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PIP breast implants: European Commission says reform neededBy James GallagherHealth reporter, BBC News

The implants were manufactured by the French company Poly Implant Prothese (PIP)

Clinic will not remove implantsWelsh NHS to replace all implantsPIP implants - no free replacement

The PIP breast implant scandal "reinforces" the need to reform Europe-wide regulation, according to the European Commission.

About 300,000 implants were sold around the world, many of them to the European market.

Commission proposals, to be presented later this year, are likely to recommend tougher rules.

Cosmetic surgeons have called for more spot checks and a register of all devices implanted into the body.

French, German and Dutch health authorities have all recommended that women fitted with banned PIP implants should have them removed as a precaution.

The UK has said there is no need for routine removal, but that women should be able to have the implants taken out by private clinics or the NHS if they are anxious.

A new government advertisement was published in English newspapers on Saturday, repeating its position. The chief medical officer, Professor Dame Sally Davies, said the government had already been issuing the advice through a number of sources.

"What we're doing... this weekend is making sure the clarity of the information, with the advice from an expert group involving plastic surgeons, is out there for the whole population to see."

In the UK, private cosmetic companies have been urged to remove implants they fitted - however, some have said it would be unaffordable and have blamed a failure of regulation.

Continue reading the main story

“Start Quote

There's got to be a mandatory register of all implants - pacemakers, buttock implants - if it's inside a human we need to know what happens to it.”End QuoteNigel MercerPlastic surgeon'Tougher'

Breast implants in Europe are regulated by the 2007 directive on medical devices. The European Commission has been reviewing the rules for the past three years and is due to give its recommendations this year.

There are more than 10,000 medical devices ranging from class I devices such as plasters, class IIa and IIb which include X-ray machines and class III, such as breast implants, pacemakers and hip replacements.

Frederic Vincent, health and consumer policy spokesperson for the European Commission, told the BBC: "It [PIP] reinforces our opinion that we have to be tougher on medical devices, particularly class III."

In order for a product to be placed on the market in the EU it needs to be given a CE mark to show it has reached health and safety standards. He said the thinking was to keep the CE label, but there could be debate around being "a bit more tough for things like breast implants and pacemakers".

CE marks are awarded by one of up to 80 "notified bodies".

Mr Vincent said a new directive could ask the member states to be "more stringent" when appointing and monitoring the notified bodies as some were "more serious than others".

However, he added: "We are dealing with a case of fraud. It means that what happened in France could have happened even with a more stringent pre-market assessment of the products."

PIP implants

Implants by the French company Poly Implant Prothese (PIP) were banned in 2010. It emerged the implants contained industrial grade, rather than medical grade, silicone. There has been no evidence of an increased risk of toxicity. However, there have been reports that they are more likely to rupture.

Q&A;: Breast implants health scare

Gemma Pepper is taking part in a protest in London, which is calling on the government to do more to help the women who have been affected.

"I just feel like with these adverts the government has come out and they are still pretty much sitting on the fence," she said.

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