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PIP breast implants

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PIP breast implants



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PIP breast implants were withdrawn from the UK after it came to light that they'd been deliberately manufactured with industrial grade silicone and were far more prone to rupture than other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

Although the  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 arrangeremoval 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 , 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.

 

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  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 , 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  will offer you clinical advice and support, including referral to an appropriate  specialist. Your GP can arrange the referral for you to see a  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 

 

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  if necessary.

The Department of Health has promised that the  will take care of women with PIP implants by removing them free of charge regardless of whether they were fitted on the 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 will look after you if the clinic has closed down or refuses to honour its duty of care to you.

 

How do I arrange replacement of PIP implants?

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

Normally, the will remove but not replace PIP implants.

The  in England, Scotland and Northern Ireland have promised that they will replace breast implants free of charge if they were originally fitted by the, but they won't replace implants fitted in private clinics.

The Welsh government has said it will pay to remove and replace both 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.

 

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  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.



 


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.

Read about PIP implant removal and replacement.

 



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.

Anxiety is a health risk so the  will remove your implants with or without clinical signs of a rupture.

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.

 

 PIP implant removal

If you had PIP breast implants as part of breast reconstruction surgery under the, you can go back to the  to have your implants removed at no cost.

The will fund PIP implant removal if they are showing symptoms of rupture, or if you are worried about the possibility of future problems.

 

Private PIP implant removal

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.

If you find that the original private clinic won't help you with removal either because it has closed or because it's unwilling to do so, be reassured that you will be able to have your PIP implants removed free of charge by the 

 

 PIP implant replacement

Normally, the will remove but not replace PIP implants, with the following exceptions:


If your original PIP implant surgery was performed by the, you will also be able to have new breast implants fitted by the  after the PIP implants have been removed.

If you live in Wales. The  in Wales will remove and replace both  and privately fitted PIP implants.

If you had private breast augmentation surgery for medical rather than cosmetic reasons, your GP can make what's called an "exceptional aesthetic referral" on your behalf to your local hospital trust. Medical reasons for  breast augmentation include assymmetry of more than two cup sizes; no natural breast tissue or a psychological need because of mental health problems such as body dysmorphia.

 


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

Initially, certain  hospitals offered women with private PIP implants a "top-up" scheme, whereby they could have free implant removal followed by private implant replacement in a single operation.

However, top-up schemes are no longer available, as they contravene Department of Health guidance that states that the] and private components of treatment should normally be carried out at a separate time and place. This is to ensure that the] does not inadvertently cross-subsidise private treatment, and that patients are not required to pay for treatment to which they are entitled on the ]

 

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?

How many private patients have had] help?

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 happens if I got a PIP implant through the ]

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?

Why can't I pay for a breast implant replacement as part of a combined operation in which the ] pays for removal of the PIP implants?

Do my implants need to be removed early?

Official government advice is that there is no medical need for PIP implants to be removed early if they are intact. But the

has pledged to remove PIP implants without charge whether they have ruptured or not. 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. The remaining 5% were fitted on th

The

provides breast implants only where there is clinical need. 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.

What happens if I got a PIP implant through the 

If you received a PIP implant from the  you should have been contacted to let you know that.

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.

The  will offer removal and replacement of PIP implants if a woman and her doctor decide that it is the right thing to do.

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


If a private clinic that provided PIP implants no longer exists or refuses to help, then the  will offer you clinical advice and support, including referral to an appropriate specialist.

The  will also cover the cost of the removal of PIP implants if you and your doctor agree. This would not include the replacement of private cosmetic implants.

How many private patients have had help?

Around 7,000 women who had their PIP implants put in privately have been referred to a specialist on the . So far, 4,349 scans have been done and 490 women have decided to have their implants removed on the 

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.

If you originally received your implants from the , then the  will remove and replace them if that is your choice. If you originally received your implants from a private provider, you should in the first instance see if they will remove and replace them free of charge. If not, the  will carry out the operation to both remove and replace them.

 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.

Why can't I pay for a breast implant replacement as part of a combined operation in which the  pays for removal of the PIP implants?

At present, this would go against the guidance issued by the Department of Health in 2009. This sets out the rules for combining and private treatment and makes clear that the  and private components of treatment should normally be carried out at a separate time and place.

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..


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 breast implants