Europe's substandard breast implants may signal bigger regulatory problem

The scandal rocking Europe over substandard breast implants is heating up. And flaws in the EU's regulatory system may point to a looming crisis with other implantable devices.

Let's start with the initial scandal and the company behind it: French implant maker Poly Implant Prothese (PIP), which is now in bankruptcy. Company founder Jean-Claude Mas admitted during a brief radio interview that he used unapproved silicone in breast implants, Reuters reported. Surprisingly, he also termed the French government's recommendation that women have the suspect implants removed "criminal" and denied any health risks. (Officials advocated removal after a French woman with PIP implants died of cancer last year, and when reports surfaced that the implants ruptured more easily than standard ones.)

British regulators, by contrast, have downplayed the implants' link to cancer and said they don't need to be taken out unless they've ruptured.

Meanwhile, an expert on patient safety is warning that substandard breast implants could be the least of Europe's device-related problems, according to the U.K. newspaper The Independent. Brian Toft, a professor of patient safety at Coventry University, told British officials in July and September the CE mark designation through which the PIP implants gained approval is flawed, and that is a problem because it provides the same guidelines for other implants such as artificial hip joints.

He argued the CE mark status, which certifies a product meets European quality standards, is based on "design specifications" rather than safety. The European regulatory system does allow regulators to check manufacturing standards through the Medicines and Healthcare Products Regulatory Agency. But he asserted there is no way to make sure regulators are conducting their inspections, The Independent reported. PIP avoided this, according to the article, because the company was notified in advance and workers stashed away the non-medical-grade silicone they were using before regulators arrived.

- here's the Reuters piece
- read The Independent's story

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FDA deems silicone breast implants to be safe