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

    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

    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

    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

    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

    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.

  • rate this

    Comment number 26.

    In United States, PIP implants were sold through Heritage Worldwide until May 2000. At the time, US market accounted for 40% of Heritage Worldwide's revenues, according to corporate documents filed in 2009 with SEC. The firm posted significant losses in subsequent years, especially starting in 2007, as users & distributors filed complaints against PIP.

  • rate this

    Comment number 25.

    Thousands of victims in 65 countries, mainly in S.A. & western Europe. Wow, number has implications for major class-action. Indeed PIP breast implants have turned into lawsuits in US, where they were sold up till 2000. Prosecutors in Marseille have received more than 2000 complaints from French women who received the implants, & have opened a criminal investigation.

  • rate this

    Comment number 24.

    In France, implants analyzed last year showed gel used contains tissue toxic substances, in other words poisons. PIP's implants have only been used in cosmetic breast augmentation surgery, NOT IN RECONSTRUCTIVE SURGERY. Health Minister Eugenia Sader: Venezuela's public health service will remove for free French-made breast implants feared to be at risk of rupturing.

  • rate this

    Comment number 23.

    As early as 2009, French authorities discovered increased tendency towards leakage from PIP implants. PIP had used another type of gel than approved. Company apparently chose to replace medical-grade silicone in its implants with industrial-strength material when facing financial troubles. The Swedish Medical Products Agency banned all PIP implants THE VERY NEXT DAY.

  • Comment number 22.

    This comment was removed because the moderators found it broke the house rules. Explain.

  • rate this

    Comment number 21.

    What this company has done seems CRIMINAL. Now worried voices have expressed concern PIP's implants also increase the risk of breast cancer, after 8 cases of breast tumors have been uncovered after removing the implants. French authorities have recommended women bearing PIPs have them removed.
    Why is Britain so far behind the movement?

  • rate this

    Comment number 20.

    Some 5,000 implants from now bankrupt company PIP (Poly Implant Prothèse), have already been sold in Sweden. Gert Bruse, Swedish Medical Products Agency, said implants were sold at 9 different clinics in Sweden. Sweden banned implants in March 2010 when it was discovered substandard silicone gel was causing many implants to burst. Recommended: Swedish women who had the implant get them removed.

  • rate this

    Comment number 19.

    Should the review team find that data collection is poor or that evidence is not passed on promptly, it may result in further action. Meanwhile, thousands of Swedish women, & many more worldwide, have substandard breast implants from French-based company PIP. These women have now been urged to surgically remove their implants by French authorities.

  • rate this

    Comment number 18.

    The implants done in the private sector should be “corrected” in the private sector and not with NHS resources. However, NHS resources may usefully be put to providing psychiatric treatment for people who so stupid and superficial they believe their life would be improved by changing the shape their breasts.

  • rate this

    Comment number 17.

    Q. Why did French medical watchdog find that the implants have a 5% rupture rate, whereas equivalent body here, the Medicines & Healthcare products Regulatory Agency (MHRA), found a 1% rupture rate?
    The low rupture rate was reason that Health Secretary Andrew Lansley said last week routine removal was unnecessary.
    Shouldn't the comprehensive investigation preceded the announcement?

  • rate this

    Comment number 16.

    Oh Benbowlane! So so naive! For what ever reason women have the surgery done is neither here nor there, & most definitely has nothing to do with you! Quick fix...Now please stop with these comments, you look so very foolish, if you think it's a 'quick fix', far from it! Your opinions are cave man like, PLEASE understand what you are commenting on before you do so, as you clearly have no idea!!!!

  • rate this

    Comment number 15.

    Lets face it Ali with the exception of cancer patients who may need reconstructive surgery, women have these things put into their bodies as a sexual enhancement. A quick fix to try and look better. Make the best of what you are born with. Beauty comes from within, not a piece of silicone planted in your body.

  • rate this

    Comment number 14.

    I like others find the comments made by 'benbowlane' and 'bluest man' extremely small minded & offensive, I am extremely worried and alarmed at the recent findings concerning the PIP implants. I was 20 years old when I underwent this surgery, the implants were chosen for me by the surgeon with whom I had placed my trust in, I accept as I imagine other women do that this surgery was elective &(TBC)

  • rate this

    Comment number 13.

    This incorrect reporting happens every week. SCOTLANDS Health Secretary will deal with it here! BBC, Get your facts right. what do we pay a licence fee for , the BBC cant get facts on health correct.

  • rate this

    Comment number 12.

    In reply to bluest-man.......before you cast your opinion in thinking that women choose the 'cheap option' you are so wrong and shame on you.
    I had implants done in 2004 and paid the going rate for the procedure at the time.
    There was no picking and choosing which were the cheapest options I have just found out that l have PIP implants, but have made my mind up to have them removed.
    At my expense


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