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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Sunday, January 4, 2015

Surgical Mesh Ban Scandal in Scotland

Former SNP Health Secretary Alex Neil accused of lying over suspension of mesh implant
FORMER Health Secretary Alex Neil has been accused of lying over the suspension of mesh implants blamed for crippling thousands of women.
Neil banned the controversial surgeries in June and promised they would not resume until a major investigation into the procedures and their side-effects.
But, months after the announcement, he wrote in secret to a surgeon who supports mesh, promising to reinstate the use of implants before the results of a European Commission safety inquiry.
Campaigners yesterday voiced anger and said Neil was claiming credit for launching the investigation while secretly prejudicing the outcome.
He wrote to Aberdeen-based Dr Mohamed Abdel-fattah and pledged to ask the Independent Review – a probe he launched claiming to be proud that Scotland was leading the way in investigating concerns about mesh safety – to reintroduce the use of standard mid-urethral slings (SMUS).
Consultant gynaecologist Abdel-fattah is at the centre of a probe into a trip to Brazil and laptops being offered to the medical team who sign up the most mesh patients.
The surgeon, who has accepted “travel sponsorships” from mesh manufacturer Ethicon, a subsidiary of medical giant Johnson & Johnson, had written to Neil demanding he lift the suspension, claiming it would affect a research programme worth £4million.
In his response, Neil wrote: “I acknowledge the difficulties you highlight as a result of boards’ decisions to suspend the use of SMUS and the impact this is having on patients and on research.
“It is clear from the summary that there is significant evidence to support the use of SMUS in the treatment of stress urinary incontinence.
“What I intend to do is ask the Independent Review for their view about how quickly they can update the evidence base you have summarised in relation to the use of SMUS to consider if they are content to recommend that the use of SMUS can be reinstated ahead of the expert opinion being published from the European Commission.”
Neil was forced to take action against mesh implants last June after a Sunday Mail campaign led to him being called before the Public Petitions Committee.
He was ordered to explain what he was doing in light of mounting evidence of injuries to women being treated for bladder problems and pelvic organ prolapse.
Mesh manufacturers have already pledged payouts of more than £1.5billion in the US and the NHS are braced for an avalanche of negligence claims, with more than 400 cases in Scotland alone. As a result, Neil announced he was suspending mesh procedures across Scotland pending an independent safety review and introducing new patient consent forms spelling out all the possible dangers, including permanent nerve damage and life-changing injuries.
Neil told the Public Petitions Committee: “We should all be very concerned to hear how these implants have affected the lives of some women in Scotland and elsewhere.
“I’ve personally met with women who’ve been adversely affected and I was deeply troubled to hear how they have suffered.”
Campaigners say they feel badly let down by Neil, now Secretary for Social Justice, Communities and Pensioners’ Rights.
Elaine Holmes, of the Scottish Mesh Survivors’ Hear Our Voice campaign, said: “To say we feel betrayed is an understatement. We trusted Alex Neil to do the right thing. To find he was saying one thing in public and something else in private is awful.”
Neil’s successor Shona Robison has assured campaigners she has no plans to reinstate mesh procedures before the report is published.

She said: “All efforts are being made to ensure as much evidence is collected as swiftly as possible. This includes work to gather evidence regarding use of SMUS.
“The Independent Review will be asked for an update prior to the next meeting in January.
“There are no plans for any pronouncements prior to the final report.”

A spokesman for Neil said that he did not wish to comment.

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