A resolution passed unanimously by MEPs from the Environment and Public Health Committee proposes measures such as a breast implant register, more stringent checks and product traceability, and a pre-market authorisation system. The proposed measures are aimed at preventing recurrence of the PIP defective breast implants case.

The Environment and Public Health Committee of the European Parliament approved unanimously a resolution which stressed that transposing EU legislation into national laws has not avoided the PIP defective breast implants health fraud. It has led and will lead to an international serious negative impact on public health, according to the text. In January 2012, in relation to this issue, Public Health Committee asked for a new legislation to protect patient safety.

The French manufacturer Poly Implant Prothèse (PIP) made an estimated 400,000 implants that 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. MEPs highlight in the text that the PIP case has shown a malfunctioning at European and national levels, notably a lack of cooperation (…), and a lack of traceability of raw material used for medical devices.

The Health Committee proposes therefore measures to prevent the recurrence of this case and similar ones. Among those measures, in order to improve traceability and coordination, EU legislation in this area is to be revised this year. In addition, the European Commission is asked by MEPs to shift to a pre-market authorisation system for certain medical devices and patients must be made aware of breast implant risks. Apart of asking for a single European data base, MEPs also advocate stepping up checks, inspections, market surveillance and information sharing on adverse effects so as to ensure improve medical device traceability and follow-up.