Aodhán Ó Ríordáin
Question:457 Deputy Aodhán Ó Ríordáin asked the Minister for Health the position regarding defective breast implants (details supplied); and if he will make a statement on the matter. [2176/12]
View answerTuesday, 17 January 2012
Questions (434, 435, 436)
Finian McGrath
Question:458 Deputy Finian McGrath asked the Minister for Health the assistance available to persons (details supplied). [2188/12]
View answer
Billy Kelleher
Question:492 Deputy Billy Kelleher asked the Minister for Health if he has established the number of Irish patients affected by the poly implant prostheses scandal; the direction and action that will be undertaken by him; and if he will make a statement on the matter. [2303/12]
View answerWritten answers
I propose to take Questions Nos. 457, 458 and 492 together.
Since concerns were first raised regarding the issue of breast implants provided by the now defunct French company Poly Implant Prosthese (PIP) the Irish Medicines Board (IMB) and my Department have been in constant touch with European and UK investigators of the matter and with any relevant initiative involved. 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. The advice remains consistent: that there is no evidence to date 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 and/or surgeon.
Approximately 1,500 Irish patients have received PIP breast implants at three centres in Ireland. The implants used were for aesthetic purposes only; none was used in reconstructive surgery for breast cancer patients and no public hospital has used these implants. The IMB has been in regular contact with the three centres which implanted the devices 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'. 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.
The Irish Medicines Board is the competent authority for medical devices in Ireland and is responsible for monitoring of post market surveillance of medical devices and sale. Medical devices are regulated in a different way to medicinal products in that the competent authority does not approve products for placing on the market. Medical devices may be placed on the market anywhere in the EU following certification by a notified body. In this instance a notified body in Germany was responsible for the certification.
In addition my Department and the IMB continue to liaise with the Health Security Committee's Health Threats Unit which is maintaining the up to date position on the issue for all Member States.
I am satisfied that all relevant emerging information and updates on the PIP implant issue are being thoroughly assessed and all concerned and interested parties kept aware of the emerging position.