Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
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Monday, October 6, 2014

Criminal?: Scottish Surgical Mesh Scandal

Revealed: Two doctors on mesh safetyreview team linked to makers of controversial devices

         Oct 05, 2014 13:53
         By Marion Scott  Daily Record (UK)  FiDA highlight

HEALTH Secretary Alex Neil under fire after victims claim the government probe into mesh implants is being rigged to give operations the all-clear.

Health Secretary Alex Neil
TWO doctors on the government team reviewing the safety of mesh implants have links to the makers of devices used in the controversial surgery.
The appointments have fuelled concern of campaigners that the review has been weighted to support the continued use of the procedures, which have left women around the world crippled and led to multi-million-pound compensation payments.
Ash Monga and Karen Guerrero have been paid by Ethicon, the makers of a mesh product called Gynecare.
Dr Monga described himself as a “consultant for Gynecare” in a 2009 medical research paper.
Dr Guerrero, a surgeon at Glasgow’s Victoria Infirmary, received “educational sponsorships” – including payments and travel costs – from Ethicon and another major mesh manufacturer called Bard.

Dr Karen Guerrero

He won plaudits in June after apparently suspending mesh procedures when Hear Our Voice campaigners, supported by the Sunday Mail, gave evidence to reveal how they have been left in crippling agony by mesh, used to treat prolapse and bladder problems.
At the time, Neil said: “I’m proud Scotland has taken this stance and I believe we are leading the way on what is a significant global problem.”
But we revealed the anger of campaigners last week after discovering government medical advisers wrote to hospitals within weeks of Neil’s announcement to say the suspension was voluntary and encouraged them to use mesh on patients as part of clinical trials.
Yesterday, politicians and campaigners raised new concerns about the appointments to the review body to establish if there are any conflicts of interest.
Scottish Labour’s shadow health secretary Neil Findlay said: “It is outrageous that, after taking over a year to reach a decision on mesh implants, the Health Secretary has appointed doctors to the review who might appear to have a vested interest.
“Those affected have been through far too much in the past few years and this latest development is simply inexcusable.”

Mesh product

Olive McIlroy, of Scottish Mesh Survivors, said: “We are dismayed that people appointed to carry out this vital review have such links to the manufacturers who profit from the use of these devices.
“Alex Neil promised victims would be at the very heart of the independent review but it feels very much like we are lone voices pitted against the country’s most powerful mesh supporters.”
Ethicon, a subsidiary of Johnson & Johnson, have twice had their TVT-O device declared as “defective” by a US court.
It has also emerged that Gibraltar-born Guerrero was among 23 signatories backing an objection to Neil’s suspension of mesh use in the NHS in June.
Dr Guerrero backed the call made by Aberdeen-based urology consultant Mohamed Abdel-Fattah asking for mesh trials to be exempted.
Abdel-Fattah, who has also received “travel sponsorship” from Ethicon, was supported by two other members of the review group, Professor Charis Glazener and consultant urologist Voula Granitsiotis.
Ethicon’s Lucinda Macari said: “Ethicon, in conjunction with the Association of British Healthcare Industries, are supporting efforts by the Scottish Independent Review to gather full and accurate information about pelvic mesh products.”
The Scottish Government said: “This must be an entirely independent review and will be completed as such.”
         Sep 14, 2014 14:11
         By Marion Scott  Daily Record (UK)
MARTHA Salazar's case in Dallas, Texas – the second major victory for mesh victims in America within days – prompts new calls for criminal inquiry in Scotland.

Campaigner Elaine Holmes in the Scottish Parliament.
AN American mesh patient has been awarded £60million compensation by a US court.
Martha Salazar won the huge payout after the court in Dallas, Texas, heard that the Obtryx implant made by Boston Scientific was defective.
They jury was also told that the manufacturers had failed to properly test the device on humans.
It was the second major victory for mesh victims in the States within days.
Earlier this month, Jo Huskey was awarded damages totalling £3million by a West Virginia court for pain and suffering caused by a TVT-O mesh 
implant made by Johnson & Johnson firm Ethicon.
Both these mesh devices were given to Scottish women on the NHS before the procedures were suspended pending safety reviews after an outcry by mesh victims.
The US payouts have led to politicians and victims calling for the Scottish Government to sue manufacturers and launch a criminal probe.
Labour’s shadow health secretary Neil Findlay said: “These cases are proof, if any further evidence is needed given the hundreds of women injured here, that the mesh scandal is shaping up to be a very big issue for Scotland’s NHS.
“It’s high time the Scottish Government challenged the manufacturers over the catastrophic health problems these devices have inflicted on so many women.
“If there’s evidence of clinic data and trial evidence being deliberately withheld, criminal action should be considered.”
Elaine Holmes, of Scottish Mesh Survivors, added: “A car manufacturer who did this would face a criminal investigation and lengthy jail sentences. It should be the same for mesh manufacturers.”
Lawyer Cameron Fyfe, who is acting for over 400 women involved in the biggest-ever medical legal action in Scotland, said: “Potential damages in 
Scotland would be a fraction of those in the US but we expect to have similar success.”

Gareth Easton

Scottish Health Secretary Alex Neil

Health Secretary Alex Neil suspended mesh operations in March pending an independent safety review.

It followed a Sunday Mail campaign which exposed the hidden agony of hundreds of women given mesh implants to treat incontinence and bladder problems.

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