Preview Newsletter
Ethicon Media Monitoring 4/4/2017
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Mesh Survivors Shall See The Justice They Deserve
Apr 4, 2017 | Morning Star
By Neil Findlay
TRANSVAGINAL mesh. Have you heard of it? Probably not — why? Because it involves the “V” word. -
100,000 Reasons Why Johnson & Johnson Wants to Forget 2016
Apr 3, 2017 | Daily Hornet
By Elizabeth Bradley
The number of lawsuits is staggering. So is the amount of money Johnson & Johnson has been ordered to pay to people who were injured. -
Scottish Inquiry into Transvaginal Mesh Mess Called a Whitewash
Apr 3, 2017 | Mesh Medical Device Newsdesk
nlike the U.S., the transvaginal mesh mess, in Scotland is front page news.
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Mesh Survivors Shall See The Justice They Deserve
Apr 4, 2017 | Morning Star
By Neil Findlay
TRANSVAGINAL mesh. Have you heard of it? Probably not — why? Because it involves the “V” word.
Apparently in 2017 our society still runs a mile from talking about parts of our bodies that might offend.
For the last four years I have been working with some of the most determined, decent and honest women I have ever had the good fortune to meet.
The Scottish mesh survivors are a group of women who have come together to expose a global scandal that will have a huge impact on healthcare systems across the world.
Transvaginal mesh is a polypropylene product that is implanted in a women’s body to treat pelvic organ prolapse or stress urinary incontinence and is described by the medical profession as “the gold standard” treatment for these conditions.
However, this product has left hundreds of thousands of women across the world disabled and in agony, many have to use wheelchairs, walking aids, some have lost organs and a great many have lost careers and relationships, all because of a product and procedure that was supposed to help them.
You see, being a mesh, when it is implanted the body tissue grows in and around it to anchor it to the body.
This means that should there be complications (and there have been many) it is extremely difficult to remove without causing internal damage to nerves, etc.
Indeed, some have had operations to remove the mesh only for the surgeon to report he has been unable to even find it.
The procedure has been compared to trying to remove chewing gum from hair.
In Australia the biggest class action in Australian history is sitting in the courts.
In the US, litigation against Boston Scientific and Johnson and Johnson has resulted in multimillion-dollar payouts to victims and in Scotland the NHS faces one of its biggest ever claims.
Last week, the Scottish government published the final report of a review into the use of transvaginal mesh. A draft report had been agreed by all members of the review group in 2015.
Since then it transpires that secret meetings were being held without patient representatives Elaine Holmes and Olive McIlroy being invited.
The chair of the review resigned for “personal reasons” and a senior clinician resigned as did Holmes and McIlroy.
The final report, published last week, bore no resemblance to the agreed draft report.
It is claimed that key evidence was omitted, up-to-date information hidden and the independence of the report completely compromised.
In short, the report is a complete and an utter whitewash.
Last week the Cabinet Secretary for Health and Wellbeing Shona Robison and First Minister Nicola Sturgeon were given a torrid time by MSPs furious at this attempted cover up.
Former health secretary Alex Neil, who previously suspended transvaginal mesh implants and who set up the review, was scathing in his critique and joined a chorus of MSPs calling for an investigation into what has gone on with the review.
In the meantime, the mesh suspension in Scotland will be lifted and, despite new guidelines, more women could face the same life-changing consequences that have affected so many women worldwide.
What is crystal clear, however, is that the magnificent Elaine Holmes and Olive McIlroy and the hundreds of women they have been working with are going nowhere — they are more determined than ever to secure justice. I will be with them every step of the way.
Neil Findlay is Labour MSP for Lothian.https://www.morningstaronline.co.uk/a-c460-Mesh-survivors-shall-see-the-justice-they-deserve#.WOMz52-GOCg
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100,000 Reasons Why Johnson & Johnson Wants to Forget 2016
Apr 3, 2017 | Daily Hornet
By Elizabeth Bradley
Johnson & Johnson was hit with 6 out of 7 of the biggest injury verdicts of 2016. The company is accused of putting profits above public safety in 100,000 lawsuits over baby powder, vaginal mesh, hip implants, Risperdal, Xarelto, and more.
The number of lawsuits is staggering. So is the amount of money Johnson & Johnson has been ordered to pay to people who were injured.
In 2016, the company lost six of the seven largest product injury verdicts in the United States. Those big trial losses include:
§ February 2016 — $72 million talcum powder verdict in St. Louis to a woman from Alabama who died of ovarian cancer from using baby powder for 35 years
§ March 2016 — $502 million DePuy Pinnacle metal-on-metal hip implant verdict in Dallas to five people who suffered metal poisoning, device failure, and surgery
§ May 2016 — $55 million talcum powder verdict in St. Louis to a woman from South Dakota with ovarian cancer who used baby powder for 45 years
§ July 2016 — $70 million Risperdal verdict in Philadelphia to a teenage boy from Tennessee who grew breasts (gynecomastia) at the age of 5 years old
§ October 2016 — $70 million talcum powder verdict in St. Louis to a woman from California who survived ovarian cancer after using baby powder for 40 years
§ December 2016 — $1 billion DePuy Pinnacle metal-on-metal hip implant verdict in Dallas to six people from California who suffered metal poisoning and device failure
The company’s most recent filing with the U.S. Securities and Exchange Commission reported nearly 103,000 lawsuits involving five products: Vaginal mesh (54,800), Risperdal (18,500), Xarelto (16,900), Pinnacle hip implants (9,400), and talcum powder (3,100).
The lawsuits involve different products, but all claim that Johnson & Johnson knew the products were dangerous and downplayed risks, putting corporate profits over public safety.
Here’s one example: Alex Gorsky was in charge of marketing Risperdal at Johnson & Johnson. His strategy downplayed side effects, encouraged “off-label” use in children, lobbied states to buy Risperdal over equally-effective inexpensive generics, and paid kickbacks to Omnicare for prescribing Risperdal in nursing homes.
The company paid $2.2 billion in fines to the Justice Department for some of this illegal conduct in 2013, but Risperdal generated over $30 billion during Gorsky’s tenure. For his success, Gorsky was rewarded with a CEO as Johnson & Johnson, where he remains today.
https://dailyhornet.com/2017/100000-reasons-why-johnson-johnson-wants-to-forget-2016/
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Scottish Inquiry into Transvaginal Mesh Mess Called a Whitewash
Apr 3, 2017 | Mesh Medical Device Newsdesk
Mesh Medical Device News Desk, April 3, 2017 ~ Unlike the U.S., the transvaginal mesh mess, in Scotland is front page news.
The government conducted an investigation into the hundreds of injuries there, but the report is falls short of expectations, say campaigners.
They call it a “Whitewash” report that anti-mesh campaigners in Scotland now refuse to sign onto.
The report was supposed to be an official Scottish inquiry into polypropylene transvaginal mesh in Scotland – why was it imported and what were doctors and patients promised about its safety and efficacy.
Johnson & Johnson (Ethicon) and American Medical Systems transvaginal mesh was used on an estimated 1,500 women a year in Scotland between 2000 and 2014.
An interim report issued 17 months ago, (here) recognized the dangerous complications of using untested polypropylene pelvic mesh. This new report does an about-face.
Olive McIlroy and Elaine Holmes are campaigners who are among the hundreds of women in Scotland to receive the implants. Like many of the other women, their lives have been devastated after what was promised to be a simple 20 minute minimally-invasive procedure to treat incontinence. Holmes is in a wheelchair, McIlroy on crutches.
The campaign group, Scottish Mesh Survivors, encouraged a Scottish government review of what’s been described as the biggest medical scandal since thalidomide. Petitioning Parliament and speaking directly to lawmakers, the campaigners became so vocal the country issued a moratorium on the use of transvaginal mesh.
The independent review, headed by Neil Findley and former health secretary, Alex Neil, of opposing parties, has fallen short of expectations.
Now Holmes and McIlroy refuse to associate with it. Here is the Scottish Independent Review.
*The inquiry concludes in the surgical treatment of pelvic organ prolapse, (POP) “current evidence does not indicate any additional benefit from the use of transvaginal implants over native tissue repair.”
*When it comes to treatment for incontinence the language is wiggly. “Women must be offered all appropriate treatment, which includes mesh and non-mesh as well as the information to make informed choices,” it says.
*The report suggests a retropublic approach to surgery rather than transobturator.
*“If we do not carry the confidence and trust of our patients, these reports will not be worth the paper that they are written on,” Alex Neil told Holyrood magazine.
*The report is as notable for what it omits. There is no mention of the 140,000 or so product liability lawsuits filed in the U.S. against seven mesh makers. It does not include evidence of the dangers of transvaginal mesh, which includes nerve damage, chronic pain and infection, mesh shrinkage and erosion, among them.
Marion McBeth of Scottish Mesh Survivors tells MNDthe report is a complete betrayal of everything the women fought for.
“The Mesh campaigners feel betrayed and disgusted that the report has been published with missing evidence and safety warnings withheld. They are so angry they have distanced themselves from it completely and are now threatening legal action called a judicial inquiry in which a law lord will be appointed to question whether the decisions made by the Health Secretary Shona Robison are so perverse they are actionable.
The justice she will also examine whether there was bias within the set up of the inquiry members- which there most certainly was given Mesh injured patients were supposed to be at the heart of the inquiry when in fact they faced a barrage of opposition from pro-Mesh surgeons appointed to the review along with government officials facing the biggest medical claim in Scottish legal history.”
In fact, the report allows the current moratorium to be lifted once so-called “safeguards” are in place. The Scottish version of the U.S. Food and Drug Administration is the Medicines & Healthcare products Regulatory Agency or MHRA. Government regulators insist it is up to MHRA to impose a ban on transvaginal mesh.
According to the Scotsman (here), Both McIlroy and Holmes are not surprised about the report’s shortcomings. They noted they were not invited to meetings they knew that were taking place. One of the clinicians, Dr. Lesley Wilkie, resigned from the inquiry. The enthusiasm that met them initially when they first addressed Parliament had cooled.
Opposition party leaders have backed the mesh-injured women and have pledged the scandal will be raised again in parliament. Labour leader Kezia Digdale described it as a ‘national scandal and disgrace.’ Health committee chairman Neil Findlay has told the SNP government that ‘this fight is far from over- these women are not going away!’ And Conservative MSP Jackson Carlaw has described it as a ‘whitewash’
Mesh is still used but in the EU it is being upgraded from class II to III. In the U.S. only pelvic organ prolapse mesh, an implant larger than that used for incontinence, has been upgraded to the highest level of concern, class III.
n Scotland, since the publicity generated by Scottish Mesh Survivors, there have still been about 400 implants procedures in recent years. Holmes and McIlroy are concerned informed consent is still inadequate in Scotland.
About 420 women there have filed lawsuits with more coming forward weekly. Thompsons law firm is handling the cases.
McBeth and the others are still hopeful.
Mesh campaigners are determined to fight on for justice stove and a judge may now have the final say on deciding whether the government should lift the suspension on a procedure which has inflicted life changing injury on so many women around the world.
At least then campaigners can be assured there will be no bias or conflict of interest from pro-mesh surgeons.
Cheers jane. It’s not over till the fat lady sings and I’ve not uttered a single note. Lol. X
http://www.meshmedicaldevicenewsdesk.com/scottish-inquiry-transvaginal-mesh-mess-called-whitewash/
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