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Friday 2 December 2016

Women with faulty breast implants are left in limbo

Lawyer says authorities 'playing down seriousness of situation'

Published 08/01/2012 | 05:00

Irish women who had breast implants inserted which were manufactured and supplied by French company Poly Implant Prothese (PIP) are in limbo regarding the possibility of their removal.

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Cork solicitor John McCarthy launched a stinging attack on the Irish authorities this week for "attempting to play down the seriousness of the situation".

"Unlike the French women affected," he said, "Irish patients are not being offered surgery if they want to have their PIP implants removed.

"If a woman decides that she wants to undergo explant surgery as a precaution, where the implant has not ruptured, depending on the terms of the policy, some health insurers might well argue that this is an entirely elective cosmetic procedure for which they are not obliged to cover the costs."

The present position of the Irish Medicine Board (IMB) is that there is no current evidence of health risks associated with these implants.

However, French authorities have urged the 30,000 French women with these implants to have them removed following revelations that the implants contain industrial fuel additives unsafe for humans.

Irish Association of Plastic Surgeons (IAPS) secretary Jack Kelly believes that the IMB may have to alter its position.

"It's something we might have to consider here," he told the Sunday Independent. "There's no evidence linking these implants to cancer. However, it is the nature of the gel within them that will create a problem if they rupture."

Mr Kelly added he feels "there is definitely a moral and ethical obligation on the clinics that performed these operations to facilitate the removal of the implants for free or at a bare-minimum cost".

One of the Irish clinics that used PIP implants in the past did not comply with IMB recommendations to contact women affected.

On Friday afternoon the IMB issued the following statement regarding The Harley Medical Group: "The Harley Medical Group provided the IMB with detailed written confirmation on two separate occasions in November 2010 that it 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.

"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 was subsequently told by The Harley Medical Group that it would send a "direct specific patient contact letter" to all affected patients by tomorrow at the latest.

A spokesperson for The Harley Medical Group told the Sunday Independent recently that the possibility of corrective surgeries for women who received PIP implants in their clinics would be "entirely up to the surgeon".

Mr McCarthy, who presently acts for clients nationwide in pursuing compensation for injuries sustained from defective medical devices, believes the legal landscape surrounding this scandal is yet to unfold.

"PIP, the French company which manufactured the defective implants is an obvious target for women seeking compensation," he said. "However, as the company went into liquidation some time ago, there's almost certainly no point in pursuing it.

"It's also likely that a German company called TUV Rheinland, which was responsible for evaluating the implants in accordance with the relevant European directive on medical products, will be dragged into the fray.

"In the UK, over 250 women will shortly apply for a group litigation order to enable a class action to be launched."

According to the IAPS's Mr Kelly, the best advice at the moment for women affected is to "be careful, to monitor themselves, and if they're in any doubt whatsoever, to return to their operating surgeon or family doctor".

Sunday Independent

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