It is clear that at present there is much media and public interest in the use of mesh in pelvic floor surgery. Most of the attention has been directed at the gynaecological use of synthetic mesh in the vagina for stress urinary incontinence (SUI) and vaginal prolapse. As a result Baroness Cumberledge, at the request of the CMO, is at present undertaking a review of the use of mesh in pelvic floor surgery.
There is no doubt that the use of mesh (including mesh rectopexy for obstructed defaecation and prolapse) does carry a risk and a minority of patients have been severely affected by complications related to the use of mesh, namely; pain, erosions and fistulation.
Given the magnitude of some of the symptoms caused in women with complications following surgery the attached report calls for an immediate restriction in the use of mesh in surgery for vaginal prolapse and SUI. It does not at present include restricting the use of mesh for rectopexy.
There are recommendations for the safe use of mesh in rectopexy surgery, classified under the category of “high vigilance”. These recommendations mirror the existing advice from the Pelvic Floor Society in the position statement on the use of mesh in rectal prolapse surgery, which can all be found on the website; www.thepelvicfloorsociety.co.uk
The following interventional procedure has been issued by NICE:
At present we would strongly advise any surgeon wishing to perform mesh rectopexy for either obstructive defaecation or rectal prolapse to follow the advice below;
- Become a member of the PFS (if not already one), to have full access to all resources and support from the society.
Free to join if a member of the ACPGBI details on website or contact secretary Karen Telford
- Only operate on patients who have maximised conservative treatment for their condition and who have been discussed in an MDT forum.
- Provide adequate written and verbal information on all surgical and non/surgical options (leaflets available on PFS website)
- Allow enough time for full valid consent (enhanced consent document available on PFS website)
- Enter ALL cases on prospective VMR database, hosted through PFS (for log in details and registration contact Shahab Sidiqi [email protected] )
- Document compliance with all of the above
- Report any mesh complications to MHRA –via yellow card system www.gov.uk/report-problem-medicine-medical-device
Rest assured that the Pelvic Floor Society on behalf of the ACPGBI has already put in place all “high vigilance” requirements to support members of the ACP at this difficult time for surgeons involved in pelvic floor surgery.
Please disseminate to any non-ACPGBI colleagues you think might be interested in the guidance.
Andrew Williams, Chair PFS
Brendan Moran, President, ACPGBI
Please see this document which includes a letter from NHS England and NHS Improvement’s medical directors, Clinical Advisory Group recommendations and actions to be taken in regards to use of synthetic mesh/tape.