;   Medical Translation Insight: First faulty implants, now push for tougher device regulations - ForeignExchange Translations

Uh oh. It's not as if the scandal about the use of unapproved silicone in breast implants in France wasn't bad enough. At the time, the French government advised 30,000 women to have implants manufactured by Poly Implant Prothese (PIP) removed because they were more prone to rupture than standard implants. (Reuters did a great recap of the scandal here.)

But now things look likely to get worse, at least for medical device manufacturers. On the heels of the scandal, the European Union is proposing to medical device regulations. According to FierceMedicalDevices,
"...the EU wants to expand its definition of medical devices to include aesthetic implants, like the faulty silicone ones unmasked in the Poly Implant Prothese scandal, Reuters reports. Otherwise, the EU proposes to expand the powers of independent regulators, allowing them to conduct random inspections of device manufacturers and regular product testing. The government also wants to focus on traceability, giving physicians and patients easier access to information on device failures."
Critics make much of the fact that an "ad hoc" (according to Yahoo!) network of about 80 agencies oversee controls on medical devices. That setup, it is alleged, allows products like faulty implants to slip through the cracks.

However, there are plenty of folks who question the move to designate breast implants as medical devices - and who doubt the effectiveness of the CE marking process that is supposed to make medical devices safer.

For example, one patient safety expert warned that substandard breast implants could be the least of Europe's device-related problems: a CE mark is based on "design specifications" rather than safety (and thus less meaningful) and companies like PIP can scam the system because there is advance notice of audits.

Valid as these concerns may be, here is a Euro that bets that breast implants will be regulated as medical devices before long.

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