Bernard Durkan (Kildare North, Fine Gael)
Link to this: Individually | In context

Question 189: To ask the Minister for Health the total number of women known to have had PIP breast implants; the extent to which defects in the procedure have been reported or detected; if it is intended to address any issues arising therefrom; and if he will make a statement on the matter. [14544/12]

James Reilly (Dublin North, Fine Gael)
Link to this: Individually | In context

My Department is aware of the issues being raised by concerned recipients of PIP implants. 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. Approximately 1500 Irish patients were implanted with the Poly Implant Prothese (PIP) silicone breast implants. Recall of these implants was taken following an inspection of PIP's manufacturing plant where it was found that most implants manufactured were filled with an unauthorised silicone gel which differs in composition from the originally approved material.

Currently the Irish rupture rate is approximately 5% of devices. Reports received indicate that ruptures have occurred at or between one month to eight years after implant. Factors which may contribute to the rupture rate seen include the fact that there is more intensive patient follow up, use of diagnostic scans, the increased time since implantation and more active rupture reporting by surgeons. In early February 2012, the European Scientific Committee on Emerging and Newly Identified Health Risks published its initial findings on 'The Safety of PIP Breast Implants'. The scientific opinion concludes that "further work is proposed to establish with greater certainty the health risks, if any, that may be associated with PIP silicone breast implants". The report also concludes that each case needs to be assessed individually.

The advice from the IMB and my Department continues to be that there is no evidence 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 or surgeon. 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. 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.

My Department is engaged at present in meeting all the treating clinics with a view to ensuring that best practice and patient support is paramount in the service provided to concerned recipients of PIP implants. My Chief Medical Officer will arrange to meet with a representative group of concerned recipients of PIP implants as soon as possible with a view to assisting in the resolution of the concerns raised.

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.