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
    0

    Comment number 31.

    If you are women making nasty comments you are very lucky to have not been in the position where you feel augmentation will help you self esteem, we are not all 18 year olds who want big Jordan like boobs! And if your a man lets just hope that nobody every removes your penis and along with it everything you associate with being a man!

  • rate this
    0

    Comment number 30.

    Small minded people on here! Theres always some idiotic person getting personal. Nobody that has had these implants in deserves the worry that this is causing. These implants were used by Harley Medical Group, one of the biggest cosmetic surgery companies! These weren't cheap implants to have inserted just cheap for the company to buy. Harley Medical have obvious made a packet.

  • rate this
    0

    Comment number 29.

    i have had these implants but dont no who to turn to now as the surgery is no longer trading.
    would any one no what i can do please im very worried i have had pain with my chest and went back to see the surgoen who didnt want to no

  • rate this
    +1

    Comment number 28.

    The complaints cited defective merchandise not suited for its intended purpose & violations of local consumer legislation.
    PIP was once the world's third-largest producer of silicone implants.
    So again, with all this going on, I have to ask: why was Britain so far behind the movement?

  • rate this
    0

    Comment number 27.

    1996 - 2009, PIP was target of lawsuits in the US, filed not only by victims but also by business partners, claiming breach of contract or unmet payments. The plaintiffs said they were shareholders of PIP distributor PIP/USA Inc' they sought unspecified damages from PIP arising out of alleged tortious & other purported wrongful acts. Evidently, something was very wrong.

 

Comments 5 of 31

 

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