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Implant danger extends to all medical devices

Expert warns that European kitemark system is flawed and does not protect patients

The scandal of substandard breast implants placed in thousands of British women is symptomatic of a wider regulatory failure affecting all medical devices, an expert on patient safety said yesterday.

Brian Toft, professor of patient safety at Coventry University, warned ministers last July that the CE mark which certifies that a product such as a hip joint or breast implant reaches the European quality standard was seriously flawed and did not protect patients.

There were 113 alerts issued by the Medicines and Healthcare Products Regulatory Agency (MHRA) about medical devices last year, ranging from hip joints to surgical instruments, but the agency has no power to check devices until a failure is reported.

In a meeting with Simon Burns, the Health minister, on 13 September, Professor Toft said CE marks were allocated to medical devices on the basis of "design specifications" without checks on whether the devices were "being made in the way they should be made".

In July, in a presentation to the Committee on the Safety of Devices, revealed by The Lancet, he warned that the CE mark "provides a smokescreen for faulty and dangerous devices that place patients at risk". He cited a BBC Panorama programme that exposed faulty surgical instruments imported into the UK from Pakistan despite being manufactured in a "clearly substandard way".

Professor Toft said the present system, under which checks were carried out by "notified bodies" authorised by the MHRA, was flawed because there was no guarantee the checks were being done. In the case of the PIP breast implants, the manufacturer had evaded the checks because they were announced 10 days in advance and workers hid the substandard silicone.

"The regulator in this country has neither the resources nor the power to make its own checks," Professor Toft said. In a follow-up letter to Mr Burns, sent on 2 January, Mr Toft asked what the Government was going to do to "ensure unsafe medical devices do not reach patients".

Richard Horton, editor of The Lancet, said the Committee on the Safety of Devices had debated failings in the regulatory system for two years. "The operating principle of the MHRA seems to be to do nothing until something goes wrong," he wrote.

An MHRA spokesperson said: "We monitor all adverse incident reports and take prompt action to address any safety or performance concerns."

A review of the regulation of medical devices was announced by the Health Secretary, Andrew Lansley, last week.

Surgeons issue 'definitive' advice to women

Surgeons issued "definitive" guidance to women with PIP implants yesterday. In a rebuff to the Government, which had said only women with symptoms needed treatment, the professional bodies said all women, including those without symptoms, should be entitled to an assessment and removal of the implant on request. They said private clinics had "an ethical and moral duty" to provide free treatment.

The joint statement by the Association of Breast Surgery, the plastic surgery associations and the Royal College of Surgeons said the move should not be a "time-limited, take-it-or-leave-it offer." Tim Goodacre, of the British Association of Plastic, Reconstructive and Aesthetic Surgeons, said: "It has been a distressing time. We hope this guidance will ensure we can conclude this effectively."