Poly Implant Prothèse (PIP) implants

PIP (Poly Implant Prothèse) is a type of breast implant made by a French company, also called Poly Implant Prothèse. These implants have been under investigation and widely covered in the news in recent years, due to concerns that they may be more prone to leakage or rupture than other types of breast implants.

The PIP implant scandal first came to light back in 2010, when a French investigation discovered that many PIP implants contained a cheap industrial-level silicone rather than medically-approved fillers. Health authorities discovered that PIP was saving an estimated €1m in annual profit, simply by using unapproved, industrial-grade gel in 75% of the implants. The company was immediately liquidated and its products were banned.

In 2011, French health authorities advised 30,000 women to have their PIP implants removed – to date their government has already overseen the removal of 15,000 French women’s implants. Outside of PIP’s home country, it has been estimated that approximately 400,000 women in 65 countries have been affected, 47,000 of whom are British.

In 2013, TÜV Rheinland (the German company that awarded EU safety certificates to PIP) was successfully sued for £42m by 1,672 women (including around 100 Brits), alongside six implant distributors. The German company is now left open to further compensation claims potentially totalling €6bn from the plaintives as well as the distributers originating from Bulgaria, Brazil, Italy, Syria, Mexico and Romania.

Meanwhile, following a month-long trial the same year (recorded as the most expensive in French history), PIP founder Jean-Claude Mas was jailed for four years in December 2013, having being found guilty of aggravated fraud. In addition to his prison sentence, he was ordered to pay a €75,000 fine and has been permanently banned from working in medical services or running a company. Four other PIP executives were also convicted with lesser sentences.

At the time of writing, Mas also faces a future trial for causing involuntary harm. Many thousands of women are yet to receive any compensation.

Am I affected?

According to the Department of Health, around 47,000 British women may have PIP implants – and the majority of these are purely cosmetic. If you are one of the women affected by PIP implants, please read on for more information and advice.

It was initially thought that only Poly Implant Prothèse implants manufactured before 2001 contained the lower-grade silicone but after further investigation by the MHRA (Medical and Healthcare Products Regulatory Agency), it was reported that implants made prior to 2001 may also be affected.

If you have implants and are concerned that they may be PIPs, talk to your GP. They will be able to check your medical notes and confirm whether or not yours originate from the French company. If your initial operation was done privately, contact your clinic and ask to see your notes – there should be no charge for this.

What to look out for

If you think you may have PIP implants, there are a number of signs to look out for, which may indicate that you have a rupture or leakage. If you feel that you are experiencing any of the following symptoms, consult your GP:

Lumps in the breast, or the area surrounding the breast.
Deflation, swelling or changing of the shape of the breast.
Tenderness, firmness, pain or sensitivity in the breast.
Redness of the breast and its surrounding area.

What can I do?

If you are concerned about your implants, the NHS has provided the following guidelines with regard to what to do next:

If you have PIP implants that were done on the NHS, you should receive a letter informing you of the next steps to take. You should also speak to your GP for further advice.
If your implants were done at a private clinic, contact your clinic or surgeon for further information.
After a discussion, you may be offered a scan and you can then decide – with advice from your doctor – whether or not your implants should be removed and/or replaced.
If you decide you’d like to have the implants removed, this will be done free of charge on the NHS, if your original operation was on the NHS.
All private clinics operate differently so speak to yours to see if they will remove or replace your implants for free.
If your operation was done privately but the clinic no longer exists or is refusing to remove your implants, the NHS will remove them if your GP feels there is a medical reason to do so.

What do the experts think?

An expert review into PIPs, including chemical and toxicology tests, was completed in June 2012. The report advised that the tests found there was no significant risk to human health from PIPs: they are not toxic, nor are they carcinogenic (cancer-causing). They do, however, contain high levels of siloxanes compared with other silicone implants (siloxanes are chemically similar to silicone and can be found in some health and beauty products).

The review found that PIP implants are two to six times more likely to leak or rupture than other types of silicone implants. It is thought that rupture is more likely to occur the older the implants get – although lots of implants have to be replaced after five to ten years.

Speaking to The Guardian, Bruce Keogh, NHS Medical Director said: “This has been an incredibly worrying time for women. We have been determined to look thoroughly at all available evidence, so we are able to give them the best clinical advice possible. We would therefore advise that women who have symptoms of a rupture – for example tenderness, soreness or lumpiness – should speak to their surgeon or GP. I would ask all GPs to refer any patient who has concerns about their PIP implants to a specialist. I sincerely hope this helps to reassure women that their long-term health is not at risk.”

Fazel Fatah, President of The British Association of Aesthetic Plastic Surgeons (BAAPS) explained: “Despite rigorous testing showing no long-term danger to human health from the individual chemicals in the gel, the fact remains that PIPs are significantly more likely to rupture and leak and, therefore, cause physical reactions in an unacceptable proportion of the patient. It will come as no surprise to the many women affected that PIPs have been officially confirmed as defective – this has also been our long-held view, and that the choice of removal should be offered to them by their provider regardless of rupture or symptoms.”

The Department of Health issued a statement saying: “We stand by the conclusions of the original report and want to reassure women that PIP implants do not pose a significantly increased risk to health. The expert group report thoroughly analysed the toxicology of chemicals in the implants, including the potential effect on women of reproductive age. The main panel was advised by a sub group that contained four independent toxicology experts. The wellbeing of women who have had PIP breast implants has always been our main priority.”

PIPs are still under investigation and are being monitored by the Department of Health and MHRA, and the government has finally announced a trial register for all breast implants, to start data capture in this field and begin the daunting task of regulating the cosmetic surgery industry more effectively.