Clinic did not warn clients over faulty breast implants

HARLEY MEDICAL Group, which fitted 1,100 Irish women with below-grade silicone breast implants, did not write to any of its clients in November 2010 to warn them of the problems, but told the Department of Health it had, an Oireachtas committee was told yesterday.

Department of Health chief medical officer Dr Tony Holohan said women had difficulty accessing clinical information and “appropriate clinical follow-up” with the group.

He also said it had emerged that the non-medical-grade silicone used in the poly implant prostheses might have been used in implants before 2001, which could add an additional 50 women to the 1,500 already identified as having been fitted with the implants.

Concerns about the French-made implants emerged in 2010. They were filled with a type of industrial-grade silicone used in mattresses, which was 10 times cheaper than medical-grade silicone.

Three organisations had used the implants in Ireland: Clane General Hospital, in Kildare; the Hospital Group, which worked in Shandon Street Hospital in Cork; and the Harley Medical Group.

So far, 138 of the implants had been found to have ruptured in Irish women.

In November 2010, the Irish Medicines Board (IMB) instructed clinics to write to women who had received the faulty implants. The Department of Health recommended routine removal of the implants should not take place, but implants should be removed if rupture had occurred.

The Harley Medical Group, which carried out operations on 1,100 women at three centres around the country, “did not write to its clients in Ireland . . . having stated in writing that it did so”, Dr Holohan said.

The hospital had now written to all of its implant clients, he said, and had apologised to the IMB and to the Department of Health.

Dr Holohan said the response of Clane hospital had been “impressive”.

The hospital had contacted all of its patients and, so far, 10 per cent had their implants replaced.

“The service they have provided meets with the expectations I would have for women who find themselves in such a situation through no fault of their own,” he said.

The Hospital Group did not respond as quickly as Clane, but “now appears to have largely dealt with their concerned women”, Dr Holohan said.

But he was very concerned with the response of Harley Medical Group. He said he had “serious discussions” and “intense negotiations” with the group and the provider had recognised the shortfall in the service and was developing a plan to provide for early surgical consultation for all the women involved. “Significant detail remains to be clarified and the department is continuing to discuss the matter with the provider,” Dr Holohan said.

Harley had dealt with 70-80 women surgically and had 30 more “on their books”, he added.

Senator John Crown (Ind) said women should be allowed to have the implants out, even if they had not ruptured. Billy Kelleher TD (FF) highlighted the psychological impact of the faulty implants. Caoimhghín Ó Caoláin TD (SF) said the State should be “generous”, take care of the women and pursue the organisations for refunds afterward.

Mr Holohan said he wanted to ensure the providers and not the taxpayer met the costs.

He also said the Department of Health was examining whether the powers of the Health Information and Quality Authority could be extended to encompass cosmetic surgery clinics.