German health authorities recommended on Friday that women with potentially faulty breast implants made by French firm Poly Implant Prothese (PIP) should have them removed, amid differing risk assessments across Europe.
“The BfArM recommends that the implants in question should be removed as a precautionary measure,” the Federal Institute for Medications and Medical Products said in a statement, using its own abbreviation.
Following complaints from hundreds of women, investigators in France opened a probe into sub-standard silicone used in implants made by the now-defunct PIP.
A deluge of accusations against PIP has triggered a worldwide scare, with several countries, including France, now advising thousands of women to have the implants surgically removed.
However, the assessment of the danger has varied widely in Europe. The British government said on Friday there was no evidence to recommend that more than 40,000 women in Britain with PIP implants should have them removed.
Fears over its implants spread around the world last month after French health authorities advised 30,000 women to have their PIP implants removed because of the increased risk of rupture.
Officials have also said that cancer, including 16 cases of breast cancer, had been detected in 20 French women with the implants, but have insisted there is no proven link with the disease.
The German government has not released a figure on how many women here have the implants, although it has said just 19 have reported silicone leaking.
The German institute said recent information had led it to revise its advisory from Dec. 23 in which it said that patients should ask their doctors to examine whether their implants had developed tears and then decide whether further measures were necessary.
It said the likelihood of rupture depended largely on how long the women had the implants, adding that it was in close contact with other European health authorities to assess the risk.
The institute urged doctors and hospitals to continue to report problems as they develop.
About 300,000 women in 65 countries are believed to have PIP implants. An unknown proportion are made with sub-standard gel which the firm, once the world’s third-largest silicone implant producer, used to cut its costs.
PIP was shut down and its products banned in 2010 after it was revealed to have been using a silicone gel that caused abnormally high rupture rates.
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