Saturday, 14 January 2012

Government Commissioned Report on PIP Breast Implants - Our Thoughts

Article by
Kevin Timms
Andrew Lansley, the Health Secretary, commissioned a report into the problems with PIP breast Implants. The result of the report was that those on the NHS who have been provided with PIP breast implants could have them removed and replaced where there was a clinical need and those who had surgery privately, but where there clinics were no longer in business or refused to assist, would be able to have their PIP breast implants removed only where there was a clear clinical need.

There are a few critical issues I think have been overlooked from Andrew Lansley's report.


Though it is accepted that the UK data is inconclusive, this was obvious from the outset. There has been no evidence to suggest that the UK authorities have considered the French, German, Czech Republic, Costa Rica and Venezuelan data. Furthermore, there has been no evidence that the UK authorities have considered the French test results on the implants.

The French regulator released a Topical Report in June 2011 detailing all the problems with the PIP implants. I accept the MHRA conducted testing on whether the implants can cause cancer or other toxic effects. What they should have done, considering more women in the UK have these implants than in France, is convene their expert advisory panel in 2010 to conduct their own independent tests on the implants as a whole. I do not believe that, until very recently, the MHRA considered the French test results and only focused in the inaccurate, voluntary adverse incident reports from clinics. The MHRAs role is to investigate and no meaningful investigation has taken place prior to now, but why has it taken almost two years?

The MHRA has not commissioned testing into whether the implants shell is satisfactory, what materials are in the unauthorised gel and what effects the irritant properties in the gel can have on the human body. Garden House Solicitors has commissioned testing on the implant shell and has confirmed that the particular implant tested does not conform to international standards by quite a considerable amount. Furthermore, the PIP silicone gel can 'run' whereas competing implants with a cohesive gel binds itself together and by design does not leak. We continue to have PIP breast implants examined.

Another issue with the data is that it could never be accurate as the government has concentrated on the rupture rate on PIP implants and comparing that with available data of other implants on the market. However, PIP implants, unlike others, can perspire (or ooze) silicone gel through the implant shell, usually within the first three years, meaning early exposure of the unauthorised gel to women. The data will also not be accurate as there can be 'silent ruptures'. The government should therefore investigate all the issues with the implant - not only if they have a higher rupture rate.

Furthermore, the MHRA is also to take into account adverse incidents reported by the manufacturer. However, PIP has a history of non reporting which the MHRA should be well aware of. PIP manufactured hydrogel breast implants which were recalled in 2000 due to toxicity concerns. Many claims were brought in the UK and PIPs insurer would not indemnify the company as a result of the company's failure to report adverse incidents. PIP therefore has a questionable past and should have therefore been under closer scrutiny.

This is the reason Garden House Solicitors has set up the National PIP Breast Implant Register to take into account approximately how many people are likely to have suffered a rupture or experienced adverse symptoms as a result of silicone leak without a rupture, thereby widening the scope of those actually affected by PIP breast implants as opposed to solely concentrating on the scope of those generally affected by other breast implants, namely a rupture only. It has to be acknowledged that PIP breast implants have different characteristics to other implants on the market - I have been pressing the MHRA since 2010 to confirm this.

The MHRA has consistently stated, until very recently, that there were no health risks associated with the implants. Whilst it is accepted across the board that there is no link to cancer, there are still serious health risks. If an implant ruptures and the silicone leaks into the lymph nodes more extensive surgery is required. The Lansley report states that "The NHS will support removal of PIP implants if, informed by an assessment of clinical need, risk or the impact of unresolved concerns, a woman with her doctor decides that it is right to do so. The NHS will replace the implants if the original operation was done by the NHS ... [they] expect private sector providers to take similar action".

Clearly this indicates that there must be a clinical need before implants will be removed, however, they will remove where exceptional concerns are not satisfactorily dealt with. The report further states that those who had surgery privately can have their implant "removed" where their clinic will not assist them or where their clinic is no longer in existence. This suggests that women who cannot afford to replace their implants will have to wait until they suffer a rupture and a leak of unauthorised silicone gel into their body before the defective PIP breast implants can be removed. 

When you strip away the complications of funding and private vs public sectors, you see that the implants were put there for a reason (what ever that reason was - we are after all in today's society not supposed to be judgmental). If PIP breast implants are removed only under ruptured circumstances and women are left without implants (where they would otherwise wish to have them replaced) following a particularly prolonged period of having these implants and having suffered a rupture and additional health risks associated, there will clearly be subsequent psychological symptoms. These symptoms in themselves may affect individuals to a degree where the NHS will have to treat them in any event. These women will then suffer financially by having to save up for further surgery, which again, will involve further surgery risks.

The legal position is that the clinics should foot the bill and pay additional compensation but many are incapable of funding the surgery. However, the legal remedy is not a quick one and considering the mental anguish experienced by women and the risks associated with rupture, which could happen at an unknown time, something needs to be done to protect the interests of these women. Women with PIP breast implants need a proper investigation, not a hard time trying to get in contact with their clinic. The most accurate way of establishing problems is by way of an MRI scan as often ultrasounds do not necessarily show leaks or abnormalities. This should be available to all. This is not as a result of the legal issues but the risk to the health of these women.

The French and Germans have order the removal of PIP implants to 'prevent' (as opposed to a precautionary measure) problems arising in the future. The Welsh have confirmed they will also replace PIP breast implants used in the private cosmetic surgery industry. The removal of lymph nodes is generally associated with cancer surgery and we do not know what the long term effects of silicone being left in the body are. We know they are not as serious as cancer but any health risk should be avoided where possible.

I think a lot of this is common sense and I am surprised that the UK authorities have taken this long to take the concerns with PIP implants seriously. It has been known for almost two years that the silicone was unauthorised. You would assume that unauthorised products would be fully investigated regardless of whether it affects over 50,000 women or not.

I would be very interested to here peoples thoughts on this topic - please put your comments below.



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19 comments:

  1. Why has a straight county court route under trading laws not been brought?.....why not at least try?

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  2. The issues in dispute are more much more complex than what would generally by brought in a County Court. We already have a Group Action in the High Court against the private cosmetic surgery clinics for breach of contractual terms.

    The issue is that women concerned need a quick remedy as many are incredibly distressed. The legal remedy is not a quick one though it is necessary as a means of financial redress for the pain, suffering, hardship and financial loss women are being subjected to.

    Another issue is that the manufacturer would normally be pursues in these circumstances but PIP has gone into liquidation and we established in 2010 that it has inadequate insurance. Therefore the circumstances for these claims are quite unique. Regards, Kevin

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  3. Why would women want to wait to have the implants removed until they rupture, it is unlikely the surgeon would be able to remove all traces of silicone so women are still left with silicone in their bodies, given that the long term effects on health are unknown this does still not put them at ease even if they are removed!!

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    1. That is my point precisely. The UK authorities must test how these implants behave differently to other breast implants to properly understand how the implants can affect women. Whilst many women are not experiencing any adverse symptoms as yet, the mental anguish which naturally follows from a scare like this has to be taken much more seriously.

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    2. Totally agree, that is my thought and worry, and i didnt have PIP implants. mine still ruptured and leaked, and was there for up to 5 yrs. I have health issues and I believe silicone to be a contributory factor.

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    3. There has been a silicone safety debate which has been ongoing for decades, perhaps medical device regulators throughout the world should consider conducting more clinical trials.

      The FDA in the US have been very strict on silicone implants and had banned silicone implants until 2006 You may be interested in the information on their website: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/default.htm

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  4. Interesting argument,Whats the point of having a government who sit on the fence waiting to "see" "what happens" they should be doing all they can to support these ladys who now have a chest full of stuff made for "silent night",and engine systems. This is a criminal act. These implants are toxic and are making them poorly,but then Im of the opinion that this actually applies to all silicone implants, given my own situation, I have to disagree with the opinion of "Cohesive Gel binds itself together and by design does not leak" The shell of my Cohesive Gel Implant was completely empty, my medical notes indicated that a wash out +++ was needed to remove silicone. My health has also suffered since my not PIP implants ruptured. I think PIP implants and other implants on the market should all be tested for long term leakage, rupture and silent rupture rates, as well as how long they actually lasted i.e from implant to problem, and collective data on subsequent health problems.This will ensure Medical Clinicians can also be more appropriately trained in advising persons wishing to undergo any form of plastic surgery,so clients can be properly informed. This may also allow for an informative measure of long term effects of silicone as some of these ladies have had implants for more than 12 yrs and will help to identify if indeed it has an impact on health. Therefore leading the way to find a more conducive material to be used in the art of plastic surgery, reducing the risk to the Client, plastic surgeons and clinics, ensuring this can never happen again.

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    1. petrula Demetriou14 January 2012 at 13:12

      Which make of implants did you have, because I have replaced my PIP with Nagor and it would be interesting to know if in the future this PIP scandal will surface again. I still worry about what was left in my body that maybe has not been picked up.

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    2. Petrula Demetriou. sorry to say both my sets of implants were supplied by Nagor, am awaiting to see consultant as right breast is now hard and left one has appearance of being the same as when my right one first ruptured x

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    3. Hello Andrew,i have had 3 breast implants between 1986-2000.My first had a rupture in right breast,GP refered to consultent who replaced 1st set with soya bean which were recalled by goverment in i think it was 1999.I was told by goverment if i didnt have these removed they would not take responability for future illness.i had them removed and replaced by NHS with another silicon and was rewarded with £5000 spread over 2 years for the "trouble"The solicitors dealing with this case was Freith Cartright,this was in 2000.ive had problems since with the implants and bad health but did not want to go through all that again,now all this has started and only last year suspected another right rupture.These implants iam told after contacting breast nurse are supposed to be nagor and was also told "they are british"which iam not sure is the truth!I will be visiting my GP this week for advice,i just thought you would be interested in my story.regards Margaret Martin.

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  5. We all hope that the French criminal justice system will adequately deal with PIPs management.

    Cohesive implants, by definition, are intended to bind their gel together, though there are variations in the 'cohesiveness' of implants.

    I agree about the issues of regulation and your experience highlight that regulation needs to be reviewed. The National Breast Implant Registry needs to be reinstated but this will not assist women currently experiencing problems with PIP breast implants. This is one reason Garden House Solicitors have set up a PIP Breast Implant Register: http://www.pipbreastimplantregister.co.uk

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    1. I think what you are doing is great, and I hope all the PIP ladies get satisfactory resolution to this awful messy situation. I can only hope that silicone of any grade is proved beyond reasonable doubt, not impact on human health, but should it be proved that it infact does have health related consequences, those ladies who have suffered from non PIP implants can also recieve assistance and acknowledgement of this clinical breach of conduct.

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  6. i went to HMG thinking i had picked one of the best known places with the best reputation, i paid for the best implant and got assured they were only the best used in there clinics. i had no paperwork given only my recipt for the operation itself, i got lots of leaflets but no paperwork withbatch numbers on. i had to ring round myself to find out df i had PIP and got tolf yes 100% you will and we are sending letters out in due time. HMG are refusing to do anything, the NHS are saying yes when theres a problem so do we have to get ill first and risk our health before anything is done? i ve seen alot of symtoms are the same as depression how many women have been told they are depressed when actually its their implants?
    everyones problam seems to be about money and whos gonna pay HMG want NHS to pay NHS dont want to pay unless they have to, i know everyone has a selfish intrest and the UK is so money focused based but surely this is more than a money issue? thaks Andrea

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    1. It should be about the women with these implants who are completely innocent in all of this. However, it would seem that much of it is money focused which is a terrible state of affairs.

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  7. Hi I am seeing the surgeon who did mine. I had my implants done in 2000 through bodylooks, which went into liquidation in 2003, at the Nuffield North Staffs. As I have some paperwork with pip printed on it, in extremely small type, does this mean if tests show they are leaking/ruptured they would have to remove free of charge ? I'm not really interested in having replacements. Kaz

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    1. If a clinic is dissolved it is no longer able to provide surgical services. It may have insurance, however. Please email me and we can discuss this further as there are some particular complications with this clinic. My email address is kevin@gardenhousesolicitors.co.uk . Kevin

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    2. hi there

      i had mine done in july 2000 at the north staffs nuffield. they told me that i can have them replaced or removed for free. i think i am going to have them removed. have you any news? what did the clinic say? was it mr roberts who did them?

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  8. Hi I found out a few weeks ago that I too have these PIP implants. I had them done in 2001 through bodylooks in Manchester. I had my operatation at Spire Methley park hospital in Leeds, who I got into contact with about the implants and they have sent me for a MRI scan which now I'm waiting for results. On their spire website is does state that after advice from consultant if the patient does wish have them removed and replaced then they will do so free of charge. But now I'm worried that they will only do so if there's a clinical need, as I went through bodylooks, who went into administration in 2003, iv had these implants for over 10 years now. I would just like some advice about the whole situation of who's going to have to pay for replacement. Myself or the hospital. Thank you very much

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  9. I had implants in May 2000 by Bodylooks (went into administration in 2003) at Highgate Hospital. I have no paperwork to confirm that my implants are PIP, but from the research I've done I'm pretty certain they are. Can I get Highgate to replace for free or are they not responsible or deny knowledge if I have no proof?

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