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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Thursday, March 16, 2017

By Lucy Adams FiDA highlight
Political correspondent, BBC Scotland
  • March 15, 2017

An expert at the centre of the independent review group looking at the safety of mesh implants in Scotland has resigned.
The consultant, who does not wish to be named, stepped down following the revelation that an entire chapter of the final report had been removed.
It follows the resignation of two patient representatives who claimed the report had been watered down.
Health Secretary Shona Robison said no evidence would be hidden.
Transvaginal mesh implants are medical devices used by surgeons to treat pelvic organ prolapse and incontinence in women, conditions that can commonly occur after childbirth.
Over the past 20 years, more than 20,000 women in Scotland have had mesh or tape implants but some have suffered painful and debilitating complications.
There are more than 400 women currently taking legal action against Scottish health boards and manufacturers as a result of mesh implant surgery.
In 2014 former health secretary Alex Neil called for the suspension of such procedures, and an independent review group was set up to look at safety issues.


Patients representatives Olive McIlroy and Elaine Holmes have already resigned from the review group
An interim report published in October 2015 did not advocate a blanket ban on mesh implants but noted that some women do experience serious complications and it made suggestions for reducing the risks. The final report is expected shortly.
Earlier this month, the BBC revealed that an expert member of the review group had written to its chairwoman, raising concerns about the final draft.
The letter states that an entire chapter, which highlighted concerns about the use of mesh in some procedures and contained tables displaying the risks of treatment, had been taken out.
Patients representatives Olive McIlroy and Elaine Holmes, who have both suffered complications as a result of such surgery, resigned from the review earlier this month, claiming that the final report now lacked integrity and independence.


Responding to the latest resignation, Health Secretary Shona Robison said clinical experts sometimes disagreed on complex medical matters.
She said: "I want to reassure the Scottish Mesh Survivors Group their views have been heard, and I want them to remain at the centre of the crucial work.
"I have been clear that all evidence must be made publicly available alongside the report once published. The chair of the Review Group has stressed to me the evidence has been fully considered by the review and none has been hidden.
"This is a complex, technical area and on occasions professionals will disagree. I am aware of the resignation of a clinical member from the group and, while this is unfortunate, their views and contribution to the review is much-appreciated and have proven valuable."
Ms Robision is due to meet Olive McIlroy and Elaine Holmes later this week to discuss their concerns.
In December, the BBC revealed that hundreds of mesh implant operations had been performed in Scotland despite ministers recommending their suspension.
Figures obtained by the BBC revealed that 404 women had received mesh and tape implants since the health secretary called for the suspension in June 2014.

http://www.bbc.com/news/uk-scotland-39279028?SThisFB

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