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Cosmetic Surgery

Dáil Éireann Debate, Tuesday - 19 June 2012

Tuesday, 19 June 2012

Ceisteanna (530, 531, 532)

Catherine Murphy

Ceist:

621 Deputy Catherine Murphy asked 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]

Amharc ar fhreagra

Freagraí scríofa

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 was 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.

Catherine Murphy

Ceist:

622 Deputy Catherine Murphy asked 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]

Amharc ar fhreagra

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.

Catherine Murphy

Ceist:

623 Deputy Catherine Murphy asked the Minister for Health if he will confirm that surgeons working at the three private clinics which fitted defective silicone breast implants manufactured by a company (details supplied) participated in continuing professional development in 2006 and 2007; if he will explain the way the concerns regarding faulty breast implants raised in the same years in a leading professional journal in the field went unnoticed by cosmetic surgeons here; and if he will make a statement on the matter. [29309/12]

Amharc ar fhreagra

Part 11 of the Medical Practitioners Act 2007 (No. 25 of 2007) provides that it is the duty of medical practitioners to maintain their professional competence on an ongoing basis. This part of the Act was commenced by the Minister for Health in May 2010. Requirements for the professional competence schemes were put in place by the Medical Council in May 2011 and it has been mandatory for all medical practitioners to participate in a professional competence scheme in line with their individual practice since that time.

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