6th Jan 12
UK to conduct urgent risk review on breast implants
by Harry Oldfield
In need of a review: UK in urgent silicon risk revision
In need of a review: UK in urgent silicon risk revision
The British government is to conduct an urgent review on the risks posed by faulty breast implants to thousands of UK women, announced the health secretary. The analysis will re-examine disputed data on the possible dangers of implants manufactured by the French company Poly Implant Protheses (PIP), who have been charged with using low-cost industrial silicone rather than standard medical material.
Andrew Lansley said new figures provided last week conflicted with prior information submitted to the Medicines and Healthcare Products Regulatory Agency (MHRA). The watchdog group had previously said the chance of the implants breaking was 1 per cent, rather than the 3.6 per cent calculated by France.
Lansley said Professor Sir Bruce Keogh, medical director at the NHS, would now conduct an analysis of the facts. The MHRA is due to carry out an inspection of its evidence to settle anxieties about the quality and content of the information that plastic surgery providers are providing to the regulator.
Lansley confirmed that all was being done to ensure that patients with these implants have access to the best advice possible. All the evidence so far from around the globe suggests that patients should not be anxious, he said, adding that there had not been any unusual levels of issues reported with the implants. However, if any patient is worried, they are advised to contact their GP or surgeon, he stated.
However, the government has recently received figures from an organisation that was not formerly acknowledged or conveyed to the MHRA. The veracity of this data still needs full evaluation and assessment, says Lansley, who has asked Professor Sir Bruce Keogh to carry out an immediate investigation in order to establish whether the government should change the regulatory regime.
Stressing his desire to reassure patients that if any new information came to light about the safety of the implants, Lansley said the government would act swiftly to aid them. He added that the top priority was to ensure that women had access to sound advice.
According to the MHRA, there was no sound evidence that the implants were associated with cancer, so on that ground it has argued that removal was not necessary.
PIP was obliged to stop trading last October after an investigation by French health authorities for allegedly manufacturing substandard implants. It was revealed that last week that the US Food and Drug Administration had warned the company 11 years ago that its saline implants were “adulterated” and failed to meet standard medical requirements.
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