The Department of Health has today 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 theUKwhen 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 this year and will look at:
- 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;
- how these concerns and any related information were handled;
- what advice was sought and from whom;
- what information was shared between MHRA and its counterparts in other countries in the EU and elsewhere;
- how decisions were taken, and who was involved in this process;
- what action was taken to safeguard and advise patients;
- 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.
“Women with PiP implants are, quite rightly, very concerned. We need to give them answers and set out lessons for the future.”
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.
The interventions to be considered for the purpose of this review could potentially include:
- the surgical insertion of a medical device or prosthesis, or other surgery intended to change the appearance of the body;
- injection with any product, whether medicinal or otherwise; and
- any other form of intervention at the discretion of the review team.
where the intervention is not clinically indicated to safeguard or improve the physical health of the recipient including interim recommendations if appropriate including interim recommendations if appropriate.
NHS Medical Director, Professor Sir Bruce Keogh, said:
“I am working with experts from the plastic surgery field to look at what we can do to make sure people who choose to have cosmetic surgery and other cosmetic procedures are safe.
“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.”
Notes to editors
- For media enquiries, contact the Department of Health Press Office on 020 7210 5703
- Professor Sir Bruce Keogh’s expert group published findings into a review of the data available on PIP implants in theUKon Friday 6 January. The report can be found on the Department of Health website.