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.