PIP breast implants – latest from the NHS

Behind the Headlines

Monday June 18 2012

Talk to your GP or surgeon if you are worried about PIP implants

Women concerned about PIP breast implants can find all the latest NHS information about PIP implants.

Worries about the implants have emerged since news of a major investigation into them in France was widely covered in the media in December 2011.

Initially it was thought that around 40,000 women in the UK had the implants but on March 15 the Department of Health said new evidence meant a further 7,000 women in the UK might have them. About 95% of the implants were provided privately for purely cosmetic reasons.

The French implants caused global concern after it was revealed they contained industrial silicone rather than medical-grade fillers and that they may be more prone to rupture and leakage than other implants.

Symptoms to watch for

If you have any of the following signs or symptoms, you should discuss them with your GP, who will refer you to a specialist:

  • lumpiness of the breast
  • lumpiness or swelling in the area around the breast
  • change in shape of the breast
  • deflation of the breast
  • redness
  • tenderness of the breast
  • swelling of the breast
  • pain or sensitivity

The Chief Medical Officer for England has issued GPs and surgeons with specialised guidance on how to check and care for women with PIP implants (PDF, 119kb).

Initially reports also linked the implants to a rare form of cancer known as ALCL. This cancer link has been now been firmly discounted by medical experts here and in Europe.

Most recently, a European Commission report ruled out a link between PIP implants and breast cancer.

 

What type of implants are involved?

The implants involved are called Poly Implant Prosthèse (PIP) and were made by a French company of the same name.

In a Medical Device Alert in March 2010, the Medical and Healthcare products Regulatory Agency (MHRA) said: " ... most breast implants manufactured by the company since 2001 have been filled with a silicone gel with a composition different from that approved".

That alert was based on advice from French regulators. However, after an investigation by the MHRA, the French authorities reported in March 2012 that PIP implants made before 2001 may also contain unauthorised silicone gel.

PIP gained approval to market its silicone implants in 1997 but it is not clear when it began using a cheap type of silicone gel intended for making mattresses.

The marketing, distribution and use of the PIP implants was suspended in March 2010.

 

Do the implants have to be removed early?

About one breast implant in five needs replacing within 10 years, whatever the make, so it is unlikely that all the 7,000 women who had PIP implants before 2001 still have the same implants.

An expert committee was set up recently to examine the specific risks associated with PIP implants. It concluded that there was not enough evidence to recommend their early removal. That advice has not changed.

If you are worried

  • Find out if you have PIP implants by checking your medical notes.  You can get these free from your clinic or GP. If you had a PIP implant on the NHS, you will receive a letter.
  • Speak to your GP, if you had them done on the NHS, or your clinic if you had them done privately.
  • Agree what’s best for you – get advice on whether or not you need a scan then discuss removal with your doctor.
  • If you decide you want your implants replaced, the NHS will do it free if your original operation was done on the NHS.
  • If your original operation was in a private clinic you will need to speak to the clinic to see if they will replace them free.
  • If your private clinic no longer exists or refuses to remove the implants, speak to your GP. The NHS will remove your implants if your doctor agrees there is a medical need.

 

What does the final report from the expert review group say?

The final report from an expert review group chaired by Sir Bruce Keogh was published on June 18 2012. It has concluded that rigorous chemical and toxicological analyses of a wide variety of PIP implants have not shown any evidence of significant risk to human health, and that no further tests would change this conclusion. The only significant chemical variation in PIP implants is that they have higher levels of siloxanes than other silicone breast implants. No other organic impurities and no significant inorganic impurities were found in any batch of PIP implants. A very low level of caesium was found, but this is not thought to be a health risk.

The review also found that PIP implants are more likely to rupture or leak silicone than other implants (twice to six-times as likely). Rupture rate for PIP implants is estimated at around 6-12% at five years, and 15-30% at 10 years, although these estimates are not very certain. Patients with PIP implants are at greater risk of developing associated local reaction and lymph node enlargement from a rupture. Some failed PIP implants caused local reactions but the signs of this happening are usually obvious.

The expert group recommends that before any woman has breast implants removed, she considers that:

  • any surgery involves a risk of harm, including unexpected death, even for generally healthy people
  • evidence suggests that the risks of complications are greater for subsequent breast augmentation operations than for a first breast augmentation operation
  • all kinds of breast implants have a risk of failure
  • the more significant adverse consequences of rupture or leakage of PIP implants appear to occur mainly where there are clear signs on a clinical examination
  • despite extensive testing in the UK and internationally, there is, to date, no evidence implicating PIP or any other silicone breast implants in other forms of long-term damage to health

The Department of Health and MHRA are continuing to monitor developments. The regulation of cosmetic surgery and other cosmetic procedures is under review.

 

When did the concerns first come to light?

Some papers have reported that a surgeon wrote to the MHRA in 2006 suggesting that PIP implants should be withdrawn from the market. According to a report into the authorities' actions on PIP, published by health minister Lord Howe (PDF,649kb) on May 14 2012, “adverse events” involving PIP implants, including ruptures, have been reported since 2002. In all, 269 adverse events were reported between 2001 and 2009 (of which 240 were ruptures).

Lord Howe’s report said that the MHRA passed its concerns on to the German organisation responsible for assessing PIP implants in April 2007. It concluded that the MHRA “was fulfilling its obligations in terms of reviewing in responding to the incidents reported to them”, was “active in pursuing PIP” about the problems, and took surgeons’ concerns into account.

 

Did the authorities act appropriately?

The report concluded that there is “no evidence that the MHRA acted inappropriately” and that “nothing about this case provides evidence to suggest the system for regulating medical devices is fundamentally unsound”.

 

What could the authorities have done better?

Some newspapers recorded concerns that Lord Howe’s report might be a “whitewash”. However, the report included key criticisms of the MHRA and the Department of Health and included 15 recommendations for action.

One of the main criticisms was levelled at the MHRA for “not making greater and more co-ordinated efforts to ensure that information reached people with a direct interest in it, specifically providers, health professionals and affected women”. It said: “the MHRA and the Department of Health must learn lessons so that they can continue to improve their approach to communicating with affected individuals and the general public.”

The report said: “Ultimately the responsibility for the great distress caused to UK women … lies squarely with the fraudulent manufacturer who actively covered up its deceit and showed a complete disregard for the welfare of its customers.”

 

Is the situation being investigated further?

Yes, the Department of Health has set a further review to look at how the PIP situation occurred and the issue of regulating the cosmetic surgery industry as a whole.

This second review will look at whether the cosmetic surgery industry needs to be regulated and, if so, how this should happen. This review is due to be submitted by March 2013 and will be led by Professor Sir Bruce Keogh, the NHS Medical Director, who said:

“I am working with experts from the plastic surgery field to look at what we can do to make sure people who choose to have cosmetic surgery and other cosmetic procedures are safe.

“I will be looking at all aspects of regulation – at the regulation of implants and fillers, at whether the people who carry out cosmetic interventions have the right skills, at whether the clinics look after the care and welfare of their patients."

The extensive report is due to be submitted by March 2013.

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Comments

The 26 comments posted are personal views. Any information they give has not been checked and may not be accurate.

saraathollies123 said on 26 August 2012

I had implants in March 2001 and initially was delighted with the result. I had no ill effects at all until 2004 when my labrador pulled me violently to one side - the left. I was spun around so hard that I thought my left shoulder was dislocated. However, for a further 3 weeks I was ok with no pain but then the nightmare started. Ever since that time I have suffered from a 'bad' back and / or shoulder and have visited a physio twice weekly at my own cost plus had every single type of scan, xray, ultrasound etc on my neck, back, chest, shoulders.

I used to row on my water rower daily for up to an hour at a time plus I enjoyed gardening but any repetitive movement of my shoulders caused pain - if not immediately then the next day. I was a constant visitor at my local surgery and I am convinced that all of the GP's think I am a hypochondriac. I have visted chiropractors, osteopaths, had acupuncture and I have religously followed all of the exercise plans given to me but nothing has worked. I have been unable to sleep at night as I can not lie on my front or my side as the pain is too intense.

I saw recently on the internet that ladies who have implants - not necessariyly PIP implants - with rheumatological problems are 97% improved when the implants are removed.

I have pain in my chest, down the back of my arms and in my armpits which the physios tell me is referrred pain from where my dog pulled me. However, I discovered recently that the implants I had were in fact PIP's and I now see that other ladies also have had my symptoms.

After a lump appeared in my right breast and a 'bubble wrap' sensation in my left I visited a consultant privately who confirmed that one implant is ruptured and it is highly likely the other one is too. He told me I have extensive internal scar tissue but confirmed that I can have them removed free by the NHS.

The original consultant is retired and the clinic is closed!

Are all of my symptoms due to PIP's?

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totally_toxic said on 22 June 2012

I had a PIP reconstruction after breast cancer surgery ten years ago. My implants have 'deflated', changed shape and I have chest, back and shoulder pain. My shoulder is frozen and I have recently been diagnosed with inflammatory arthritis which affects my hands, wrist and elbows, I am tired, vulnerable to infection, suffer debilitating headaches/migraines lasting weeks at a time. I have difficulty sleeping and I suffer with fatigue. I take daily medication and I am frequent visitor at my GP's surgery. I was there yesterday. My axilla lymph nodes were removed during cancer surgery and I have multiple lumps in various parts of my body (diagnosed as lipomas by doctors on palpitation) I have yet to hear when I will have surgery, but i am told to expect to be admitted for a minimum of 4 days. I think the Keogh Report is a disgrace and the MHRA has failed British women affected by this scandal spectacularly!

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helena66 said on 31 May 2012

I am very upset by the way I am being dealt with by Transform. Delay delay delay and I have made a formal complaint now. Not that this is being responded to in any kind of timely manner ! Do they realise how upsetting this all is ? It takes over your life with the worry !

I need to have my PIPs removed due to rupturing but am expected to find nearly £3000 for them to be replaced ! I am appalled that this is not being carried out free of charge.

I am interested in the Provision of Goods and Services Act 1982 information and whether this can be used in our cases ? Has anyone found out any more on this ?

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sallyannejane said on 25 April 2012

I've just found out I have a very large lymph node under my arm that is filled with silicon. Its worrying that The consultant I recently saw at Transform didn't notice this when he examined me. I've now seen a consultant at My NHS Hospital and at a private hospital to see about having my PIP implants removed and replaced.

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Primarniqueen said on 28 March 2012

i had implants done in 2000 by Highgate Hospital. they tell me they only have to keep records for 8 yrs so have no record of if they are PIP.They also said the consultants themselves buy the implants.as the Dr had left them i managed to e mail him and he said this was not accurate and he had no records either so i can not establish if mine are PIP or not!
the dr also tells me that all implants can need replacing in time- i wasnt told this at the time of surgery.
although I have no problems-yet- I feel very let down.

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sallyannejane said on 17 March 2012

I have now been for a review at the private clinic I had my implants and they quoted me between 5 and 6 thousand pounds to have them removed and replaced. I believed at least there would have been a discounted price as I didn't expect to be given non medical silicon in the first place. I think they have treated me very badly.

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elgnid0 said on 28 February 2012

I referr to this and now im really worried for my daughter,just what is going on (sallyannejane said on 27 January 2012
" I can't seem to get through to anyone that PIP implants have been in this country longer than the Government and cosmetic clinics are reporting or admitting to. I had mine in 1998 and my clinic tried to lie to me even though I have proof. I am so worried.) I know the feeling and I believe many more lies are told perhaps with the best intention but they are still lies!.


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maggieleo said on 12 February 2012

my pips have ruptured about 2 months ago, pains in arms, lumps in armpit ,chestpain, anxiety and a load of other symptoms. I am sure the authoritys do not know the kind of pain we are suffering. I have been scanned and they have ruptured. Gone from GP to hospital, from hospital to clinic and nobody wants to help. All the info from nhs and government is incorrect and no-one wants to take responsibility. I am scared for my five children. What if the medical porfession is wrong about long term results of pips. They were wrong about thalidomide look how long that took to resolve . This is a timebomb waiting to go of. Is nobody going to take responsobility for this. It seems not. We are still waiting to get them removed even when they have ruptured. It is disgraceful. All we red about is human rights where are ours. The right to a pain free life.

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nikkihay said on 11 February 2012

Hi Ladies, I am going through this too, I had my implants done in 2003, I have had lots of problems with them, from about 2yrs after till now, they are lumpy, flat in places and often feel sore, they don't look even but don't seem deflated. I went back to see my surgeon when I first noticed the problem and was told it was due to me losing weight! I had maybe lost between 7-14lb at the most! He said he would replace the worst one of the 2 but couldn't guarantee that they would be ok or look even. So I just felt fobbed off, a year or two ago I noticed more lumps which seem to be separate from the implants so went to my GP who told me it was more than likely just down to the implants and that if I had concerns I should go back to the surgeon who put them in. fobbed off once again. I just went away in the hope I could one day be able to afford to get them replaced without crippling my family financially. After all the media reports my husband has been asking me to contact the clinic and see if I have PIP implants, I heard back from the clinic to confirm I have on Tuesday. They said I need to arrange an MRI scan myself either pay for it or wait for one on the NHS then I have to take the results to them and if I have ruptured implants they will replace them for £2k and if they are not ruptured it will be £3k. I have been to my GP yesterday who has referred me to a breast reconstruction clinic for an MRI but he said there could be a long wait due to the amount of women who have PIP's. It is so worrying and seems that we have all been let down terribly by the government and the private clinics. I just pray that these don't cause long term or permanent health problems.

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chloe1994 said on 11 February 2012

What happens to us ladies who have had PIP Implants done by a private sector and that particular company has now gone into liquidation? Who is it all done to?? How do we get out of the mess that we are all in! Is it all down to us ladies to pay out yet again to have proper medical grade silicone implants and have the industrial silicone implants removed? As far as i am concerned it is not down to us at all. We all paid good money to the private sectors so why should we pay out yet again, surely these private sector companies must have some sort of insurances in place just incase things go wrong! The latest is some private clinics want us women to sign waivers before more surgery, this means that then these private companies are not responsible to us women if things then go wrong. I think they have all got a cheek! We all paid good money to the private sectors so it is down to the private clinic's to Remove the PIP Implants and Replace! As far as i am concerned it is down to Medical Group to remove and replace my implants! All it seems to me is these private clinics do not seem to careless about any of us and all they want to do is put their hands out for more and more money for removal and replacement. I think it is a disgrace and they should not beable to get away with it. As far as i am concerned the private sectors are responsible, the government and the department of health are all to blame for this. It is about high time this whole mess was sorted out and that all us women are treated fairly and with compassion, not ignored and pushed aside. I think it is also discusting that these PIP Implants had been put in women who have had breast cancer, how disgraceful is that. Its about time the department of health, government, private sectors all took responsibility for their actions, or lack of actions!

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ZoeH76 said on 10 February 2012

I had implants in 2004 by transform, I have just made an enquiry and am waiting 2-3 weeks for my medical records. Apparently removal is free by replacement is 2500 pounds even if theyve ruptured! I've had no problems so far but its a bit unnerving.

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chloe1994 said on 10 February 2012

HI ladies I had breast implants done january 2010 by surgicare ltd. I only found out that I had pip implants on the 23rd january 2012. I am very much traumatised, angry, depressed and discusted with the fact that these implants us ladies have had, they had not even been approved tested. When I telephoned surgicare ltd early part of january this year, I was told directly we are not surgicare ltd and that surgicare ltd went into liquidation sept 2010 conveniently. We are surgicare medical group. We are nothing to do with surgicare ltd, I was then told by them to contact the hospital where I had the implants done and that is when I found out I had pip implants, I paid nearly four thousand pounds for these poisoness implants. I want them removed and replaced like all you other ladies. Why on earth should us ladies pay more money. What angers me is I have been told to try and contact your surgeon, well what a joke that is, I have tried every way possible to get hold of the surgeon but of no joy whatsoever, no-one wants to help, I have even phoned the general medical council to try and get information and they will not pass any information on to me so I can contact the surgeon, they told me sorry we cant give you that information because of data protection act. So what should I do now?? Any suggestions ladies??? I realise we are all in the same boat but I am so upset. I desperately want these god damn things out. Also another thing is that I had the implants done january 2010, well march 2010 the pip implants were taken off the market banned, then I went to see my surgeon at surgicare may 2010 for a check up and he never even had the decency to inform me that I had the pip implants, it seems to me that a lot of surgeons do these breast op's for money money and dont careless about their patients, what happened to patient aftercare, what a joke that is! To get the pip's out and replaced ive been quoted over three thousand pounds money money dont care about us!!

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loolypop said on 09 February 2012

I have had my implants since 2004 on the NHS and when i called my doctor regarding finding out if they where PIP i was told only a majority had the PIP done on the NHS. I asked for my medical records and was told to call back in a few days i called back on the 5th day and was advised by my GP that the receptionist has been walking about with her hands on her head due to misplacing my records. The GP gave me the number of the records dept of the hospital where i had my surgery to obtain the records, i called and was told that they would send me paperwork to fill in to retrieve my records.Today i have received a letter from the hospital advising me that my records have been destroyed. Iam sick to my stomache with worry. Iam seeking legal advice regarding this i feel totally let down by my GP also with the NHS.

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Karen42 said on 09 February 2012

PiP implants should be removed free of charge regardless of where you had the surgery. All private cosmetic surgery companies should bite the bullet and pay for at least the removal. By using PiP implants they are in breach of the "Provision of Goods and Services Act 1982" by supply implants filled with industrial silicone which is not meant for medical use.

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Karen42 said on 09 February 2012

I had PiP implants in October 2006. For the last two years I have had lumps appear, pain to the point of clothes hurting, sweats, arm ache, pains in my armpits. I contacted my plastic surgery clinic two years ago to complain about my symptoms. They told me that my surgeon had left the company. I waited about six weeks to see another surgeon at the same company who felt the lumps and told me to go to my GP for a scan and they to come back and see him. They want to charge me £4190 to remove the implants. That's more than I paid for them in the beginning. After all the media coverage and new information about PiP implants I contacted my plastic surgery company again in january to book another appointment. They could fit me in February, a whole month later. They telephoned me yesterday, 8 february to say my appointment on 9 February is cancelled due to the surgeons schedule changing. I am fed up of being fobbed off. I am now seeking legal advice. Is there anyone else out there doing the same?

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Paris64 said on 07 February 2012

I had implants at transform in 2009 over the past month a have pain in my left breast and in my arm also it feels like the left breast is slipping I have rang transform and asked for my medical records I'm still waiting

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Lily Louise said on 31 January 2012

To anybody who needs advice,support or someone to talk to , there are several support groups on facebook,regarding PIP breast implants:)

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sandra darbs said on 30 January 2012

Message for sallyannjane.I also had implants in 1998 ,and having just looked at my reciepts,I have an aftercare leaflet from PIP implants,I have rang Transform today and they said ones used before 2001 are OK ,but I have MS type symptoms which are getting worse ,and when I have looked it up it says the bad implants are calledpoly implants protheses in ortherwords PIP implants ,I have requested my records and said I want a scan

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advice123 said on 27 January 2012

sorry guys didnt mean to send that so many times! lol :) x

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sallyannejane said on 27 January 2012

I can't seem to get through to anyone that PIP implants have been in this country longer than the Government and cosmetic clinics are reporting or admitting to. I had mine in 1998 and my clinic tried to lie to me even though I have proof. I am so worried.

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AlysonW said on 26 January 2012

I had implants in 2004. I started being ill in 2007 - extreme tiredness, hands shaking, anxiety, abcesses in my left breast, pins and needles in my mouth, right arm constantly aching, hot sweats, nightmares, hair falling out the list goes on - My Doctor tells me over and over again that I am suffering from depression, I told him that I feel like something is attaking my immune system, that something is poisoning my system, He tells me it's depression again. So I take the pills he perscribed, and decided to carry on suffering in silence with the worry of him thinking im a hypocondriact.. When all this came out about PIP implants, I thought finally maybe this is the answer as to why. I contacted my clinic straight away and they confirmed I had the PIP implants. I need to know if anyone else has suffered these symptoms.
Thank you

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elgnid0 said on 26 January 2012

I am concerned for my daughter,early on when people were talking about the removal of this poison,the doctors talked about the creation of more problems if the prosthesis was not replaced,the membrane created by the implant on both sides would create a permanent cavity which could infect or fill with anything from the body, its not like a cut which would heal,these things have been inside the body and the natural effect of this is that the implant would be cased off from it by the bodies own reaction which would be to build up a membrane as they suggested,drains would have to be put in place and anti-biotics administered, any further problems created by none replacement would fall to the health service,why not ask for the extra money just to cover the replacement prosthesis,it cant be too much money,and to my way of thinking , whilst your removing them surely its just as easy to replace them at that time,my daughter went private,she had some anorexia problems that all but destroyed he breasts, we had to pay £4000 for the operation,she is healthy now and is on the mend but this is a disgrace, this goverment never think ahead,if left alone these implants will cause massive problems,people will get older and less able to tollerate a major operation like this, i believe the longer you leave these things in place the more likely it will lead to death or disease,

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Irened said on 25 January 2012

To the lady at the top of page, mine were also not very helpful, but was told to phone the hospital I had them done and they had my info. I think this is disgusting the way we are being treated, and expected to pay again for the replacement even though it's a fault, my friend brought a new car recently and 2day received a letter recalling it as there is a manufacture fault, it will be sorted FREE...... Same principle, hang in there ladies...

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User635957 said on 19 January 2012

i have had implants since 2006 put in by transform i now have bad pain in one breast an not geting any info of what type i have etc from transform as of yet they are being very unhelpful and saw nhs doc today and was not intrested at all said not there problem what am i meant to do now

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PIP Victim said on 17 January 2012

As above I think many women have concerns over breastfeeding or becoming pregnant with these implants in.

Also it is not simply a matter of whether these implants have ruptured or not-What about the fact that the silicone is said to bleed out from the shell into the body. A woman may not even be aware this is happenning! Any advice please...

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Bernard Murphy said on 16 January 2012

Patients are asking about the following concerns, which remain unaddressed here:
1. breastfeeding safety? (with PIPs and after removal);
2. MRI or ultrasound? (for best assessing state of implant);
3. rebranding concerns - this guidance still does not reflect the likelihood that a significant number of UK women have PIP implants under a different name (Rofil M-implants, at least) - how are they to know what to do? who is alerting them about this in the first place?
(Bernard Murphy, journalist at Clinica Medtech Intelligence)

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