For Immediate Release 25th May 2012

The Medicines and Healthcare Regulatory Agency in the UK (MHRA) was warned about the safety of PIP breast implants 4 years before the devices were recalled.
According to a report by Lord Howe, the UK Health Minister, Surgeons had contacted the MHRA as far back as 2006 regarding concerns they had about the PIP Breast Implants claiming that they had split more often than other brands
The defective implants remained on the market until March 2010 when French Authorities discovered that silicone mattress filler gels were fraudulently used in the implants.
The Surgeons, who are not named in Lord Howe’s report had offered to carry out audits of their own records to help authorities deal with potential safety issues with the implants.. Instead the regulator contacted the German firm that had assessed the PIP implants and had provided a ‘CE Kite’ mark with assurances saying “while it is possible that the MHRA could have derived further helpful information had they followed up the offers made by individual surgeons, it seems unlikely that any further information would have done anything other than to reinforce the course of action the NHRA subsequently took’’.
Over 50,000 women in the UK have been implanted with the defective devices, mostly from private clinics. In Ireland, over 1,500 women have also received the PIP implants. Some of the clinics who provided the implants have since agreed to remove them but not replace them without cost.
Over 300,000 PIP implants have been sold worldwide. PIP have admitted it used unapproved silicone in the implants and have dismissed fears of a health risk.
Liam Moloney a Naas based Product Liability Solicitor who is representing many of the women in Ireland affected by the PIP scandal said today “ this shocking information shows that the UK Regulators were aware of the potentially serious health risks associated with these implants. The IMB and Department of Health should confirm, as a matter of urgency, whether they also received this information in 2006 and if so what action they took on foot of it. Both the Medicines Board and the Department of Health need to put in place the necessary systems and checks to avoid a repeat of this fiasco. Changes are also required immediately at the European level of the CE marking approval process to ensure much stricter post market surveillance in relation to medical devices.”
-ENDS-
For Further Information Contact:
Liam Moloney Solicitor Telephone No. 045 898000
E-mail: liammoloney@moloneysolicitors.ie
Website: www.moloneysolicitors.ie