Department of Health sets
out scope of PiP implant and cosmetic surgery reviews
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 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 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;
andany 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 the UK on Friday 6 January. The report can be found at
http://www.dh.gov.uk/health/2012/01/pip-implants-interim-report/
Contacts:
Department of Health
Phone: 020 7210 5221
NDS.DH@coi.gsi.gov.uk