Catherine Murphy (Kildare North, Independent)
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Question 621: To ask the Minister for Health if his attention or that of the Irish Medicines Board was drawn to articles published in the British Journal of Plastic Surgeons in 2006 and 2007 concerning the unusual consistency of silicone in breast implants following reports from multiple British plastic surgeons; and if he will make a statement on the matter. [29304/12]

James Reilly (Dublin North, Fine Gael)
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In Europe, medical devices are regulated under 3 EU Directives which specify the requirements which must be met before any device can be placed on the market. A medical device cannot be marketed in any country across Europe without carrying a CE mark. A CE mark is obtained from an independent 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 throughout the EU and should perform as intended.

Since October 2001 the Irish Medicines Board has been the competent authority for medical devices in Ireland. As the competent authority the Irish Medicines Board monitors the products that have been placed on the market and are in use. Neither my Department nor the IMB were aware of articles referred to by the Deputy. Market recall of the PIP silicone breast implants was initiated in Ireland by the Irish Medicines Board in March 2010 following receipt of a notification under the EU vigilance system from the French medical devices regulatory authority (AFSSAPS). At that time the IMB had no reported incidents relating to the PIP breast implant. No concerns about the performance of the PIP silicone gel filled devices had been highlighted or communicated via the EU vigilance system prior to March 2010.