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Breast implants: UK to review risk assessment data Breast implants: UK to review risk assessment data
(40 minutes later)
A review of data used to assess the risks posed by faulty breast implants is to be carried out by the government. A government review of data used to assess the risks posed by faulty breast implants is to be carried out, Health Secretary Andrew Lansley has said.
Health Secretary Andrew Lansley, who announced the move, reiterated the government's advice that the implants did not need to be routinely removed. Mr Lansley said the review was due to conflicting data on implant ruptures.
He reiterated government advice that the implants, which 40,000 UK women have, do not require routine removal.
The implants by French firm Poly Implant Prothese (PIP) were banned last year after they were found to contain a non-medical-grade silicone filler.The implants by French firm Poly Implant Prothese (PIP) were banned last year after they were found to contain a non-medical-grade silicone filler.
It is thought some 40,000 British women have the implants.
Mr Lansley repeated the stance, expressed by the government last week, that there was "no evidence" of a safety concern.
However, he said "conflicting data" had been provided by a large private provider of the implants, which had left him "concerned and unhappy".
The health secretary said a group of experts would assess the latest data and report back to ministers next week.
Last week, French authorities recommended that 30,000 women have faulty breast implants removed as a precaution.Last week, French authorities recommended that 30,000 women have faulty breast implants removed as a precaution.
France's government, which said there was no evidence of a cancer link, will cover the cost. The French government will cover the cost of the removals.
Eight cases of cancer have been reported in women with the implants but the French authorities say these are not necessarily linked to faulty implants. Mr Lansley repeated the stance, expressed by the UK government last week, that there was "no evidence" of a safety concern over the implants.
But he said he was concerned by the content and quality of some data, which required further analysis to answer issues around rupture rates.
He said the NHS Medical Director, Professor Sir Bruce Keogh, had been asked to launch a review into PIP breast implants and scrutinise the data.
The group of experts will report back to ministers next week.
Mr Lansley said: "We are doing everything we can to ensure that women with these implants get the best possible advice.
"So far all the evidence from around the world suggests that women should not be worried and that there have not been abnormal levels of problems reported with these implants. But if any woman is worried, then they should contact their surgeon or GP."
In France, eight cases of cancer have been reported in women with the implants but authorities in the country say these are not necessarily linked to faulty implants.
One woman with an anaplastic large cell lymphoma (ALCL) cancer died. However, French and US experts have said there appears to be a small increased risk of this kind of rare cancer with any brand of implant.One woman with an anaplastic large cell lymphoma (ALCL) cancer died. However, French and US experts have said there appears to be a small increased risk of this kind of rare cancer with any brand of implant.
Meanwhile, UK medicines watchdog the Medicines and Healthcare products Regulatory Authority (MHRA) has said it recognises women's concerns.
PIP used non-medical-grade silicone believed to be made for mattresses, according to the British Association of Aesthetic Plastic Surgeons (BAAPS). This meant the low-cost devices were more likely to split.PIP used non-medical-grade silicone believed to be made for mattresses, according to the British Association of Aesthetic Plastic Surgeons (BAAPS). This meant the low-cost devices were more likely to split.
PIP went into administration last year and the use of its implants was banned. At least 250 British women are taking legal action against the clinics that treated them.PIP went into administration last year and the use of its implants was banned. At least 250 British women are taking legal action against the clinics that treated them.
More than 300,000 implants are believed to have been sold globally by PIP over the last 12 years in some 65 countries.More than 300,000 implants are believed to have been sold globally by PIP over the last 12 years in some 65 countries.
More than half of its exports went to South America, including to Venezuela, Colombia, Argentina and Chile. In Brazil, some 25,000 women are believed to have had the implants, according to the AFP news agency.More than half of its exports went to South America, including to Venezuela, Colombia, Argentina and Chile. In Brazil, some 25,000 women are believed to have had the implants, according to the AFP news agency.
Western Europe was another major market. In addition to the UK, Spain, Italy, Germany and Ukraine are known to have imported PIP silicon sacs.Western Europe was another major market. In addition to the UK, Spain, Italy, Germany and Ukraine are known to have imported PIP silicon sacs.