Following the discovery of the fraudulent use of non medical grade silicone in breast implants manufactured by the Poly Implant Prothèse (PIP) Company in France, the priority now is for the Member States and the Commission to act together to tighten controls, provide a better guarantee of the safety of medical devices and to restore patient confidence in the law that protects them. Commissioner Dalli has outlined his proposals for a joint plan of immediate measures in a letter written to the EU's Health ministers, asking for their full co-operation in beginning work without delay.
Commissioner Dalli said "Patients' health is the priority in this situation. I have proposed to the Health Ministers a set of the most urgent and important actions which should be implemented under the current legislative framework in the course of this year. At the same time we are taking on board the lessons learned from the PIP case in the upcoming revision of the Medical Devices legislation to be tabled before the summer. In particular, we will strengthen the legislation in relation to market surveillance, vigilance and functioning of notified bodies."
What can be done now : a joint plan of immediate actions
Commissioner Dalli has written to Member States asking for their co-operation within the existing legal framework to tighten controls, in order to provide a better guarantee of the safety of medical technology, especially high risk devices. The actions proposed include the following:
- Verify the designations of notified bodies to ensure that they are designated only for the assessment of medical devices and technologies that correspond to their proven expertise and competence.
- Ensure that all notified bodies in the context of the conformity assessment make full use of their powers given to them under the current legislation which including the powers to conduct unannounced inspections.
- Reinforce market surveillance by national authorities, in particular spot checks in respect of certain types of devices.
- Improve the functioning of the vigilance system for medical devices for example by giving systematic access for notified bodies to reports of adverse events; encouraging healthcare professionals and empowering patients to report adverse events; enhanced coordination in analysing reported incidents in order to pool expertise and speed up necessary corrective actions.
- Support the development of tools ensuring the traceability of medical devices as well as their long-term monitoring in terms of safety and performance, such as Unique Device Identification systems and implant registers.
In parallel to the above plan for immediate actions, the European Commission:
- has asked the Scientific Committee for a more in-depth investigation on the potential health impact of faulty PIP silicone breast implants based on data from investigations by Member States in order to have greater certainty regarding the health risks.
- is continuing the preparation of the revision of the Medical Devices legislation scheduled for adoption in the course of this semester, which will take account of the results of a 'stress test' that is identifying the shortcomings come to light by the PIP case.
Breast implants fall under the European legislation on medical devices. This legislation requires that, before placing such devices on the market, the manufacturers must carry out an assessment to ensure that their devices fulfil the relevant legal requirements, and in particular that their devices will not compromise patient safety. For high risk devices, such as breast implants, a third party conformity assessment body, so-called notified body, is involved in the conformity assessment procedure. In the present case, an investigation triggered by an unusually high short-term breast implant rupture rate has shown that a manufacturer (Poly Implant Prothèse Company) fraudulently made use of industrial silicone instead of the approved medical grade silicone. The product was withdrawn from the EU market in 2010.
To see the recent scientific opinion on the safety of PIP breast implants, see:
Link to Medical Devices Directive: