European med-tech lobby Eucomed joined forces with regulators in calling for a revised framework for medical device review in light of the ongoing public health crisis surrounding substandard breast implants.
The European Commission called for immediate action to tighten controls and increase surveillance following the discovery of "fraudulent use of non medical grade silicone in breast implants" manufactured by a French device company, Poly Implant Prothese.
"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," Commissioner John Dalli said in prepared remarks. "In particular, we will strengthen the legislation in relation to market surveillance, vigilance and functioning of notified bodies."
Proposed measures include verifying that the appropriate bodies, those with proven expertise and competence, are reviewing medical devices and reinforcing market surveillance by national authorities.
Eucomed proposed (PDF) that the agency focus on coordinating exchanges of information to ensure that efforts aren’t duplicated in identifying and responding to incidents, and called for a centralized reporting and surveillance system.
The breast implant controversy sent ripples through France, Germany and the U.K. when reports revealed that PIP had been distributing substandard silicone breast implants that were prone to leakage.
"We have to remove all these implants," Dr. Laurent Lantieri, a plastic surgeon on a special committee investigating the issue told reporters at the time. "We’re facing a health crisis, linked to a fraud."
Challengers pointed to the public health crisis, in which thousands of women were at risk of needing revised breast implant surgery, arguing that the CE Mark system uses the same system to review pacemakers as it does toasters.
