Following the publication of a report on Emerging and Newly Identified Health Risks (SCENIHR) on the safety of silicone products manufactured by the Poly Implant Prothèse (PIP) Company, the European Commission asked its scientific committee on Thursday to conduct a more in-depth investigation based on data from Member-States on the potential health impact of faulty breast implants.
Faulty silicone breast implants made by the now-defunct French company Poly Implant Prothese (PIP) triggered health concerns among tens of thousands of women worldwide, mostly in Europe.
Jean-Claude Mas, the founder of the company, was arrested last month as part of a judicial investigation in the south-eastern French city of Marseille into manslaughter and involuntary injuries.
An investigation triggered by an unusually high short-term breast implant rupture rate has shown that PIP fraudulently made use of industrial silicone instead of the approved medical grade silicone. The product was withdrawn from the EU market in 2010 in the wake of the death from cancer of a woman who had received a suspect implant.
The European Commission said in a statement that it would discuss with Member-States how surveillance of the medical devices already in the market could be reinforced immediately within the existing legislative framework. These issues could include further recourse to unannounced inspections, enhanced controls of notified bodies and additional sample testing on products already on the market.
The Commission is also conducting a stress test in order to identify how best the questions raised by this issue can be addressed in the upcoming revision of the legislation on medical devices which is already underway. The Commission still envisages adopting a proposal on the revision of the Medical Devices legislation in the course of this semester.
National health authorities in the Health Security Committee convened by audio conference today is to discuss the follow up to the opinion.
EU Health and Consumers Commissioner John Dalli said: "In the current situation, patients' health remains the priority. The opinion published today sums up the current scientific knowledge on this case."
"We had already been working on a revision of the Medical Devices Directive, envisaged for adoption this spring. We will now also take into account the lessons learnt from this case and take them on board in redrafting our legislation, in particular with regard to market surveillance, vigilance and functioning of notified bodies," he added.
Scientists concluded that data available today was insufficient to lead to firm conclusions regarding the health risk for women with PIP silicone breast implants.
The SCENIHR report (requested by the Commission in early January) stresses that, based on the limited data currently available, there is some concern regarding the possibility of inflammation induced by ruptured PIP silicone implants. The report concludes that each case needs to be assessed individually, and advised that women who are worried should contact their surgeon.
Scientists also recommend that further work be undertaken as a priority to establish with greater certainty any health risks associated with PIP silicone breast implants, in order to ensure that potential risks are properly established, quantified and managed.
With regard to the question of whether the breast implants manufactured by PIP are more prone to failure than those of other manufacturers, SCENIHR said that PIP implants have been found to vary considerably in composition and as a result are likely to vary substantially in performance characteristics.
SCENIHR concluded that many PIP implants were manufactured from non-medical grade silicone. This type of silicone may contain some components that can weaken the implant shell and diffuse into the body tissues.
EU Scientific Committee estimates that around 400,000 PIP silicone breast implants were sold worldwide. These implants were available in nearly all European Union Member-States - in particular they were widely used in the United-Kingdom, France, Spain and Germany, where respectively around 40,000, 30,000, 10,000 and 7,500 women were implanted with PIP silicone breast implants.
For comments and feedback contact: editorial@rttnews.com
Political News
June 12, 2026 17:14 ET Major central bank action was the focus this week in economic news. The European Central Bank became the first major central bank to move in response to the rising inflationary pressures in the backdrop of the conflict in the Middle East. In North America, the U.S. inflation and trade data as well as Canada’s central bank decision gained attention. The Chinese trade data was the main news in Asia.