Surgical Mesh Implants
(asked on 29th August 2025) - View Source
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what the outcome was of the MHRA rectopexy review.
At the end of 2024, the Medicines and Healthcare products Regulatory Agency (MHRA) completed its’ first stage review into the use of mesh in rectopexy procedures, which involved a comprehensive review of the mesh products available in Great Britian’s market, and a patient survey which was conducted in October 2024. As part of the review, the agency conducted a thorough evaluation of manufacturer data, including assessing what products are indicated for rectopexy or may be used for this purpose. Evaluation of the literature was undertaken to understand the range of mesh products used for rectopexy procedures, and this noted that the range of mesh used in patients were wider than those ‘indicated’ by manufacturers.
The survey identified that a small majority of patients experienced worsening symptoms after their rectopexy procedure, usually within the first-year post-surgery. The survey also indicated that there was relatively low awareness of the Yellow Card adverse incident reporting scheme among responders.
In December 2024 the MHRA presented a series of recommendations to the Interim Devices Work Group (IDWG) to address the issues identified in the review. These recommendations were endorsed by the group as documented in the meeting minutes, which are available at the following link:
The MHRA is currently working to implement the recommendations agreed by the IDWG. These recommendations include, for example, exploring what broader work can be conducted across the regulatory and healthcare environment and with manufacturers to address the off-label use of mesh products and the associated risks to patient safety. This project will also involve engagement with patient and healthcare stakeholder groups to bring about greater awareness of the issues. The MHRA expects the engagement to begin in spring 2026. There is also work currently ongoing in parallel, which will aid in addressing the recommendations. This includes the application of the new Post-market Surveillance Regulations for medical devices placed in Great Britian’s market, which came into force on the 16 June 2025 and enhances both the manufacturers' and the MHRA’s capacity to detect and monitor safety issues.
The MHRA continues to work with colleagues from across the health sector and international regulators, to monitor and examine evidence as it becomes available. The MHRA is committed to helping address the serious concerns raised by patients who have experienced complications and will take further action as appropriate to protect public health.