Dublin firm 'misinformed' over breast implants


THE IRISH Medicines Board (IMB) has said a Dublin cosmetic surgery company that said it had written to its patients about breast implants made of a suspect silicone gel when it had not, had “misinformed” the board.

The IMB said the Harley Medical Group told it on two occasions in November 2010 it had written to all patients implanted with a defective silicone gel made by the now-defunct company Poly Implant Prothese SA (PIP).

An investigation into PIP found it was using silicone not approved by health authorities but was about 10 times cheaper. The implants, 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 and are implicated in other cases.

It is understood that up to 1,500 women in Ireland have the PIP implants with 878 of those being former patients of the Harley Medical Group, according to the IMB. Other Irish clinics said to have used the implants were Shandon Street Hospital in Cork and Clane Hospital in Co Kildare.

In a statement yesterday, the IMB said the Harley Medical Group, which has a clinic in Herbert Place, Dublin 2, had provided the board with “detailed written confirmation on two separate occasions in November 2010 that they had written to all its Irish patients implanted with the PIP breast implants.”

The board said that it had now been informed that the letters were never sent and communication to patients was via Harley’s website only.

The IMB has said with “this direct specific patient contact letter never sent” it was “concerned that the Harley Medical Group did not follow the IMB recommendation and that the IMB was misinformed”.

The board said the Harley Medical Group had now assured it that its Irish patients would be sent a letter informing them of the issue by Monday “at the latest”.

The IMB said women who may have changed name or address should contact the Harley Medical Group directly.

Contacted last night, a Harley Medical Group spokeswoman said the company had “people going back as far as 2001 and a lot of those people had moved house and were difficult to contact”. She declined to comment on why the IMB said it had been told twice that the letters had been sent.

French health authorities have said they will offer surgery to any woman who wants to have her PIP implants removed. Yesterday, the British health ministry said it found no evidence to recommend the routine removal of the implants. However, it said if the surgery had been carried out by the NHS, as in the case of breast cancer patients, it would pay for their removal if the patient was concerned. It said it expected private clinics to do likewise.

It is thought none of the PIP implants were carried out at HSE facilities.

The IMB has said there was “no current evidence of particular health risks associated with PIP implants”. It advised those with concerns to contact their implanting surgeon.

The board said it was “continuing to monitor the situation”. It said senior representatives nominated by EU ministers for health as well as medical devices advisers had met by teleconference three times on the issue.

It had been decided to compile all the available information and data centrally at EU level and to set up “an expert panel to prepare a common risk assessment on PIP breast implants” to be completed “as quickly as possible”.