PIP scandal
February 1, 2012
Italy's association of plastic surgeons filed a lawsuit Wednesday against French breast implant maker PIP and German health certification authority TÜV Rheinland.
PIP, the world's third largest silicone producer, was forced to close in 2010 after it was discovered to be using substandard, industrial-grade silicone gel.
"Surgeons who used the incriminating implants were as much the objects of fraud as were the patients," Mario Ceravolo, deputy head of the AICPE association, said in a statement.
The lawsuit also targets TÜV Rheinland, which it says failed to ensure PIP's breast implants conformed to European safety standards.
"We were tricked by a product that carried the CE label and which, at first sight, had all the physical characteristics for this type of operation," Ceravolo said.
The CE label, which stands for European Conformity, signifies the quality of a product complies with European law. It is required for any product sold in Europe.
France calls for stricter regulation
Meanwhile France's health minister, Xavier Bertrand has vowed to strengthen regulations and monitoring of prosthetics, calling for Europe-wide controls following the health scare. He also pledged an increase in industry inspectors with ''more numerous and unannounced'' checks to take place, as well as taking samples for independent analysis.
The minister said the scare had "shown the massive deception organized by PIP," but also the "weaknesses of control and surveillance of systems." He called for a "radical overhaul" of medical device monitoring in the European Union.
French officials have said 16 cases of breast cancer had been detected in 20 French women with the implants, but stressed there was no proven link.
France, Germany and the Czech Republic are encouraging women to have them removed as a precautionary measure. British authorities not followed suit with the universal recommendations, while 13 other countries across Europe and Latin America have urged women to have check-ups. The United States' Food and Drug Administration banned the use of PIP implants in 2000.
Last week, a French court charged PIP's founder, 72-year-old Jean-Claude Mas, with causing "involuntary injuries." A mass fraud investigation is still pending.
cmk/jw/acb (AFP, dpa)