Clinics offering faulty implants ‘not accountable’

Private clinics which offered PIP breast implants in Ireland “can do what they want” because they are not regulated, the country’s medicines watchdog has said.

Official figures show about 1,500 women were given the potentially faulty implants at the Harley Medical Group in Dublin, the Clane Hospital in Co Kildare and the Shandon St Hospital in Cork.

An Oireachtas hearing into the scandal was told many more Irish women may have travelled overseas to get the now banned implants.

Pat O’Mahony, chief executive of the Irish Medicines Board (IMB), which is charged with overseeing safety for medical devices in Ireland, said it had no authority over privately-run cosmetic surgery clinics. “They are not accountable,” he said.

“They are not within any approval system. They are private clinics and they are in the cosmetic surgery area, and they are not accountable. In essence, they can do what they want.”

Asked whether this was acceptable, Mr O’Mahony responded: “Nobody finds that acceptable.”

The implants, manufactured by French company Poly Implant Prothese (PIP), were filled with non-medical grade silicone intended for use in mattresses and have been linked to rupture and swelling in the body.

Mr O’Mahony stressed all recent research found no threat to the health of anyone given the implants. “There is no current evidence of particular health risks associated with the PIP silicone breast implants,” he said.

“The IMB continues to advise women with these implants that if they have any concerns about their breasts or their breast implants they should seek clinical advice from their implanting surgeon.”

However, the watchdog has been contacted by hundreds of women who cannot get the assurances they are seeking from their clinic.

Before an Oireachtas health committee, Mr O’Mahony said most of the anxiety over the implants in Ireland was from patients of the Harley Medical Group, who, he said, had made “very, very little effort” to deal with their patients.

Access to scans and direct access to a surgeon had not yet been provided to the vast majority of the women who underwent the procedure there, he said.

“It is absolutely the case that the 1,100 women who are dealt with by Harley are not being adequately dealt with at this time.”

Only about 100 of them have seen a surgeon, he said.

Fianna Fáil TD Billy Kelleher said a blind eye had been turned in Ireland to regulation and licensing of cosmetic surgery medical facilities.

Accusing the Department of Health of “pushing away” any responsibility, hecalled for the country’s chief medical officer Tony Holohan to be hauled beforethe committee.

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