Press Statement on PIP Breast Implants Issue. Office of the Chief Medical Officer / National Treatment Purchase Fund (NTPF)

03 July 2012

Since concerns were first raised in March 2010 regarding the issue of breast implants, provided by the now defunct French company Poly Implant Prosthese (PIP), the clear priority of the Department of Health has been to try and ensure that the three treating clinics involved in the issue provide professional and appropriate care to their affected clients. However despite intensive efforts, by the office of the Chief Medical Officer, such appropriate care on the scale required has not been forthcoming.

Accordingly the Department has now commenced work on sourcing an alternative service via the National Treatment Purchase Fund (NTPF). This will encompass surgical consultation, radiology if required and removal of implants if this is deemed clinically necessary. The NTPF will make suitable arrangements with appropriate facilities to provide such consultation and follow-on support as required.

It is important to identify the resources required for this work and the plan is that by September a clear view of such capacity and the means of access to it would be available.

The Chief Medical Officer met with the clinics to attempt to ensure that best practice and patient support was paramount in the service provided to concerned recipients of PIP implants. Despite intense discussions with and ongoing and clear pressure from the CMO’s Office in relation to one provider, the Harley Medical Group, that provider has failed to provide an appropriate care package for its clients. The Department is not satisfied that the Harley Medical Group will fulfil their obligations in an acceptable manner.

Consequently it has been decided that necessary care required by the affected recipients of these implants should be made available via an alternative route, i.e. the NTPF.

The CMO met with members of the PIP Action Group on Monday 2nd July, 2012 and advised them of the proposed initiative. He will meet with them again in September to discuss progress on the matter.

It should be noted that the Chief Medical Officer, in conjunction with the Irish Association of Plastic Surgeons, has issued updated guidelines for those considering cosmetic surgery procedures; it is strongly recommended that the advice is considered before deciding on such surgery.

The advice from the Irish Medicines Board (IMB) and the Department of Health continues to be that there is no evidence of increased risk of cancer for women with this brand of implant, the risk of rupture is low and anyone with a concern about their breast implants should discuss the matter with their GP or surgeon.

Further press statements will issue as soon as possible.

ENDS

Note for Editors

In March, 2010 the Irish Medicines Board (IMB) was informed by the French medical device regulatory authority, the Agency for the Safety of Health Products (AFSSAPS), that they had suspended the manufacture, marketing, distribution and export of Poly Implant Prostheses (PIP) products, now in receivership.

This action was taken when it was found that most implants manufactured by the company since 2001 were filled with an unauthorised industrial quality silicone gel. The inspection was prompted when an increase in the number of incident reports regarding device rupture and local complications associated with these products was noted in France.

The IMB immediately instructed the three clinics in Ireland who received these devices to cease the use of the products (Shandon Street Hospital, Cork, Clane General Hospital, Co. Kildare and Harley Medical Clinic, Dublin (part of the Harley Medical Group)). The IMB tracked the devices through the PIP implant distributors, Cloverleaf; the Board does not have information on individual patients.

In November 2010 the IMB instructed the clinics to identify and contact women who have been implanted with PIP silicone gel implants after 1 January 2001 to advise them of the issue and provide reassurance that there is no current evidence of health risks associated with the implants.

Approximately 1,500 Irish patients were implanted with these products (3,000 devices) in the 3 centres above, between 2001 and 2010.

How do I find out if I’ve got PIP Implants?

The first step would be to have a look at your original information given to you by the hospital at discharge, and look for the manufacturer details. If you cannot find this information then please Call us with your details.
We will then investigate your case and get back to you as soon as possible and let you know what type of implants you have. We are working through all enquiries as quickly as we can, due to the high volume this is taking longer than anticipated. We would like to thank you for your patience and co-operation.

What do I do if I know I have PIP implants?

We are following guidelines set by the MHRA, at present they state…”there is currently no evidence to support routine removal of PIP breast implants”.
It is important to note that the only batches affected were distributed between 2001-2009. If you have PIP implants pre 2001 there is no need to worry. We are replacing all ruptured PIP implants free of charge, however for all other PIP patients who had their original procedure within this time period, we are offering various options.

Which breast implants are involved with the decision?

The breast implants in question are pre-filled with silicone gel manufactured by the company Poly Implant Prothèse (PIP). The French authorities, AFSSAPS decided to suspend the use of these implants from the market in 2011.

What is the problem with these implants?

AFSSAPS carried out an inspection on the PIP premises after vigilance reports revealed an increase in the number of declaration of implant ruptures. The results collected during this inspection showed that the implants were filled with a silicone gel different from the one the company had originally declared. These implants did not comply with current regulations and have therefore come under scrutiny. Currently the MHRA are collating data from all private clinics as well as the NHS and are due to conclude these findings on Friday 6th January 2012.

How can I find out if my implants are involved?

The first step would be to have a look at your original information given to you by the hospital at discharge, and look for the manufacturer details. If you cannot find this information then please call us with your details. We will then get back to you as soon as possible and let you know what type of implants you have.

What are the risks for my health?

At this point no complications different from those usually encountered with other breast implants have been identified.

Are these risks potentially serious?

No, but a ruptured breast implants should be replaced. There is always a small risk of breast implants rupturing with any breast augmentation.

Should I have my breast implants removed?

To date, according to experts, nothing justifies a preventive replacement of the implant under which the surgery may be considered.

Who should I contact to get further information?

You can contact Enhance Medical by calling 1850 204 090

Which PIP implants have been affected?

As quoted by the MHRA, the only batch numbers affected by the PIP investigation are IMGHC-TX, IMGHC-MX and IMGHC-LS. These were on the market between 2001 and 2009. If you have had implants prior to 2001 then you have no reason for concern.

What would you advise if I’m breast feeding?

The current advice from the MHRA is: “Since the tests have shown no cytotoxicity or genotoxicity associated with the gel, there is no reason for patients not to continue to breast-feed.”

I’m pregnant with PIP implants, should I be worried?

There is currently no evidence to suggest that having PIP implants will cause any risk to the baby.

If I choose to have a replacement procedure, what implants will be used?

PIP implants will be replaced with Allergan CUI implants. However if you would prefer to have Allergan Natrelle implants, this can be discussed at your consultation.

If I have my PIP implants replaced by THG what aftercare am I entitled to?

Replacement PIP procedures will carry a 10 year rupture warranty as well as free of charge review appointments with a nurse or surgeon.

How long have I got to take advantage of the various PIP options?

Patients have 5 years to take advantage of the various PIP procedure options.

How soon can I have my removal or replacement procedure?

As we have used the PIP implants intermittently from 2001-2009 we anticipate a high demand. We plan to stage all procedures over the forthcoming months.

Why did THG use the PIP implants?

Enhance Medical used the PIP implants because they were the third largest manufacturer of breast implants in the world. They were certified for use in the UK and passed by the MHRA. The majority of private providers and the NHS also used these implants between 2001 and 2009.

21 August 2012

The MHRA and the Department of Health have today published an interim-report of this year’s ongoing testing of PIP breast implants. The results from this interim-report were used by the expert group, chaired by NHS Medical Director Sir Bruce Keogh, that published its final report into the safety of PIP breast implants on the 18th June.

Dr Susanne Ludgate, Clinical Director of the MHRA, said:

“Analyses of the silicone contained in PIP breast implants indicates that the material does not pose a long-term risk to human health.

“None of the chemicals listed will cause harm at the levels found within PIP breast implants and many are used routinely in various consumer products.”

15 March 2012

This is the latest update on the PIP implants from the MHRA…

PIP Update

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

11 January 2012

The MHRA has issued a response to the Harley Medical Group’s 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.

6 January 2012

The government has announced new advice concerning PIP silicone filled gel implants based on advice from its Expert Advisory Group.

3 January 2012

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 Prosthese (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 Prosthese (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 on breast implants at MHRA

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

If you cannot find your manufactures information, or are worried about your implants then please call us with your details. Enhance Medical 1850 204 090