Source · Select Committees · Health and Social Care Committee
Recommendation 2
2
Accepted
Paragraph: 23
Retrospective mesh implant audit insufficient for capturing all adverse patient experiences
Conclusion
Although the retrospective audit of mesh implants is an encouraging first step, it will be unlikely to reflect and take into account all of the adverse effects women have experienced due to the nature of data used in the audit. We therefore recommend that the Government consider an alternative strategy for how to pro-actively contact those who have had the procedure about their post-operative experiences and possible side effects.
Government Response Summary
The government committed to proactive measures beyond the retrospective audit, including designing a patient questionnaire (PROMs/PREMs) to be completed by April 2023 and integrated into the Pelvic Floor Registry by May 2023, and commissioning the development of a validated PROM for pelvic floor disorders by NIHR starting May 2023.
Paragraph Reference:
23
Government Response
Accepted
HM Government
Accepted
. NHS Digital undertook an audit of all pelvic floor surgery completed between 2006 and 2011 to generate a historical baseline of outcomes by procedure type and to support further research and analysis. The audit captures subsequent procedures and re-operations over a 10-year period after the initial procedure. This audit was conducted using initial procedures, re-operations and follow up procedures recorded within Hospital Episode Statistics data. The audit is currently undergoing peer review, which may reveal the need for further enhancements, prior to publication by NHS England later in 2023. In parallel NHS England is working to ensure high-quality data is collected within the specialist mesh centres. In the short-term, a patient questionnaire is being designed and we expect to have it complete by the end of April 2023, which includes both patient-reported outcome measures (PROMs) and patient-reported experience measures (PREMs). This questionnaire incorporates the existing pelvic floor PROMs that are in use by clinicians, as well as additional questions that have been requested by clinicians who are treating patients with complications of mesh insertion. begin feeding into the existing Pelvic Floor Registry, the database that collects surgical device and implant data directly from NHS and private healthcare providers in the UK, in May 2023. When the questionnaire results are fed into the existing registry. Regarding PROMs, we are re-designing the pelvic floor PROM and working towards patient and clinician consultation on the final design by the end of April 2023. Longer-term, the National Institute for Health and Care Research is commissioning the development of a validated PROM for pelvic floor disorders. The study is expected to start in May 2023. Development, testing, evaluation and validation of a new PROM is likely to take around 3 years and requires patient, clinical and specialist academic input to ensure that the data collected is suitable for outcome-based analysis and evaluation. The study will develop a new questionnaire which will help women to report how surgery for POP, UI and mesh complications has affected their quality of life.