PIP breast implants were withdrawn from the UK after it came to light that they'd been deliberately manufactured with industrial grade silicone and were far more prone to rupture than other breast implants.
The ban on PIP implants, which has been in place since 2010, caused a global health scare that continues today.
Although the NHS and some private clinics have pledged to remove PIP implants free of charge, as of May 2014 only a minority of women have so far taken up the offer.
Of the 47,000 British women who had PIP implants fitted, many are still living with the defective implants in their body and the constant fear that the implants will burst and harm them.
This information is for women affected by PIP implants. It includes latest safety information, warning signs of rupture, and how to arrange removal and replacement.
What are PIP implants?
PIP implants are a type of silicone breast implant. The implants are so-called because they were manufactured in France by a company called Poly Implant Prostheses (PIP).
The ban relates to all PIP implants manufactured after 2001.
Why were PIP implants banned?
PIP breast implants were banned in the UK in March 2010 by Britain's drugs watchdog, the Medicines and Healthcare Products Regulatory Agency (MHRA), after it was revealed they contained cheap industrial silicone meant for use in mattresses rather than medical procedures.
The substandard implants are between two and six times more likely to rupture than standard silicone breast implants.
French health data, based on 17,000 surgical removals of PIP implants, reports a rupture rate of more than 25%.
How many women have PIP implants?
About 300,000 women in 65 countries are believed to have received the now banned PIP implants including about 47,000 British women.
In the UK, private clinics fitted 95% of the implants, while the other 5% were performed by the NHS, mostly for breast reconstruction following cancer.
What are the worries about PIP implants?
A key concern of women with PIP implants is that they will rupture and release cheap industrial silicone into their body, which may then have toxic, even cancer-causing effects.
Women with the implants describe it as like living with a timebomb inside them.
The Department of Health agrees that the faulty French implants are far more likely to rupture than other brands, but says that despite the use of non-medical grade silicone in PIP implants, there are no lasting health risks if they do rupture.
Can PIP implants cause symptoms if they rupture?
Ruptured PIP implants have no proven long-term health effects but they can certainly trigger distressing symptoms in and around the implant area.
Women may experience soreness, redness, lumpiness and pain in their breast after an implant has ruptured. Other possible symptoms are a burning sensation and/or enlarged lymph nodes in the armpit.
A ruptured implant should be surgically removed as soon as possible.
Read more about what happens when a PIP implant ruptures.
Can PIP implants cause cancer?
If you have PIP implants, it's natural to be anxious about whether the silicone gel filling can cause cancer if it leaks.
There have been widespread media reports of a possible link between PIP implants and a rare type of cancer called anaplastic large cell lymphoma (ALCL).
Findings from researchers around the world have so far have been reassuring and extensive studies have found no ingredients in PIP implants to be cancer-causing.
An independent expert committee, led by NHS medical director Professor Sir Bruce Keogh, found the materials used in PIP implants are neither toxic or carcinogenic.
In its June 2012 report, the expert review concluded "PIP implants have not shown any evidence of significant risk to human health".
Read the British expert review group's final report (PDF, 163kb).
A more recent report of the safety of PIP implants by The European Commission’s Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) supports Sir Bruce's expert review's findings.
The October 2013 SCENIHR report adds that "there is no reliable evidence that ruptured PIP implants create a greater health risk than a ruptured silicone breast implant from another manufacturer".
Read the European SCENIHR report (PDF, 963kb).
Do women need to have PIP implants removed?
Some countries, including Sweden, Germany and France, have urged women with PIP implants to have them taken out as a safety measure.
Here in the UK, official government advice is that there is no need to have the implants removed unless they have ruptured, or if you feel anxious about leaving them in.
The expert review led by Sir Bruce Keogh concluded that there was not enough evidence to recommend their early removal.
Many British doctors, however, are more cautious and advise that PIP implants should, for peace of mind, be removed whether they have ruptured or not.
The British Association of Aesthetic Plastic Surgeons (BAAPS) represents the vast majority of British plastic surgeons in private practice.
Its president Rajiv Grover said: "At the BAAPS we have remained constant in our view – these defective devices have no place within the human body."
How do I know if I have PIP implants?
You most likely received details of your implants from the clinic or hospital where the original surgery was carried out.
In most cases this will include labels that show the manufacturer, model and serial numbers of your implants. Check your serial numbers.
If your private hospital or clinic is no longer in business or unwilling to help, you can request your medical record from the hospital where your surgery was performed.
I have PIP implants, what should I do now?
If you have PIP implants, contact your doctor as soon as possible. If your surgery was performed on the NHS, speak to your GP in the first instance. If it was done privately, contact the clinic in question.
If you had your surgery privately and your clinic is unable or unwilling to help, the NHS will offer you clinical advice and support, including referral to an appropriate NHS specialist. Your GP can arrange the referral for you to see a NHS specialist.
You will have a hospital scan to assess whether your implants have ruptured or are showing signs of wear and tear. You can then discuss with your surgeon the risks and benefits of having them taken out.
How to decide if your PIP implants should be removed?
When deciding whether or not to have your PIP implants removed, a lot may depend on the condition of your implants and where you had them fitted.
If you have no symptoms, a hospital scan shows no signs of rupture and your implants do not appear to be degrading, you may decide to keep them.
However, after talking to your surgeon, and if you are anxious about living with PIP implants, you may feel it's worth further surgery to remove them.
To be clear: you don't have to wait until your implants have ruptured or begun to leak. The anxiety alone of living with PIP implants is enough to justify their removal on the NHS.
How do I arrange removal of PIP implants?
If you want to have your PIP implants removed, you're entitled to see a specialist to arrange this, with help from the NHS if necessary.
The Department of Health has promised that the NHS will take care of women with PIP implants by removing them free of charge regardless of whether they were fitted on the NHS or privately.
If you had your implants fitted privately, ask the original clinic to remove them in the first instance. But be reassured that the NHS will look after you if the clinic has closed down or refuses to honour its duty of care to you.
Read more about PIP implant removal.
How do I arrange replacement of PIP implants?
Many women will want to have their implants replaced as well as removed.
Normally, the NHS will remove but not replace PIP implants.
The NHS in England, Scotland and Northern Ireland have promised that they will replace breast implants free of charge if they were originally fitted by the NHS, but they won't replace implants fitted in private clinics.
The Welsh government has said it will pay to remove and replace both NHS and privately fitted PIP implants.
Some private clinics have agreed to replace PIP implants free of charge, but others have refused.
So, if you had private PIP implants you may have to pay for replacement implants.
Read more about PIP implant replacement.
What if I decide to keep my PIP implants?
If you decide to retain your implants, have a yearly check-up with your doctor to make sure they are still intact.
Tell your doctor if you notice any signs of tenderness or pain, or swollen lymph glands in or around your breasts or armpits, as these may indicate a rupture.
Anxiety and PIP implants
Many women affected by PIP implants have high levels of anxiety and/or depression.
If you are worrying about your PIP implants, it's important to tell your surgeon and your GP.
Anxiety is a health risk so the NHS will remove your implants with or without clinical signs of a rupture.
If you are experiencing problems sleeping or eating, or have concerns about body dysmorphia or depression or anything else affecting your psychological health and wellbeing, contact your GP.
Jan's PIP implant story
Jan Spivey had PIP implants fitted in both breasts at the age of 40 following breast cancer surgery. She remembers the chaos and worry that ensued when the scandal broke:
"A cancer diagnosis is terrifying, but you're seen quickly and given lots of information and support. This kind of support was missing after the news broke about PIP implants.
"It was several months before I was able to ascertain that they were indeed the implants that I had. And that was a very worrying time. I needed sleeping pills to help me get through. I was aware there were lots of very frightened women like myself.
"When my PIP implants were checked, the scan showed they’d begun to 'bleed' silicone into me. They were removed on the NHS but I've suffered for years since with what my consultant describes as a 'constellation of unexplained symptoms'. Lots of other women who had their PIP implants fitted privately are being forced to live with them because they can’t afford replacements."
Jan, now 52, has helped to set up the PIP Action Campaign, to inform and support women affected by PIP implants.
Page last reviewed: 09/05/2014
Next review due: 09/05/2016