Medicines body moves to calm fears over breast implants

THE IRISH Medicines Board has moved to reassure 1,500 Irish women that there is no need to have their breast implants removed, amid concerns over the French-manufactured type they have, which has been linked to the death of one woman.

French health authorities have announced that up to 30,000 women may need to have defective implants, produced by the Poly Implant Prothese company, removed.

The implants, which are filled with a type of silicone used in mattresses, have been linked to the death of a French woman from a rare form of cancer, anaplastic large-cell lymphoma, and are implicated in a number of other cases.

The implants contain an unapproved gel that 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 company closed last year and more than 2,000 women have filed legal complaints against it.

While French officials say they will offer surgery to any woman who wants to have the 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 identified.

“The IMB advised the implanting hospitals and clinics to identify women who have been implanted with PIP silicone gel implants after January 1st, 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,” it said.

“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 the implants should consult their surgeon.

Prof Michael Earley, plastic surgeon and spokesman for the Irish Association of Plastic Surgeons, said the implants were not definitively linked to cancer. The warning was precautionary, he told RTÉ radio’s News at One programme.

In Britain, where up to 40,000 women have the implants, the regulatory agency for medicines and healthcare products said there was no evidence to support their removal.

The agency 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 agency “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”, it said.

Douglas McGeorge, consultant plastic surgeon and former president of the British Association of Aesthetic Plastic Surgeons, said patients with breast implants should check whether they have had one from PIP.

“The message here is not to panic . . . These implants have a higher failure rate so there will be women who might choose to have their implants removed before that happens, whereas others will be happy to be monitored,” he told the BBC.