Catherine Murphy (Kildare North, Independent)
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Question 118: To ask the Minister for Health if his attention has been drawn to the fact that in 2000, the Food and Drug Administration of the United States revoked the licence of the French manufacturer of breast implants (details supplied) to sell their product in the United States; if such revocation was known to officials in his Department at the time; and if he will make a statement on the matter. [29394/12]

James Reilly (Dublin North, Fine Gael)
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In 2000 the Food and Drugs Administration (FDA) in the USA raised concerns in relation to Poly Implant Prosthese (PIP) saline breast implants. Although produced by the same manufacturer, the Poly Implant Prosthese (PIP) silicone gel implants, which were recalled in March 2010, are a separate product to the saline breast implants which were of concern to the FDA in 2000. In 2000 my Department was the competent authority for medical devices in Ireland. From the records available in my Department and in the Irish Medicines Board, there is no record of my Department receiving, at that time, any notification regarding the FDA action, to which the Deputy refers. There is, however, a reference to receipt of an alert from the UK regulatory authority in January 2001 concerning PIP hydrogel implant products, which are the same product as the saline breast implant withdrawn by the FDA in the USA in 2000.

I am informed that, at the time, it was the practice in my Department to fax copies of these product safety alerts to hospitals on a regular basis. In October 2001 the IMB became the competent authority for medical devices. The IMB has been actively involved in the exchange of vigilance information between EU Member States since October 2001 and the exchange of vigilance information between global medical device regulators since 2004. In addition, the IMB has a memorandum of understanding with the FDA regarding regulatory issues since 2005.

In Europe medical devices are regulated under 3 EU Directives that specify the requirements which must be met before any device can be placed on the market. A medical device must obtain a CE mark from an independent Notified Body before it can be placed on the market in any EU Member State. The PIP silicone breast implants were manufactured in France and certified by a Notified Body in Germany. This certification allowed the product to be freely placed on the Irish market.

The IMB is responsible for post market surveillance and vigilance of medical devices. Market recall of the PIP silicone breast implants was initiated in Ireland by the IMB in March 2010 following receipt of notification from the French medical devices regulatory authority. The recall followed an inspection of the PIP implant manufacturing site in France which identified unauthorised silicone gel being used in the manufacture of the product. Since March 2010 the IMB engaged with the treating clinics and the recipients of the PIP breast implants to provide up-to-date information regarding the situation. My Department has also been engaging with the clinics and recipients to ensure that follow up care meets the appropriate professional standards. The international scientific research undertaken since 2010 has found no increased medical risks associated with this implant.

The EU Commission is currently reviewing the regulatory framework for medical devices and expects to publish proposals for a revision of the legislation in September 2012. I expect my Department, with support from the IMB, to play a key role in the negotiations of this legislation during the forthcoming Irish Presidency of the EU in 2013. As the new legislation will take a number of years to come into effect, the EU Commission has prepared a plan designed to address some of the weaknesses identified in the EU medical devices regulatory system. My Department and the IMB are fully committed to the implementation of this plan.