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Healthy Skepticism Library item: 19817

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

 

Publication type: news

Laurance J
Implant danger extends to all medical devices
The Independent 2012 Jan 18
http://www.independent.co.uk/life-style/health-and-families/health-news/implant-danger-extends-to-all-medical-devices-6291116.html


Abstract:

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


Full text:

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.”

 

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Far too large a section of the treatment of disease is to-day controlled by the big manufacturing pharmacists, who have enslaved us in a plausible pseudo-science...
The blind faith which some men have in medicines illustrates too often the greatest of all human capacities - the capacity for self deception...
Some one will say, Is this all your science has to tell us? Is this the outcome of decades of good clinical work, of patient study of the disease, of anxious trial in such good faith of so many drugs? Give us back the childlike trust of the fathers in antimony and in the lancet rather than this cold nihilism. Not at all! Let us accept the truth, however unpleasant it may be, and with the death rate staring us in the face, let us not be deceived with vain fancies...
we need a stern, iconoclastic spirit which leads, not to nihilism, but to an active skepticism - not the passive skepticism, born of despair, but the active skepticism born of a knowledge that recognizes its limitations and knows full well that only in this attitude of mind can true progress be made.
- William Osler 1909