The MHRA react to the French Authorities' advice that all PIP implants should be removed
Leading surgeons have continued
to reassure UK patients not to worry
22 | 12 | 11
Following the recent reports 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 Medicines and Healthcare
products Regulatory Agency (the MHRA) have released a statement
saying that they are aware of the recent report in France of the
death of a woman implanted with Poly Implant Prosthese (PIP) breast
implants from anaplastic large cell lymphoma (ALCL).
They have stated that they
will:
“continue to monitor for any
associations of all types of breast implants, including PIP, with
cancers and any other health implications. We will continue to
liaise with agence francais de securite sanitaire des produits de
sante (AFSSAPS) and will consider any new evidence which comes to
light as a priority.”
The MHRA have reiterated that their
advice to women with any type of breast implant that have any
questions or are concerned that their implants may have ruptured,
is that they should seek clinical advice from their implanting
surgeon.
Reports this week 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.
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 written again to 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.
I do not believe that MHRA’s
reaction to date has been satisfactory; it is unbelievable that the
MHRA have not ensured that they were involved with the
consultations in France about a product that affects such a large
amount of women in this country. I am and have been very critical
of their role throughout the history of this product. This stems
from allowing this company to sell these implants in the UK in the
first place; their refusal to respond when I alerted them to the
problems; their refusal to meet with any of my clients to discuss
their concerns and now this latest health concern.”
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.
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.
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For information on joining the
group represented by Mark Harvey please contact Hugh James on 02920
224 871 or complete the enquiry
form.