Irish women reassured on implants

The Irish Medicines Board has moved to reassure 1,500 women with Ireland who have a specific type of breast implant that there is no need to have them removed despite health concerns.

French health authorities have announced up to 30,000 women in France may need to have defective implants, which were produced by the Poly Implant Prothese (PIP) company, removed.

The implants, which are said to be filled with a type of silicone used in mattresses, have been linked to the death of a  woman in France from a rare form of cancer called anaplastic large cell lymphoma (ALCL), and are implicated in another small number of other cases.

The implants are filled with an unapproved gel, which has been found to become granular and lumpy, increasing the possibility of the implant tearing and the gel leaking into the woman’s body.

There have also been reports that the protective barriers are faulty, and that 10 per cent of them split within a year of being implanted.

The PIP company has since closed and more than 2,000 women have filed legal complaints against it.

While French officials have said they will offer surgery to any woman who wants to have her PIP implants removed, both the British and Irish authorities are downplaying the need for such a step.

The Irish Medicines Board said it had been monitoring the situation since March last year, when the potential problem was first identified.

“The IMB advised the implanting hospitals and clinics to identify women who have been implanted with PIP silicone gel implants after 1st January 2001 and to contact them to advise them of the issue and reassure them that there is no current evidence of health risks associated with the implants.

“The IMB have continued to liaise with colleagues in Europe and the implanting hospitals and/ Clinics affected by this issue to ensure that the relevant patients are made aware of this issue.”

The board recommended that patients who were concerned about their PIP implants to consult their implanting surgeon.

Prof Michael Earley, plastic surgeon and spokesman for the Irish Association of Plastic Surgeons, stressed the implants were not definitively linked to cancer.

Speaking on RTÉ's radio's News at One programme today, he said there was no definitive cancer link with this implant and that the warning was precautionary.

In Britain, the Medicines and Healthcare products Regulatory Agency (MHRA) said there was no evidence to support removal of the implant.

The MHRA said its own testing last year revealed no evidence of a link with cancer. It said it had received no reports of cancer linked with breast implants in the UK. “Discussions with the relevant UK professional bodies have not identified any cases,” it said.

“The MHRA has reviewed available evidence for association of cancers for women with breast implants in consultation with the relevant UK professional bodies for breast surgery and surgical oncology and has concluded that there is insufficient evidence to indicate any association with cancer.”

In a statement this evening, St Vincent's University Hospital and St Vincent's Private Hospital said the PIP implants were not used in any procedure carried out in either hospital.