THE IRISH MEDICINES BOARD (IMB) has said it is concerned that a plastic surgery clinic in Ireland did not follow its recommendations to contact all patients affected by defective PIP breast implants.
It also accused the Harley Medical Group of misinforming them about the situation.
In a statement, the IMB said that the group had confirmed on two occasions that it had written to all of its patients implanted with PIP breast implants, which have been pulled from the market due to fears they could rupture. However, this turned out to be false information as the direct contact letters were never sent to the patients.
Communications were only made to patients through a website, it has been revealed.
Having relied on the earlier written confirmation that direct specific patient contact letters had been issued, the IMB is concerned that The Harley Medical Group did not follow the IMB recommendation and that the IMB was misinformed.”
A letter is now due to go out to all patients implanted with the faulty implants by Monday.
The IMB also urged patients to contact the Harley Medical Group.
As the PIP breast implants were in use from 2001 to 2010, it may be that some patients have changed name or address and so may not receive this direct patient contact letter. These patients should contact the Harley Medical Group directly.
The group also has operations in the UK and the IMB has informed the MHRA of the development.
Unchanged advice
The board also said it continues to monitor the situation but its advice to those affected remains the same: “there is no current evidence of particular health risks associated with PIP implants but worried patients should seek clinical advice from their implanting surgeon”.
Yesterday, the British health ministry said it had found no evidence to recommend the routine removal of PIP breast implants. The government, however, has said that if the implant surgery was carried out by the NHS (such as for breast cancer patients) then it would pay for their removal if patients were concerned.
A panel of European experts is now being put together by the European Commission to prepare a risk assessment on PIP breast implants.
Yesterday, the executive director of the European Medicines Agency told Reuters that there was an urgent need to regulate medical devices – including implants – at the same level used with drugs.
The PIP implants had received a CE Mark but were not regulated by the EMA.
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