Review of breast implant safety

A defective silicone gel breast implant, which was removed from a patient and manufactured by French company Poly Implant Prothese Image copyright Reuters
Image caption PIP implants were banned last year as they contain unauthorised silicone filler

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?

That was a key reason why the Health Secretary Andrew Lansley was adamant last week that the routine removal of the implants was unnecessary.

Around 40,000 British women have the implants, which were banned last year because they contain non medical-grade silicone. 95% of the operations were done in the private sector. The MHRA relies on data from private providers concerning safety problems with implants.

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. He said he was "concerned and unhappy about the consistency and quality of data" given by private providers.

The review body, led by the NHS Medical Director, Professor Bruce Keogh will analyse rupture data here and overseas and report back next week.

Mr Lansley said: "I want to give further reassurance to women that if there are any safety concerns we will act with whatever remedy that is required. But at present we don't evidence that would justify any routine removal of these implants, nor do we have safety concerns."

This review may have wider implications for the cosmetic surgery area, as it will look at the regulation of quality and safety of surgery in the private sector. Should the review team find that data collection is poor or that evidence is not passed on promptly, it may result in further action.

'No cancer risk'

It is important to say what the review is not looking at - namely cancer risk. The authorities in France and Britain have already said categorically that the PIP implants do not carry a breast cancer risk.

The MHRA has also said there is no evidence of toxicity from the unauthorised filler. However, it is accepted that once an implant has ruptured it can be more difficult to remove. The French investigation spoke of the risk of inflammation of the breast and the unknown potential risk from the untested silicone filler.

Should a high rupture rate be detected here, the key question will be whether it will lead to the UK following the French decision to recommend the implants are removed.

The Department of Health would not speculate on this so we will have to wait to see the evidence of the review.

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.

In the meantime, the advice from surgeons is that women with PIP implants should make an appointment with the surgeon who treated them.

Last week the Health Secretary Andrew Lansley was adamant that there was no need for the routine removal of the banned PIP breast implants.

That remains his position, but it is now dependent on the results of a review of safety data.

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