PIP implants not toxic - final report

 
A defective silicone gel breast implant, which was removed from a patient and manufactured by French company Poly Implant Prothese A ruptured PIP breast implant

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The final report into the PIP breast implant scandal has concluded that the gel material does not cause a long-term threat to human health.

It says the implants, which were made with unauthorised silicone filler, are not toxic nor carcinogenic.

The review, led by Prof Sir Bruce Keogh, the NHS medical director, said they do have double the rupture rate of other implants.

Around 47,000 women in the UK have had the implants fitted.

Around 95% were fitted privately. A minority of operations were carried out on the NHS, mostly for breast reconstruction following cancer.

In January Prof Keogh's team concluded there was insufficient evidence to recommend the routine removal of PIP implants. But it recognised the concern that the issue was causing.

It found there was no link between PIP implants and cancer, and the evidence on increased rupture rates was inconclusive.

His final report has just been published.

Gemma Pepper had PIP implants fitted days before questions surfaced about their safety

Prof Keogh said women had faced an "incredibly worrying time".

He said that repeated tests in many countries have "shown that the implants are not toxic and therefore we do not believe they are a threat to the long-term health of women who have PIP implants".

He added: "We have however found that these implants are substandard, when compared to other implants and that they are more likely to rupture. We would therefore advise that women who have symptoms of a rupture - for example tenderness, soreness or lumpiness - should speak to their surgeon or GP."

The president of the British Association of Aesthetic Plastic Surgeons, Fazel Fatah, said: "Despite rigorous testing showing no long-term danger to human health from the individual chemicals in the gel, the fact remains that PIPs are significantly more likely to rupture and leak and, therefore, cause physical reactions in an unacceptable proportion of the patients.

Rupture Rate

  • The report says the PIP implants have around double the rupture rate of other implants.
  • After five years, the rate is between 6% and 12%.
  • After 10 years, the rate is between 15% and 30%
  • Other brands have a failure rate between 10% and 14% after a decade.

"We agree with the report findings that anxiety itself is a form of health risk and thus it is entirely reasonable for women to have the right to opt for removal - regardless of whether there has been rupture."

The advice for patients has not changed.

Throughout the UK any women who had PIP implants fitted on the NHS can get them removed and replaced free of charge.

In Wales the NHS will also replace those of private patients. In England and Scotland the NHS will remove implants of private patients but not replace them.

Last month, a separate review led by Health Minister Lord Howe examined the role of the Department of Health and the UK regulator the MHRA.

It said serious lessons must be learned and questioned how well women with these implants were informed about the risks.

 
Fergus Walsh, Medical correspondent Article written by Fergus Walsh Fergus Walsh Medical correspondent

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  • rate this
    0

    Comment number 273.

    Obviously not dangerous from the start.

    All these shallow 'ladies' who have implants should be made to pay double - once for the installation and once into a fund for their eventual removal. They've got to come out in the end.

    While we're on the topic, shame on the cosmetic surgeons for wasting their abilities on such rubbish when they could be helping people with genuine problems.

  • rate this
    0

    Comment number 272.

    Me@ 271
    Sorry meant MHRA not MRHA apparently that's the Midland Regional Hockey Association. Bedtime I think! ;-)

  • rate this
    0

    Comment number 271.

    SpacePirateFTW@260 You raise an interesting point as to which body had regulatory responsibility for PIP implants but its irrelevant in my view. Their use was approved by the MRHA until 2010 despite concerns being raised much earlier. The MRHA could have acted on those concerns and issued appropriate guidance at any time and failed to do so. This gave an implied legitimacy to PIP implants.

  • rate this
    0

    Comment number 270.

    If we are to exclude the NHS from providing preventative action for this fiasco, perhaps the highly paid doctors involved would be prepared to give their time FOC. But clearly this profession is so impoverished it needs to strike to support under funded tax payer subsidised pension pots of up to 1.6 million. If you earn 100k+ try saving instead of expecting everyone else to sustain your lifestyle.

  • rate this
    0

    Comment number 269.

    239. Name Number 6
    238. No_7
    +++
    Alcohol is a massive help to physical attraction.
    --------
    Yours or theirs?

  • rate this
    +1

    Comment number 268.

    What this highlights is a continuation of the media running with a story because their friends in the government are trying to make themselves important, while giving them a topic on which they can intrude into the private lives of their citizens and give their friends in the legal profession a way to line their pockets...while good, honest women get so stressed that they kill themselves!!

  • rate this
    0

    Comment number 267.

    My partner had pip and has been ill for ages thyroid problems then no problems feeling tired lots of illness then after having them changed she is 100% better she asked loads of other women that had them they were all the same so you tell me are pip implants ok?Try talking to the woman that have been suffering do the homework!It's a big cover up our government body ok"d them and don't want 2b sued

  • rate this
    0

    Comment number 266.

    218. xyriach
    It's men who act differently to women based on their level of perceived attractiveness.
    -------
    You've seen Bernie Ecclestone's former other half, I mean 3/4,then.

    Strange how glamorous women go for small squirts - seems Debbie McGee's not alone.

  • rate this
    -2

    Comment number 265.

    I buy a car privately. It blows up after two weeks. The vendor says tough as it was okay when you drove it away. Should I get a new car off the taxpayer? No. These women chose to have breast augmentation for reasons of vanity. They could afford to have them in they can afford to have them out. If not then tough. Not the NHS's or taxpayers problem!

  • rate this
    0

    Comment number 264.

    259. breuddwyd

    White Willow Bark a natural form aspirin called salicin.

    cinchona bark contains quinine (antimalarial drug).

    Mint has been used to help settle stomach problems for centuries and is still used today.

    The Foxglove plant gave us Digitalis.

    The Poppy gave us Morphine.

    To name just a few of the many herbal roots of modern treatments.

  • rate this
    +2

    Comment number 263.

    So if there is no problem with them, what exactly is there to discuss on HYS?

  • rate this
    +4

    Comment number 262.

    This is the perfect example of why private medical providers should not be allowed to function within the NHS they did the cheapest possible operation for maximum profit then refuse to solve the resulting problems when their cheap implants are faulty imagine this with tens of thousands of knees or hips chosen for their profit margin not their longevity

  • rate this
    0

    Comment number 261.

    yes ... yes ... but they blow up .... lol ...

  • rate this
    0

    Comment number 260.

    254.

    Blah blah blah. Same thing you posted on the last anti-smoking HYS. It was false then and is false now.

    253.

    I'm not denying unannounced visits and random spot checks are necessary, but the UK doesn't license the product. The product is CE-marked for Europe as a whole. So unless you plan on leaving the EU you can't place the blame on the MHRA.

  • rate this
    0

    Comment number 259.

    258. herbal and homeopathic remedies may have been used for centuries but most of the former and all of the latter are a load of codswallop, that's why doctors 'slate' them.Evidence based medicine is key, with multiple trials to ensure a treatment works, those that are 'slated' are those that cannot be shown to be effective.
    Silicon is inert, that's why it was used in implants in the first place.

  • rate this
    -1

    Comment number 258.

    Doctors who slate unprofitable centuries old tried and tested herbal or homeopathic remedies as potentially toxic or dangerous and declaring industrial standard silicone filler leaking into women's bodies as neither are being disingenuous maybe?

  • rate this
    0

    Comment number 257.

    The GMC will, no doubt, be looking closely as to whether the real risks of this procedure were adequately explained to the women involved, particularly as few needed it and many were there thanks to high pressure sales tactics by the clinics involved, or whether the usual box ticking, cover-all exercise applied.

  • rate this
    -1

    Comment number 256.

    So putting a substance in your body That doesnt Exist in that CONCENTRATION,is OK???That is not correct.That is why,there are drug CHEATS,at Sporting Events.Bankers with no Money?Every HEROINE addict is CORRECT.spin,im AFRAID.

  • rate this
    0

    Comment number 255.

    And for all those people who say they deserve a refund or 'free removal'. Why Didn't you people first check the company and ask about the 'stuff' being used???
    We did, Little did we know that we were conned by the French company that made them. British medical health authority passed them as safe, when theyre not. Same happens with any product- THEY GET RECALLED, months or years down the line

  • rate this
    -1

    Comment number 254.

    "SpacePirateFTW
    And smokers paid £12 billion in tax last year"

    The direct healthcare cost of smoking is not the only cost to the taxpayer: lost productivity reduces GDP AND tax take; indirect cost of time of work due to illness, poor health of children, cost of fires and the fact that smoking is largely confined to the poorest group who get much of their income from the taxpayer anyway.

 

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