Asked by: Owen Smith (Labour - Pontypridd)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, with reference to the Provisional Monthly Hospital Episode Statistics for Admitted Patient Care, Outpatient and Accident and Emergency data April 2018 - March 2019 (M12), what estimate he has made of the number of procedures for stress urinary incontinence and prolapse using mesh carried out during the period of high vigilance restriction which paused such surgery.
Answered by Jackie Doyle-Price
NHS Digital publishes data on finished consultant episodes where a procedure for treatment of urogynaecological prolapse or stress urinary incontinence (insertion) is recorded.
In year commencing April 2018, data is available up to March 2019. The March 2019 data is provisional.
The most recent provisional Hospital Episodes Statistics data demonstrates that the number of procedures for insertion from April 2018 is 8,931 in total for all procedures, vaginally inserted mesh or otherwise.
For vaginally inserted mesh, to which the period of high vigilance restriction relates, there have been approximately 31 total procedures up to March 2019 for the introduction of:
- tension-free vaginal tape;
- transobturator tape;
- vaginal tape NEC;
- the repair of vault of vagina with mesh using vaginal approach;
This figure excludes data for the month of July, as guidance on the Pause was issued on 20 July to Regional Directors and Trust Medical Directors. For July, the total figure for insertions is 70, though this includes a period before the Pause came into effect.
Asked by: Owen Smith (Labour - Pontypridd)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, pursuant to the Written Statement of 10 July 2018 on Update on the Independent Medicines and Medical Devices Safety Review, HCWS841, what estimate he has made of the number of potential exceptions there will be to the pause in the use of mesh for stress urinary incontinence; and how exceptions to the suspension will be determined.
Answered by Jackie Doyle-Price
The pause in the use of vaginally inserted mesh to treat prolapse and tape/sling used to treat stress urinary incontinence will be implemented through a high vigilance programme of restricted practice. This is not a blanket ban as for some patients this can be a last treatment option for a debilitating condition.
These operations will therefore be available for carefully selected patients based on a multidisciplinary team decision, where the patient understands the risks involved and has provided informed consent. It is therefore not possible at this stage to quantify the number of exceptions that will take place.
This is similar to the position in Scotland, where mesh used to treat stress urinary incontinence and pelvic organ prolapse has been temporarily suspended, but is allowed in certain tightly controlled circumstances.
Asked by: Owen Smith (Labour - Pontypridd)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, pursuant to the Written Statement of 10 July 2018 on Update on the Independent Medicines and Medical Devices Safety Review, HCWS841, if he will publish in detail the Government’s plan for a high vigilance programme of restricted practice for the use of surgical mesh to treat stress urinary incontinence.
Answered by Jackie Doyle-Price
On 10 July, alongside the Government’s announcement of a pause in the use of sling/tape to treat stress urinary incontinence and vaginally inserted mesh to treat prolapse, NHS England and NHS Improvement wrote to provider Chief Executives and Medical Directors, advising on implementation of the pause through a high vigilance programme of restriction. It was advised that, for the majority of patients, a delay until the high vigilance programme ceased would be the preferred option. This information is in the public domain and available on the NHS Improvement website at the following link:
https://i.emlfiles4.com/cmpdoc/9/7/2/8/1/1/files/47633_mesh-letter-to-acute-ceos-and-mds.pdf
A Clinical Advisory Group has been formed, with subject matter expert members representing NHS England, British Society of Urogynaecology and British Association of Urological Surgeons. The Clinical Advisory Group is developing clinical recommendations for implementation following the initial advice given to providers. NHS England will ensure that these clinical recommendations are communicated to providers once they are agreed.