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France urges tighter EU rules on implants

Thu, 5 Jan 2012 23:28 GMT

Source: reuters // Reuters

PARIS, Jan 5 (Reuters) - France on Thursday called for tighter European Union regulations on medical devices in response to a global health scare about French-made breast implants.

Health Minister Xavier Bertrand said the EU needed to require suppliers of medical devices, like implants, to get the same sort of authorisation to sell their products as suppliers of prescription medicines.

"It's an unprecedented change but it's one that's necessary," Bertrand told France's LCI television.

The announcement came amid growing concerns about breast implants made by the now-defunct French company Poly Implant Prothese (PIP).

French authorities withdrew the prostheses in March 2010, but concerns have been deepening since the death from cancer last year of a French woman carrying PIP implants.

Unlike prescription medicines, medical devices currently only require quality certification before being sold to the public.

TUV Rheinland, the German certification body that checked PIP's products until March 2010, has said its remit was to look into the manufacturing process but not the content of the silicone used in the implants.

Bertrand said medical devices should have a marketing authorisation or AMM (autorisation de mise sur le marche) - an approval given to pharmaceutical products by national health regulators or the European Medicines Agency (EMA).

France's national medical authority, the DGS, and the medical regulatory agency Afssaps said on Thursday the system did not offer enough protection for consumers and echoed Bertrand's calls for a change in EU rules on "high risk" medical devices.

At a meeting in Paris of a committee set up to monitor women with PIP implants, both bodies also said they would launch an enquiry into why surveillance of PIP in France had failed.

"We've got our own problems to sort out, but it has to be said that there was no regulation in place requiring manufacturers to implement proper controls," Dominique Maraninchi, head of the Afssaps said.

The French government has advised the 30,000 women in the country with PIP implants to have them removed after an official report said they were more prone to rupturing than standard medical implants. Ruptured implants can cause irritation and inflammation.

Afssaps has said 20 cases of cancer have been found in women with PIP implants, but it has ruled out any link between the prostheses and cancer.

Britain has also ordered a review of the safety of implants made by the bankrupt firm, but has so far stopped short of advising their complete removal. About 300,000 PIP implants were sold worldwide before the French company went bust last year. (Reporting By Chine Labbe and Vicky Buffery; Editing by Andrew Heavens)