Mairead McGuinness Fine Gael MEP

As French police today arrested Jean-Claude Mas, whose breast implant firm Poly Implant Prothese (PIP) sparked a health scare by using substandard silicon, Ireland East Fine Gael MEP Mairead McGuinness said that the EU needs a much more effective and co-ordinated way of addressing such health issues.

“Consideration needs to be given to whether or not manufacturers and suppliers of medical devices, such as implants, should be required to get the same sort of authorisation to sell their products as suppliers of prescription medicines,” said McGuinness who has written to EU Commissioner for Health and Consumer Policy, John Dalli, on the issue.

The MEP, a member of the European Parliament’s Environment and Public Health and Food Safety Committee also said that it has emerged that 11 years ago US health officials warned the manufacturer at the centre of the breast implant scare that its products were “adulterated” and “not in conformance with good manufacturing practice.”

“The problem identified by the FDA (Food and Drug Administration) inspectors a decade ago related to saline breast implants, not the silicone implants at the centre of the latest health scare. However, both products were made at the same plant inspected by the FDA,” she said.

The MEP said that current indications from the EU Commission are that the likely measures to address the issue would include a system of traceability – perhaps a unique identifier number for each individual product, unannounced inspections of manufacturers, retailers and users and a system whereby the authorising bodies in each Member State act uniformly.

However, she said: “We need to consider very carefully if such measures would be sufficiently robust to prevent a reoccurrence of the current scare.”

In the current case the product was manufactured in France and sought authorisation in Germany where a less onerous regime exists. Once the product was authorised in Germany PIP was able to sell to any European country.

McGuinness said EU countries currently have very divergent approaches to the current health scare. “The French authorities are treating it as a criminal matter and the French, German and Dutch authorities have all recommended that women fitted with these now banned implants should have them removed as a precaution. The Irish and UK authorities have said there is no need for routine removal. This disparity has created confusion and further anxiety,” she says.

She pointed out that in the area of food and feed safety Member States are helped to act more rapidly and in a coordinated manner by way of a Rapid Alert System for Food and Feed (RASFF).

“A similar system to exchange information about medical issues could help to reassure the public,” she asks.