Transvaginal mesh implants independent review: interim report

Chapter 10: Chairman's concluding remarks

Stress urinary incontinence and pelvic organ prolapse are conditions which, while not life threatening, cause considerable distress to many women, with disruption of their normal lives. The hope of a treatment which can reduce that distress and return their lives to normal is understandably sought eagerly. Similarly the gynaecologists and urologists who see these symptoms and the distress they cause to their patients seek to test and find new and better ways of producing good outcomes for their patients. The use of mesh in this clinical area came about because of that desire and many women have had a good outcome from these operations. However no surgery is without complications and a number of women have had both minor and major complications due to the surgery itself and some have found their lives transformed completely for the worse, unable to pursue a normal family, personal and working life.

Balancing this knowledge of both good outcomes and very bad experiences has been one of the difficult tasks faced by this review. We have taken an approach of both seeking and sifting the best available research information on both safety and effectiveness as well as the epidemiological information provided by the routine NHS linked information which is so rich in Scotland. While extensive, that left us with many gaps which has formed the basis of our conclusions and recommendations. In addition we decided to listen and reflect on what our patient members and our clinical members tell us as they add their expertise and experience to that research and epidemiology. This led us to the specific recommendation we make on the use of mesh tape in particular circumstances and to ask for work on the clinical pathways to take this concern into account.

We can now see a way by which surgery can again take place but it will require a number of actions to ensure lessons are learnt and good and safe patient care is ensured. These are outlined in our recommendations but include:

• informed consent is obtained using approved processes and information;
• an approved clinical pathway is followed;
• information, including adverse events, is recorded in a universal and robust way;
• patient treatment and audit is considered as part of a clinical network involving all practitioners;
• the Expert Group develops a pathway for the retropubic approach in SUI as the routine mesh procedure with any variation considered as part of the multi-disciplinary team; and
• the Expert Group develops a pathway for the treatment of POP where transvaginal mesh is not used routinely. Any variation in the future is considered in light of the awaited results of the PROSPECT study and follows discussion within the multi-disciplinary team.

I also want to acknowledge the opinion of the Scottish Mesh Survivors Group, who consider that the report recommendations should be actioned and able to be monitored before any transvaginal mesh inplant procedures take place.

Further research which is currently awaited, information and opinion will be considered as part of the preparation of the Final Report which will also be informed by the discussions and actions following the publication of the Interim Report.

Finally, listening is a key part of good and compassionate healthcare. The many women who began the process leading to this review together with the women who valued this surgery and wanted that benefit to continue I hope will feel that they have been listened to and that patient care will benefit as a result.