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 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.
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.
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.
The vast majority of procedures, 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.
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.
It is believed the companies should be footing the bill, not the state. PIP was known within the industry as a poor quality compan 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.