French Medical Authorities to ask 30,000 women to remove their PIP implants
Leading surgeons reassure UK
patients not to worry
20 | 12 | 11
Reports by the French publication
Libération state 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 faulty implants, manufactured
by Poly Implant Prothese, 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.
The recent development in the
approach by the French Government has been made in reaction to
reports this month 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.
According to consultant plastic
surgeon and BAAPS President Fazel Fatah:
“It is important to remember
that the number of breast implant patients globally is considered
to be higher than 10 million, yet these tumours are extremely rare.
The risk of death is just 1 in 2 million from it and cure available
for 94% of sufferers, so women should continue to feel that their
implants are safe. The cause is still unknown and is probably the
result of a number of rare different factors, partly genetic,
coming together in the afflicted women. In relation to PIPs we
continue to reiterate our advice to UK patients in line with the
French authorities: if you have, or suspect you have these
implants, you should have a scan every six months. If there is any
rupture or weakening, have both implants removed.”
BAAPS further reported that
although a possible association in women with breast implants and
Anaplastic Large Cell Lymphoma (ALCL) has been observed in a small
number of reported cases worldwide, 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 250 women with PIP implants. Reacting to today’s
French coverage, Mark
Harvey says:
“The recent reports have, of
course, been very worrying to our clients, many of whom have
already suffered terrible problems as a result of their implants. I
have today written again to the Medicines and Healthcare products
Regulatory Agency (the MHRA), to urge them to react to the
developments in France and, similarly to France, to set up a
suitable protocol for women affected in this country.”
Earlier this month, The French
Health Products Safety Agency (Afssaps) published new
recommendations for patients with PIP breast implants, advising
that they should contact their doctor or surgeon to arrange a
clinical, and or radiological examination to determine the
condition of their PIP implants. If any rupture or leakage is
detected, Afssaps recommend that women have both PIP implants
removed. Mark
Harvey calls on affected women to take heed of these
recommendations and to seek medical advice if they are worried
about their implants.
The Medicines and Healthcare
products Regulatory Agency have not yet reacted to the recent
updated release by Afssaps.
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