Poly Implant Prosthèse (PIP) - what do I need to do?
If you have had breast implants for whatever reason, you may have had a cosmetic procedure for enlargement, a breast reconstruction following major surgery, or have undergone a transgender procedure; we understand you will be concerned about the recent information regarding PIP breast implants.
We have put together some potential questions and answers to try to help you clarify at least some of the issues.
Q1. What brand of breast implants do I have?
Q2. Are all breast implants the same?
Q4. Why are these PIP implants sub-standard?
Q5. Why were these sub-standard implants sold in the UK?
Q6. I have heard that there is an increased risk of cancer with PIP implants is that correct?
Q7. I know I have PIP implants put in after 2001 and that I need to do something, but what next?
Q8. Do I have to have the PIP implants removed if they were put in after 2001?
Q10. Is there any risk to my health in having the implants removed and replaced?
Q12. I am a Nuffield Health PIP patient with implants put in after 2001, what will you do for me?
Q13. I did not have my PIP implants inserted in a Nuffield Hospital, are you able to help me?
Q14. I know that I do not have PIP implants put in after 2001 – I am unsure what I should do next?
Q15. I have breast implants that are not PIP – do I need to worry?
Q16. What if I have other questions not covered here?
Q1. What brand of breast implants do I have?
A1. The consultant who put in your implants and the hospital or clinic where you had the procedure will have records of the implants used in your surgery. All hospitals and clinics keep implant records and these are attached to your medical records. If your procedure was recent the records will be easily available, if it was several years ago the records may need to be retrieved from archive and so it may take a few days to retrieve the records and let you know what implants were used. If your procedure was over eight complete years ago then records may not be available in some hospitals and clinics as records do not have to be kept after this time.
You should always keep a record of your implants no matter what type and make sure you have that information available.
Q2. Are all breast implants the same?
A2. No – there are many different types and brands of breast implant (See also MHRA Information). They vary in size, shape and texture and the content can typically be silicone, hydrogel or saline. Some can have the size changed in situ. The current alert only relates to silicon implants produced by Poly Implant Prosthèse (PIP) after 2001.
Q3. Are all PIP implants part of this alert from the Medicines and Healthcare products Regulatory Authority (MHRA) alert?
A3. No – there are different types of PIP implants and the alert only relates to those silicon implants manufactured by PIP after 2001 (MDA/2010/025).
Q4. Why are these PIP implants sub-standard?
A4. The MHRA has stated that the implants had been filled with a non-medical grade silicone gel that was different to the one that had been approved.
Q5. Why were these sub-standard implants sold in the UK?
A5. All medical devices and implants used in the UK have to be approved by the MHRA, and this is subject to UK law. These implants received a CE mark (which is the system used in the UK and Europe to ensure a product is suitable for the purpose) and were subsequently approved for use by the MHRA. At the time the CE mark was applied the manufacturer was using medical grade silicone and appropriate manufacturing processes. At some stage after 2001 the manufacturer changed the constituents and manufacturing process of these implants whilst continuing to use the CE mark. At present the exact date when the company made these changes is unknown. These changes were discovered on a checking visit by the French regulator. Having made this discovery, manufacture of these implants was halted and an alert issued.
Q6. I have heard that there is an increased risk of cancer with PIP implants is that correct?
A6. The MHRA and Chief Medical Officer have reassured patients that there is no evidence of any increased risk of cancer. Tests have not shown any geno-toxity in the silicon gel.
Q7. I know I have PIP implants put in after 2001 and that I need to do something, but what next?
A7. Talk to the hospital or clinic where you had the implants put in. They will be able to tell you the next steps. Broadly the advice is as follows:
- If you have any symptoms in your breast, for example (but not exclusively) pain, soreness, redness or inflammation; or any hard lumps in the breast area, your chest or under your arm or you have any concerns at all then you should seek the advice of your implanting surgeon.
- If your implanting surgeon is not available, the hospital or clinic where you had your procedure will be able to direct you to an alternative surgeon.
- If your hospital or clinic is no longer operating or declines to help you then the statement from the Chief Medical Officer says you can receive help from the NHS. You should consult your GP in the first instance. Your GP will be able to facilitate a consultation with a cosmetic/plastic surgeon who will be able to offer you appropriate advice and investigations or surgery if required.
- Clinical consultation could be accompanied by an ultrasound or MRI of your breasts for further diagnosis if the consultant feels that is appropriate.
Q8. Do I have to have the PIP implants removed if they were put in after 2001?
A8. It will depend on the condition of your implants. Your implanting surgeon is best placed to advise you what the best course of action is. If you have no symptoms and your implants do not appear to be degrading then you may not need to have them removed at this time. However, after consultation with your surgeon, you may feel the risks associated with further surgery are not as great as the risks associated with retaining the implants and therefore opt to have them removed.
Q9. If there are signs the implants have ruptured, such as pain, swelling in the breast or chest area or swelling in the armpits, should I have the implants removed?
A9. If there are any signs the implants may have ruptured Nuffield Health believes that you should seek early attention, initially an appointment with a consultant plastic or cosmetic surgeon who will arrange imaging investigations. Where implants are shown to be ruptured the consultant surgeon will advise you on their removal and/ or replacement.
Q10. Is there any risk to my health in having the implants removed and replaced?
A10. There is always a risk in having a medical procedure of any kind. There is a risk in having a general anaesthetic and there is risk from infection and other complications. These risks should be borne in mind when making the decision about whether to have further surgery and your consultant can give you further information and advise you to enable you to make an informed decision.
Q11. I have decided to have my PIP implants removed and replaced and would like to increase the size of my implants, can I do that during the surgery?
A11. Nuffield Health is very happy to facilitate the removal and replacement of PIP implants on clinical grounds; any request for a change in size will need to be reviewed on an individual basis in consultation with your surgeon. Whilst this would remove the need for further surgery, it is not a reason for having the implants removed and would need careful discussion with your consultant.
Q12. I am a Nuffield Health PIP patient with implants put in after 2001, what will you do for me?
A12. As a Nuffield Health PIP patient you should have already been contacted by us in 2010. If you have not already done so, contact the Nuffield Health hospital where you had your original procedure. If that hospital is no longer owned by Nuffield Health then please contact our enquiry centre on Tel: 0845 603 4346 and they will direct you to the nearest hospital that will be able to help you.
Nuffield Health will facilitate a free consultation either with your original surgeon or a consultant who has experience in the same area. You will then be offered a free ultrasound or MRI scan if the consultant feels that is appropriate for you.
Should your implants be ruptured or you consider that they are adversely affecting your wellbeing in any way then Nuffield Health will remove and replace your implants at no cost to yourself.
Q13. I did not have my PIP implants inserted in a Nuffield Hospital, are you able to help me?
A13. Nuffield Health is always happy to help all potential patients; however, we are an independent provider and we would need to make a charge for that service. If you wish to pursue treatment at a Nuffield Health hospital please contact either the enquiry line on Tel: 0845 603 4346 or your local hospital which can be found on the website http://www.nuffieldhealth.com/hospitals and they will advise you of the process. Alternatively, if your original clinic is no longer able to support you, you should contact your GP for support.
Q14. I know that I do not have PIP implants put in after 2001 – I am unsure what I should do next?
A14. You should review the advice given by the MHRA and the advice given by the Department of Health Chief Medical Officer which outlines the reasons for having implants and the care required.
You should ensure you have a regular check up with the surgeon and/or hospital/clinic where you had your implants. The frequency will depend on the length of time your implants have been in place. All implants have an increased complication and rupture rate the longer they have been in place. After 10 years the rupture rate is considerably higher and patients should expect to need to have implants replaced. Whatever the type of implant, it is not expected that it will last forever.
Q15. I have breast implants that are not PIP – do I need to worry?
A15. Breast implants have a very good safety record with a low risk of complication. However, you should be aware that implants will not last forever and the longer they have been in place the higher the risk of failure or complications. You should ensure you seek regular follow up with your implanting surgeon and examine yourself regularly as all women are advised to do to check for any changes in the breast, or abnormalities.
Q16. What if I have other questions not covered here?
A16. We hope we have been able to answer some of your questions and queries. If you have any specific questions please contact our enquiry line on Tel: 0845 603 4346 and they will be able to direct your questions to someone who is able to answer them for you.
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