New regulations could include barcodes on breast implants

What we are now looking for is a unique identifier - something like a barcode - so that every single implant can quickly be traced from factory, to distributor, to hospital, to patient - says MEP

The idea that a French company manufactured breast implants for women with silicone designed to stuff mattresses is truly shocking. The truth came to light in France only after some women experienced ruptures, but by the time the problem at Poly Implant Prothese – or PIP - was unearthed by French regulators, it is estimated that 300,000 implants had been sold across the world. In the United Kingdom alone, it is believed about 40,000 women have the implants. Yet what has emerged over the past few weeks is not just a tale of appalling corporate deceit. The scandal has also highlighted serious loopholes in the current regulatory framework for putting medical devices like breast implants on the market and for post-surgery monitoring of how those devices perform after implant.

Medical devices are currently regulated by European Union law, which is implemented in member states through national regulators. The Medical Devices Directive is due to be revised this year so at our first meeting in January, MEPs on the European Parliamentary committee responsible for health matters started work on reviewing the current law. The first question we wanted answers on was how, in what we are told is such a tightly regulated market, was PIP able to sell their faulty implants for over 12 years without detection? What emerged was that while the company was inspected, PIP was given a six-week notice period before inspections. It is alleged that this gave the company time to swap the industrial grade silicone for the more expensive medical grade silicone, so the inspectors went away happy. Clearly, this cannot happen again and one change I want to see in the revised directive is a system of unannounced inspections.

A second major flaw in the current laws is a lack of traceability. In an age when supermarkets and online retailers track my shopping preferences, it is truly shocking that some clinics who fitted breast implants did not keep proper records of which implant was used on which patient, making it impossible to identify which women had PIP implants; and causing needless worry for many other women, who cannot be sure either way. There is a widespread consensus now that this must change. What we are now looking for is a unique identifier – something like a barcode – so that every single implant can quickly be traced from factory, to distributor, to hospital, to patient. To complement this, a mandatory register of patients must be introduced. Currently, record keeping is not standardised and up to each clinic to arrange as they see fit. Should a clinic close, there is no formal requirement for a register of their patients to be kept. For MEPs, the lack of traceability is particularly galling because at the time of the last revision of the directive, MEPs had asked for mandatory registers to be set up in every member state, but this issue was seen as falling under the remit of national governments. All the EU could do was encourage governments to take up the idea.

International cooperation between regulators must also step up to the mark. During our investigations, it emerged that the American medical regulator, the FDA, had concerns about the quality of PIP implants back in 2000 and stopped the sale of their implants in the United States as a result. Yet, despite the fact a US regulator was investigating a French factory, the French authorities remained in the dark for years afterwards. At the moment, there is no role in regulating medical devices for the EU counterpart to the FDA, the European Medicines Agency or EMA, which oversees pharmaceutical products and their side effects. Now, MEPs are looking at whether we need to overhaul the whole system of authorising medical devices and to give greater oversight to EMA.

There are many more questions and lessons from the PIP scandal for government, regulators, clinics and surgeons. Why did clinics and surgeons not question why PIP´s implants were cheaper than competitors? Why did clinics that spend millions of pounds advertising cosmetic surgery not pay more attention to patient protection and can private clinics be obliged to do remedial work for free when something goes wrong? Should clinics not have to insure themselves for going out of business in case follow-up surgery is needed? Is the marketing of cosmetic surgery properly regulated and are the full facts and risks properly explained to patients? Many of these matters will have to be sorted out by national, not EU law. But what MEPs, the European Commission and national governments must now agree are comprehensive reforms so that a scandal like this is never repeated.

Linda McAvan is a British MEP for Yorkshire and the Humber, and a member of the Socialist and Democrat group in the European Parliament