PIP scandal not over

The scandal of women whose breast implants were made of industrial-grade silicone has not gone away, with the State this week stepping in to guarantee removal of dangerous PIP implants. But how did it come to this, asks Sinéad Moore

In autumn 2011 news broke that the French company Poly Implant Prosthese (PIP) had been using unapproved in-house manufactured industrial-grade instead of medical-grade silicone in the majority of its implants. 

This impure gel releases toxic substances into the body and can also cause implant rupture as well as inflammation and irritation. It is believed that over 1,500 Irish women - including patients of Cork's now-closed Shandon Street Hospital - received the defective implants and may now face alarming health risks including Anaplastic Large-Cell Lymphoma.

The PIP implants were recalled in Ireland in March 2010. This caused an overwhelming amount of panic for those affected, especially amongst pregnant women who cannot have the implants removed during their pregnancies, despite the fact that they are leaking industrial grade silicone into their bodies.

PIP implants were used in Cork in the Shandon Street Hospital, which closed last year.

On 3 May, the Health Committee discussed the PIP silicone breast implants issue with the state's Chief Medical Officer, Dr Tony Holohan. Dr Holohan received a written commitment from Harley Medical Group  to provide a care package for their patients, but the clinic in question has not fulfilled this commitment.

Cold comfort

The Department of Health will now take the lead on delivering this care package to PIP patients. The National Treatment Purchase Fund will pay for 1,550 women affected to undergo a surgical consultation. If the consultant deems it clinically necessary then the implants will be removed. The CMO stated that only 10-15 per cent of women affected are expected to have the implants removed. The women whose implants have already ruptured will have priority.

However, the women whose implants have not yet ruptured may have to wait until they rupture in order to have them removed. This is a cold comfort. These women are simply waiting for their faulty implants to rupture and leak industrial grade silicone into their lymph nodes and breast tissue. These women face alarming health risks. 

Gráinne O'Donovan, a solicitor in the Cork-based Kieran McCarthy & Co. Solicitors, deals with medical negligence cases and has been keeping up to date with the developments in this scandal since the news broke in December. It's thought there are several Cork based women affected as the Shandon Street Clinic carried out several procedures, and they are particularly inconvenienced as the Clinic closed last year.

The vast majority of procedures however, were carried out in the Harley Medical Clinic in Dublin. Many women affected have not yet sought legal advice as they are still figuring out their medical advice and are unsure if they even have a case. 

According to Ms O'Donovan, legally, this is an unusual situation as a defective product case does not apply - the women cannot go directly to the manufacturer as it has shut down. However, they could have a medical negligence case against the clinic or a breach of contract case under consumer legislation. 

Women nationwide have been reluctant to come forward due to the negative public attitude regarding their situation. This is adding to the difficulty of the scenario.

Ms O'Donovan believes the companies should be footing the bill, not the state. PIP was know within the industry as a poor quality compan, she says, and these women paid a substantial amount of money for surgery in good faith that they were receiving a product which was of merchantable quality.

"These clinics, who are very liquid, should take responsibility and provide these women with replacement implants", she said.  

An advocacy group known as PIP Action Group Ireland has also been set up by a group of five women who have all been touched by the PIP implant scandal. They aim to provide support and guidance for anyone who is involved with this issue. The women have put a significant amount of pressure on the government to hold the private clinics accountable and responsible for removing and replacing the faulty implants. The founders of the action group feel that the women involved in the PIP Issue deserve to be treated with the care and respect that they were all promised by their clinics.

These women are advocating that the clinics pay for replacement implants, not the taxpayer. The PIP Action Group will be meeting with the CMO and the Department of Health again in September 2012 when clear details of this plan have been clarified. 

The PIP Action Group can be contacted via their website www.pipactiongroup.com or on their twitter and facebook pages.