The Department of Health has published the terms of reference for two reviews established following the recent concerns about PIP implants.
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. Lord Howe will submit a report to the Health Secretary by the end of March.
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. This review will take around a year to complete given the complexities of the issues. He will aim to give a report to the Health Secretary by March 2013.
In particular, it 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;
- 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;
- 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 such organisations to offer redress in the event of harm, and if so how this could be funded;
- what improvements are needed in systems for reporting patient outcomes, including adverse events, for central analysis and surveillance.
The review will consider issues of governance, data quality, record keeping and surveillance, as well as ensuring that sufficient information is provided to secure patients’ informed consent. It will include consideration of the feasibility of an outcomes-based register of commonly implanted devices.