Patient Advice

Final Opinion on The safety of Poly Implant Prothèse Silicone Breast Implants (2013 update)

On 15 May 2014, the European Commission and its non-food Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) published the final opinion on the safety of Poly Implant Prothèse Silicone Breast Implants (2013 update), of which the aim was to update the 2012 SCENIHR Opinion on the same subject, taking into account evidence that has become available in 2012 and 2013.

The Committee’s Findings:

The silicone Poly Implant Prothèse (PIP), which has been produced in France since 2001, had been found to contain non-medical grade silicone and had thus not been produced according to legal requirements to achieve CE marking. It is estimated that worldwide about 400.000 women have received these implants.

PIP breast implants are reported to have a higher prevalence and incidence of implant ruptures than other silicone breast implants, and that ruptures also tend to occur earlier in the implant life than is the case with other implants.

In some cases, implant gel-bleed or rupture has been associated with an inflammatory reaction either locally or in regional lymph nodes. In other cases, ruptures were free of symptoms. Neither implant rupture, nor local inflammation, has been found to be associated with breast cancer or anaplastic large cell lymphoma. While there are differences in rupture rates, there is no reliable evidence that ruptured PIP implants create a greater health risk than a ruptured silicone breast implant from another manufacturer.

To date, no increased health risk has been associated with exposure to silicone gel emanating from a ruptured PIP implant, as compared with a conventional implant from another manufacturer.

SCENIHR concluded that explantation is advised in the case of implant rupture; however, there are no convincing medical, toxicological or other data to justify routine removal of intact PIP implants. However, the decision to remove an intact PIP implant for this reason should be based on an individual assessment of the woman's condition by her surgeon or other treating physician after consultation.

FREQUENTLY ASKED QUESTIONS

What are PIP implants?
PIP implants are a type of silicone breast implant that were manufactured in France by a company called Poly Implant Prostheses (PIP). A ban has been placed on all PIP implants manufactured after 2001.

Why were PIP implants banned?
The 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 Harley Medical Group did not use PIP implants after March 2010.

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. The Department of Health agrees that the implants are far more likely to rupture than other brands, but says that despite the use of non-medical grade silicone there are no lasting health risks if they do rupture.

Are they linked to cancer?
A European Commission scientific report released 30th October 2013 found that women who have the faulty implants are not at higher risk of cancer. SCENIHR found that while gel-bleed or rupture can cause an inflammatory reaction either locally or in regional lymph nodes neither implant rupture, nor local inflammation, has been found to be associated with breast cancer or ALCL (anaplastic large cell lymphoma).

Can PIP implants cause symptoms if they rupture?
Ruptured PIP implants have no proven long-term health effects but they can 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. Should you experience any of these symptoms, contact The Harley Medical Group PIP Helpline 0800 288 4106. A ruptured implant should be surgically removed as soon as possible.

I am breastfeeding, should I be concerned?
The MHRA has consulted clinical experts regarding the risk to infants from PIP implants in women who are breast feeding; it was considered that they would not pose any increased risk. There is also no evidence of any harm to breast feeding infants in women who may have experienced ruptures in their PIP implants.

Do I need to have my implants removed immediately?
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.

The SCENIHR recommend that women with PIP breast implants should have regular clinical examinations, and where appropriate, individual counselling and breast imaging with ultrasound or MRI. However, it says that there is currently no convincing medical, toxicological or other data to justify routine removal of intact PIP implants as a precautionary approach.

How do I know if I have PIP implants?
You should have received written confirmation regarding your implants, please call our helpline on: 0800 288 4106 who will be happy to help you with your enquiry. Please provide your name and address at the time of your procedure, and your date of birth. 

I have PIP implants, what should I do now?
If you are concerned, contact The Harley Medical Group PIP Helpline 0800 288 4106

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.  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.  You don't have to wait until your implants have ruptured or begun to leak, if you are unhappy you can have explantation at any time.

How do I know if my implants are ruptured?
If you have symptom described above and you are concerned that your implants may be ruptured, you will need to have an MRI or Ultrasound scan, contact The Harley Medical Group.

The Harley Medical Group does not have the facility to carry out scans on site.  However, we can send you a referral letter which allows you to have a scan at reduced rate.  A list of private scan centres will be provided.  Once we have the result of the scan, we shall contact you and  discuss the way forward.

How do I arrange removal / replacement of PIP implants?
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 with The Harley Medical Group, please contact us.

The Harley Medical Group will remove ruptured implant confirmed by a scan free of charge if under 10 years old of implantation.  There is a charge for replacement implants.

How much does it cost to remove PIP implants?

  • If it is under 10 years since the original procedure then:
    • Removal of PIP implants is free of charge
    • Change of PIP Implants for the first time: £2,950 (including MRSA but excluding any other tests such as extra blood tests, ECG)
    • Change of PIP implants with Mastopexy: £6,950
    • If you require a second operation at any time then this will be charged at our standard price. 
  • If it is over 10 years since the original procedure then:
    • All procedures will be charged at our standard price. 

 

FURTHER INFORMATION – VISIT WEBSITES

www.mhra.gov.uk

www.nhs.uk

www.dh.gov.uk

 

 


Updated: July 2014