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, June 16, 2014

Surgical Mesh: Scandal Deepens in Scotland

         Jun 15, 2014 12:33
         By Marion Scott  Daily Record  FiDA highlight
MESH victims have become concerned over the news that Dr Fred Milani, who worked for one of the mesh manufacturers will be investigating safety issues.

A doctor who was once a consultant to one of the world’s biggest mesh manufacturers has been appointed by the European Commission to investigate safety issues.
The appointment of Dutch urogynaecologist Dr Fred Milani has sparked concern among mesh victims, who say they would have preferred someone with no ties to the industry that they blame for their injuries.
We can reveal that, less than two years ago, Dr Milani stated in medical papers that he had a “consultancy agreement” with Ethicon, the Johnson & Johnson company who produce mesh implants to treat pelvic organ prolapse and bladder problems.
The firm also manufactured the TVT-O mesh implant device which was ruled as defective in a US court of law two months ago.
Milani co-authored a number of medical studies and papers with some of Ethicon’s high-profile management team including Dr Piet Hinoul, former medical director of Ethicon’s Gynecare women’s health and urology.
He has also written medical papers with Ethicon’s clinical director in Scotland, Judi Gauld, and Vanja Sikirica, another ex-associate director at Ethicon.
And in his report to Holland’s Health Care Inspectorate into mesh complications last year, it was noted Milani’s research was partially financed by Ethicon.
Campaigner Olive McIlroy, 57, of Scottish Mesh Survivors, said: “This investigation will have a huge influence across European countries in how they deal with the emerging mesh injury crisis.
“We already feel let down by doctors because so very few of them bothered reporting adverse incidents, allowing the mesh industry and medical watchdogs to continue saying the benefits outweigh the risks. It is vital that the victims have complete confidence in what happens from now on.”
Despite 328 women having repeat surgeries to correct damage, just 12 cases were reported by Scottish doctors.
Dutch health experts have delivered new guidelines on mesh surgery but said a ban on products was not in the best interests of patients.
However, mesh will only be used in patients where traditional methods fail.
A spokeswoman for European Commissioner for Health Tonio Borg said: “Strict rules are in place to assure an independent, excellent and transparent 

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