In a specially arranged meeting with the European Commission, Yorkshire and Humber Euro MP, Linda McAvan, demanded changes to healthcare regulations across Europe following the breast implant scandal that has affected thousands of women in Britain, France and across the continent.
The scandal began after it was discovered that PIP, a French manufacturer of breast implants, had for years been making and selling implants with cheaper industrial quality silicone rather than the medical grade silicone that is required.
One of the major obstacles of dealing with the scandal has been assessing the extent of the problem as there is no standardised record keeping of who receives what implant and from whom.
Linda McAvan, who is Labour’s spokesperson on health in the European Parliament, is calling on the European Commission to act to prevent a repeat of the implant fraud.
Linda said: “The fact this scandal has occurred is shocking enough but the major issue since we became aware of the problem is the difficulty in tracing who exactly has received the faulty implants.
“We need better traceability of implants. All 27 member states must have a ‘unique identifier’ - eg a barcode on every item - and this must be done at the EU level.
"Currently it is up to individual hospitals to maintain their own records and these all too easily can be insufficient or even lost. To counter this issue we want to see a mandatory register of patients. Only then can we trace faulty implants back to individual women.
PIP escaped censure for so long because they would use only medical grade silicone during mandatory inspections, which occurred only after a six week warning.
Linda said: “The scandal shows that if a company is determined enough cover ups can take place so we want the European Commission to introduce unannounced inspections to deter companies from taking shortcuts.”
Linda has also called for better coordination between the European Medical Agency and other regulatory bodies across the world.
She said:”Incredibly the American regulator, the FDA, investigated PIP and banned their products for sale in the United States back in 2000. Despite this, France and the EU remained in the dark until years later. This is obviously an unacceptable situation which must be rectified quickly.”
Linda concluded: “There is a whole host of lessons to be learned from the PIP breast implant scandal and the European Parliament, European Commission and national governments must take the necessary reforms to prevent this from happening again.”
• By the end of June 2012, the European Commission will present a proposal to revise the Medical Devices Directive
• Linda McAvan is the spokesperson for Labour and the wider Socialists and Democrats group in the European Parliament.