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.
Read the full news release here.
