47,000 UK women have faulty PIP breast implants

By Dr. Ananya Mandal, MDMar 18 2012

According to Britain's health ministry an additional 7,000 women were fitted with potentially faulty French-made breast implants, raising the total in the U.K.to about 47,000.

The ministry said Thursday that the new cases follow confirmation by French authorities that implants manufactured before 2001 by the now-defunct French company Poly Implant Prothese, or PIP, also may have contained non-medical grade silicone. The implants were banned in March 2012. Previously, authorities had said that only implants made by PIP after 2001 were affected.

Health Minister Lesley Griffiths said based on fresh information all women concerned they may have had the implants should speak to their surgeon. Britain has said women given the implants by the public National Health Service can have them removed for free, and that private surgeries should offer the same deal. Those denied help by private clinics will receive a free assessment and possible treatment.

The change is not expected to add significantly to the 1,000 cases so far identified in Wales. PIP implants were never used by the NHS in Wales. The Welsh government has agreed to pay to replace them for those treated privately only if there is a clinical need. But it said there is still no clear evidence at present that patients with a PIP implant are at greater risk of harm than those with other implants.

Ms Griffiths said, “It remains the case that there is no clinical evidence to suggest that PIP breast implants should be removed routinely. We are continuing to meet with a range of private providers to remind them of their duty of care to their patients. My overriding concern remains the health and wellbeing of the women who received these implants.”

The Medicines and Healthcare products Regulatory Agency still advises women that there is no evidence to recommend routine removal of the implants.

Mark Harvey, of Hugh James, the lead solicitors for a group action being brought by British women, said it was ‘very disappointing’ news for thousands more women who are being drawn into the scandal. He added, “We call for a public inquiry into the whole way in which medical devices and products are regulated in the UK and across Europe.”

Nigel Mercer, from the British Association of Aesthetic Plastic Surgeons, said, “It now looks as though the time bomb has completely exploded – I don’t think we will definitely have caught all the women. We know of some patients who do not know what implants they have got in and they have been unable to find out. We may never completely  know who does have them in or who doesn’t.”

The MHRA has said the risk of rupture is only one per cent, but a cosmetic surgery chain told ministers privately that the figure could be as high as eight per cent. Many affected women have criticized the health authorities in Britain for being too slow in both giving clear advice and taking any action.

Chief medical officer Professor Dame Sally Davies said, “The expert group advises that there is no evidence to suggest that every woman with a PIP implant should have them removed. But we know this is a worrying time for them and want them to be able to see a GP or specialist to get reassurance and have them removed if necessary.”