Chamber and committees

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.

In coming to the conclusions noted in its Final Report, the Independent Review considered a range of evidence, including the patient survey, all of which is summarised within the Report. The conclusions are based upon the totality of that evidence.

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.

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 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.

Chapter 6 is a clinicians' review of the evidence and experiences noted elsewhere in the Report. Based on that evidence, it concludes that:

• retropubic mesh tape is a valid option to be offered routinely to women considering surgical treatment for SUI;

• colposuspension and autologous fascial pubo-vaginal sling are both appropriate alternatives for women who wish to avoid the use of a permanent implant, provided they accept the increased associated short-term morbidities and longer recovery, and increased long-term risk of prolapse following colposuspension;

• women may wish to consider urethral injection therapy; they should be made aware that the efficacy is less than with other interventions, and decreases over time; hence the risk of re-admission for complications or re-operation for SUI is very much higher; and

• in the case of pelvic organ prolapse, vaginal wall repair using native tissue (anterior and posterior colporrhaphy) should be the procedure of choice for women seeking surgery for POP; the use of polypropylene mesh or biological graft should not be offered routinely but may be considered in complex conditions – only after discussion at an appropriately constituted multi-disciplinary team.

The Independent Review confirmed to me that it agreed, in considering the effectiveness of procedures, it would only use Cochrane Reviews as these are the international “gold standard” for systematic reviews. This was to avoid re-reviewing research data that was already reviewed in other documents and might therefore have introduced the potential for bias. This review fell outside of the scope as it is neither a formal Safety Agency Review, nor is it a Cochrane Review.

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.

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.