which could result in a permanent ban.
https://www.essexlive.news/news/essex-news/essex-mums-reveal-horrific-side-2316880
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The DWP has been under the microscope ahead of a debate in parliament
Dec 19, 2018 | The Canary
By Steve Topple
The Department for Work and Pensions (DWP) has been the subject of a meeting, protest and some public shaming on social media today. But all that was before an official parliamentary debate into it even began.The DWP: nothing to see here
Back in 2012, the WOW (War on Welfare) Campaign launched. Centred around a petition that got over 100,000 signatures, it forced a debate on DWP reforms and their effect on people. Ultimately, it aimed to get the DWP to do a “cumulative impact assessment”. This is where the effects and consequences – both positive and negative – of actions or policies are assessed.
But despite the petition and the debate, the DWP and government still haven’t done an assessment. Both have also ignored calls from the UN to carry one out. The DWP claims it cannot do a cumulative impact assessment because it “cannot be reliably modelled”.
So, WOW Campaign has returned and secured another debate in parliament on the issue. It was due to take place on Wednesday 19 December at 2pm. Timetable changes in parliament meant it was pushed back. At the time of publication, the debate should be happening at 7pm . But activity around the debate began much earlier.Making moves
During the morning, Labour’s Debbie Abrahams, who supported WOW Campaign’s debate, chaired a meeting:“Go private or die”
But campaigner Cat’s story was particularly heartbreaking. She has had numerous problems with the DWP. Cat said in a series of tweets:
My #PIP was reviewed in 2017. Stopped in Aug 2017 the week I had a suprapubic catheter fitted. Assessor ignored my medical conditions & left me with no income for 17 months. I travel to London to see specialists. Without PIP I lost my disability railcard…
I suffer from debilitating pelvic #mesh injuries including nerve damage, severe bladder dysfunction, multiple autoimmune diseases, chronic fatigue, kidney damage, years of chronic infections & biofilms leading to antibiotic resistance. High risk sepsis…
By June 2018, under specialist in complex chronic lower urinary tract infections in London. Have to pay privately to see this specialist. Still no word about tribunal. Still no income. But without treatment? Kidney failure & sepsis. Go private or die…
#Austerity cuts mean access to treatment on #NHS isn’t available. #PIP withdrawn meant accessing life-saving treatment increasingly difficult due to lack of income. By August 2018, a year after PIP was stopped, I just wanted to [stop] fighting & die. This is the cost…
But her story is probably not unusual.A hostile environment
As The Canary exclusively revealed, the DWP, despite its denials, has actually cut disabled people’s benefits in recent years. Moreover, the UN has now produced five separate reports following investigations into UK human rights violations. Yet nothing has changed. And amid all this, 10 claimants a day have been dying in recent years; people who the DWP said were ready to move towards work.
It is this ‘hostile environment’ at the DWP which people have been highlighting. But it will probably also form part of the debate. And for people like Cat, this cannot happen soon enough. So let’s hope that the DWP will be getting the serious scrutiny it deserves.
https://www.thecanary.co/trending/2018/12/19/the-dwp-has-been-under-the-microscope-ahead-of-a-debate-in-parliament/
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