Serious concerns raised by patients and their families around the use of vaginally inserted surgical mesh for stress urinary incontinence (SUI) were a central driver of the Independent Medicines and Medical Devices Safety (IMMDS) Review: First do no harm (Cumberlege Review), published in 2020. Government supported the recommendation at the start of the review in 2018 for an immediate pause on use of mesh in SUI procedures, due to reported complications and episodes of patient harm. The pause was subsequently extended to the use of vaginal mesh for pelvic organ prolapse (POP).

Data captured by the POPSUI Registry will be used to evidence that some of the patient safety criteria outlined in the update on the Independent Medicines and Medical Devices Safety Review have been met, a prerequisite to lifting the pause on mesh procedures.

About the POPSUI Registry

The Secretary of State for Health and Social Care directs NHS England to operate the POPSUI Registry.

The POPSUI Registry lies within the implantable device-level modular framework of the Medical Devices Outcomes Registry (MDOR), which was established in 2024 to fulfil Recommendation 7 of the Cumberlege Review to improve patient safety and outcomes and reduce variation in clinical practice associated with procedures involving high-risk implantable medical devices.

To fulfil the recommendations of the Cumberlege Review and Paterson Inquiry, the POPSUI Registry captures data on the healthcare provider, patient, operation, risk factors, clinician and implantable medical device(s) in relation to the following:

• pelvic floor surgery (SUI and POP)
• prolapse of the vagina and/or roof of the vagina if hysterectomy
• prolapse of the uterus
• prolapse of the rectum

All healthcare organisations, including independent sector organisations, that provide NHS-funded care and undertake surgical or interventional procedures involving a Class IIb or III implantable medical device must comply with the requirement to submit this data to NHS England. Independent sector organisations that provide privately-funded care for the same procedures may submit data to NHS England on a voluntary basis.

POPSUI data collection

Data submissions to the POPSUI Registry started in March 2025 and are collected via the Outcomes and Registries Clinical Application. Access to this system is via an approved account and requires log in.

Data is collected daily and can be entered 24 hours a day, 365 days a year. The collection is ongoing with no end date.

Supporting documentation

More information on POPSUI and the wider work on the Outcomes and Registries Programme can be found in:

• Outcomes and Registries Directions 2024 outlining the legal requirement from the Secretary of State for NHS England to collect these data
• MDOR requirements specification detailing what providers in scope must do to comply with the mandate to submit data
• MDOR data specification defining what data fields are to be collected to fulfil the legal requirement
• MDOR data provision notice detailing the legal instruction to providers in scope to submit data
• MDOR transparency notice informing data subjects (patients and the public) how and why NHS England collects, uses, stores and shares their personal data

Enquiries

For POPSUI general enquiries and technical support from the Outcome Registries Clinical Application liaison team, please contact england.support.outcomeregistries@nhs.net