This article highlights two written questions tabled in the House of Commons relating to recommendations of the Independent Medicines and Medical Devices Safety (IMMDS) Review concerning surgical mesh implants.
The Independent Medicines and Medical Devices Safety (IMMDS) Review, led by Baroness Julia Cumberlege, examined how the healthcare system in England responded to reports about harmful side effects of medicines and medical devices, focusing on three specific interventions: hormone pregnancy tests, sodium valproate and pelvic mesh implants. These interventions have resulted in a truly shocking degree of avoidable harm to patients over a period of decades.
One of the Review’s patient safety recommendations was to create a database for all implantable medical devices. The Review in its findings noted that the healthcare system does not have a clear assessment of the true long-term complication rate for pelvic mesh procedures, and recommended that an audit should be attempted to establish complication rates.
Below are details of two written questions tabled by Feryal Clark MP, Shadow Minister for Primary Care and Patient Safety, concerning these issues. Both questions were answered by Maria Caulfield MP, Minister for Primary Care and Patient Safety.
Creation of a database
Question: To ask the Secretary of State for Health and Social Care whether his Department plans to create a database for people who have permanently implanted medical devices, including details on the type of device.
Answer: The Independent Medicines and Medical Devices Safety Review recommended that “a central patient-identifiable database should be created by collecting key details of the implantation of all devices at the time of the operation. This can then be linked to specifically created registers to research and audit the outcomes both in terms of the device safety and patient reported outcomes measures”. The Government accepted this recommendation.
In 2021/22, we worked with partners in the healthcare system to scope, test and cost methods of achieving a United Kingdom-wide medical device information system. This explored establishing national systems, expanding clinical registries and approaches to electronically tracking implanted medical devices at the point of care. We aim to publish an update on the implementation of the Review’s recommendations, including work on a medical device information system, in summer 2022.
Question: To ask the Secretary of State for Health and Social Care, if he will make an assessment of the potential merits of a retrospective audit of mesh implants to everyone who had one implanted in 2010 as called for in the Cumberlege Review.
Answer: We accepted the Independent Medicines and Medical Devices Safety Review’s recommendation to undertake a selective retrospective audit of a defined cohort of women who have undergone mesh procedures. NHS Digital is currently completing an audit of all pelvic floor surgery completed in 2010, to generate a historical baseline of outcomes by procedure type and support further research and analysis. We aim to publish the results of the audit later this year.
- House of Commons, Surgical Mesh Implants – Question for Department of Health and Social Care, UIN 21319, tabled on 20 June 2022.
- House of Commons, Surgical Mesh Implants – Question for Department of Health and Social Care, UIN 21320, tabled on 20 June 2022.
- Doctors shocking comments to women harmed by mesh
- First Do No Harm. The report of the Independent Medicines and Medical Devices Safety Review (8 July 2020)
- Regulatory flaws: Women were catastrophically failed in the mesh, Primodos and Sodium Valproate tragedies
- “There’s no problem with the mesh”: A personal account of the struggle to get vaginal mesh removal surgery