Poly Implant Prosthese (PIP) breast implant updates

15 May 2014

Further to the publication of the Preliminary Opinion on the safety of Poly Implant Prothese (PIP) Silicone Breast Implants by the European Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) in October 2013, we can advise that  the Committee have now, following a period for public consultation,  published the final opinion.

The Health Products Regulatory Authority (HPRA) notes the final scientific opinion continues to state that ‘There is currently no convincing medical, toxicological or other data to justify routine removal of intact PIP implants as a precautionary approach. Implant removal in the absence of malfunction may be considered for women who are experiencing significant anxiety because they have a PIP breast implant. 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’.
The final opinion and the results of the public consultation may be found at the following  links

1. Opinion on The safety of Poly Implant Prothese (PIP) Silicone Breast Implants, Update of the Opinion of February 2012

2. The results of the public consultation SCENIHR’s Preliminary Opinion on the safety of Poly Implant Prothese (PIP) Silicone Breast 

The HPRA continues to advise women with these implants that if they have any concerns about their breasts or implants they should seek clinical advice.

29th October 2013

Further to our update of the 2nd February 2012 below we can now advise that the European Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) was asked to provide an updated opinion based on additional data from the Member States and other international stakeholders, such as the International Laboratory Testing Panel for PIP breast implants. 

Today the committee published its findings.

The Health Products Regulatory Authority (HPRA) notes the scientific opinion which states that ‘There is currently no convincing medical, toxicological or other data to justify removal of intact PIP implants as a precautionary approach. Implant removal in the absence of malfunction may be considered for women who are experiencing significant anxiety because they have a PIP breast implant. 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’.

The HPRA continues to advise women with these implants that if they have any concerns about their breasts or implants they should seek clinical advice from their implanting surgeon.

 

11 February 2013

The HPRA notes the update published today by the Therapeutic Goods Administration (TGA) in Australia concerning testing of PIP breast implants. The update contains the latest information about reports of rupture as well as test results obtained to date on new and explanted implants. 

According to the update, 'testing undertaken by the TGA has not found evidence that the risks involved with the use of PIP breast implants are any greater than those for any other brand of silicone gel-filled breast implants’. 

On 1 February 2013, the Medicines and Healthcare Regulatory Agency (MHRA) in the UK publishing the final test results for PIP breast implants. The report concluded ‘that the silicone contained in PIP breast implants does not pose a risk to human health'. 

The HPRA continues to advise women with these implants that if they have any concerns about their breasts or implants they should seek clinical advice from their implanting surgeon or GP. 

18 June 2012

The HPRA notes the final report from the department of Health in the UK in relation to the PIP breast implants.

The HPRA continues to advise women with these implants that if they have any concerns about their breasts or implants they should seek clinical advice from their implanting surgeon.

15 March 2012

To date, all advice issued internationally regarding the PIP breast implants issue has referred to patients who received PIP breast implants from 2001 to 2010. The Health Products Regulatory Authority (HPRA) now advises that updated information from the French Regulatory Authority (AFSSAPS) suggests that it is possible that PIP silicone gel breast implants manufactured prior to 2001 may also have contained the unapproved non medical grade silicone. The HPRA has advised the implanting clinics of this development today and requested that they identify and contact any women who may have been implanted with PIP silicone gel implants before 1 January 2001. 

Whilst the number of Irish women involved is unknown at this time, current information suggests a small number of patients could be affected. To ascertain this information, the HPRA is awaiting feedback from the clinics that are known to have used the PIP silicone implants and, in addition, HPRA compliance staff are currently conducting a detailed examination of the records of the UK distributor. As further information becomes available the HPRA will publish additional updates. 

The HPRA continues to advise any women with these implants who have any concerns about their breasts or implants to seek clinical advice from their implanting surgeon or their GP. 

The UK’s MHRA has also published information in relation to this matter and this is available through its website

Testing 
The HPRA continues to monitor the testing that is currently being conducted on unused and explanted PIP implants. 

The most recent update in this respect has come from the TGA in Australia. To investigate whether PIP breast implants contain chemicals that can cause irritation, the TGA commissioned intra-dermal irritation tests that were conducted in laboratories both in Australia and France. The first stage of the tests included the shell and gel from four batches of PIP silicone breast implants and the shell and gel from one batch of another brand of silicone breast implant. Results to date have not identified any safety concerns. None of the batches tested displayed irritant properties. 

02 February 2012

In early January, the European Scientific Committee on Emerging and Newly Identified Health Risks was requested to provide a rapid scientific opinion on ‘The Safety of PIP Breast Implants’. 

Today the committee published its initial findings

The Health Products Regulatory Authority (HPRA) notes the scientific opinion which concludes that “further work is proposed to establish with greater certainty the health risks, if any, that may be associated with PIP silicone breast implants". It also concludes that each case needs to be assessed individually.

Therefore, the HPRA continues to advise women with these implants that if they have any concerns about their breasts or implants they should seek clinical advice from their implanting surgeon. 

06 January 2012

6:25 pm

The HPRA notes the UK’s Department of Health announcement. 

The HPRA advises women with these implants that if they have any concerns about their breasts or implants they should seek clinical advice from their implanting surgeon. 

5:25 pm

The HPRA provides the following information concerning direct contact from The Harley Medical Group with their patients: 

The Harley Medical Group provided the HPRA with detailed written confirmation on two separate occasions in November 2010 that it had written to all its Irish patients implanted with the PIP breast implants. We have now been informed that this direct specific patient contact letter was never sent and communication to patients was via their website. Having relied on the earlier written confirmation that direct specific patient contact letters had been issued, the HPRA is concerned that The Harley Medical Group did not follow the HPRA recommendation and that the HPRA was misinformed. 

We have now received confirmation that a direct specific patient contact letter to all patients who received the PIP implant at The Harley Medical Group will be issued at the latest by this Monday 9 January to inform them of the issue. As the PIP breast implants were in use from 2001 to 2010, it may be that some patients have changed name or address and so may not receive this direct patient contact letter. These patients should contact the Harley Medical Group directly. Given The Harley Medical Group has operations in the UK too, the HPRA has informed the UK’s MHRA of this development in Ireland. 

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The HPRA continues to closely monitor the situation. Over the past few weeks National Health Authorities from across the EU have met three times in teleconference in the form of the Health Security Committee (chaired by the European Commission with high level representatives nominated by the Ministers of Health, together with representatives from the national medical devices authorities) in order to evaluate the latest available information. 

The most recent teleconference took place on the 4 January 2012. During this teleconference, the European Commission proposed, with the support of several Member States including Ireland, to compile all the available information and data centrally at EU level and to set up an expert panel to prepare a common risk assessment on PIP breast implants. The completion of the risk assessment will depend on access to relevant data and the availability of experts, but it will be conducted as quickly as possible. More information on this will be circulated in the coming days by the European Commission. 

The advice of the HPRA remains unchanged; there is no current evidence of particular health risks associated with PIP implants. The HPRA continues to advise women with these implants, that if they have any concerns about their breasts or implants, they should seek clinical advice from their implanting surgeon. 

The HPRA understands that the UK’s Department of Health will be releasing a statement later today regarding their recent review of the PIP issue. The HPRA will review this statement and the supporting data as soon as it is made available to us. 

Note: The Regulation of Medical Devices 

A medical device cannot be marketed in any country across Europe without carrying a CE Mark. A CE mark is obtained from an independent certification organisation; a Notified Body. A CE mark is applied for by the manufacturer and once the mark is awarded the device is recognised as having met the relevant regulatory requirements and should perform as intended. The competent authority, in this case the HPRA, has no direct role in the authorisation of any medical device before it comes to market. 

The HPRA is responsible for designating the Irish Notified Body and regularly audits it to ensure that it continues to perform to the required standards. It did not grant the CE mark in this case. 

The PIP implant came onto the market via this process. The product was manufactured in France and approved by a Notified Body in Germany (TUV Rheinland). Having received a CE mark it could be freely placed on any market in the EU, including Ireland. 

23 December 2011

The Health Products Regulatory Authority (HPRA) is aware of the statement that was issued by the French Ministry of Health today regarding the Poly Implant Prosthese (PIP) breast implants. The HPRA note, in particular, the findings of the French expert committee confirming that to date there is no evidence of increased risk of cancer for women with the PIP brand of breast implants compared to women with other breast implants. 

The HPRA notes the preventative and non urgent recommendation made by the French Ministry for French women with these implants to discuss / consider explantation with their implanting surgeon. 

In co-operation with other EU colleagues, the HPRA will continue to monitor this issue. 

The advice of the HPRA remains unchanged and it reassures women that there is no current evidence of health risks associated with PIP implants. The HPRA continues to advise women with these implants that if they have any concerns about their breasts or implants they should seek clinical advice from their implanting surgeon. 

22 December 2011

The Health Products Regulatory Authority (HPRA) is aware of the recent report in France associated with Poly Implant Prosthese (PIP) Breast Implants. 

A recall of these implants was initiated in Ireland on 30 March 2010. The recall followed a manufacturing site inspection in France which identified unauthorised silicone gel being used in the product. 

Since the issue was identified, the HPRA has closely monitored the situation in liaison with our colleagues in Europe to determine potential safety implications. The HPRA advised the implanting hospitals and 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 1500 Irish patients were implanted with these products and the HPRA has received reports of potential adverse incidents from a small percentage of patients. The HPRA understands that the PIP implants that were used in Ireland were for aesthetic purposes only and not for reconstructive surgery for breast cancer patients. The implants were implanted in 3 private hospital / clinics* and were not used in public hospitals. 

The French regulatory authority (AFSSAPS) has confirmed to HPRA and other EU colleagues that they will issue a statement on the safety of the implants but have not indicated what advice will be given in relation to patient health and the need to remove these implants. The HPRA will continue to ensure that the implanting hospitals and clinics affected by this issue are kept updated should any new issues come to light. 

The HPRA advice to women with PIP implants continues to be that if they have any concerns about their breasts or implants they should seek clinical advice from their implanting surgeon. 

*Implanting Clinics and Hospitals: Shandon Street Hospital in Cork, Clane Hospital in Co Kildare and Harley Medical Clinic in Dublin.