This website is dedicated to providing public information regarding DePuy Hip recall and other related information to the recall. None of the information on this site is intended to be formal legal or medical advice, nor should any information on this site be construed as advice that should be used in lieu of information from your attorney or physician.
Tuesday, September 11, 2012
New rules to end secrecy over safety of medical implants...in Britain
not in the US but in Britain
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
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
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.