Breast implant data from some clinics is 'poor'
Wednesday 04 January 2012
Some private clinics have provided poor quality data to a review into the risks of rupture posed by a breast implant, Health Secretary Andrew Lansley has warned.
The Government is willing to lend data experts to private clinics over the next 48 hours, if necessary, to help gather statistics for a Government-commissioned panel investigating the risks posed by the French-made PIP implants.
He told BBC Breakfast that medical advice at the moment was that there was no safety concern justifying the routine removal of the implants but any woman who is worried should talk to her surgeon or GP.
“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.
In France, the government has told women they should have the implants removed after they were found to contain non-medical grade silicone intended for use in mattresses.
There have also been fears of a link to cancer although the MHRA insists it has found no evidence for that.
Speaking on Sky News, Mr Lansley denied the costs of removing the implants on the NHS had influenced advice.
“It is entirely a question of what is in the best interests of women,” he said.
“We will do whatever is right based on the evidence and the clinical advice in order to ensure the safety of women and in order to ensure that we only do those things which are justified in terms of the relative risk.”
Mr Fatah, who is president of the British Association of Aesthetic Plastic Surgeons (BAAPS), said yesterday that the review of rupture rates, expected to be published on Friday, would not provide robust data.
“The truth of the matter is that none of these figures are completely reliable or are a true reflection of what's happening,” he said.
“In all cases so far, they are simply recording the ones they have seen with ruptured implants.
“There may be a significant number of silent ruptured implants that we don't know about.
“A significant number of patients also do not go back to the clinic where they had their surgery if they suffer a rupture.
“Instead, they go to the NHS and are dealt with in the NHS.
“We do not know the exact rupture rate in the UK.”
Mr Fatah said he believed women should plan for having implants removed.
“The point is not so much the rupture rates but that the quality of the silicone in these implants is not of medical grade.
“Therefore, the implants are not fit to be implanted into humans.
“They are substandard, they are defective.
“The Government must make sure that women who have these implants are not caught in the middle of an argument over who's going to pay for their removal.
“I think we have reached a point and the level of anxiety is such that there should be clear advice over what is the right course of action for women to take.”
He said private clinics which carried out the surgery had a moral obligation to women and must not be allowed to profit from removing them.
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.”
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.
And he called on private clinics to offer access to consultations and medical records in the same way.
Mr Lansley told the programme: “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.”
Transform's 7% figure is based on data from 108 of its patients who had the implants.
The firm has not used PIP implants since 2005.
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