I have PIP implants, what are my options?
I have PIP implants. They have not ruptured but I feel like I am a ticking time bomb. Legally what is the story? I am very worried and confused.
The PIP implant scandal hit the headlines internationally over the past few weeks and many women, like you, have been left in the dark.
Following an investigation into the French-made products it was reported that the silicone used in the PIP implants was not of medical grade, instead it's a type of silicone used in mattresses. They were manufactured by the now-closed company Poly Implant Prostheses (PIP).
Different governments have issued different guidelines in terms of dealing with the problem, leading to confusion.
The French government have said they will offer surgery to any woman who wants the PIP implants removed. French health authorities also announced that up to 30,000 women there may need to have the defective implants removed. More than 2,000 women in France have initiated legal action against the PIP company.
The British and Irish approach is different. The British health ministry have said they found no evidence to recommend the routine removal of the PIP implants.
The British government have said that if the surgery was carried out by the NHS, they would pay for the removal if the patient was worried.
They are still negotiating with private clinics about this approach. Health Secretary Andrew Lansley is putting pressure on private clinics to step up to their responsibilities.
In Ireland the Irish Medicines Board is the body with jurisdiction. They have moved to reassure the 1,500 Irish women with PIP implants that there's no necessity to have them removed despite health concerns.
The Medicines Board said: "There is no current evidence of particular health risks associated with PIP implants."
The IMB said that women who are concerned should contact their implanting surgeon.
The Irish Medicines Board initiated a recall of PIP implants as far back as March 30, 2010, following revelations in France that unauthorised silicone gel was being used in them.
Of the 1,500 women in Ireland who have the PIP implants, most got them in Harley Medical Group, Shandon Street Hospital in Cork and Clane Hospital in Co Kildare. It's believed no PIP implants were used in HSE facilities.
In providing medical devices there are legal responsibilities all the way along the chain from the manufacturer to the clinics providing the service to patients. This makes the process of apportioning blame complex.
There is an obligation on the manufacturer to provide a safe non-defective product. Regulatory bodies must then approve the product before it is allowed on the market and clinics have a duty to carry out the procedure without causing injury or damage using safe approved products.
It has been reported some Irish women intend to sue under defective product law.
Medical devices can't be marketed in Europe without a CE mark. The CE mark for PIP implants was obtained from an independent certification organisation in Germany (TUV Rheinland) allowing it to be placed freely on any market in the EU.
The problem for women who have had the implants is that there may be no damage as such -- meaning they were an approved product at the time, they were put in correctly, they haven't ruptured and the Medicines Board is saying there is currently no proven health risk.
This leaves angry recipients of PIP implants petitioning clinics for removal. Many fear they will be left footing the bill for removal and new implants.
In Britain, the Medicines and Healthcare products Regulatory Agency (MHRA) has failed so far to find a causational link between the implants and cancer even though this spectre has been raised in France.
Every case is different and must be assessed on this basis. I would advise you to contact your surgeon, obtain your medical records and definitively establish that they are the PIP implants. If you're concerned, have your implants examined and take it from there.
This is an evolving story, the situation may change and more definitive evidence may come to light. Keep an eye on the Irish Medicines Board website www.imb.ie.
Mary Kirwan is a barrister and can be contacted with queries at mkirwan@independent.ie
Originally published in
