Chamber and committees

The Independent Review members considered it appropriate that all evidence considered by the Review be grouped together in chapters 4 and 5, whilst chapter 6 includes commentary on that evidence. The table that was included in chapter 6 of the Interim Report is, however, included in the Final Report as an annex. The tables developed by a single clinician are included in chapter 5 where agreed by the Independent Review, and for transparency the tables are published in totality on the website.

Questions asked in the Chamber are the responsibility of the Member. Scottish Government officials serve the Scottish Ministers and provide no support to Members appointed as Parliamentary Liaison Officers.

The Independent Review was established due to wider concerns around mesh usage. It is the job of the MHRA to regulate medical devices across the UK, and it has not issued a Medical Device Alert regarding the implants concerned. The MHRA has found no evidence to indicate that polypropylene mesh implants are unsafe, and has not been required to initiate any enforcement action against Boston Scientific, or any other manufacturer in the UK. Under current arrangements, regulation is a reserved matter, and the MHRA will therefore continue to monitor and evaluate the safety and performance of these devices, and will inform the Scottish Government if circumstances change.

The Independent Review's Final Report concludes that mesh procedures should not be offered routinely in the case of prolapse, and the Chief Medical Officer has accepted this conclusion. However, in each individual patient's case it is necessary to apply individually focused clinical care, and there will be exceptions where this type of operation is considered suitable, subject to agreement by the patient and her clinicians. The Oversight Group that is being established will be expected to continue to be provided with - and review - the routine data on number of cases and complications.

When I met with Ms McIlroy and Ms Holmes they requested that their minority report be removed from the Independent Review's Final Report. I relayed this to the Chair of the Review and she acceded to this request. Subsequently, Ms McIlroy and Ms Holmes asked that further material be removed and this request was, again, relayed to the Chair. However, the Chair confirmed that, by that point, the Final Report had been submitted to the Chief Medical Officer, and no further changes could therefore be made. Any changes to the Report were a matter for the Chair to decide upon, not Scottish Government Ministers or officials.

Chapter 5 reviews evidence relating to risk. The evidence on risk was considered together with the patient survey (chapter 3), the evidence from the routine data sources (chapter 4) and the clinicians views (chapter 6), in order that the Independent Review could reach its final conclusions. All the evidence considered is included in the Final Report.

Members were asked to complete standard Scottish Government declarations of interests, which cover a 12 month period.

The Chief Medical Officer has accepted the conclusions made by the Independent Review in its Final Report, Health Boards have been asked to take them forward, an Oversight Group is being established to work with Health Boards in doing so, and an expert will be appointed to examine the process of the Independent Review. Furthermore, arrangements are presently being made for my appearance at the Public Petitions Committee on 18 May. I have also agreed to meet with the opposition spokespeople on health to discuss these matters further.

The evidence considered by the Independent Review, and the conclusions drawn from it, are outlined in its Final Report. The conclusions reflect the need to offer mesh and non-mesh procedures for stress urinary incontinence, and also that mesh should not be offered routinely in the case of prolapse surgery. The conclusions also note that women should be given all necessary information and advice to allow them to make an informed decision on the best treatment in their case.

Appendix D of the Final Report contains the table from the Interim Report's Chapter 6, and Annex A contains the evidence tables referenced in the Interim Report's chapter 5. The evidence from the Interim Report was built upon by new evidence to provide the Independent Review with its final conclusions. For transparency, all the evidence has been published.