Malcolm raises the concerns of women with PIP breast implants
Question about PIP breast implants Malcolm Chisholm (Edinburgh North and Leith) (Lab):
To ask the Scottish Executive what discussions it has had with the Medicines and Healthcare products Regulatory Agency regarding PIP breast implants. (S4O-00860)

Nicola Sturgeon (The Deputy First Minister and Cabinet Secretary for Health, Wellbeing and Cities Strategy): :

Scottish Government officials have been in regular contact with colleagues in the Medicines and Healthcare products Regulatory Authority and the Department of Health about PIP silicone breast implants. I take this opportunity to inform members that we have recently been advised that one patient from NHS Highland received PIP implants at St John’s hospital in 2006. Our extensive checks have not identified any further patients who had PIP implants on the NHS. Therefore, with that one exception, the position remains that no NHS patients were affected.

We have combined that intelligence with information from our bilateral discussions with companies such as Virgin, BT and others - and our discussions with the Office of Communications, which has done some work in this regard - on the assumptions around participation levels. For example, if we get a participation level in excess of 20 per cent, the likelihood that the private sector will invest is much higher than if the level is below 20 per cent. If we can get those areas that fall just below 20 per cent over that level, we can move them from the grey area into the black area. It is very much based on market intelligence across the board.

The feedback that we have had since we published the action plan seems to indicate that there is general agreement that our assumptions around that figure are broadly correct.

Malcolm Chisholm:
There are many issues and anxieties for the women affected. I will raise a couple on behalf of a constituent who has contents of a ruptured PIP implant inside her body. First, will the cabinet secretary put pressure on the MHRA to analyse the contents of my constituent’s implants, which were removed by the NHS? Failing that, will she ensure that the contents are tested in Scotland? Secondly, given that the MHRA put out an alert two years ago this month, is it not reprehensible that the women affected heard nothing about the problem until December 2011?

Nicola Sturgeon:
Malcolm Chisholm will appreciate that two reviews are on-going just now. The one into the more recent incidents around notification and how the matter was handled is due to report soon. It is appropriate for all of us to wait and see what that review has to say about whether all the correct information was given at the correct time. I understand the reason for Malcolm Chisholm’s first question and the desire to ensure not only that all the women affected get the clinical care, treatment and support that they need and deserve, but that the right testing and data audit are carried out so that lessons can be learned. The MHRA is responsible for collecting all the evidence, but that does not require it to retrieve every PIP implant, although it needs sufficient evidence to carry out the checks. I will pass the concerns that Malcolm Chisholm has raised on behalf of his constituent to the MHRA, and I will be happy to share its response with him.
March 29th 2012