Chamber and committees

The Deputy Chief Medical Officer and colleagues have participated in discussion with the Medical and Healthcare products Regulatory Agency and other professional bodies on the reporting and use of the implant database. The professional bodies have agreed in principle to work together on reporting complications and outcomes. There have been no discussions on suspending the use of transvaginal mesh implants.

The Deputy Chief Medical Officer met with Mark Lloyd Davies, Senior Director, Johnson and Johnson, and a colleague from the Association of British Healthcare Industry on 16 July 2013 to hear views on research and medical device regulations. There was no discussion on the suspension of the use of transvaginal mesh implants. A research paper was provided on biocompatibility for information.

There have been no recent changes to the risk classification of Transvaginal Mesh Implants.

Alternative treatment options to transvaginal mesh implants for vaginal prolapse include pelvic floor exercises, changes to diet to reduce weight, eating a high-fibre diet with plenty of fresh fruit, vegetables, wholegrain bread and cereal, the use of vaginal pessaries or a range of surgical techniques.

There are a number of treatment options available for stress urinary incontinence. These include changes to diet to reduce weight and physiotherapy to strengthen the pelvic floor muscles. Surgical treatment is recommended only if conservative (non-surgical) management is ineffective. There are a number of surgical procedures for this condition.

The Deputy Chief Medical Officer and colleagues have recently participated in two telephone conferences and three review conversations with the Medical and Healthcare products Regulatory Agency. These discussions focussed on medical device regulation.

Discussion on an implant registry is on-going, and includes the British Society of Urogynaecology (BSUG), The British Association Urological Surgeons, the Royal College of Obstetricians and Gynaecologists and the Medicines and Healthcare products Regulatory Agency.

There is an existing BSUG database, currently being used by 20-30% of urogynaecologists, that may be adapted to record procedures, complications and some outcome data for specific urogynaecological procedures, including the urethral tape and vaginal mesh insertion procedures. A number of Scottish clinicians already contribute their data to the BSUG database and we will work with the Scottish Association of Medical Directors to identify the barriers to using the database amongst Scottish clinicians so that we can find ways of increasing uptake.

The consideration of clinical procedures including the use of ultrasound as a treatment in the removal of transvaginal mesh implants will be considered by the transvaginal mesh working group. This working group has been set-up to look in detail at issues surrounding transvaginal mesh implants. The next meeting of the working group will take place 13 December 2013.

The multi-disciplinary approach, using the core skills and expertise of paediatric dieticians and speech and language therapists, and with a network of support from the children’s hospitals for more complex cases, is considered, effective, safe and person-centred.

This information is not held centrally.