PIP Breast Implants
French company Poly
Implant Prothese (PIP) manufactured and supplied purportedly
cohesive silicone gel breast implants. It is reported that as
many as 50,000 women, including thousands in the UK, could
have received these implants.
News
alert: PIP breast implants manufactured prior to
January 2001 are now the subject of Medical Device Alert
15 | 03 | 12
PIP Breast Implant Claims
On 9 March 2012 the High Court
recommended a Group Litigation Order be pursued in relation to
personal injury claims being made by women who received PIP breast
implants, with Hugh James appointed as lead solicitor. The
Group Litigation Order will allow those affected to have their case
heard by a Judge. Women who have not yet registered their claim
will need to do so to be included in any further action.
Please read about
Hugh James PIP Breast Implant
Claims
On the 31 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 29th 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 PIP Breast Implant
Recommendations
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
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.
Recent PIP Breast Implant
Developments Diary
15 | 03 | 12
A new Medical Device Alert has been issued by the MHRA
warning that PIP breast implants manufactured before
January 2001 are also believed to have been filled
with unapproved silicon gel, intended for industrial use. It
is estimated that a further 7,000 women are now linked to PIP
breast implants, in addition to the 40,000 women fitted after
January 2001.
14 | 03 | 12
On 9 March 2012 a group litigation was recommended by the High
Court, allowing women affected to have their case heard by a Judge.
Mark Harvey has been appointed as lead solicitor to administrate
claims on behalf of the PIP group action.
20 | 12 | 11
During December 2011, reports were published by the French
publication Libération that the French medical authorities will ask
all women in France who received breast implants supplied by the
Poly Implant Prothese (PIP) company to have them removed.
The recent development in the
approach by the French Government has been made in reaction to
reports during December 2011 of an association between the death of
a French woman with PIP implants.
The British Association of
Aesthetic Plastic Surgeons (http://www.baaps.org.uk/) has,
however, reiterated previous recommendations by urging UK patients
not to worry and confirming that a direct link with the implants
has not been established.
Since the recall of the faulty
implants, PIP has gone into liquidation, leaving victims with no
clear route for legal recovery. Renowned campaigning lawyer
Mark Harvey, Partner
and head of the top ranked Personal Injury Team at Hugh James
solicitors, is acting for over 1,000 women with PIP
implants.
Hugh James is advising
all women with PIP implants to seek medical advice as soon as
possible.
For information on joining the
group represented by Hugh James please contact Mark Harvey on 02920 224
871 or complete our enquiry form.
PIP Implants News
Click on the links below to read
further coverage on this issue:
Hugh James latest
news:
Latest external news
articles:
View our news archive on PIP breast
implants
Visit our PIP breast
implant blog
Hugh James harmful products experience
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