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Prosthetics EU controls urged

02/02/2012 09:53:00
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France vowed to strengthen the regulation and monitoring of prosthetics and called for Europe-wide controls after a defective breast implant case sparked a global health scare.
More than 400,000 women around the world are thought to have received implants made by Poly Implant Prothese (PIP), which shut in 2010 after it was found to have used substandard, industrial-grade silicone gel.
European Union rules on regulating and monitoring medical devices “must be radically overhauled”, French Health Minister Xavier Bertrand said in a statement.
Bertrand said inspections of manufacturers of medical devices will be reinforced following the incident, with the number of inspectors increased and the inspections “more numerous and unannounced”.
A report released by French health authorities yesterday had “shown the massive deception organised by PIP” but also “the weaknesses of control and surveillance systems” urging stronger national and European regulation and monitoring of medical devices, he added.

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