Health regulator criticised
Tuesday 15 May 2012
The Government and health regulators have "serious lessons" to learn over the way they inform the public about concerns with medical devices, a review of the handling of the PIP breast implants scandal has found.
Lord Howe, a Health minister, demanded improvements in communications from both the Department and the Medicines and Healthcare products Regulatory Agency (MHRA), both of which have already been criticised in a parliamentary report into the affair earlier this year.
Around 47,000 British women are believed to have been given the implants, manufactured by the French company Poly Implant Prothèse, which were filled with non-medical-grade silicone intended for use in mattresses and have been linked to rupture and swelling in the body.
Lord Howe said: "Regulation alone cannot prevent fraudulent activity such as this. 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.
"It needs to better analyse reports about higher risk medical devices. And it needs to improve the way it communicates with the public."
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