Hundreds of Irish women are being warned about faulty breast implants in a new safety alert issued by the Irish Medicines Board. A recall of the breast implants was initiated in Ireland on the 30th March 2010. The recall followed a manufacturing site inspection in France which identified unauthorised silicone gel being used in the product.
The French manufacturers of the implants Poly Implant Prothese (PIP) was closed down by the French authorities, which accused it of illegally using a non-approved silicone gel for almost 10 years. The implants have an abnormally high rupture rate which means affected patients require surgery to remove them.
In addition, there are concerns that a protective coating designed to stop the implant from splitting and preventing any gel leaking is missing. The implants were among the cheapest on the market and so were widely used in commercial clinics in Ireland and abroad.
The Irish Medicines Board has advised plastic surgeons and cosmetics clinics to immediately cease use of these products.
Women with these implants have been advised to contact their plastic surgeons and the cosmetic clinics where they may have had procedures carried out so that ultra sound tests can be done to check for flaws.
PIP, which was once the worlds third largest manufactures of implants has now gone into liquidation meaning that thousands of women affected may not be able to recover compensation.
Liam Moloney, a Medical Negligence Solicitor commented on the latest recall of defective medical products “This latest recall of defective medical products,
coming so soon after the recall of faulty hip implants confirms the need for the State to establish a Medical Devices Authority separate from the Irish Medicines Board as exists in the United Kingdom. There should also be greater monitoring of artificial implants by the State and there should be a register maintained of defective products to protect consumers.
Any patient who is adversely affected by this recall, would be entitled to seek damages against the suppliers of these defective products.”
NOTES TO EDITOR
- In March 2010, the IMB was informed by the French Medical Device Regulatory Authority that they had suspended the marketing, distribution and expert of these products.
- This action was taken following an inspection of PIP ’s manufacturing plants, where it was found that most implants manufactured since 2001 were filled with an unauthorised silicone gel which differs in composition from the originally approved material.
- In the UK, at least 40,000 British women have received these gel implants which have an abnormally high rupture rate – double that of rival products – which means that victims need surgery to remove them.
- These implants were distributed in Ireland and many Irish women will unfortunately be affected.
- Compensation in Ireland can be claimed for defective products under EU law and Irish Law.