Breast implants: UK to review risk assessment data

Andrew Lansley said he was concerned about the quality of some data provided on the implants

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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.

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.

Last week, French authorities recommended that 30,000 women have faulty breast implants removed as a precaution.

The French government will cover the cost of the removals.

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.

Higher rate

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has previously indicated that its data suggests the risk of rupture is only 1%, rather than the 5% estimated in France.

It relies on data from private providers concerning safety problems with implants. Of the 40,000 implant operations, 95% were carried out in the private sector.

Analysis

Now that the Health Secretary Andrew Lansley has ordered a review of the safety data on the banned PIP breast implants, we may be closer to solving a puzzle.

The puzzle is this - why did the French medical watchdog find that the implants have a 5% rupture rate, whereas the equivalent body here, the Medicines and Healthcare products Regulatory Agency (MHRA), found a 1% rupture rate - no worse than other makes?

Yesterday, a significant private health provider gave conflicting new evidence which revealed a higher rupture rate than their previous submitted data.

This prompted Mr Lansley to launch a review of the evidence.

Although this announcement means a further period of uncertainty for many women, the speed of the review should mean that they will have clearer answers about the safety of the implants within a matter of a week or so.

On Friday a significant private health provider gave conflicting new evidence which revealed a higher rupture rate than their previous submitted data.

Mr Lansley 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.

'Unacceptable' delays

The authorities in France and Britain have said categorically that the PIP implants do not carry a breast cancer risk.

What are the risks?

  • The silicone inside the implants is not medical grade - but was intended for use in mattresses
  • Tests have not shown any increased risk of toxicity from this filler compared to normal implants
  • But mechanical testing has shown the implant covers have an increased risk of rupturing
  • The gel inside can be irritative, increasing the risk of inflammation reaction - making removal more difficult
  • There is no increased breast cancer risk
  • One case of a rare form of cancer called anaplastic large cell lymphoma (ALCL) was recently reported in France
  • French and US experts suggest there is a small but increased risk of this cancer for women with breast implants in general

Shadow health secretary Andy Burnham backed the decision to review data but urged the government to reassure anxious women.

He said it was "unacceptable" some women were experiencing delays in accessing records from private cosmetic surgery companies.

"The government should work with all healthcare providers to ensure all women have access to their records without delay and without charge," he said.

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.

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.

Western Europe was another major market. In addition to the UK, Spain, Italy, Germany and Ukraine are known to have imported PIP silicon sacs.

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