Press Statement on PIP Breast Implants Issue. Office of the Chief Medical Officer / National Treatment Purchase Fund (NTPF)

03 July 2012

Since concerns were first raised in March 2010 regarding the issue of breast implants, provided by the now defunct French company Poly Implant Prosthese (PIP), the clear priority of the Department of Health has been to try and ensure that the three treating clinics involved in the issue provide professional and appropriate care to their affected clients. However despite intensive efforts, by the office of the Chief Medical Officer, such appropriate care on the scale required has not been forthcoming.

Accordingly the Department has now commenced work on sourcing an alternative service via the National Treatment Purchase Fund (NTPF). This will encompass surgical consultation, radiology if required and removal of implants if this is deemed clinically necessary. The NTPF will make suitable arrangements with appropriate facilities to provide such consultation and follow-on support as required.

It is important to identify the resources required for this work and the plan is that by September a clear view of such capacity and the means of access to it would be available.

The Chief Medical Officer met with the clinics to attempt to ensure that best practice and patient support was paramount in the service provided to concerned recipients of PIP implants. Despite intense discussions with and ongoing and clear pressure from the CMO’s Office in relation to one provider, the Harley Medical Group, that provider has failed to provide an appropriate care package for its clients. The Department is not satisfied that the Harley Medical Group will fulfil their obligations in an acceptable manner.

Consequently it has been decided that necessary care required by the affected recipients of these implants should be made available via an alternative route, i.e. the NTPF.

The CMO met with members of the PIP Action Group on Monday 2nd July, 2012 and advised them of the proposed initiative. He will meet with them again in September to discuss progress on the matter.

It should be noted that the Chief Medical Officer, in conjunction with the Irish Association of Plastic Surgeons, has issued updated guidelines for those considering cosmetic surgery procedures; it is strongly recommended that the advice is considered before deciding on such surgery.

The advice from the Irish Medicines Board (IMB) and the Department of Health 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.

Further press statements will issue as soon as possible.

ENDS

Note for Editors

In March, 2010 the Irish Medicines Board (IMB) was informed by the French medical device regulatory authority, the Agency for the Safety of Health Products (AFSSAPS), that they had suspended the manufacture, marketing, distribution and export of Poly Implant Prostheses (PIP) products, now in receivership.

This action was taken when it was found that most implants manufactured by the company since 2001 were filled with an unauthorised industrial quality silicone gel. The inspection was prompted when an increase in the number of incident reports regarding device rupture and local complications associated with these products was noted in France.

The IMB immediately instructed the three clinics in Ireland who received these devices to cease the use of the products (Shandon Street Hospital, Cork, Clane General Hospital, Co. Kildare and Harley Medical Clinic, Dublin (part of the Harley Medical Group)). The IMB tracked the devices through the PIP implant distributors, Cloverleaf; the Board does not have information on individual patients.

In November 2010 the IMB instructed the clinics to identify and contact women who have been implanted with PIP silicone gel implants after 1 January 2001 to advise them of the issue and provide reassurance that there is no current evidence of health risks associated with the implants.

Approximately 1,500 Irish patients were implanted with these products (3,000 devices) in the 3 centres above, between 2001 and 2010.