Reuters: Regulatory News: UK regulator rapped over breast implant scandal

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UK regulator rapped over breast implant scandal May 14th 2012, 11:36 Mon May 14, 2012 7:36am EDT * Government review says "serious lessons" from PIP scandal * Watchdog urged to obtain data from wider range of sources By Ben Hirschler LONDON, May 14 (Reuters) - Britain's healthcare regulator has "serious lessons" to learn from the PIP breast implant scandal, according to a government review published on Monday. The review was commissioned after the discovery that for up to a decade hundreds of thousands of women around the world, including 47,000 in Britain, had received substandard silicone breast implants manufactured by France's Poly Implant Prothese (PIP). Although the Medicines and Healthcare products Regulatory Agency (MHRA) followed sound scientific advice, the review said, it should in future do more to obtain evidence from a wider range of sources, including detailed data from clinicians. This would make it better placed to take robust action and communicate more clearly with both affected individuals and the wider public. The PIP case involved deliberate fraud, which regulation alone could not have prevented, said health minister Lord Howe. "But serious lessons must be learned from this scandal. The MHRA needs to look at how it gathers evidence so it is able to identify problems early," Howe said. "It needs to better analyse reports about higher risk medical devices. And it needs to improve the way it communicates with the public." MHRA Chief Executive Kent Woods, who earlier this year said the PIP case should not prompt a knee-jerk reaction, said his agency would "act quickly" to implement Howe's recommendations and improve the regulatory system for medical devices. A second review by Bruce Keogh, the medical director of the National Health Service, is currently looking at the wider question of regulation for cosmetic procedures, which might include a breast implant registry to monitor for any problems. The European Union's health and consumer affairs commissioner John Dalli said in February that EU governments should strengthen safety controls on high-risk medical devices by using spot checks on products and manufacturing facilities. France's health authorities have also called for tighter controls after a near two-year investigation into PIP, which has now gone out of business. More than 500,000 medical devices are sold in the EU, ranging from bandages, dentures and wheelchairs to pacemakers and implants. They are regulated under the Conformite Europeenne, or "CE mark", system. Major makers of medical devices include Johnson & Johnson , Medtronic, Boston Scientific, Abbott , Allergan and Smith & Nephew. Link this Share this Digg this Email Reprints

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