PIP breast implants Medical Device Alert

On 15 March 2012, the Medicines and Healthcare products Regulatory Agency (MHRA) issued a new Medical Device Alert for PIP breast implants manufactured before January 2001.

The PIP breast implants manufactured after January 2001 by Poly Implant Prothèse are already the subject of a Medical Device Alert issued in October 2010, amidst concerns of increased rupture rates and the use of an unapproved, industrial grade silicone gel.

 

The French authorities have provided new information to the MHRA which suggests that no guarantees canbe made that PIP breast implants manufactured prior to January 2001 are filled with approved, medical grade silicone.

It is estimated that a further 7,000 women may have been fitted with PIP breast implants prior to January 2001, in addition to the 40,000 who are believed to have already been affected.

Mark Harvey of Hugh James represents more than 1,000 PIP patients and has been appointed as lead solicitor by the High Court. Mark says “This will be very disappointing for the women involved. We are not surprised given that PIP were facing compensation claims through much of the late 1990s but together with the recent scandal of the metal on metal hip prostheses it does of course simply reinforce our previously stated concerns of just how ineffective the regulation of these products has been.

We call for a public enquiry into the whole way in which medical devices and products are regulated in the UK and across Europe."

Read the full news release here.