Guidance
1 Recommendations
1 Recommendations
1.1 Current evidence on the safety of infracoccygeal sacropexy using mesh to repair vaginal vault prolapse shows there are serious but well-recognised complications. The evidence on efficacy is inadequate in quality. Therefore, this procedure should not be used unless there are special arrangements in place for clinical governance, consent, and audit or research.
1.2 Clinicians wishing to do infracoccygeal sacropexy using mesh to repair vaginal vault prolapse should:
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Inform the clinical governance leads in their NHS trusts.
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Ensure that patients understand the uncertainty about the procedure's safety, including the risk of mesh erosion (for example, into the vagina) and the risk of recurrence, and provide them with clear written information. In addition, the use of NICE's information for the public is recommended.
1.3 Patient selection and treatment should only be done by specialists experienced in managing pelvic organ prolapse and urinary incontinence in women. Clinicians doing this procedure should have specific up-to-date training.
1.4 Clinicians should enter details about all patients having infracoccygeal sacropexy using mesh for vaginal vault prolapse repair onto an appropriate registry (for example, the British Society of Urogynaecology database) and the results of the registry should be published. All adverse events involving the medical devices (including the mesh) used in this procedure should be reported to the Medicines and Healthcare products Regulatory Agency.
1.5 Clinicians are encouraged to collect long-term data on clinical outcomes and patient-reported quality-of-life outcomes using validated scales. NICE may update the guidance on publication of further evidence.