Licensing authorities confirm that PIP implants are more prone to rupture
French Regulator, AFSSAPS
release PIP testing results and have confirmed that PIP implants
are more prone to rupture and recommend affected women to undertake
tests and to have ruptured implants removed
28 I 09 I 10
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The French medical device
regulatory authority, AFSSAPS have released the results of their
testing into the safety of PIP breast implants.
AFSSAPS have confirmed
that the gel within the PIP implants is not the same as it is
described in their manufacturer’s design guide, that it does not
reach the level of quality required before a silicone gel can be
used in breast implants, that it can lead to an inflammatory
reaction in some women and that PIP implants have a higher
propensity to rupture. AFSSAPS recommends that all women with PIP
implants should be referred for an ultrasound scan and all women
with ruptures or suspected rupture should have both their PIP
implants removed.
Mark Harvey is now
representing approximately 165 clients in relation to concerns over
the safety of PIP breast implants. Reacting to today’s release, Mr
Harvey commented that:
“these results will be
extremely worrying for our clients. AFSSAPS' results have found
what we have expected from the outset of representing women with
PIP implants – that the implants are more prone to rupture. It is
frustrating that we have had to wait until now for confirmation of
this and that we have had to rely on the French Authorities to
produce these results. We are again disappointed by the MHRA as
they have failed to support affected women through what can only be
described as a nightmare scenario for them. Further, they have
failed to re-iterate the recommendations made by AFSSAP - that
affected women should have their implants removed.
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”.
Please click here for a link to the AFSSAPS press release:
http://www.afssaps.fr/var/afssaps_site/storage/original/application/38fbe37bdd1897eb09de4f892a317c14.pdf