PIP breast implants warning
Unsafe medical devices allowed into the UK without
sufficient insurance for when things go wrong.
14 I 07 I 10
Hugh James reported in April and
June
news relating to the recall of the purportedly cohesive silicone
gel implants manufactured by French company, Poly Implant Prothese
(PIP).
Calls are now being made by victims and legal
experts for British licensing agency – the Medicines and Healthcare
Products Regulatory Agency (MHRA) – to introduce more stringent
testing and regulation of medical devices being brought into the
UK.
The faulty implants – manufactured by French
company Poly Implant Prosthese (PIP) – 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 follows an
earlier issue with PIP implants using recalled Hydrogel solution in
2006. PIP has since gone into liquidation, leaving the
company unable to fulfil legal claims from distressed
victims.
With no chance of successful claims against
PIP, the NHS is also having to meet the cost of removing many of
these implants from affected women who are facing problems
including ruptures and leakages.
Despite being aware of the 2006 problem with
breast implants made by the same company, it has emerged that the
MHRA – which is responsible for the safety and licensing of drugs
and medical devices used in the UK – does not have the authority to
check that manufacturers or distributors have liability insurance
to cover their products.
In a Freedom of Information request – put
forward by Hugh James solicitors – the MHRA confirmed that, “The
MHRA is responsible for the regulation of medical devices in the
UK. It is not within the remit of the agency to check that
manufacturers or distributors have liability insurance to cover
their products.”
Renowned campaigning lawyer Mark Harvey,
Partner at Hugh James solicitors, is acting for women who want
their PIP implants removed. The worry is that this licensing
loophole could mean that other medical products could be affected –
as well as breast implants. Mr Harvey has written to Health
Secretary Andrew Lansley to call for more rigorous regulation by
the licensing body. 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 Harvey says, “It seems incredible that
companies can import into this country without any satisfactory
checks being taken out to ensure that they are in a position to
deal with any repercussions of any devices that should subsequently
become a problem. It ought to be a requirement that they must
produce a certificate of insurance suitable to cover the
appropriate claims.
“As well as causing substantial physical and
emotional distress – not to mention financial distress – to these
women, these faulty implants are now putting increasing pressure on
the NHS, who are obliged to remove many of the implants due to
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.
Yet many women have found that the PIP
implants have ruptured prematurely, causing the silicone gel from
inside the implants to leak out into the surrounding breast
tissue. These leakages have resulted in deposits of silicone
building in the lymph nodes and, in some cases, causing extensive
damage to the breast tissue as well as severe pain and
swelling.
Results are currently being awaited from the
MHRA regarding ongoing tests into the possible long-term effects of
the PIP implants. This week the Sunday Express has reported
further on this issue, to read their story please follow the link
below.
http://www.express.co.uk/posts/view/186233/Cancer-tests-ordered-on-breast-implant-gel
Mark Harvey
Partner, Head of the Claimant Division
Head of Harmful Products and Overseas Accidents Team
E mark.harvey@hughjames.com
T 029 2039 1174