Background info

Hugh James solicitors are representing over 225 women with implants manufactured by Poly Implant Prothese (PIP).

On the 31st March 2010 the UK Medicines and Healthcare products Regulatory Agency (MHRA) released a Medical Device Alert in relation to all silicone gel filled breast implants manufactured by PIP, recalling all devices to the UK supplier.

The MHRA acted upon receiving information from the French medical device regulatory authority (AFSSAPS) that they have taken similar steps in France following a recent inspection of the PIP manufacturing plant which revealed that most breast implants manufactured by the company since 2001 have been filled with an unapproved silicone gel.  The AFSSAPS inspection was prompted by an increase in reported incidents (mainly ruptures) involving the implants over the past three years. Reports of higher rates of rupture and other complications connected to these implants raised concerns with regulatory authorities and in March 2010 an inspection of the PIP manufacturing plant revealed use of an unapproved gel.  Further studies have also revealed that PIP dispensed with using a protective barrier and that the unapproved gel was intended for use in mattresses.

The French medical device regulatory authority (AFSSAPS) released the results of their testing on 29^th September 2010 and have confirmed that there may be a higher rate of rupture in PIP breast implants. AFSSAPS has confirmed that the gel within the PIP implants is not the same as it is described in their manufacturer’s design guide, that the gel does not reach the level of quality required before a silicone gel can be used in breast implants and that the gel can lead to inflammatory reactions in some women, because of the irritant character of this gel. The tests also show that PIP implants have a higher propensity to rupture. AFSSAPS have however agreed with the results of the MHRA’s recent testing that the gel itself is not toxic.

AFSSAPS conclude that their testing shows that the performance and safety of PIP breast implants are not in accordance with current expected standards.

AFSSAPS recommends that:

·          All women with PIP implants should be referred for an ultrasound scan

·          All women with ruptures or suspected rupture should have both their PIP implants removed

The MHRA however have not recommended such steps.

All PIP silicone gel implants were recalled and women who have them advised to seek an ultrasound within the next six months to check for any rupture or weakening of their implants.

Hugh James is advising all women with PIP implants to seek medical advice as soon as possible.