(CN) – A “boom” in ruptured breast implants from France led the European Commission on Thursday to call for increased oversight of medical devices.
After breast implants manufactured by the Poly Implant Prothèse (PIP) Company in France began to rupture at an “unusually high” rate, French health authorities discovered in 2010 that the company was using industrial, rather than medical-grade, silicone.
PIP stopped producing breast implants in March 2010, and the defective implants were withdrawn from the EU market.
On Thursday, the European Commission called for preventative action.
“I have proposed to the Health Ministers a set of the most urgent and important actions which should be implemented under the current legislative framework in the course of this year,” European Health and Consumer Policy Commissioner John Dalli said in a statement. “At the same time we are taking on board the lessons learned from the PIP case in the upcoming revision of the Medical Devices legislation to be tabled before the summer. In particular, we will strengthen the legislation in relation to market surveillance, vigilance and functioning of notified bodies.”
In a Feb. 1 report, the EU’s Scientific Committee on Emerging and Newly Identified Health Risks found that “the physical integrity of a sample of PIP silicone breast implants indicated weaknesses in PIP shells not found in other commercially available implant.”
The jury is still out on whether the implants caused health risks, according to report.
“The evidence to date, indicating a health risk for women with PIP silicone breast implants, is not strong,” the study found. “However there is some concern regarding an increased inflammation from ruptured PIP silicone breast implants. It is not possible to make a general risk benefit statement at this time. Rather, for the time being, the risk benefit assessment needs to be based on a patient by patient basis by the aesthetic surgeon, bearing in mind the time since the implantation and the psychological state of the patient.”
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