MHRA announce that PIP implants are not health risk
Licensing body's initial tests
find that recalled PIP breast implants show no serious danger to
health
06 I 09 I 10
For more PIP news stories visit our
dedicated PIP page
The Medicines and
Healthcare Products Regulatory Agency (MHRA) have released the
interim results of their tests on the safety of breast implants
manufactured by French company Poly Implant Prothese (PIP).
The tests indicate that the gel inside the implants is not toxic
although more tests are needed to examine their potential for
premature rupture.
The faulty 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.
The MHRA has announced
that its independent UK tests found no evidence of chemical
toxicity or the implants potentially causing cancer to
victims. However, the MHRA has also admitted to its testing
not being “as extensive” as the tests being carried out in
France. The MHRA has advised women with any concerns over
their PIP implants to speak to their implanting surgeon.
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 at Hugh James solicitors, is acting for
over 140 women with PIP implants.
Reacting to Friday’s
announcement by the MHRA, Mr Harvey said "It is obviously of
great comfort to us all - and particularly our clients who have
suffered ruptured implants - that the initial tests results
reveal no serious danger to their health, but they remain anxious
for the results of the French authority's more detailed
studies.
“However it remains
a significant concern to us all that these implants not only
rupture prematurely but leak silicone when they were all
promised that by their very design they would not and could
not. For those of our clients whose implants have not yet ruptured
this remains a source of considerable worry to them.
We call on both the
French and UK licensing authorities to speed up their
testing as a matter of urgency and also for all the clinics
who were involved in the implantation of these prostheses to
cooperate with us in providing our clients with
urgent remedial treatment wherever it is needed."
Mr Harvey is taking a
proactive approach with these cases, and has written to Health
Secretary Andrew Lansley to call for more rigorous regulation of
medical devices by the MHRA. The licensing of the PIP
implants was dealt with on a European level where the CE (European
Conformity) marking of a device means that the manufacturer has
full access to the EU market, including the UK, without the UK
licensing authority undertaking its own checks. Mr Lansley’s
response is that this is a matter for the MHRA. Mr Harvey has
written again to the Health Secretary, and to the MHRA to voice his
concerns that this matter is not being taken seriously
enough.
Mr Harvey has also
written to all of the clinics involved in the treatment of his
clients to ask for their co-operation in negotiating a protocol
whereby they agree to recall all affected patients and to render
the suitable treatment free of charge. By working with the
clinics, Mr Harvey hopes to remove any burden from the NHS which –
in some cases – has been meeting the cost of removing many of these
implants from women affected by problems such as leakages and
ruptures.
Almost all of the women
who were given PIP implants were told in advance of their surgery
that the implants could not leak – even if ruptured – because they
contained a particular composition of silicone gel.
Mark Harvey is seeking a
solution for these women to get legal recovery. He continues,
“Our preferable course of legal action would be to claim against
the manufacturers or their insurers. But the MHRA’s flawed
licensing system has allowed the properly culpable parties to walk
away. We are now investigating other routes of action for
these women.”
For more information please see the MHRA’s
full
press release: