As of 10 July 2018, NHS England has restricted the use of mesh for stress urinary incontinence (SUI) and pelvic organ prolapse surgery (POP). The “high vigilance restriction period” is in response to a number of recent well-publicised cases of patients reporting associated harm.
Paragraph 12 of the NHS communication advises: Pending the agreement of these high vigilance protocols, all cases should be postponed if it is clinically safe to do so. This excludes cases in which clinicians judge that there is clinical urgency to carry out the procedure, and no suitable alternative exists. Surgery should proceed if a delay would risk harm to the patient (such as for procedures involving cancer), based on a multidisciplinary team decision and informed consent.
The move by NHS England is reflective of the decision taken in Scotland in 2014 to instigate a similar suspension – which remains in place, and also adopts the same approach taken by the Department of Health in Northern Ireland and the Republic of Ireland.
Medical Protection advises all UK members who are considering using mesh to comply carefully with the requirements imposed on their NHS practice and, for maximum protection, take the same approach to their private practice.
Where mesh is the only viable option
If you consider mesh to be the only viable treatment option, you must:
- seek assurance across your Trust’s multidisciplinary team
- work within your competence
- seek informed consent from the patient – and fully document having done so
- follow relevant NICE interventional procedure guidance (IPG577, IPG581, IPG582, IPG583, IPG584, IPG599 and IPG608)
In the event of a complaint or claim regarding the management of patients with SUI or POP, you can request assistance from Medical Protection in the following circumstances:
- The patient’s care was delivered by an appropriately trained specialist gynaecologist, urologist or colorectal surgeon holding a substantive post at a specialist unit who maintains a multidisciplinary team approach, including in private practice, having fully explored all available non-operative and surgical options for the patient’s condition.
- The specialist member belonged at the time of their professional involvement to one of the following specialist societies: British Association of Urological Surgeons (BAUS), British Society of Urogynaecology (BSUG) or Association of Coloproctology of Great Britain & Ireland (ACGBI). The relevant professional guidance regarding patient selection and mesh use must have been followed.
- The specialist participated fully with reporting requirements (for example, MHRA, hospital clinical governance reporting systems, BSUG or BAUS databases, if relevant) and appraisal in relation to mesh use and management of mesh complications.
- There is evidence of informed patient consent, which includes explaining the potential risks and benefits of all available treatment options.
Where assistance is granted, this will only apply to the individual’s professional practice and does not extend to product liability.