Welcome to TreatmentAdviser.com's info page on PIP implants. If you know, or suspect, that you have had PIP implants and are worried then we hope that this page has all the help/information you need.
Scroll down to read an interview with leading breast specialist surgeon Mr Philip Turton where he explains how the PIP scandal unfolded and his advice on what to do.
If you need to chat to others in our forum who are going through a similar situation to you, then click here...
Think your implants may have ruptured? CALL US TODAY ON 01789 520982
PIP implants: Firstly, don't panic!
The UK's Medicines and Healthcare product Regulatory Agency (MHRA) has stressed that there is 'no evidence' of a link between these ruptured implants and cancer. The Chief Medical Officer Dave Sally Davies said: “Women with Poly Implant Prosthese (PIP) implants should not be unduly worried. We have no evidence of a link to cancer or an increased risk of rupture. If women are concerned they should speak to their surgeon.
This is backed up by Mr Philip Turton who says the following: "I've looked at this in detail and I'm satisfied about this – the gel is an irritant and causes an inflammatory effect but it doesn't 'poison' the surrounding tissue. Furthermore, the reports of cancer from France have been anecdotal. There has been no increase in patients developing cancer and these implants have been on the market since 2001 – we would have seen a link by now."
PIP implants: Then follow these simple steps:
1) Ascertain which implants were used in your breast augmentation procedure.
2) If you have had PIP implants, contact the surgeon who performed the surgery and ask for a scan to establish whether there are a problem with the implants.
3) At the same time as contacting your original surgeon, visit your GP and ask their advice.
4) If there are problems with the implants they should be removed and replaced. Some of the market leaders in implant manufacture (including Nagor and Johnson & Johnson) are operating schemes where new implants will be offered free of charge or subsidised.
Some useful links:
Tell your story on the PIP page on this site, there are always surgeons on hand to answer any questions: PIP implants
Government Report - click here
NHS Advice - click here
MR PHILIP TURTON ON ITV'S INVESTIGATION INTO PIP IMPLANTS
TREATMENTADVISER.COM DISCUSSES PIP IMPLANTS WITH LEADING UK BREAST SURGEON
Mr Philip Turton, a leading Specialist Consultant Breast, Oncoplastic and Cosmetic Breast Surgeon, gives his views on the PIP scandal and his advice to women who know or think they may have had these implants
How the PIP scandal unfolded
Poly Implant Prosthese (PIP) implants – made by a French company of the same name – have been on the market since 2001 and it was in early 2010 that the French regulator – alerted by the much higher rupture rate of these implants – put them through what they describe as a 'vigilance period' and discovered that the gel contained in the implant was not what the company had claimed it was.
There were two significant problems found with the PIP implants. Firstly, an issue with the protective casing which contributes to this increased rupture rate and, secondly and most importantly, the gel on the inside. This is the key to this scandal – the gel inside was not pure medical-grade silicone. It was made of raw silicone ingredients that are not approved for use in humans and when the implants rupture or leak this causes problems that are different to the other safe implant brands(left, ruptured PIP implant removed by Mr Turton).
The gel acts as an irritant to surrounding tissue which medical-grade silicone wouldn't do. It causes an inflammatory reaction which is usually the first indication that something is wrong with the implant – pain, local irritation in the form of redness and swelling of the breast caused by tissue fluid which is drawn in by this irritation. Other patients are getting symptoms caused by the migration of this silicone gel into the lymph nodes and other areas of the body. Some get the spread of the gel but don't get symptoms, so there are not always warning signs present.
In the decade that the implants were approved they were used around the world, bar North America, with 30,000 women affected in France and even more in the UK, with estimates of over 50,000.
PIP was a rogue company that deliberately deceived their regulatory body and the inspectors with a criminal level of negligence over a device that was going to be implanted into women. I still have the marketing material from the UK distributor and you would be dismayed at the difference between what is in the brochures and what is now being reported around the world.
The French versus UK government
The situation as it currently stands is that the French government is supporting the removal and replacement of PIP implants, but the advice from the UK government – 'based on the current evidence' – is that women should not worry if they have no associated problems with the implants.
What I think is crucial here is that the UK government is basing their advice on incomplete evidence. Take the rupture rate; the UK government's data suggests it is approximately one per cent whereas the French regulatory agency reported it to be closer to ten per cent. The reported rate will likely be low in the UK because until now there has been no requirement for a surgeon to report if they have removed ruptured PIP implants. The pre-existing National Breast Implant register was funded by the Department of Health, but they pulled the plug on it in 2006. So I feel that you have to consider the highest known rupture rates as being a possibility as the very low ones are more likely to be as a result of a lack of reporting rather than any other reason. Some of the rates from certain clinics were implausible.
It is also important to realise that these implants not only have a high rupture rate but they also have a high bleed rate. This is where silicone gel can gradually pass through the casing into the area around the implant. This can occur with other implants, though Allergan, for example, have three layers to the casing of their implants which includes a special barrier layer to reduce this. For the PIP implants, any silicone bleed is significant as the gel on the inside is an irritant so it can cause a problem. So a patient might not necessarily have a rupture but still might not be safe.
I think the UK government is taking an increasingly proactive stance, after the expert advisory group reported on the 6 January. But it is still offering less than other countries such as France and Germany. I am updating my own website regularly to reflect the changing information available:www.cosmeticbreastsurgeon.co.uk. Other governments have been adopting a more precautionary stance with a 'removal for all' recommendation policy. However, there is a massive cost implication which is why the original clinic has the duty of care to sort out their customers. In the UK if you have a problem with your implants but can't get help from your clinic then the government allows you to have them removed free of charge by the NHS. The problem comes with the replacement of implants – this not currently being allowed in the UK – because if the NHS was to replace the implants it would then fall on the NHS to manage these implants for the rest of these women's lives.
Personal experience with PIP
I have never used PIP implants ever. My patients are fortunately greatly reassured that I personally use Allergan implants in almost all situations except in some special circumstances. Allergan implants have been approved by the FDA in the US, one of only two implants that have this approval although there are other breast implant manufacturers that are currently within the lengthy approval process.
I first came across a PIP ruptured implant in 2006 and problems from another in 2008. However, it was very soon after March 2010, which coincided with them being suspended from the market, that I started seeing more and more patients who'd had these implants placed by other clinics and now were having problems. Since December 2011 and the announcement of the French government, people have become enormously worried and I'm seeing a massive increase in patients concerned about their implants.
I have also had concerns with what I have found in some patients: I was removing PIP implants from a patient recently. On the one side, where she had reported swelling and redness, the gel had diffused into multiple holes in the breast tissue itself which had then sealed. After removing the implant I had to puncture each hole individually and the gel oozed out. It was painstaking to clean the breast fully. The other breast had looked completely normal after removing the implant except for right at the very top of the breast where there was a shiny membrane. After dividing this I tracked a tunnel that the gel had formed, up under her collar bone and into the base of her neck. This was an eye opener for me and illustrates the very different behaviour of this silicone gel compared to medical-grade breast implant gel. It also emphasises the importance of a meticulous search for the gel at the time of surgery, from within the breast cavity, where there has been any silicone bleed or rupture. The tissue in the picture to the left is a 6cm swollen painful lymph node that I removed which was full of silicone.
PIP implants and cancer
As an oncoplastic breast surgeon I also work in the NHS treating women with breast cancer and it is important to reassure patients that there is no significant increased risk of cancer associated with implants, even the faulty PIP type. I've looked at this in detail and I'm satisfied about this – the gel is an irritant and causes an inflammatory effect but it doesn't “poison” the surrounding tissue.
Furthermore, any of the reports of cancer from France have been anecdotal. There has been no increase in patients developing cancer and these implants have been on the market since 2001 – we would have seen a link by now.
Advice for women with PIP implants
For a women who knows or suspects that they have PIP implants but doesn't necessarily have any related problems such as redness or swelling or pain, I would advise them to follow these steps:
1. Contact your original place of surgery to start the process, particularly in case of potential future legal actions. But be aware that many of these places will not have the facilities to perform the necessary checks, so it is crucial that at the same time you …
2. See your GP and request to see an NHS breast specialist (ideally one who also performs breast augmentation procedures as well) – I think most GPs would agree and readily advise this as well – as the breast specialist would normally do the following ...
3. A full clinical review and examination, plus an ultrasound by a breast radiologist to reveal if there are any problems
If I was seeing a patient who had no symptoms and demonstrated no problems with her implant so far but wished them to be removed then initially I would be duty-bound to pass on the advice of our own regulator the MHRA. It is important to go through that data with women. Furthermore, I would reassure them that there is no increased rate of cancer or evidence yet available to demonstrate a major health concern. But I would point out that the gel can leak out even without a rupture, that we don't know all the problems that can occur in the long term from non-medical grade silicone and they may wish to have the implants removed and replaced with new implants to limit future problems. It is easier surgery to operate when a rupture has not occurred. If it has occurred then a specialist with the experience of dealing with this problem is particularly important.
Perspective on PIPs and breast augmentation
Breast silicone implants have been used in general for augmentation since the early 1970s and there are approx 10 million women worldwide who have undergone breast augmentation. The PIP implant is a scandal, but we're talking about a tiny, albeit very significant, subset of the population overall that has been affected by a rogue manufacturer. Overall it has never been a safer environment to undergo this procedure, but it really emphasises that patients do their research into both the product and practitioner and be wary of prices that seem too good to be true as they probably are.
I had pip implants in 2005, in 2007 I went back to my clinic with pains & a popping in my left side. My surgeon said it was nothing to worry about so I thought no more of it. I have recently had mri scans and have been told i have free silicone that has leaked from the implant, I also have leaking into my lymph nodes and my left axiallary lymph node contains silicone and is now 3cm wide. I've been told i may have to have that lymph node removed when I have the implant removed and it will not be a straight forward removal due to the amount of leaking etc. does anyone know the risks or complications involved in this?? Also is it possible that it's been leaking since 2007 when I started having the pain? Is there anything yet to suggest side effects of these implants leaking into your body & lymph nodes?
The gel from a PIP silicone implant is non-medical grade and I have found more instances of it migrating to lymph nodes than would be expected. I have seen many cases now where this has been into the surrounding breast tissue as well as the regional lymph nodes. This gel is also known to have an irritant effect which is totally different to tests on medical grade silicone. It can therefore cause lymph nodes to enlarge and become painful.
Breast surgeons are very used to removing lymph nodes from the arm pit (the axilla) as this is part of their normal work, and will advise you on the balance of risks. On the whole, my advice is that if you have an enlarged node but no symptoms from it, axillary surgery can be safely avoided once you know that it is enlarged just due to silicone and not another cause. You do not want to get lymphoedema of your arm by having unnecessary axillary surgery.
The PIP implants and adjacent leaked silicone should of course be removed. I have detailed a lot of this information on a special page about PIP implants on my web site: www.cosmeticbreastsurgeon.co.uk. I hope you find this useful.
As far as when the rupture occurred, you would have no way of knowing, and as breast pain is such a non-specific symptom, it would be difficult to comment whether there was a link. It is entirely possible that if you have had symptoms non-stop since the symptoms first began that the two are related.
Consultant Breast Oncoplastic and Aesthetic Breast Surgeon
Think your implants may have ruptured ? CALL US TODAY ON 01789 520982