Poly Implant Prothese (PIP) breast implants update

24 January 2012

The Department of Health has today published the terms of reference for two reviews established following the recent concerns about PIP implants.

Department of Health sets out scope of PIP implant and cosmetic surgery reviews


24 January 2012

The MHRA has written a letter to the editor of the Lancet in response to two articles.

MHRA letter in response to Lancet articles


14 January 2012

Women concerned about PIP breast implants can find all the latest NHS information on NHS Choices via the following link:

PIP breast implants – latest from the NHS (external link)


11 January 2012

The MHRA has issued a response to the Harley Medical Group’s position on the replacement of PIP implants.

MHRA response to the Harley Medical Group position on the replacement of PIP implants


11 January 2012

The Health Secretary, Andrew Lansley, today announced a series of steps to respond to recent concerns regarding French Poly Implant Protheses (PiP) implants.

The first step will be a review led by Professor Sir Bruce Keogh, the NHS Medical Director and will look at the arrangements for ensuring the safety of people seeking cosmetic interventions such as breast implants and dermal fillers.

Reviews to ensure safety of people seeking cosmetic treatments (external link)


6 January 2012

The government has announced this afternoon new advice concerning PIP silicone gel filled breast implants, based on advice from its Expert Advisory Group. This advice can be found on the Department of Health website:

Department of Health statement on breast implants and response to expert group report (external link)


3 January 2011

Our current advice to women with questions about PIP breast implants remains to seek advice from their consulting surgeon. 

There is no evidence of increased rupture rates associated with PIP implants. A group lead by NHS Medical Director Professor Sir Bruce Keogh is currently reviewing the data on rupture rates of these implants and is due to release its findings on Friday.


23 December 2011

Following the announcement in France today, the Medicines and Healthcare products Regulatory Agency (MHRA) is not recommending routine removal of PIP silicone gel breast implants in the UK.

We recognise the concern that some women who have these implants may be feeling but we currently have no evidence of any increase in incidents of cancer associated with these implants and no evidence of any disproportionate rupture rates other than in France.

We therefore do not believe that the associated risks of surgery from breast implant removal can be justified without further evidence.

We will continue liaising with the French medicines and medical devices regulator and we are awaiting the evidence to support the decision made in France. This will be evaluated as a matter of priority by our clinical and toxicological experts and we will issue further advice if necessary.

In the absence of strong clear evidence to the contrary, we see no reason to alter our current advice that there is no need to routinely remove these PIP breast implants.

In the meantime we would recommend that all patients who have questions about their PIP breast implants should seek advice from their implanting surgeon.

We had discussions on 21 December 2011 with other health or regulatory experts from France, the Netherlands, Portugal, Italy, Ireland, Hungary, Austria, Denmark and Malta. They all agreed that there was no evidence of any increase in incidents of cancer associated with PIP breast implants and no evidence of any disproportionate rupture rates other than in France. Information obtained from the Australian Regulatory Authority (TGA) is consistent with the figures from all the above European countries other than France in terms of rupture. They have no reported cases of lymphoma.

We have continually monitored the safety of these breast implants. In March 2010 we advised clinicians not to implant these devices and at the same time advised patients who were concerned about their PIP implants to consult their implanting surgeon. MHRA commissioned toxicity testing on the unapproved silicone gel used to fill PIP breast implants, including genotoxicity and chemical toxicity. The results of these tests have been discussed with relevant experts and we have concluded that there is no safety issue related to this filler material. Similar testing carried out by the French medicines and medical devices regulator confirmed these conclusions.


22 December 2011

The MHRA had discussions yesterday (Wednesday) with other health or regulatory experts from France, the Netherlands, Portugal, Italy, Ireland, Hungary, Austria, Denmark and Malta. They all agreed that there was no evidence of any increase in incidents of cancer associated with PIP breast implants and no evidence of any disproportionate rupture rates other than in France. Information obtained from the Australian Regulatory Authority (TGA) is consistent with with the figures from all the above European countries other than France in terms of rupture. They have no reported cases of lymphoma.

We are currently advising that women with any concerns should make an appointment with their implanting surgeon and have a full discussion. The MHRA and its experts will be looking carefully at the French safety statement when it comes out as a matter of priority and issue further advice as necessary."

Background

Based on reports to the MHRA approximately 1% of women in the UK with PIP breast implants have suffered implant failure, including rupture. This contrasts with information from the French medical device regulatory authority, AFSSAPS, which suggests a failure rate, including rupture, of around 5% in France.


21 December 2011

The MHRA is aware of the recent report in France of the death of a woman implanted with Poly Implant Prothese (PIP) Breast Implants associated with an anaplastic large cell lymphoma (ALCL).  This is a rare form of cancer which affects cells of the immune system.  

We are also aware that it has been widely reported in the press that the French government will, on Friday 23 December 2011, recommend that all women who have PIP breast implants should have them removed as a preventative measure because of health concerns about high rates of implant rupture and cancer. The French regulatory authority (AFSSAPS) have confirmed to MHRA that a statement on the safety of the implants will be made on that day although they have not indicated what advice will be given in relation to patient health and the need to remove these implants.   

  • We have continued to monitor the safety of these breast implants. In 2010 we commissioned testing on the silicone gel filler.  Results from this testing demonstrated that there was no evidence of genotoxicity (potential for cancer) or chemical toxicity.  
  • In addition, we were aware of the US Food and Drug Administration's (FDA) (external link) January 2011 Medical Device Safety Communication entitled 'FDA Medical Device Safety Communication: Reports of Anaplastic Large Cell Lymphoma in Women with Breast Implants'.
  • We informed UK healthcare professionals about the FDA’s communication via a Medical Device Alert (MDA/2011/017) which was issued in February 2011.  
  • We have also continued to review available evidence for association of cancers of women with breast implants in consultation with the relevant UK Professional Bodies for breast surgery and surgical oncology and has concluded that there is no evidence to indicate an association with cancer.  Additionally the MHRA worked with the Cancer Registry and could find no evidence for an association.  The MHRA has not received any reports of women with breast implants of any type in the UK with a diagnosis of ALCL.
  • Also, we consulted with experts to discuss whether there was any danger to babies having been breast fed by mothers with these implants.  It was concluded that there were no safety issues.
  • We continue to monitor any associations of all types of breast implants, including PIP, with cancers and any other health implications.  We continue to liaise with AFSAPPS and will study the French evidence, discussing these findings with our experts as a matter of priority.
  • Our current advice to women with PIP breast implants continues to be that should they have any questions about their breasts or implants, that they should seek clinical advice from their implanting surgeon.
  • There is currently no evidence to support routine removal of PIP breast implants.

20 December 2011

The MHRA is aware of the recent report in France of the death of a woman implanted with Poly Implant Prothese (PIP) breast implants from Anaplastic Large Cell Lymphoma (ALCL). ALCL is a rare form of cancer which affects cells from the immune system.

We continue to monitor for any associations of all types of breast implants, including PIP, with cancers and any other health implications. We will continue to liaise with agence francais de securite sanitaire des produits de sante (AFSSAPS) (external link) and will consider any new evidence which comes to light as a priority. The MHRA's current advice to women with any type of breast implant continues to be that women who have questions about their breasts or think that their implants may have ruptured, should seek clinical advice from their implanting surgeon.

Find out more in our section on breast implants


Information for women considering breast implants

The MHRA has published a booklet for all women who are considering having breast implants. It summarises the issues associated with breast implant surgery and includes questions to ask in order to enable you to make an informed choice about breast implants, based on independent advice, before agreeing to surgery.

Information for women considering breast implants

 

Page last modified: 30 January 2012