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THE EUROPEAN PARLIAMENT has adopted measures to improve medical safety in the wake of the worldwide scare over faulty breast implants from France.
The measures adopted after nearly five years of debate aim to ensure devices like breast and hip implants can be traced, meet EU patient safety requirements, and face tighter approval procedures.
The assembly in Strasbourg, France also approved laws to tighten up information and ethical requirements for diagnostic medical devices, such as pregnancy or DNA testing.
“We’ve introduced much stricter requirements for the bodies that authorise medical devices,” said Glenis Willmott, a British member of the Socialists and Democrats group who steered the bill through the European Parliament.
Willmott said in a statement that supporters “will insist that particularly high risk devices, such as implants, joint replacements or insulin pumps, be subject to additional expert assessments before they can be authorised”.
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The measures, for example, require patients be given a card allowing them and doctors to trace which product has been implanted, the European Parliament said in a statement.
The conservative European People’s Party, the largest bloc in parliament, said the new EU rules had been agreed on between Parliament and the 28 member states and will enter into force by mid-2020.
A court in the French city of Toulouse in January ordered German safety certifier TUV to pay €60 million in compensation to 20,000 women who received defective breast implants that the group had approved.
TUV Rheinland was ordered to make a provisional payment of €3,000 to each plaintiff for certifying that implants made by French firm Poly Implant Prothese (PIP) met safety standards.
In the far-reaching health scandal, the devices were later found to contain substandard, industrial-grade silicone gel that was seven times cheaper than medical-grade silicone.
Ireland as always behind the times. 10 years ago my friend had implants in Spain. She was given a book from the implant manufacturer and it contains the barcodes, name, product no’s and a raft of other information about them. There was no problem with her quickly identifying that her implants were not involved in the scandal.
Why is this made out like its a great thing to be happen. It is common sense this Information should be provided. You couldn’t by a loaf of bread without knowing where it came from, and what batch it was etc.
@Carina Clarke: we will wait now for years before Ireland does anything about it and quietly gets fixed by the EU over not implementing it. Funnily enough they were all talk about fines for water with the EU. I wonder exactly what laws Ireland hasn’t passed that we get fined for because the government hasn’t done anything about it.
@Kieran O’dwyer: unlike the problem with the individual countries who may take decades, or never, bring in laws.
To be fair the EU brings in reasonable legislation which it’s constituent countries feel unwilling to bring in to law but know in their heart is the right thing to do.
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