Clare Daly (Dublin North, Socialist Party)
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Question 1268: To ask the Minister for Health the position regarding private clinics and women who have received PIP breast implants; and if he will make a statement on the matter. [18317/12]

Anne Ferris (Wicklow, Labour)
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Question 1373: To ask the Minister for Health further to Parliamentary Question No. 189 of 14 March 2012 and No. 633 of 27 March 2012 in relation to breast implants from a company (details supplied); if he will clarify the current rupture rates for these implants; the way a normal and expected rupture range is decided; and if he will make a statement on the matter. [19136/12]

James Reilly (Dublin North, Fine Gael)
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I propose to take Questions Nos. 1268 and 1373 together.

The Chief Medical Officer (CMO) of my Department has met with and is engaging with the treating clinics which provided breast implant surgery with a view to ensuring that best practice and patient support is paramount in the service provided to concerned recipients of PIP implants.

The PIP Action Group also met with the CMO and officials of the Irish Medicines Board (IMB) on Friday 23rd March last and discussed their very reasonable concerns. The meeting was very constructive and identified a number of follow on activities which the Department will take to help these women in their unsatisfactory dealings with one of the treating clinics. The CMO has agreed to meet the Group again and will continue to engage with the treating clinics with a view to reaching an acceptable arrangement for resolving this serious issue for all concerned. The IMB have advised that, to date, 138 women who received PIP breast implants have reported ruptures. Reports received indicate that ruptures have occurred at/between one month - eight years after implant. The Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) in 'The Safety of PIP Silicone Breast Implants' published on 1st February, 2012 said that all silicone breast implants can fail, regardless of manufacturer, and the probability of failure increases with time since implantation. The Committee also states that 'estimates of breast implant rupture prevalence range widely, in part because the methods of estimating rupture prevalence rates differ among studies'. On average it is estimated that there is a 10% -15% rupture risk within 10 years of implantation.

However, officials of my Department are currently working on the Licensing of Health Facilities Bill which will provide for a mandatory system of licensing for public and private health service providers. The legislative proposals are being prepared broadly in line with recommendations made by the Madden Commission in 2008 and are designed to improve patient safety by ensuring that healthcare providers do not operate below core standards which are applied in a consistent and systematic way. The intention is to have a proportionate system which has the confidence of the public. Standards and other requirements will be enforceable through inspection and imposition of sanctions as necessary. Licensing will be targeted at areas which are not currently subject to regulation. 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 better information in place for people who in good faith use services of non-State providers, especially for cosmetic surgery.