Written answers

Thursday, 8 March 2012

5:00 pm

Photo of Tommy BroughanTommy Broughan (Dublin North East, Labour)
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Question 176: To ask the Minister for Health if he has met a group (details supplied); if he is taking any measures to address the health concerns of the 1,500 women in Ireland who have been affected by PIP breast implants; and if he will make a statement on the matter. [13296/12]

Photo of Caoimhghín Ó CaoláinCaoimhghín Ó Caoláin (Cavan-Monaghan, Sinn Fein)
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Question 198: To ask the Minister for Health if he or his Department have been in contact with their counterparts in France in relation to the PIP company which is responsible for breast implants using industrial rather than medical silicone, causing huge distress and possible medical complications to the women involved, including nine women in Ireland; if he and the Department have initiated any action on this matter to assist the women involved and, if not, if he will do so; and if he will make a statement on the matter. [13373/12]

Photo of James ReillyJames Reilly (Dublin North, Fine Gael)
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I propose to take Questions Nos. 176 and 198 together.

The IMB, the competent authority for the implementation of EU and national legislation relating to medical devices, including breast implants, has been in contact with national health authorities across Europe on this issue including the French Regulatory Authority (AFSSAPS). National health authorities across Europe have met via the Health Threats Unit of the EU's Health Security Committee and from January the European Commission set up an expert committee (the EU Scientific Committee on Emerging and Newly identified Health Risks (SCENIHR)) which provided a rapid scientific opinion on the safety of the PIP silicone implants and proposed further work to establish 'the health risks, if any, that may be associated with PIP silicone breast implants'.

As information on PIP implantation worldwide and within the European Community emerges, my Department and the IMB are continuing to review advice for recipients of PIP implants and any issues of concern will be communicated immediately. To date the advice remains consistent: that there is no evidence of increased risk of cancer for women with this brand of implant and the risk of rupture remains within expected norms. Anyone with a concern about their breast implants should discuss the matter with their GP and/or surgeon.

As you may be aware, approximately 1,500 Irish patients have received PIP breast implants at three centres in Ireland. The IMB has been in regular contact with the three centres and instructed all three to contact their clients on the matter and to reiterate its continuing advice: 'that there is no current evidence of health risks associated with PIP implants'. Although, as Minister for Health, I do not have a remit at present over the private health care sector, I expect that any private hospital in Ireland which provided a PIP breast implant procedure would provide for its removal should that course of action be recommended for a woman after consulting with her surgeon.

To that end, the Chief Medical Officer of my Department has written to the three clinics involved in providing the implants and it is intended to meet with them this coming Friday, 9th March, 2012. Due to the number and variety of queries raised by both providers and patients my officials would like to tease out the issues raised with a view to ensuring that concerned clients receive appropriate aftercare and management in accordance with normal standards of good professional practice. Following consideration of all the issues, my officials will be in touch with the group concerned to arrange a meeting. I must reiterate that my Department and the IMB continue to liaise with the EU Scientific Committee's Health Threats Unit which is maintaining the up-to-date position on the issue for all Member States.

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