Catherine Murphy (Kildare North, Independent)
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Question 622: To ask the Minister for Health his views on whether faulty breast implants manufactured by a company (details supplied) were not merchantable at the time of sale in this State and that consequently hospitals and clinics who fitted them were in breach of their contracts with patients who were fitted with the faulty implants; and if he will make a statement on the matter. [29305/12]

James Reilly (Dublin North, Fine Gael)
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A recall of the Poly Implant Prosthese (PIP) Breast Implants was initiated in Ireland on 30th March 2010 by the Irish Medicines Board following notification from the French medical device regulatory authority (AFSSAPS) that they had suspended the manufacture, marketing, distribution and export of the PIP products. This action followed an inspection of the PIP manufacturing plant where it was found that most implants manufactured since 2001 were filled with an unauthorised silicone gel which differed in composition from the originally approved medical grade silicone, which had been approved in line with the CE mark. This fraudulent activity has resulted in criminal proceedings against the manufacturer.

Issues relating to the contractual relationship between a private healthcare provider and the patient are outside of my remit. The private clinics and their patients must work together to arrive at a solution. The Chief Medical Officer in my Department has met and is engaging with the treating clinics with a view to ensuring that an appropriate professional service is provided to the affected women.

Officials of my Department are working on the Licensing of Health Facilities Bill which will provide for a mandatory system of licensing for public and private health service providers. It is expected that outline proposals for the new system of licensing should be finalised by year end. In the meantime I am making arrangements to put in place better information for people who are planning to undergo cosmetic surgery in Ireland.