The threat of substandard implants is wide spread extending beyond breast implants and symptomatic of regulatory failure affecting all medical devices. This was the warning of Brian Toft, professor of patient safety at Coventry University, who felt that the CE Mark approval system was seriously flawed and did not protect patients.

An article in The Independent reported that 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.

Professor Toft, in a meeting with the U.K. Health minister last year, said that 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".

Prof.  Toft, in another presentation, warned that the CE mark "provides a smokescreen for faulty and dangerous devices that place patients at risk" and cited a BBC Panorama program that exposed faulty surgical instruments imported into the U.K. from Pakistan despite being manufactured in a "clearly substandard way."

Under the present system, checks are carried out by “notified bodies” that are authorized by the MHRA. And this system is flawed as it doesn’t guarantee that the checks are actually being done. In 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, Prof. Toft felt. 

In a follow-up letter sent on 2 January to the Health minister,  Prof. Toft asked what the Government was doing to "ensure unsafe medical devices do not reach patients".

The paper has quoted an MHRA spokesperson as saying: "We monitor all adverse incident reports and take prompt action to address any safety or performance concerns." Last week, the U.K. Health Secretary announced a review of medical device regulation. 

In the latest development, U.K. surgeons have 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 have asked that all women, including those without be entitled to an assessment and removal of the implant on request. 

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