PIP breast implants: 'serious lessons must be learned'

 
Breast implant The implants were manufactured by the French company Poly Implant Prothese (PIP)

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A government review into the PIP breast implant scandal has found that serious lessons must be learned.

The review was led by Health Minister Lord Howe and examined the role of the Department of Health and the UK regulator the MHRA.

It questions how well women with these implants were informed about the risks.

It says that although the MHRA followed scientific and clinical advice, it should "review and further develop its communications capability."

And it must "obtain evidence from a wider and more detailed set of sources..."

The issue is with safety of silicone breast implants made by the French company Poly Implant Prothese (PIP).

The firm's products were banned in 2010 when it emerged that industrial grade silicone was being used. Implants should be made from medical grade material, which has passed safety tests for use in a human body.

PIP timeline

  • December 2002 Surgeon writes to MHRA about patient whose PIP implants have both ruptured within two years
  • 2003-2010 Over 20 letters from MHRA to PIP about adverse incidents
  • March 2010 PIP implants are banned due to concerns over unapproved filler
  • July 2010 Test results reveal no evidence that filler is harmful
  • 23 Dec 2011 French government recommends all women with PIP implants have them removed as a precaution
  • 23 Dec 2011 MHRA says no need for routine removal
  • 6 Jan 2012 Expert committee says NHS will remove and replace PIP implants if women want and private firms should do same

The report says this was a case of deliberate fraud by the PIP manufacturer and regulation alone cannot prevent that.

But it says a "higher level of proactive public communication could have been helpful", especially while awaiting toxicology test results. It suggests a more creative interaction with affected women, perhaps through use of social networking (like Facebook) could have been useful.

In March the Commons Health Committee criticised the government and health regulator for failing to adopt a high profile sooner.

'Serious lessons'

Lord Howe says there is no evidence that the MHRA or the Department of Health significantly failed to do their job.

"But serious lessons must be learned from this scandal. The MHRA needs to look at how it gathers evidence so it is able to identify problems early. It needs to better analyse reports about higher risk medical devices. And it needs to improve the way it communicates with the public."

You can hear my interview with Lord Howe here:

Lord Howe: "In the private clinics... many of the women were left completely in the dark"

Between 2003 and 2010 more than 20 letters were sent from the MHRA to PIP raising concerns about the implants. In hindsight, "this body of evidence could be seen as suggestive of a problematic manufacturer."

The review concludes that regulators in all EU countries need to work better together to support early detection of problems, share the information they gather and take appropriate action to protect patients.

Commenting, the President of the British Association of Aesthetic Plastic Surgeons, Fazel Fatah, said: "Poor post-marketing surveillance of medical devices lies at the root of the PIP crisis. At the BAAPS we feel there needs to be significantly more stringent monitoring of all medical devices including breast implants and all cosmetic injectables, via compulsory, regular reporting of adverse effects and mystery shopping which are all part of our regulation proposals."

cosmetic surgery

Around 47,000 women in the UK have PIP breast implants. Around 95% were fitted privately. A minority of operations were carried out on the NHS, mostly for breast reconstruction following cancer.

Lord Howe's review into PIP implants is one of two set up by the Department of Health in January.

The second review, led by Professor Sir Bruce Keogh, the NHS Medical Director, will look at whether the cosmetic surgery industry needs to be more effectively regulated.

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.

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.

Latest figures from the Department of Health in England show that 6,632 women with private PIP implants have been referred for hospital checks; 3,865 scans have been completed.

433 women have decided to have the implants removed and 185 have had the surgery.

836 NHS patients with PIP implants have been contacted, 82 scans completed. 214 decisions have been made to remove the implants and 66 women have had this surgery.

 
Fergus Walsh Article written by Fergus Walsh Fergus Walsh Medical correspondent

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  • rate this
    -1

    Comment number 18.

    I think that any non vanity surgery should be covered by the NHS with the costs to be recouped from litigation against PIP and or the private surgery involved.

    Whatever improvements in regulation that come from this can only be useful; but, I wonder what responsibilities the companies have when developing medical products of any nature.

  • Comment number 17.

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

  • rate this
    +6

    Comment number 16.

    Lesson to learn = your actions always have a consequence

  • rate this
    +13

    Comment number 15.

    Lesson 1: Maybe private healthcare isn't the holy grail that we (Tories) all thought it was

    Lesson 2: We have now realised the NHS has to pick up all the costs when private goes wrong

    Lesson 3: Maybe private healthcare's 'efficiency savings' will result in endangering the public's lives

  • rate this
    +41

    Comment number 14.

    11. Arun 47
    "Wow, some really hateful and idiotic comments from people who are just bigoted. Women should be able to buy an inplant and know that it is safe to use, it is none of your business to judge them."

    Utterly laughable comment. Women who buy breast implants for the sole purpose of making themselves look more attractive are doing so because they WANT to be judged. You have no argument.

  • rate this
    +55

    Comment number 13.

    @11.Arun
    "some really hateful and idiotic comments from people who are just bigoted"

    Why is it hateful or idiotic for not wanting my hard earned wages to go to correct someone else's botched cosmetic surgery - this has nothing to do with the NHS and it shouldn't be expected to cover the cost.

  • rate this
    +2

    Comment number 12.

    Profiteering by allowing sub -standard and even dangerous implants to be placed in human bodies is wrong?
    Gosh, next they will be telling us that water is wet and that Hitler was a bad man.

  • rate this
    -15

    Comment number 11.

    Wow, some really hateful and idiotic comments from people who are just bigoted. Women should be able to buy an inplant and know that it is safe to use, it is none of your business to judge them. They should be able to purchase a product knowing that it is safe and if it is revealed later that the seller has created a faulty product then they should cover the cost.

  • rate this
    +9

    Comment number 10.

    This is the kind of debacle we can expect when the parts of the (safe in our hands) NHS currently being privatised & sold off to American health care companies hit any problems.

    Yes folks, that's right it'll be the ordinary taxpayer who will pick up the bill, the private companies always have a "get out clause", just like the banks -

    "Oh sorry we messed up, stump up taxpayers & suffer cuts"

  • rate this
    +4

    Comment number 9.

    I am disgusted by the UK governments lack of positive action in this case. Once again big business holds sway over British citizens lives. The government should have ordered PIP to remove at their own expense the faulty implants immediately it became obvious that there was a problem.

  • rate this
    +18

    Comment number 8.

    The lesson to be learnt is, other than reconstructive surgery, that personal vanity comes at a price. Better to be happy how we are.

  • rate this
    +2

    Comment number 7.

    The only lesson to learn is that money and medical decisions don't mix.

    Many companies reformed under a different name so that they are not liable for the losses but how can a company ever have sufficient losses to cover the worse case of loss of human life.

    Yet, this is the ideology the government wish to pursue for the NHS.

  • rate this
    +4

    Comment number 6.

    So many lessons being learnt & measures taken on board. Onward & upward to the next crisis & failure.

  • Comment number 5.

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

  • rate this
    +4

    Comment number 4.

    What I find worrying about this investigation is that all of its recommendations were not already in place. I am also concerned that women in different parts of the country are being treated differently, whereby those living in Wales who went private can have them removed and replaced on the NHS and those in England and Scotland can`t. A true post code lottery for NHS care

  • rate this
    +65

    Comment number 3.

    To those with a real reason for reconstructive surgery that have been caught up in this then you have my sympathy, and you need to have the mistakes put right.
    For those who wish to look like some inflated 'z' list celeb then I'm afraid your vanity has a cost, and that cost should be carried through to putting it right or removing them. You could afford to put them in you should pay for removal.

  • rate this
    +27

    Comment number 2.

    Surely the lesson is: "Don't stick unnecessary implants in your body"? If you don't like that lesson, perhaps the lesson should be "Don't go to the cheapest provider when your health is concerned"

  • Comment number 1.

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

 

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