Introduction 

PIP breast implants were withdrawn from the UK after it came to light that they'd been deliberately manufactured with industrial grade silicone and were far more prone to rupture than other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. 

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.

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.

 

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.

In its June 2012 report, the expert review concluded "PIP implants have not shown any evidence of significant risk to human health".

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".

 

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 it was done privately, contact the clinic in question.

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.

How do I arrange removal of PIP implants?

 

If you had your implants fitted privately, ask the original clinic to remove them in the first instance.

 

How do I arrange replacement of PIP implants?

Many women will want to have their implants replaced as well as removed.

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.

 

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.

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 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.

 

Warning signs of a ruptured PIP implant 

PIP implants are two to six times more likely to rupture than other silicone implants.

They also leak tiny amounts of silicone through the shell, called gel bleeds, which can result in similar symptoms to a rupture.

How can you tell if an implant has ruptured?

Most women with a ruptured PIP implant will not notice anything different. This is known as a "silent" rupture.

Some women develop symptoms in and around their breast after implant rupture. The breast may change shape or feel harder or lumpy as the implant deflates and scar tissue forms. Also, the leaked silicone gel can act as an irritant, causing pain and inflammation and swollen glands in the armpit.

Is it dangerous if an implant ruptures?

The prospect of a ruptured implant is alarming, but all the research to date has shown no evidence that a ruptured PIP implant can cause cancer or other lasting health problems.

However, there clearly are unpleasant symptoms associated with implant rupture, including pain, swelling and redness of the breast. It can also be more difficult to remove an implant once it has ruptured.

 

Spotting signs of implant rupture

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



lumpiness or swelling in and around the breast  



change in shape of the breast



deflation of the breast



redness



tenderness of the breast



pain or sensitivity



What to do if you suspect an implant has ruptured

See your GP to arrange a hospital scan, either by ultrasound or MRI, to confirm whether an implant has ruptured.

Current advice from The Royal College of Radiologists is to start with an ultrasound examination. If this does not show any sign of a rupture but you are still anxious or experiencing symptoms, then you are entitled to an MRI scan, as this is a more sensitive method.

If the scan shows that an implant has ruptured, you should have the burst implant (and any intact implant in the other breast) removed as soon as possible.




If you are anxious

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.

If you are experiencing problems sleeping or eating, or you have concerns about your psychological health and wellbeing (for example you think you may have body dysmorphia or depression), contact your GP.

 

Removal and replacement of PIP implants 

Your options for removal and replacement of PIP implants depend to a large extent on the circumstances in which they were fitted.

If you had your PIP breast implants at a private clinic and you want to have them removed, your first move should be to go back to that clinic to have an assessment. Some private clinics have agreed to remove PIP breast implants free of charge, others charge a fee.

The government expects private providers who used PIP implants to take their responsibility of duty of care towards their patients seriously and treat you with dignity and compassion.

Unfortunately, this hasn't been the experience of some women who have been blocked or thwarted by private clinics in their quest to have their implants removed and replaced.

 

Private PIP implant replacement

Some private clinics have agreed to replace PIP implants free of charge, but others have not.

These private clinics have said they will replace PIP implants free of charge if clinically necessary:



BMI Healthcare



HCA International



Holly House



Highgate Hospitals



Make Yourself Amazing/MYA Cosmetic Surgery



Nuffield Health



Ramsay Health Care



Spire Healthcare



 These private clinics charge a fee to replace PIP implants:



Harley Medical Group



Transform



The Hospital Group



'Top-up' schemes for implant replacement

How are PIP implants removed and replaced?

The operation to remove/replace PIP breast implants is done wherever possible in the conventional way and through the original surgical cut.

 

Frequently asked questions 

Background

How many women are affected?

Are silicone implants banned in the US?

 

Safety of PIP implants

Do my implants need to be removed early?

What’s the evidence around the safety of PIP implants?

What is a rupture?

What are the signs of rupture?

Is it safe to have a mammogram with PIP implants?

 

 

Your rights

What if I got a PIP implant privately?

I want a scan – should I ask for an MRI or an ultrasound?

My original provider said they would only accept an MRI image as evidence of a rupture – what should I do?

What should I do if my local hospital only offers me ultrasound, and not MRI?

I received PIP implants as part of reconstruction surgery following breast cancer. What are my rights?

Do my implants need to be removed early?

So, if you are worried and want your implants removed before they rupture, see your GP or surgeon.

How many women are affected?

In the UK, around 47,000 women are thought to have the implants. Private clinics fitted 95% of these for women seeking cosmetic breast augmentation.

For example, women who have a mastectomy (breast removal surgery) as part of treatment for breast cancer are often offered implants as part of reconstructive surgery.

You can speak to your GP or with the surgical team that carried out the original implant for advice on the best way forward. This could include a scan to see if there is any evidence that the implant has ruptured.

 

What if I got a PIP implant privately?

The following private clinics have said they will replace PIP implants free if clinically necessary:



BMI Healthcare



HCA International



Holly House



Highgate Hospitals



Make Yourself Amazing/MYA Cosmetic Surgery



Nuffield Health



Ramsay Health Care



Spire Healthcare



 

This would not include the replacement of private cosmetic implants.

What should I do if my local hospital only offers me ultrasound, and not MRI?

Current advice from the Royal College of Radiologists is to start with an ultrasound examination. If this does not show any sign of a rupture or gel bleed but you are still anxious or experiencing symptoms that you think are associated with the PIP implants, then you are entitled to an MRI scan, as this is a more sensitive method.

I received PIP implants as part of reconstruction surgery following breast cancer. What are my rights?

Every woman who has had breast cancer and has PIP implants will be able to have them removed and replaced without charge.

 

What’s the evidence around the safety of PIP implants?

There have been media reports of a possible link between PIP implants and a rare type of cancer called anaplastic large cell lymphoma (ALCL).

The reports arose after a French woman with PIP implants developed the cancer and died.

However, after reviewing the evidence, the British independent expert review led by Sir Bruce Keogh agreed that there was no specific link between PIP implants and cancer.

More recently, attention has focused on the rupture rate of the implants, and whether the unapproved gel filling of PIP implants could have a toxic effect.

The review has specifically looked at these issues, and found:



PIP implants do have a higher rupture rate than other breast implants.



There appears to be no risk of dangerous toxic effects in the event of a PIP implant rupture.



 

What is a rupture?

A rupture is a split in the implant’s casing. A rupture can happen if:



the implant’s shell gets weaker over time



the implant is damaged during the operation



there is a flaw in the implant



the breast is injured



What are the signs of rupture?

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



I want a scan – should I ask for an MRI or an ultrasound?

The current consensus is that MRI is more sensitive than ultrasound in detecting ruptures of breast implants. This means it is less likely than ultrasound to produce a "false negative" result (i.e. suggesting that the implant hasn't ruptured when it actually has).

However, MRI is much more expensive than ultrasound and waiting times for an MRI scan are likely to be longer.

Therefore if you and your doctor feel a scan is necessary to help determine whether your implant needs removing, the Royal College of Radiologists recommend having an ultrasound first, and:



If the ultrasound is negative and you are still concerned, proceed to MRI.



If the ultrasound is positive (detects a rupture), this should be a sufficient basis for the clinical decision to remove the implant.



My original provider said they would only accept an MRI image as evidence of a rupture – what should I do?

If you've already had a positive scan and decided to use this as evidence to encourage your original (private) provider to agree to remove or replace the implants, evidence from ultrasound should be sufficient. In the light of the advice from the Royal College of Radiologists, it would be unreasonable for the provider to insist on an MRI image.

 

Are silicone implants banned in the US?

Although there have been reports suggesting the US has banned silicone implants, this is not accurate. Silicone implants are currently approved and readily available for women who want them, although they must be enrolled into studies to collect data about the performance and safety of their implants.

 

Is it safe to have a mammogram with PIP implants?

During mammography, the breast has to be squeezed fairly tightly, which could theoretically cause a breast implant to leak or rupture. Also, scarring and calcium deposits around the implant may look like cancerous tissue and make the mammogram harder to interpret.

If you have PIP breast implants and need to have a mammogram, tell the technician when you arrange the appointment. You may need more views taken than during a typical screening.

 

PIP implants safety concerns 

Women with PIP implants are not at higher risk of cancer or other long-term health conditions, says the Department of Health.

An independent expert panel, chaired by Sir Bruce Keogh, was appointed by the Department of Health to investigate the consequences of the PIP scandal.

They concluded in their final report of June 2012 that "PIP implants have not shown any evidence of significant risk to human health".

The review concluded that all breast implants are associated with a slight excess risk of a rare form of cancer called anaplastic large cell lymphoma (ALCL), but there is no evidence of an additional risk for PIP implants compared with other breast implants.

The expert group, led by Professor Sir Bruce Keogh, collected and reviewed available data including estimated rupture rates, data on clinical findings when implants were removed, and further examination of the chemical make-up for PIP silicone gel.

The group studied information on 240,000 implants of different makes used throughout England, which had been given to 130,000 women, along with detailed findings from 5,600 removal operations.

 

Conclusions regarding PIP implant safety

The expert group concluded that:



Exhaustive worldwide testing of the PIP gel material has not revealed anything that could cause a long-term threat to human health – it is not toxic and does not cause cancer.



PIP implants do have a higher rupture rate – around two to six times higher than other breast implants.



If the implant does rupture, it can cause inflammatory reactions around the implant area in some women, which can result in symptoms such as tenderness or swollen lymph glands. There is no evidence these reactions causes any significant health concern.



Learn about the warning signs of a ruptured PIP breast implant.

 


What happened to the PIP implant boss?

The boss of the French company that distributed the defective breast implants has since been sentenced to four years in prison.

Jean-Claude Mas of Poly Implant Prosthese (PIP) was found guilty of fraud.

Mas founded PIP in 1991 to take advantage of the booming market for cosmetic implants.

He built the company into the third-largest global supplier of implants, but came under the spotlight after an unusually high number of them ruptured.

Health authorities later discovered he was saving millions of euros by using industrial-grade gel in the implants.

PIP implants were banned and the company eventually liquidated.






PIP implants