Thursday, 5 January 2012

Breast implant scandal: private clinics providing poor data, says Andrew Lansley

Mr Lansley indicated should a register could be re-introduced, saying: "At the Department of Health we are using anonymised databases to allow us to be much more confident and clear about the safety of what we do."

Mr Lansley denied the costs of removing the implants on the NHS had influenced advice. In France the state has offered to pay for surgery on any woman who has received the sub-standard implants.

"It is entirely a question of what is in the best interests of women," the Health Secretary said.

Mr Lansley told the BBC Radio 4 Today programme that he wanted to be in a position by the end of the week for his expert advisers to have solid figures and evidence on the failure rate of the implants.

He told the programme: "There is no evidence of a link with cancer. Toxicity tests have demonstrated to the satisfaction of the regulator this material is not toxic.

"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 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," he said.

"I wanted to make sure that we did get all of the data and we got as good data as we possibly could.

"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."

He added: "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."

Mr Lansley's comments come after consultant plastic surgeon Fazel Fatah, who is sitting on the panel investigating the implant scandal, said yesterday that there were no firm figures in the UK on what proportion of devices have ruptured.

The Medicines and Healthcare products Regulatory Agency (MHRA) has said its figures indicate 1% of implants in the UK have ruptured, but one clinic, Transform, put its own implant rupture rate nearer 7%.

Some 42,000 women in the UK are thought to have have had the implants, manufactured by the now-closed French PIP company.

Mr Lansley said women should seek advice from their surgeon on what the best approach was and added that where a procedure had been done on the NHS - for example, in the case of breast reconstruction after cancer - scans would be available.

He called on private clinics to offer access to consultations and medical records in the same way.

"We want women who are worried to see their consultants to have advice. Scans will be available. Exactly the same should be expected of private providers," he said.

Professor Williams said implants could be placed into a patient with "relative impugnity" once it had been granted a CE mark of European approval. He criticised the lack of requirements on surgeons to take responsibility for an implant's safety.

"Whereas there are strict criteria that must be met before a new drug can be administered in the UK, the regulation around surgical implants is far more lax - putting patients at risk," Prof Williams wrote in a letter to The Times.

"The minimum requirement is for mandatory databases to be established for all surgical implants and associated techniques. This would need funding, but the NHS would benefit in the long run from avoiding the heavy costs of treating patients whose implants had failed. Such a system would detect problems at a much earlier stage and would reduce the chance of disasters and misery, such as that associated with these PIP breast implants, from occurring again," he wrote.

Source: http://telegraph.feedsportal.com/c/32726/f/568409/s/1b83217f/l/0L0Stelegraph0O0Chealth0Chealthnews0C89916490CBreast0Eimplant0Escandal0Eprivate0Eclinics0Eproviding0Epoor0Edata0Esays0EAndrew0ELansley0Bhtml/story01.htm

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