18.01.12
Device regulation deemed inadequate
The Medicines and Healthcare Products Regulatory Agency (MHRA) has been criticised for failing to conduct effective checks on medical devices, including instruments and implants like stents, hip replacement joints and silicone breast implants.
The editor of medical journal the Lancet, Richard Horton, suggested today that device regulation was effectively outsourced to third party organisations of “variable quality” and noted that the MHRA devotes far more resources to drug regulation.
Horton said: “The operating principle at the MHRA seems to be: do nothing until something goes wrong. The PIP breast implant scandal is an inevitable result of MHRA’s paralysis and inability to correct the failings of a severely flawed system.”
In the case of the faulty breast implants, manufacturers Poly Implant Prothese (PIP) received CE marking after appraisal by Tüv Rheinland, a German-based company. The CE mark is certification that a product reaches European quality standard.
Last July, Professor Brian Toft warned ministers that the CE mark was flawed and did not provide patients with protection. The agency also has no power to check devices until a failure is reported.
He said: “The regulator in this country has neither the resources nor the power to make its own checks.”
However, Dr John Perrins, chairman of the UK Committee on the Safety of Devices, argued: “We have got to be practical: there are only about 100 people working on devices regulation in theUK.”
A Department of Health spokesman said: “We agree that this incident has raised questions over safety and regulation. That’s why we have launched a review, headed up by Lord Howe – the Minister for Quality – to investigate what happened. We will also feed in to the ongoing review of the EU Medical Devices Directive.
“Above all, we are determined that something like this should not happen again. That’s why we have got together a group of the country’s leading experts on this issue to consider regulation of the cosmetic industry.”
In terms of the faulty PIP breast implants, some private companies who fitted them are refusing to perform replacement operations unless they have already ruptured or if the patients pay for surgery. Over 40,000 women received PIP implants between 2001 and 2010.
A joint statement by professional bodies, including the Association of Breast Surgery, the plastic surgery associations and the Royal College of Surgeons 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.
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