IMB says clinic misled it about patient contact

THE Irish Medicines Board (IMB) has claimed that the Harley Medical Group misinformed them on two separate occasions concerning the recent breast implants scare.

About 1,500 Irishwomen received the French-made Poly Implant Prothese (PIP) implants, which were withdrawn from use last year amid concerns they were prone to rupturing and leaking an inferior grade silicone.

In a statement issued last night, the IMB said the Harley Medical Group provided the IMB 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.

“We have now been informed that this direct specific patient contact letter was never sent and communication to patients was via their website,” the statement read.

“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.”

The IMB has now received confirmation that a direct specific patient contact letter to all patients who received the PIP implant at the Harley Medical Group will be issued at the latest by Monday to inform them of the issue.

As the implants were in use from 2001 to 2010, some patients may have changed their name or address and so may not receive this direct patient contact letter. These patients should contact the Harley Medical Clinic directly.

Over the past few weeks national health authorities from across the EU have met three times via teleconference in the form of the Health Security Committee in order to evaluate the latest available information.

The IMB said that if those affected had concerns, they should seek clinical advice from their implanting surgeon.

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