Members of the European Parliament move to tighten controls after implant scare
STRASBOURG – The European Parliament is aiming to tighten controls on the safety of medical devices in the wake of a worldwide scare over faulty breast implants from France.
More than 16,000 women have had breast implants removed since it was found in 2011 that those from France’s Poly Implant Prothese (PIP) were twice as likely to rupture as rival brands.
The European Commission set out new rules in September for authorities responsible for the inspection of 10,000 medical devices — from plasters to pacemakers.
The vote to tighten controls on breast or hip implants and on devices used in pregnancy or for DNA testing now requires the go-ahead from European Union member states.
The Parliament said it was a case of “lessons learnt from the PIP breast implant scandal”, which led to company founder Jean-Claude Mas being charged with manslaughter and fraud. PIP’s implants were banned and the company was liquidated.Leave a reply
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