MASSDEVICE ON CALL — British medical regulatory Kent Woods warned against reactionary reforms to the European device review process amid growing clamor for overhaul in light of the public health crisis surrounding substandard breast implants.
"The question that arises is whether the broad principle of how we do it in Europe is right or not?" Woods told a press briefing in London. "Are we looking for incremental improvements to a system that is in place, or are we looking for root and branch change?"
The call for a fundamental overhaul to the European system has grown louder in recent months as the European Commission and EU med-tech lobby Eucomed called for a revised framework for medical device review.
Late last year, news broke that France was considering a recall of 30,000 sets of breast implants supplied by Poly Implant Prothese over concerns that they might contain a non-authorized silicone gel known for high rupture rates.
Woods said that the breast implant issue is rare and that no medical device review system can perfectly protect against intentional fraud, Reuters reported.
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