On Wednesday 25th of April, Members of Parliament (MEP) unanimously voted in favor of a resolution, tackling the recent PIP breast implant scandal. Members of the Environment and Public Health Committee call for the implementation of a breast implant register, stricter checks, product traceability, and a pre-market authorisation system. Furthermore, they stressed that converting EU legislation into national laws failed to avoid the PIP defective breast implants health fraud.
400,000 PIP implants by the French manufacturer, Poly Implant Prothèse (PIP) were sold worldwide, most of them in Germany, France and the UK, the number of harmed women is however still unknown.
This case clearly indicates the failing of implementation and translation of EU policies on both EU and national level. Compliance, traceability, coordination and surveillance of medical devices have to be improved, to secure health status of EU citizens. In addition, an EU data base of medical devices that are on the market, registration of economic operations, vigilance and market surveillance; clinical investigations, notified bodies and EC certificates issued, say MEPs.
According to MEPs: patients’ associations, patient groups and health care professionals must be encouraged to report all adverse events and harmful effects of these devices without being hampered by a great deal of red tape.
Patient’s awareness of risks and access to health information also need to be improved. Furthermore, medical professionals should improve communication towards their patients about potential health hazards.
Let’s wait and see what measurements will be introduced and implemented on both EU and national level to secure the use of medical devices for patients.