Sixth Report - Follow-up on the IMMDS report and the Government’s response

Without records of which patient has undergone which procedure, or been prescribed which drug, the health system will continue to, in the words of the IMMDS review team, “fly blind”. We recommend that the Government urgently ensures that the accepted recommendations 6 and 7 of the IMMDS review are fully implemented.

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.

We were encouraged to hear that the Government is going ahead with pilots of a register of clinicians’ interests, but we are disappointed by the speed at which the Government is acting on this recommendation. We urge the Government to make the arrangements necessary to ensure the register can be set up swiftly, subject to the pilot phase concluding, to prevent further delay.

Although the Government has also given itself the powers to set up a register of industry payments to clinicians, no decision has been made yet about how to implement it, and officials were not able to share a plan of when the register would be active. A register would provide transparency and reassurance, and we urge the Government to move at pace to bring in the necessary secondary legislation to set this up.

Although the vision for what the role of Patient Safety Commissioner will achieve is publicised by the Department, no statement of specific assignments or areas of responsibility, have been published yet. As we set out in our report on the pre- appointment hearing with Dr Hughes, metrics for success and clearly defined responsibilities are needed. Only when these are clearly established can resources be adequately assigned. The risk if this is not done is that the maximum benefit to patient safety will not be fully realised. We therefore urge the Secretary of State to ensure that the Patient Safety Commissioner’s ability to carry out her important role, as her duties and responsibilities become more clearly defined, is not impeded by a lack of resource for and within her office.

We are concerned that although the letter from the Department seems to outline various interactions and consultations with stakeholders, and mentions Sling the Mesh by name, this is not the experience of some patients. Patient input is vital in setting up care schemes such as this one. We therefore urge the Department to reflect on the experience of some of the stakeholders with lived experience in this instance, and to consider how to improve engagement with them in the future.

It is positive that the Government has improved its communication and information online around how to bring claims of clinical negligence through the 20 Follow-up on the IMMDS report and the Government’s response new “pathways”. However, these pathways do not represent a substantial change or benefit to stakeholders who have repeatedly expressed their frustration regarding seeking redress.

The focus of Patient Safety Commissioner and small team, and must remain, patient safety and harm prevention. If the additional responsibility of reviewing redress is placed on the Patient Safety Commissioner, the Secretary of State must ensure that the Commissioner and her office has access to proper independent expert advice and support. We urge the Secretary of State to make a statement detailing the Patient Safety Commissioner’s review of redress schemes for the medical interventions dealt with by the IMMDS review, and what additional resources will be made available to her to undertake it.

We would welcome a statement from the Minister on the review of redress and a possible Redress Agency, with more details on what such a review would include and seek to achieve, and timeline for completion. (Paragraph 60) Follow-up on the IMMDS report and the Government’s response 21