PIP breast implants: preventing a repeat of an international scandal

Breast implants are regulated by Directive 200/74/CE on medical devices. This directive improved the legal provisions underlying oversight by the relevant authorities of medical devices, by enabling them to better monitor the medical devices market. The PIP controversy has nevertheless shed light on several inconsistencies on the traceability and market surveillance of medical devices and on the monitoring of Notified Bodies - organisations that have been accredited by a Member State to assess whether a product meets certain preordained standards and that can label a product with the CE mark.

An international scandal with far-reaching implications

The 'Poly Implant Prothèse' (referred to as PIP) breast implant controversy is not confined to any one country - it is far from being simply a national scandal. The stakes are therefore high and the various health and safety issues pertaining to these controversial implants have far-reaching implications.

It is worth bearing in mind that the PIP firm has sold its breast implants in 71 countries around the world, especially in European Member States such as the United Kingdom, Spain and Germany. In these four countries, up to 87 500 women are believed to have been given transplants.

Considering the international dimensions of the controversy and the blatant failure of EU regulation of medical devices, there is a pressing need to revise Directive 2007/74/CE.

Proposals for a revision of the Medical Devices Directive

The Medical Devices Directive is to be revised some time in 2012. Amid mounting controversy, the European Parliament has taken it upon itself to draft a resolution on the matter. On March 21, this draft resolution was discussed in the Committee on Environment, Public Health and Food Safety. I am pleased to see that all political parties reached a consensus on public safety issues surrounding medical devices.

Concerned about the lack of both epidemiological data and cooperation between Member States and the international community in sharing information on side effects, and dissatisfied with the current medical device tracking requirements, members of the ENVI Committee have included five main proposals in their draft resolution.

They suggested two measures for the European Commission to take: on the one hand, strengthen surveillance of those medical devices carrying potential risks already on the market and, on the other, to tighten up criteria upon which Notified Bodies are designated. At the moment, lamentably, there is no European guidance on the designation of Notified Bodies, or on the audits they carry out. But to create a safe medical devices internal market, it is essential to harmonise standards and therefore to have an EU-wide agreement on accreditation criteria, pre-market requirements and post-market surveillance.

Moreover, the resolution highlights the need for Notified Bodies to carry out mandatory, frequent and unexpected inspections.

Finally, MEPs call on the European Commission to increase information-sharing between Member States on both the traceability and conformity of medical devices.

What next?

The assessment of medical devices and the issue of Notified Bodies will now be discussed with the Council and the Commission. The outcomes of these talks will be of primordial importance.

I would like to invite them both to draw conclusions from the PIP Breast Implants controversy ahead of the forthcoming revision of Directive 2007/47/CE.

We have to balance the fight against fraudulent medical practices and patient safety with the need for medical research and innovation, so that the European Union offers a competitive and innovative internal market that ensures public health and safety.