PIP breast implant scandal continues to be debated
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19 | 01 | 12
The Royal College of Surgeons (RCS) have issued a statement
which calls for all women affected by the PIP breast implant
scandal to have them removed upon request.
The advice contradicts guidance given by the
UK Government, which states that the PIP implant poses no risk and
should only be removed if a rupture is found. The RCS statement
insists that all patients should have access to an assessment and
be given the opportunity to have the implants removed upon
requests. It also criticised private clinics by saying they
“have an ethical and moral duty of care to offer patients
treatment without charge”.
The statement follows a report issued in the
Lancet medical journal which discusses how Brian Toft, Professor of
patient safety at Coventry University had last year warned
ministers of short comings in the regulatory process for approving
medical products in the UK and Europe.
Medical devices and products such as the PIP
implants all receive a CE marking under the European regulatory
system. Notification bodies are accredited by the European Union to
evaluate and ultimately approve the product/device for medical
use.
The Medicine and Healthcare products
Regulatory Agency (MHRA) allow any products with a CE marking to be
used and sold in the UK, and is only able to issue product
examinations or safety tests when an alert is raised.
Professor Toft has criticised this method of
certification and called it “a smokescreen for faulty and
dangerous devices”. The now defunct company Poly Implant
Prothese (PIP) who made the PIP breast implant were given the CE
mark by German company Tüv Rheinland. It was later discovered that
prior to being examined for certification PIP concealed the use of
non medical grade silicon.
The PIP scandal has triggered the Health
Secretary, Andrew Lansley to issue a review of the regulatory
system in the UK.
Mark Harvey, Partner
and Head of the top ranked Personal
Injury Team at Hugh James solicitors is representing nearly 1,000
women with PIP implants after being contacted by over 650 women in
the last few weeks. Mark says “I agree with the position of the
RCS; concerned women should have their implants removed but also
replaced free of charge by their implanting clinics should they
request it. However, I am also equally concerned that unless
significant changes are made to the whole process by which medical
products are brought to market, patient safety remains at risk.
There was, after all, a whole failure of patient protection from
the licensing of this product for a company with an adverse record
of patient safety, through a failure to identify the changes to the
product, a lack of the recording and reporting of the products
failing. And of course an ability to obtain a swift remedy when it
was known things had gone wrong”
Mark Harvey will be
continuing to pursue legal claims on behalf of his clients and will
be making an application to the Court for a Group Litigation Order
at the end of the month so that the legal issues
may be dealt with by a Judge later this year.
For information on joining the group
represented by Partner, Mark Harvey please contact Hugh James on
029 2022 4871 or complete our enquiry
form.