Belfast Telegraph

Thursday 28 August 2014

Clinics' breast implant data 'poor'

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.

He said: "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."

Mr Lansley's comments come after consultant plastic surgeon Fazel Fatah, who is sitting on the panel investigating the implant scandal, said on Tuesday 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 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. Speaking on Sky News, Mr Lansley denied the costs of removing the implants on the NHS had influenced advice.

Mr Fatah, who is president of the British Association of Aesthetic Plastic Surgeons (BAAPS), said on Tuesday 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.

"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."

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