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Recommendations to increase safety of medical devices
A breast implant register, more stringent checks and product traceability, and a pre-market authorisation system are among the measures proposed by the European Environment and Public Health Committee to prevent a recurrence of the PIP defective breast implants case. The resolution was passed unanimously.
An estimated 400,000 implants made by the French manufacturer Poly Implant Prothèse have been sold worldwide. These implants were widely used in the UK, France, Spain and Germany. However, the number of women who have received them is unknown.
The resolution has called for "increased traceability of implanted medical devices", and for "increased coordination between Member States when it comes to reporting and warning about serious side effects or damage done" by these devices.
It also says that 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.
The resolution asks the European Commission to introduce a pre-market authorisation system for certain medical devices and to do more to ensure patients are aware of breast implant risks.
MEPs have also called for the introduction of an implant recipient's passport, stating the implant's specific characteristics and its potential adverse effects, and the introduction of a breast implant register in each Member State. These registers should be interconnected and allow for the exchange of information when needed, for example in cases where important defects are detected in implants.
A system of collective redress should also be put in place to help patients obtain compensation when medical devices go wrong.
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