Germany urges removal of PIP breast implants

AFP - German health authorities recommended Friday that women with potentially faulty breast implants made by French firm 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 have opened a probe into sub-standard silicone used in implants made by the now-defunct Poly Implant Prothese (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 Friday there was no evidence to recommend that more than 40,000 women in Britain with PIP implants should have them removed.

Meanwhile the Czech Republic said that up to 2,000 Czech women who received the implants should have them taken out.

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 December 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.

"Due to the rising number of notices from doctors, trade organisations and hospitals in recent days, the BfArM has expanded its risk assessment for PIP and Rofil breast implants," it said.

"These notices say that silicone from such implants increasingly and over time can leak, even in those without tears."

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.

Around 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.

The founder of PIP said Thursday much of the information emerging in the scandal was untrue but refused further comment.

In a statement, Jean-Claude Mas denounced the "impressive number of untruths" that had emerged but said he would refrain from making other public comments because of a judicial investigation.