ALMOST one out of every 10 Irish women who had breast surgery with controversial PIP implants later suffered ruptures, new figures obtained by the Irish Independent reveal.
The shocking extent of the impact of the defective implants is only now fully emerging, two years after they were withdrawn from use.
The number of those affected now stands at three times more than medical authorities first estimated.
It is now known that at least 138 Irish women fitted with Poly Implant Prothese (PIP) breast implants have suffered ruptures, with 35 of these women suffering ruptures in both breasts.
This led to industrial-grade silicone — more commonly used to stuff mattresses — leaking into the women’s bodies. Some 1,500 Irish women received the implants over the past decade.
A briefing document prepared for Health Minister James Reilly revealed the potential cost of each of these women having their implants removed and replaced could be as much as €10m.
So far, the Department of Heath has refused to commit any funding to such procedures — saying it is the responsibility of the clinics involved.
However, one of these clinics has since gone out of business, while others say they will only replace ruptured implants free of charge, or replace intact implants at a reduced rate.
Meanwhile, eight law firms specialising in medical negligence say at least 370 women who received the implants are considering claims against plastic surgery clinics.
Records released by the Department of Health show how last January, the Irish Medicines Board (IMB) was aware of just 42 confirmed ruptures in women with PIP implants.
In an email to chief medical officer Dr Tony Holohan, a departmental official noted that this figure would be “within acceptable limits”. but in the past three months the IMB has had to update figures for ruptures as more of the affected women have had scans.
Some 138 patients have suffered ruptures, some within a month of the surgery and others as much as eight years later.
The IMB did not clarify what percentage of ruptures would be considered an unacceptable number for PIP breast implants.
Instead a spokeswoman said that this new figure was still below the “10pc to 15pc” rupture risk rate for all brands of silicone breast implants.
The most recent fears about PIP implants surfaced late last year when authorities in France announced that they would be funding the removal of the implants in affected women there.
The move came after a medical report highlighted increased rupture rates with the PIP implants, as well as possible links to breast cancer in eight women.
Subsequent tests have found no evidence that the PIP implants cause cancer, while a recent IMB statement on the implants said the latest studies “to date have not identified any safety concerns”.
The French firm that made the implants has gone out of business and is under investigation for fraud. its founder, Jean-Claude Mas, was jailed after he was charged with “involuntary injury”.
Here, the three Irish clinics that used the PIP implants may be facing a slew of legal actions.
In recent weeks, papers in six legal actions against two of the clinics, five against Harley Medical Group and one against Clane Hospital, have been filed in the High Court.
The complaints include allegations of personal injury and medical negligence. Both clinics declined to comment on the legal actions.
The directors of the other clinic, Cork-based Shandon Street Hospital, which was dissolved last year, could not be contacted.
A spokeswoman for PIP Action Group Ireland they were “very concerned that the rupture rate continues to rise”, calling the number of women affected “unacceptable”.
The group is holding an information day for women with PIP implants on may 5 in the Red Cow Inn. Information on registering for the day can be found at www.pipactiongroup.com.