Mr. Pat O'Mahony:

I am accompanied by Dr. Niall MacAleenan who is clinical assessment manager at the Irish Medicines Board and also the medical devices lead person for the authority. We are grateful for the opportunity to update the joint committee, as requested, on the PIP breast implant and the DePuy ASR hip recall issues. In addition, we would like to take the opportunity to provide committee members with an overview of the implementation of the European Commission’s joint plan for immediate action on medical devices which was put in place in response to these crises. Members may recall that in September we provided an update on the PIP breast implant issue. We advised that we anticipated imminent publication of the report from the European scientific committee on emerging and newly identified health risks - its second comprehensive review of these implants. The SCHENIHR committee's report, published on 29 October, states:

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 SCENIHR opinion correlates with the advice of the IMB and the Department of Health to the women affected that "there is no current evidence of health risks associated with PIP implants and concerned women should seek clinical advice from their GP or surgeon".

In 2012 and, more recently, September 2013 we outlined to the committee the details of the worldwide recall of DePuy ASR and ASR XL hip implants. The recall of these products was based on data from the National Joint Registry of England and Wales which showed higher than expected implant revision rates at five years. At the time of our update, approximately 3,500 ASR hips had been implanted in Ireland. The IMB has since worked closely with the HSE and Irish orthopaedic surgeons on the recommendations for individual patient follow-up. When we met the committee in July 2012, the HSE had outlined that at the time 96% of patients had attended review appointments and over 350 had had revision surgery, with another 166 scheduled for surgery. We understand all patients have been reviewed and the HSE representatives will give details of updated figures for revision surgeries.

The IMB continues to assess the reported incidents received and analyse data generated from revisions, joint registry data, as well as from clinical studies. Independent analysis of explanted devices which have been returned for investigation is being conducted in the United Kingdom at the London Implant Retrieval Centre. The ASR recall experience has been central to wider international discussions on metal on metal implants. The research in this area suggests increased revision rates associated with large diameter-head metal on metal hip implants. Mechanical wear of an implant is experienced with all types of hip replacement implant over time, as the femoral head and acetabular cup component surfaces rotate against each other.

With a metal on metal hip system, this can lead to the production and accumulation of cobalt and chromium metal ions within the area surrounding the implant. While many patients have no significant reaction to these materials, for some, there may be an inflammatory response which can lead to problems such as local bone and tissue reactions.

The SCENIHR has been mandated to conduct a review of the safety of metal on metal implants. This investigation is focusing on the potential health effects caused by metal ions resulting from the implanted medical device. We advised the committee in September that the opinion from the SCENIHR was expected shortly. We have recently been informed that it is now expected in mid-December. The IMB will consider, with the HSE and orthopaedic surgeons, the implications of the review for Irish patients.

I wish to provide the committee with an overview of the implementation of the European Commission's joint plan for immediate actions which was published in early 2012 in response to the crises relating to the PIP breast and metal on metal hip implants previously mentioned. At the time, as a result of the issues identified by the PIP breast and metal on metal hip implant crises, the Commission took a series of initiatives which included a stress test of the then draft proposals to revise the medical devices legislation to assess its ability to manage such issues; mandating specific reviews of the scientific and safety aspects to be conducted by the SCENIHR; and publication of the joint plan for immediate actions to strengthen and restore confidence in the regulatory system for medical devices. The joint plan recognises the need to further develop and strengthen the existing regulatory system in advance of the broader revision of the legislation which is ongoing. Focusing on measures to strengthen oversight of notified bodies, increase market surveillance activities for medical devices and increase inter-authority collaboration and information exchange, the purpose of the joint plan was to enhance the existing regulatory framework. These objectives were set out as a series of short and medium-term actions for member states, competent authorities and the Commission.

The implementation of the joint plan is nearing completion across Europe. Overall, it is judged to have been a highly successful programme resulting in significant action and development of the regulatory regime since its publication. In the context of the important area of notified bodies, the plan has led to the introduction of a voluntary joint assessment scheme for the designation and oversight of notified bodies. The assessments involve an independent review by the European Commission, assisted by appropriate experts selected from member states. The purpose of the review is to assess the competency and performance of national designating authorities such as the IMB and ensure they are applying designation criteria in a harmonised way. Some 20 joint assessments have been conducted to date in 2013 across Europe. The programme continues to have a positive tangible impact on the oversight and functioning of European notified bodies. In addition, the Commission has published its recommendation for notified bodies. This provides guidance for those bodies on best practices relating to their assessment and monitoring activities.

The joint plant has also led to the introduction of new and enhanced legislative requirements for notified bodies and the authorities responsible for their oversight. These include a more specific definition of operational requirements for notified bodies and mandatory joint assessments to be conducted on an ongoing basis. There is also a requirement for notified bodies to conduct unannounced inspections of the manufacturing facilities for which they are responsible. The positive impacts of these inspections have been evident throughout the Europeand Union. The plan also put in place a requirement for notified bodies to update their contracts with manufacturers to ensure proactive communication of important vigilance-safety information. This requirement has yielded positive benefits in terms of increased proactive communication throughout the European network.

In the context of market surveillance, co-operation between authorities and communication, the joint plan has resulted in the establishment of a forum, led by the European Commission, for a regular exchange and sharing of information on emerging safety issues. The forum has been operational since July 2012 and successful in further developing collaboration and achieving a collective resolution of key issues.

The joint plan has also given rise to a review of the scope of current market surveillance activities on medical devices conducted by member states. This has provided a platform from which a co-ordinated approach to surveillance can be developed, allowing for enhanced co-operation and targeted proactive market surveillance, including joint activities. Under the plan, there has also been a detailed review of the European regulatory authority structures to promote co-operation, communication and work-sharing. This review is nearing completion. It will not only enhance co-operation and communication between authorities but also seek to increase the management and transparency of the system.

Another initiative for authorities to promote as part of the joint plan has led to an increase in the number of reports received by the IMB from health care professionals on medical device issues. Dialogue with clinical societies and professional bodies on medical devices has increased and become commonplace at European level. It allows for key input and advice from expert clinicians and device users.

The plan has led to increased discussion on the use of registers for medical devices at European level. This is under way and the European Commission's so-called cross-border PAtient REgistries iNiTiative, PARENT, initiative is seeking to ensure such registers are appropriately established and have datasets which can be compared and analysed cumulatively across the European Union.

The IMB has been strongly committed to the joint plan from the time of its introduction and contributed significantly at both national and European level to ensure realisation of its objectives. The IMB considers that the plan has been critical in ensuring the existing regulatory system is enhanced to provide for increased levels of protection for patients. We are also committed to the future development of the plan which we believe can play a vital role in ensuring continued strengthening of the regulatory framework in the interim period prior to the adoption of the new legislation.

In the context of future developments to build on the existing regulatory system, it is anticipated that the European Commission will publish a report on the implementation of the joint plan either during this month or early in 2014. In response to appeals from several authorities, including the IMB, the Commission has indicated its intention to build on the principles of the existing plan and is shortly expected to make an additional formal proposal with details of further actions to develop the regulatory system during the period 2014 to 2015. Specific areas which the IMB has proposed for inclusion in the future development of the plan include placing further emphasis on practical measures to enhance market surveillance of medical devices; a continued focus on notified body oversight; enhanced emphasis on clinical data for medical devices and, in particular, assessment by notified bodies; and the development of further mechanisms for improving the availability of information on medical devices, particularly in the context of adverse incidents and safety issues.

The IMB will work to optimise and develop the regulatory activities conducted for medical devices at national and European level. This will include ongoing provision of dedicated support for developments at European level. We recognise that, in order to meet increasing challenges and requirements, it is necessary to continue to review and improve our approach to providing for regulatory oversight. Specific objectives in this regard include developing cross-organisational, that is, within the IMB, co-ordination of medical device activities to ensure a sufficient focus on new and emerging requirements; developing existing resource capabilities in line with advances in technology and innovation; and fostering and developing international collaboration within the medical device authority network at both European and international level. This will ensure our continued capability in providing a robust and relevant system of regulation for medical devices which affords the appropriate level of protection for patients and device users.

We will be pleased to take whatever questions members may wish to pose.