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EU urges governments to tighten breast implant controls

09 February 2012, 22:27 CET
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(BRUSSELS) - The European Union's executive arm urged governments on Thursday to tighten controls of medical devices after faulty French-made breast implants sparked a global health scare.

The European Commission called for immediate action within existing laws to restore patient confidence, including by conducting surprise inspections, testing products and ecouraging doctors to report broken devices.

Governments could also set up registers to trace implants, a measure that does not exist in every EU country.

France vowed last week to strengthen the regulation and monitoring of prosthetics and called for EU-wide controls after several governments advised women to have implants made by French firm Poly Implant Prothese (PIP) removed.

"I am deeply concerned about the potential health impact for the many women, in Europe and in other parts of the world, who received faulty silicone breast implants manufactured by the French company PIP," said EU health commissioner John Dalli.

"The consequences for their health are still uncertain," he said, adding that he had ordered an in-depth study into the health impact of PIP implants.

Dalli has written to the EU's 27 health ministers urging them to take immediate action. He said the commission will present revisions to the medical devices legislation before the summer break.

More than 400,000 women around the world are thought to have received implants made by PIP, which shut in 2010 after it was found to have used substandard, industrial-grade silicone gel.

EU regulatory framework for medical devices


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