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Written Answers - Medical Aids and Appliances

Tuesday, 27 March 2012

Dáil Éireann Debate
Vol. 760 No. 3

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 14.  Deputy Sandra McLellan Information on Sandra McLellan Zoom on Sandra McLellan  asked the Minister for Health Information on James Reilly Zoom on James Reilly  if he has been in contact with their counterparts in France in relation to the PIP company which is responsible for breast implants using industrial rather than medical silicone, causing distress and possible medical complications to the women involved, including nine women here; if he has initiated any action on this matter to assist the women involved and, if not, if he will do so; and if he will make a statement on the matter. [16265/12]

 53.  Deputy Mick Wallace Information on Mick Wallace Zoom on Mick Wallace  asked the Minister for Health Information on James Reilly Zoom on James Reilly  the total number of women affected by the PIP breast implants controversy in view of the recent revelation that PIP implants manufactured prior to 2001 may also have contained industrial grade silicone; his views on reports that some women are being obstructed by private clinics from obtaining their medical records in order to get confirmation of PIP implants and on reports that information is missing from some medical files; if his Chief Medical Officer has met with a representative group for the women affected by the PIP breast implants issue to discuss these and other concerns; and if he will make a statement on the matter. [16440/12]

 542.  Deputy Joanna Tuffy Information on Joanna Tuffy Zoom on Joanna Tuffy  asked the Minister for Health Information on James Reilly Zoom on James Reilly  if he will provide an update on the advice or assistance being given to Irish women in respect of concerns raised regarding the safety of breast implants (details supplied) [17302/12]

 547.  Deputy Finian McGrath Information on Finian McGrath Zoom on Finian McGrath  asked the Minister for Health Information on James Reilly Zoom on James Reilly  if he will support PIP Action Ireland (details supplied) [16078/12]

 633.  Deputy Billy Kelleher Information on Billy Kelleher Zoom on Billy Kelleher  asked the Minister for Health Information on James Reilly Zoom on James Reilly  if he is correlating data in relation rupture rates and tissue sampling analysis of Irish victims of PIP implants; and if he will make a statement on the matter. [16798/12]

[697]

 635.  Deputy Billy Kelleher Information on Billy Kelleher Zoom on Billy Kelleher  asked the Minister for Health Information on James Reilly Zoom on James Reilly  if his attention has been drawn to the fact that breast implantation clients continue to experience difficulties in getting confirmation of PIP implants while these and other clients are also having difficulty obtaining their medical records; the action he will take to rectify this situation; and if he will make a statement on the matter. [16800/12]

Minister for Health (Deputy James Reilly): Information on James Reilly Zoom on James Reilly I propose to take Questions Nos. 14, 53, 542, 547, 633 and 635 together.

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.

The IMB in its role as Competent Authority for medical devices in Ireland is correlating data regarding the PIP Breast implant recall.

The Board keeps my Department advised of the device rupture rate, currently at 6.63% which is within the expected range.

The IMB tracks the number of implants and their dispersal to treating clinics via the product’s distributors. Detailed examinations of the records of the UK distributors indicate that approximately 1,500 Irish patients received implants between 2001 and 2010.

On 15th March, 2012 the IMB received updated information from the French Competent Authority for Medical Devices suggesting that PIP silicone gel implants manufactured before 2001 may also have contained the unapproved non-medical grade silicone; current information suggests that in the region of 50 additional Irish recipients could be affected. As further information becomes available the IMB will publish additional updates.

The IMB has continued to liaise with European and international colleagues in relation to this issue and tests conducted to date support the Board’s and the Department’s position that:—

there is no evidence of increased risk of cancer for women with this brand of implant;

the risk of rupture is within expected norms and routine explanation is not recommended;

and anyone with a concern about their breast implants should discuss the matter with their GP or surgeon.

The EU Commission is currently reviewing the regulatory framework for medical devices, deriving from three EU directives. The Commission expects to publish its proposals for new medical devices legislation this year.

The Chief Medical Officer of my Department has met and is engaging with 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. He has discussed the concerns raised by affected clients including access to surgeons for consultation and the provision of full medical records in relation to one of the treating clinics. The provider concerned has advised that it is addressing the CMO’s concerns including the delay in retrieval of clients’ medical records. It says that work is ongoing to locate these records and that additional personnel have been recruited to address more quickly the requests from those still seeking their records.

The PIP Action Group also met the Chief Medical Officer and IMB officials on Friday 23rd March last and discussed their very reasonable concerns. The meeting was very constructive and the focus was largely on one provider. The meeting identified a number of follow on activities which the Department will take to help these women in their unsatisfactory dealings [698]with this provider. 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.

Finally, I am pleased to note that one major provider has dealt very well and responsibly with its patients. All providers should act in a reasonable and responsible manner to their clients and I expect the other treating clinics to follow suit. I will also be seeking to put better information in place for people who in good faith use services of non-State providers, especially for cosmetic surgery.


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