European Health and Consumer Affairs Commissioner John Dalli wrote to the EU’s 27 health ministers suggesting increased vigilance to avoid incidents like the recent scare on French-made silicone breast implants.
Although a preliminary study conducted by EU experts was inconclusive and more in-depth analyses is ongoing, Mr Dalli expressed his “deep concern” about the potential health impact on women using such implants.
He said that, in view of this incident, member states should tighten control to “restore trust in our regulatory system”.
The measures he lists include more rapid notification of problems to the relevant authorities, improved vigilance systems for medical devices, unannounced inspections of manufacturers’ premises and proper monitoring of independent bodies that sign off pre-market assessments of medical devices.
He said work should start on ensuring medical devices could be traced.
In this respect, he said the Commission would propose new legislation governing regulation of medical devices by summer.
The EU Executive said last week that a preliminary study on the safety of silicone breast implants produced by Poly Implant Prothese (PIP) had not produced any evidence that they posed any serious health risks to women.
The study was done by the Commission’s Scientific Committee of Emerging and Newly-Identified Health Risks following reports that PIP breast implants were made from unauthorised industrial silicone and were posing series cancer risks to women using them.
The EU scientists said that, based on the limited data available, there was some concern regarding the possibility of inflammation induced by ruptured PIP silicone implants. However, they concluded that “each case needs to be assessed individually, so the advice remains that women who are worried should contact their surgeon”.
The largest number of women who have received such implants were in the UK, France, Spain and Germany, where the majority of the 400,000 implants produced by PIP were sold and used in breast augmentation surgery.
According to the government, nine Maltese women underwent this type of cosmetic surgery using PIP implants.
Although France has suggested that women with these implants should replace them, medical and scientific information on the risks involved in such a procedure is still scarce.