PARLIAMENTARY WRITTEN QUESTION
(14 January 2025)

To ask the Secretary of State for Health and Social Care, what assessment his Department has made of the adequacy of (a) the NHS and (b) MHRA's response to women suffering as a result of vaginal mesh implants.

Asked by:
James McMurdock (Independent)

In response to the Independent Medicines and Medical Devices Safety Review (IMMDS Review) the National Health Service and the Medicines and Healthcare products Regulatory Agency (MHRA) have worked to improve support for women who have experienced complications from pelvic mesh, and to improve patient involvement and system responsiveness to patient safety issues.

NHS England established nine specialist mesh centres across England, ensuring that women in every region with complications of mesh inserted for urinary incontinence and vaginal prolapse gets the right support. NHS England is working with the mesh centres to review and gain feedback on their outcomes and patient experience, to ensure they are supporting patients as planned.

The Medical Devices Outcomes Registry was established by NHS England in April 2024 to fulfil recommendation seven of the IMMDS Review. The Pelvic Organ Prolapse and Stress Urinary Incontinence registry will be launched this year. This will ensure that appropriate clinical vigilance data is collected, surgical outliers can be identified, and comparative performance and outcomes across centres is routinely available.

In response to recommendation six of the IMMDS Review, the MHRA underwent an organisation-wide transformation to become a more progressive and responsive patient-focussed regulator of medical products, including pelvic mesh. This included the creation of a publicly accessible registration system for medical devices, putting a new SafetyConnect vigilance service in place, and improving the responsiveness and awareness of the Yellow Card reporting system. The MHRA continues to work across the health sector and with international regulators, to monitor and examine evidence as it becomes available to continue to improve patient safety.

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