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State to cover removal costs after clinic criticised over PIP breast implants

The Department of Health has said it does not believe the Harley Medical Group will fulfil its obligations in an acceptable manner and so care will be provided by the State.

A woman whose PiP impants ruptured shows the removed implants.
A woman whose PiP impants ruptured shows the removed implants.
Image: Andrew Milligan/PA Wire/Press Association Images

IRELAND’S CHIEF MEDICAL Officer has strongly criticised a cosmetic surgery clinic for failing to provide an appropriate care package for clients affected by the PIP breast implants issue.

In a statement issued this afternoon, the Department of Health said it is not satisfied that the Dublin-based Harley Medical Group will fulfil its obligations to patients in an acceptable manner.

As a result, Dr Tony Holohan’s office is arranging for the care required by the recipients of the defective implants to be made available via an alternative route. Services, including surgical consultation, radiology (if required) and removal of implants (if deemed clinically necessary) will be sourced via the National Treatment Purchase Fund.

The NTPF will make suitable arrangements with appropriate facilities to provide such consultation and follow-on support as required.

Holohan said the move comes despite “intensive efforts” and “clear pressure” to ensure the appropriate care was forthcoming from the surgery. In May, he announced that the three clinics, which used the faulty silicone implants, would cover the cost of surgery to remove the implants from the more than 1,500 women affected in Ireland. While two of the clinics provided satisfactory packages, the Harley Medical Clinic did not.

The CMO met with members of the PIP Action Group yesterday to advise them of the proposed initiative and another meeting has been scheduled for September, when there will be a clearer view of the resources required for the services.

The PIP breast implant scandal came to light in March 2010 when the French medical device regulatory authority suspended the manufacturing and distribution of the Poly Implant Prostheses (PIP) products. The agency had discovered that unauthorised, industrial-quality silicone gel had been used instead of medical-grade substances.

There had been an increased number of incidents reported about the devices rupturing or leaking – 138 in total in Ireland. Three clinics in Ireland – the Harley Medical Clinic in Dublin, Clane General Hospital in Kildare and Shandon Street Hospital in Cork – had implanted the devices into some 1,500 patients between 2001 and 2010. In November 2010, the Irish Medicines Board instructed those clinics to identify and contact women who had received PIP implants to advise them of the issue.

The advice from the 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.

The CMO has noted, however, that he – in conjunction with the Irish Association of Plastic Surgeons – has issued updated guidelines for those considering cosmetic surgery.

More: Medicines board critical of Irish plastic surgery clinic over breast implant scare>

Read more about the PIP breast implants controversy>

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