Tuesday, September 11, 2012

New rules to end secrecy over safety of medical implants...in Britain

not in the US but in Britain

The Telegraph

New rules to end the secrecy over the safety of devices such as hip replacements and breast implants are being drawn up after a series of scandals


7:50AM BST 09 Sep 2012

 
The changes will mean that for the first time the public will be able to access details of the clinical research behind the products, and their safety record since coming on to the market.
 
The rules are being drawn up by the European Commission in the wake of the PIP breast implant fiasco and the scandal of metal-on-metal hips, which were found to poison the body and suffer failure rates of up to 50 per cent.
Under the current system, the clinical evidence to support devices, and the records of adverse incidents linked with them are kept behind closed doors.
 
Manufacturers must share some information with a "nominated body" of their choice, which authorises their products for use, yet it cannot be seen by the public, nor by independent scientists because of draconian European Union regulations.
 
British regulators run a voluntary system so surgeons can report concerns about medical devices, yet the EU confidentiality rules mean their data is not published, with patients and doctors told nothing - unless the situation deteriorates so badly that a safety alert is issued.

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