EU Mulls Safety Rules after Implant Scandal

     (CN) – The European Commission proposed new laws to improve the safety of medical devices Wednesday in the wake of a breast-implant scandal which finds a French company accused of using cheap, industrial-grade silicone not fit for human use.
     The commission said the two regulations will ensure that medical devices are properly tested before they hit the market and improve the devices’ traceability through the supply chain. An identification system will enhance post-market safety and fight against counterfeiting, according to a commission statement .
     Stricter requirements for clinical evidence and regular checks on manufacturers – including unannounced factory inspections and sample testing – will protect both consumers and the EU’s $115 billion medical device industry, according to the commission.
     An enhanced database will allow patients, healthcare professionals and the public to access data about medical devices to make informed decisions.
     The proposal comes after French authorities closed down Poly Implant Prothese (PIP) – the world’s third-largest implant manufacturer – and arrested its owner Jean-Clause Mas on manslaughter and involuntary injuries charges. The company has supplied breast implants to 400,000 women in 65 countries according to an ABC report earlier this year.
     Mas reportedly told French police that he knowingly deceived EU safety inspectors for more than a decade. He insists PIP’s devices pose no threat to women and dismisses the nearly 3,000 lawsuits against him as a “craven effort to make money.”
     Health and Consumer Policy Commissioner John Dalli said the new regulations are necessary to prevent another company deceiving consumers and potentially causing injuries.
     “Just a few months ago, everybody was shocked by the scandal involving fraudulent breast implants which affected tens of thousands of women in Europe and around the world. As policy makers, we must do our best never to let this happen again,” Dalli said in a statement. “This damaged the confidence of patients, consumers and healthcare professionals in the safety of the devices on which they rely every day. The proposals adopted today significantly tighten the controls so as to ensure that only safe devices are placed on the European Union’s market at the same time, they foster innovation and contribute to maintaining the competitiveness of the medical device sector.”The commission’s proposal requires the vote of the EU legislature, which is expected to take up the issue in its current session.

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