AFSSAPS PIP breast implant test results released
Hugh James now represents over 350 women with PIP breast
implants
15 I 04 I 11
The long awaited results
of testing undertaken by the French medical device regulatory
authority, AFSSAPS on recalled PIP breast implants have today
(Friday 15 April) been released.
AFSSAPS have confirmed
today that the results of the latest analysis have found that there
is no link between PIP breast implants and genotoxicity (a
potential cause of cancer). However, test results have confirmed
that the gel inside can bleed through the pocket of the implant.
AFSSAPS have maintained their recommendation that women with PIP
breast implants should consult their doctor every 6 months for a
clinical examination and an ultrasound of the breast and lymph
nodes located under the arm.
The French authorities
have further recommended that if an implant rupture or leakage of
silicone is suspected, both PIP breast implants should be removed.
AFSSAPS advise that because of the complications associated with
removing lymph nodes, these should not necessarily be removed.
However, removal should be considered in cases where women are
suffering severe reactions as a result of silicone leakage into the
lymph nodes.
AFSSAPS have also
recommended that when women have their PIP implants removed, they
should attend a follow-up appointment within one year of
replacement surgery.
Due to the possibility of
the gel within the implant leaking outside of the shell. AFSSAPS do
not recommend that ladies with PIP implants breastfeed their
children.
In September 2010 AFSSAPS
confirmed that interim results of PIP breast implants testing had
showed that the gel within the PIP implants was not the same as was
described in the manufacturer’s design guide; that it did not reach
the level of quality required before a silicone gel can be used in
breast implants; that it could lead to an inflammatory reaction in
some women and that PIP implants had a higher propensity to
rupture. AFSSAPS recommended that all women with PIP implants
should be referred for an ultrasound scan and all women with
ruptures or suspected ruptures should have both their PIP implants
removed.
One of the French
genotoxicity tests in September was inconclusive and the results of
their further testing was not known until today.
The MHRA have yet to
release a statement on these latest results.
PIP breast implants were
the subject of a Medical Device Alert (MDA) by the MHRA on 31 March
2010, ordering a recall on all stocks of the PIP implant. This
followed an earlier issue with PIP implants using recalled hydrogel
solution in 2006. Many women who were supplied with PIP
implants during breast augmentation have experienced agonising
problems including ruptures and leakages. Studies last year
also found that the manufacturers of PIP breast implants not only
dispensed with a protective shell but used an untested gel, said to
have been intended for use in mattresses.
Mark Harvey, Partner at
Cardiff based law firm Hugh James has successfully obtained
free breast replacement surgery for some clients with PIP breast
implants and is continuing to fight to get compensation for over
350 women for the pain and suffering his clients have suffered as a
result of these breast implants.
Reacting to today’s
release, Mr Harvey commented that: “Although our clients
will be relieved to hear the results in relation to the
gentoxicology results, the AFSSAPS results will still be extremely
worrying for our clients. We are now eagerly awaiting a statement
from the MHRA; our hope is that they will support the AFSSAPS
finding that women with PIP implants should have regular
ultrasounds however, we hope that they will go one step further to
protect these vulnerable women by making it a requirement that
clinics who implanted these faulty devices provide
adequate after care for these vulnerable patients.
We are now calling on the
MHRA and all clinics who have implanted these faulty implants to
support these women. Both women who have already suffered a rupture
and women concerned that they may suffer a rupture in the future
should be treated free of charge by their clinic and this should
not be left as a burden for the NHS. AFSSAPS have confirmed that
these implants are below the standard that is expected of breast
implants and our clients should be compensated as soon as
possible”.