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 PIP implants were banned last year as they contain unauthorised silicone filler

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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.

Start Quote

I want to give further reassurance to women that if there are any safety concerns we will act with whatever remedy that is required.”

End Quote Andrew Lansley Health Secretary

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.

 
Fergus Walsh Article written by Fergus Walsh Fergus Walsh Medical correspondent

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  • rate this
    +2

    Comment number 11.

    benbowlane....some women didnt have a choice and have had serious abnormalities when born or breast cancer ...so dont judge ppl ...think about it the nhs but these in ppl who have had reconstuctive surgery......or suffered from cancer and ppl like you say we need our heads testing , think you mean the medical health association do they gave the all clear.......

  • rate this
    +2

    Comment number 10.

    wow...how ignorant are most ppl on here ie bluest-man ..... not all women had a choice, they were given these cheap implants and were not offered any other , so there clinics made more money, and most ppl are trying to pay private to have them removed , we are not all out to sue and make money so get a life before you judge....and our country should of tested these instead they trusted france....

  • rate this
    +2

    Comment number 9.

    Genuinely concerned at the moment, have some respect!
    bluest-man-Now you clearly have no idea what your talking about. I think maybe you need to UNDERSTAND. I wouldn't say £5250.00 was cheap!! Since your taking such an interest in this subject I will be happy to try & answer any other questions you may have. If not maybe start a small minded club with benblowlane ;) happy new year!!!

  • rate this
    0

    Comment number 8.

    To continue...if you feel so strongly do you also believe that people who have surgery to correct de formatives they may also need to have there heads 'looked at'. It is completely wrong & unacceptable to tar everybody with the same brush. Also I suggest if you have any future comments you think a little bit more before you post them because there will be many women, such as myself, who are..tbc

  • rate this
    +1

    Comment number 7.

    benbowlane - I find your comment awfully small minded, I respect everybody is entitled to there opinion...BUT...I suggest maybe comments such as yours should be kept within your own small mind. I myself have implants & do not believe I need my head to be 'looked at' as you so put!!! There are 100's of thousands if not millions of women who have undergone such surgery, all for there own personal...

  • rate this
    +2

    Comment number 6.

    No get your facts correct , WOMEN did not pay cheap for pip implants they were lied too by greedy people with no value for life , women do not want the tax payed to pay for this they want the government to admit what is going on and too make it clear to the private company's they they have to remove and replace them .

  • rate this
    -1

    Comment number 5.

    Happy to see an evidence review ... just as long as the women who have chosen to do this too themselves understand that they paid to have them put in and choose the cheap option and will have to pay for it to be sorted out just like buying the cheapo version of anything.... It is not the rest of the tax paying public to pay to have there cosmetic surgery sorted out!!

  • rate this
    +2

    Comment number 4.

    95% of these implants were carried out by private sector medicine.

    I presume therefore that the same private sector is going to fund the removal of these implants, if deemed necessary.

  • rate this
    +1

    Comment number 3.

    Women who have these things inserted into their bodies need their heads looking at.
    Does that sound right?

  • rate this
    +1

    Comment number 2.

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

    Ie, they lied. Typical private sector.

  • rate this
    +1

    Comment number 1.

    Wouldn't it have been better for the government to have done this before assuring us that these devices were safe? Who is going to believe them now?

 

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