UK medical journal criticises regulator over breast implant scandal
Summary of story from The Telegraph, January 18, 2012
UK medical journal, The Lancet, reported today that the breast implant scandal (see WVoN coverage) was “an inevitable result” of “paralysis” at the healthcare regulator.
Editor Richard Horton said experts held “long standing concerns about weaknesses and gaps in the UK’s regulatory system”, but the Medicines and Healthcare products Regulatory Agency (MHRA) failed to act.
Medical devices, including instruments and implants, all receive a CE marking under the European regulatory system.
Last year, a professor of patient safety at Coventry and Sussex universities told MHRA officials he thought this meant the CE marking was “a smoke-screen for faulty and dangerous devices”.
“The operating principle at the MHRA seems to be: do nothing until something goes wrong.” Horton said.
Dr John Perrins, chairman of the UK committee on the Safety of Devices, said resources and the law limited the regulation.
“We have got to be practical: there are only about 100 people working on devices regulation in the UK,” he said, which was “a tiny number” given there were 120,000 medical devices on the market.
An MHRA spokesman said: “We will be working closely with other health departments and regulators in Europe to consider whether there are wider implications for the regulation [of] other medical devices.”