France calls for new rules on breast implants as scandal deepens

Jan 5, 2012, 11:09 GMT

Paris - The French health minister called Thursday for new EU rules on medical devices such as breast implants, as France, Britain and other countries grapple with a scandal over tens of thousands of tainted implants.

'We need other rules on medical devices,' Xavier Bertrand told LCI television. 'A simple label does not suffice,' he said, calling for a change in regulations at the European level.

Medical devices are broadly defined as devices or accessories which aim to produce a physical response in the body - as compared with the pharmacological, immune or metabolic responses produced by drugs. Anti-wrinkle injections also fall under this category.

Bertrand said that, like drugs, they should be licensed for use.

His remarks came ahead of a meeting Thursday of a panel of experts appointed by the government to advise it on the implant scandal.

The experts are to discuss how to implement a recall of tens of thousands of implants manufactured by French company Poly Implant Protheses.

The government in December advised the 30,000 French women with the implant to have them removed after finding the implants - which were made with an industrial-grade silicone - carried an unacceptably high risk of rupture.

When they rupture the implants leak silicone gel into surrounding tissues, causing inflammation.

The French government has offered to cover the cost of the 'explant' procedure.

The experts meeting Thursday was expected to recommend that special surgical units be set up in public hospitals across the country to perform the operations.

Britain's government has come under pressure to follow France's example. Up to 45,000 British women are believed to have received the implants, out of more than 300,000 women with the implants worldwide.

The British government has so far held off advising all recipients to have them removed.

The scandal continued to spread Thursday, amid reports that men could also be affected.

Le Parisien newspaper reported that PIP, which was liquidated in 2008, also produced silicone-based testicular and pectoral implants for men.

The paper quoted unnamed former employees of the company, which was placed under liquidation in 2008.

Health Minister Bertrand said he had ordered the French medical products safety agency Afssaps to investigate the report.