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UK Regulator: Don't Overreact to PIP Scandal

Posted 17 February 2012 | By Alexander Gaffney, RAC 

The head of Britain's Medicines and Healthcare products Regulatory Agency (MHRA), Kent Woods, said modest improvements are necessary to correct deficiencies exposed during the Poly Implant Prothese scandal.

In remarks made at a press conference on 16 February, Woods called for "better surveillance and reporting of any problems with medical devices on the market, and more coordination between national medical regulators," wrote Reuters. Woods added that while he thinks that regulators broadly support incremental change, a complete overhaul of the system is not needed.

Woods' remarks follow efforts by National Health Service Secretary Andrew Lansley to investigate implants manufactured by the now-defunct French firm Poly Implant Prothese, which are thought to be rupturing at an abnormally high rate and exposing patients to unapproved industrial-grade silicone.

MHRA has also fired back in recent weeks against critics, including The Lancet editor Richard Horton, who lambasted the agency for what he called "serious device failures" in the face of MHRA's "paralysis and inability to correct the failings of a severely flawed system."

MHRA responded to Horton-and others-in a sharply-worded press release, saying critics lacked a "clear analysis of the facts," and blamed its French regulatory counterpart, Afssaps, for the scandal.


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