The stress and worry which Irish recipients of Poly Implant Prothese (PIP) breast augmentation implants are being needlessly subjected to can only be imagined.
Unlike the French women affected, Irish patients are not being offered surgery if they want to have their PIP implants removed, with the Irish authorities attempting to play down the seriousness of the situation.
A recall of these implants was initiated in Ireland on 30 March 2010 following a manufacturing site inspection in France which identified unauthorised silicone gel being used in the product.
The implants are alleged to be filled with a type of silicone used in mattresses and have been linked to the death of a woman in France from a rare form of cancer called anaplastic large cell lymphoma (ALCL). They have also been implicated in a number of other cases.
The gel contained in the implants has been found to become granular and lumpy. This increases the possibility of the implant rupturing, enabling the gel to leak into the woman’s body. The protective barriers are also said to be faulty, with around one in ten having split within a year of being implanted.
Whereas the recall has global consequences, the Irish Medicines Board (IMB) has reported that the PIP implants that were used in Ireland were for aesthetic purposes only and not for reconstructive surgery for breast cancer patients. The IMB has also confirmed that implants were implanted in 3 private facilities, namely:
- Shandon Street Hospital, Cork.
- Clane Hospital, Co. Kildare.
- Harley Medical Clinic, Dublin.
If they have complied with the directions provided by the IMB, each of these clinics should at this stage have contacted all of the approximately 1,500 women throughout the country who received the implicated PIP silicone gel implants after 1 January 2001.
The official medical advice in this country is that women who received these implants should seek clinical advice from their implanting surgeon if they have any concerns about their breasts or implants. The IMB has confirmed that it has received reports of potential adverse incidents from some patients. However, precise figures have not been disclosed.
The IMB has said that it awaits a statement addressing the safety of these implants together with advice in relation to patient health and whether or not removal is necessary from the Agence Française de Sécurité Sanitaire des Produits de Santé (AFSSAPS), which is the relevant French regulatory authority. However, if past form is anything to go on, decisive action from the Irish authorities should not be expected any time soon.
John McCarthy presently acts for clients nationwide in pursuing compensation for the injuries which they have sustained from defective medical devices.
If you have been affected by the PIP recall or you believe that you have been the victim of negligent cosmetic surgery and you would like to arrange a free initial consultation with John, feel free to call him on 023 883 3348.