Public Health: Now Germany recommends removal of PIP breast implants
Germany's medical regulator, the Federal Office for Pharmaceuticals and Medical Devices has issued advice that women should have the PIP breast implants removed because the silicon in them is industrial grade not approved for use in medicine or cosmetic procedures. Other countries have made decisions - and they are not all the same.
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The implants, made by French company Poly Implant Prothese (PIP) were found in 2012 to contain silicone intended for use in mattresses. The product was immediately banned in France and the company closed.
The product has been on the market since 2000 and in that time has sold an estimated 300,000 worldwide in more than 60 countries.
The Czech Republich has also advised removal or, at least, annual checking to see if there is any leakage. It is not known what the risks of leakage might be but there is agreement that the risks do not include an increased risk of breast cancer.
In the UK, health authorities say that some 40,000 women have had the implants fitted and that about 2,000 of them had them for medical reasons under the National Health Service. If those 2,000 want the implants removed because they are worried about the report, the NHS says it will perform the operation without charge.
The case against PIP and its owner, Jean-Claude Mas, is proceeding in the French courts. He has told the police that concealing the truth from inspectors was simple: his staff just hid the unauthorised material until the inspectors left the factory. He has denied that there is any risk and sees claims for damages as money-making schemes, some media has reported.
Tests in France and now elsewhere show that the implants rupture more easily than others. Although not considered toxic, the leaking material causes inflammation and that makes removal more difficult with both cosmetic and discomfort levels being worse than they would ordinarily be.
But the situation is worsening with allegations that a researcher in France engaged by radio station RTL said that it included Silopren and Rhodorsil, products more usually found in the rubber and oil industries. PIPs lawyers told RTL that they were wrong and that the substances were food grade approved for use in lipstick.
