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Government sets scope for cosmetic surgery reviews

Two reviews launched by Department of Health following PIP implant scandal

Ingrid Torjesen

Wednesday, 25 January 2012

The Department of Health has published the terms of reference for two reviews following the recent PIP breast implant scandal.

The first review, led by Lord Howe, the Minister for Quality, will establish what happened in the UK when the MHRA and Department of Health learnt about the situation with PIP implants in France.

The second review will be led by Professor Sir Bruce Keogh, the NHS Medical Director, and will look at whether the cosmetic surgery industry needs to be more effectively regulated.

The first review is expected to report by the end of March and will cover what information about PIP implants was available from routine adverse reporting systems, what external concerns about PIP implants were brought to the attention of the MHRA or the wider Department of Health and when. It will consider how these concerns and any related information were handled, what advice was sought and from whom, and what information was shared between the MHRA and its counterparts in other countries in the EU and elsewhere. The overall aim is to find out how decisions were taken and who was involved, and then what action was taken to safeguard and advise patients, and whether action was sufficiently prompt and appropriate.

Lord Howe said: “I want to quickly establish the facts of what happened so we can, as far as possible, prevent anything like this from happening again.

The second review will be more complex and is expected to take around a year to complete, so it will hopefully report to the Health Secretary by March 2013.

The second review will look at whether the regulation of the products used in cosmetic interventions is appropriate, how best to assure patients and consumers that the people who carry out procedures have the skills to do so, and how to ensure that the organisations which deliver such procedures have the clinical governance systems to assure the care and welfare of people who use their services. The review will also consider how to ensure that people considering such interventions are given the information, advice and time for reflection to make an informed choice, whether there should be a statutory requirement for organisations that offer cosmetic procedures to offer redress in the event of harm, and if so how this could be funded, and what improvements are needed in systems for reporting patient outcomes, including adverse events, for central analysis and surveillance.

NHS Medical Director, Professor Sir Bruce Keogh, said: “I will be looking at all aspects of regulation – at the regulation of implants and fillers, at whether the people who carry out cosmetic interventions have the right skills, at whether the clinics look after the care and welfare of their patients. This would include treatments such as cosmetic surgery, botox injections and dermal fillers and other cosmetic treatments where there is a potential risk to health.

“There is already considerable support for a comprehensive register of significant surgical devices – from breast implants to heart valves to replacement joints. We will be looking critically at the value and feasibility of such a register and at how best to put this into action.”

Meanwhile the House of Commons Health Select Committee has launched its own inquiry into PIP breast implants and regulation of cosmetic interventions. On 7 February MPs will hear evidence from Sir Bruce Keogh, NHS Medical Director, Sir Kent Woods, chief executive of MHRA, Dr Anne-Marie Slowther, associate professor of Clinical Ethics at Warwick Medical School and Mr Simon Withey, a consultant plastic surgeon and a member of the council of the British Association of Aesthetic Plastic Surgeons.

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