Minister demands better risk data on implants

Demanding the full picture on the dangers of the sub-standard Poly Implant Prothèse (PIP) implants, Lansley offered firms government experts to help compile the necessary data by Friday.

Nuffield Health became the first clinic to announce it would cover the surgery costs of around 150 women who had received the implants, while others moved to clarify “misrepresentative” reports based on information they had submitted to a Government-commissioned inquiry into the scandal.

Mr Lansley said there was no safety concern justifying the urgent removal of the PIP implants, since the material was not “toxic”, but any woman who is worried should consult a surgeon or GP.

Women who had operations on the NHS should have access free of charge to information on whether they have a PIP implant while private providers are expected to do the same.

Some 95 per cent of PIP implants in the UK were used by private clinics while 5 per cent were used in the NHS for operations such as breast reconstruction after cancer.

Overall, some 42,000 women in the UK are thought to have had the faulty implants, manufactured by the now-closed French PIP company, shut down last year after it was found to be using cheaper industrial silicone. At least 50 clinics have reported cases of ruptured, broken or perished implants so far.

Mr Lansley said: “One of the reasons why I established the expert review on Saturday was because it was clear from one of the private providers that we were getting inconsistent data.

“Some of the private providers, as of yesterday, had not provided any data at all, many had; some had provided what on the face of it looks quite good data, others what appeared to be very poor quality.

“We are expecting them to deliver data in consistent format, so that by the end of this week Sir Bruce Keogh, medical director of the NHS, and his colleagues can give fuller advice based on fuller data.”

He added there was no evidence of a link with cancer after tests proved the implants were not toxic, and added: “The question really comes down to the extent to which these implants fail relative to normal implants and the relative risks of their removal compared to the risk of having an operation.”

One of the clinics, Transform, said that reports suggesting its PIP implants had a rupture rate of seven per cent – seven times higher than the Medicines and Healthcare products Regulatory Agency (MHRA) figures of one per cent – were an exaggeration.

“Transform has not used PIP implants since 2005 with the exception of 108 patients out of the ten of thousands of procedures it has undertaken,” a spokesperson said. “The figure of seven per cent was based on seven cases out of the 108 patients. This is therefore far too small a sample to provide a robust statistical analysis. Our advice to MHRA on sharing these findings was that more information was required.”

The Harley Medical Group said its rupture rate was 1.3 per cent.

In France, the Government told women they should have the implants removed after they were found to contain silicone intended for use in mattresses. A full investigation into the “fully contaminated” implants was ordered on Tuesday and the state has already said it will fund removal operations for 30,000 women.

Nuffield said it had stopped using PIP implants when concerns were first raised in March 2010.

Group medical director Dr Andrew Jones said: “Investigations have yet to determine whether PIP implants pose a specific risk to patients. However, should any procedure carried out at one of our hospitals cause concern, we have always, and will continue to take responsibility to put things right. This case is no different.”

Surgeons said the removal procedure could be completed in about an hour, but did carry some risks. If the implant has ruptured the tougher scar tissue can make the operation more difficult.