PIP Breast Implants and Regulation of Cosmetic Interventions

(Limited Text - Ministerial Extracts only)

Tuesday 24th January 2012 Written Statements

[The Secretary of State for Health (Mr Andrew Lansley)]

In my oral statement to the House of 11 January 2012, Official Report, columns 181-183, I described the immediate action which the Government are taking to address the concerns of women who have received breast implants made by the company Poly Implant Prothèse (PIP). I said that, in the light of these events, we needed both to review the lessons that could be learnt, and to consider the wider issues of ensuring the safety of people who are considering cosmetic surgery and similar treatments. I therefore announced two reviews, one to be led by my noble Friend the Parliamentary Under Secretary of State (Earl Howe) which will look at what happened in the United Kingdom in relation to PIP implants; and the second, to be led by the NHS Medical Director, Sir Bruce Keogh, to look at the wider issues of clinical safety and regulation.

The review to be carried out by Earl Howe will report by the end of March 2012 and the terms of reference are:

Review of actions of the MHRA and wider Department of Health

“In the context of current EC directives on the regulation of medical devices and the information generally available at the time on the risks associated with breast implants, to review:

1. what information about PIP implants was available from routine adverse reporting systems;

2. what external concerns about PIP implants were brought to the attention of the MHRA or the wider Department of Health, and when;

3. how these concerns and any related information were handled;

4. what advice was sought and from whom;

5. what information was shared between MHRA and its counterparts in other countries in the EU and elsewhere;

6. how decisions were taken, and who was involved in this process;

7. what action was taken to safeguard and advise patients;

8. whether action was sufficiently prompt and appropriate

The review will advise the Secretary of State on what lessons can be learned for application should similar circumstances arise in the future, and on implications for UK input to the ongoing review of the European Medical Devices Directives.”

The review to be carried out by Sir Bruce Keogh will begin in March 2012 and will report within 9-12 months, that is, at the latest by March 2013, and the terms of reference are:

Review of regulation of cosmetic interventions

“Taking into account the Government’s Better Regulation framework and the concurrent review by the EU of current arrangements for the regulation of medical devices:

1. To review the current arrangements for ensuring the quality and safety of cosmetic interventions posing a potential risk to physical or psychological health, and in particular to consider:

i. whether the regulation of the products used in such interventions is appropriate;

ii. how best to assure patients and consumers that the people who carry out procedures have the skills to do so;

iii. 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;

iv. how to ensure that people considering such interventions are given the information, advice and time for reflection to make an informed choice;

v. 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;

vi. 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.

2. To make recommendations to Ministers, including interim recommendations if appropriate, and to inform the UK contribution to the EU review.

The interventions to be considered for the purpose of this review could potentially include:

a. the surgical insertion of a medical device or prosthesis, or other surgery intended to change the appearance of the body

b. injection with any product, whether medicinal or otherwise

c. 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.”