Abstract

On the 10 July 2018, the UK Independent Medicines and Medical Devices (IMMD) safety review led by Baroness Cumberlege implemented a hiatus in the use of vaginal meshes for incontinence and prolapse because of concerns about complications. The use of vaginal mesh for prolapse has seen a natural decline over the past decade (Jha Int Urogynecol J 2018;29:795–801) with robust evidence available to suggest outcomes for native tissue repair are not significantly inferior to mesh-reinforced repair (Glazener Lancet 2017;389:381–92). However, there was considerable concern in relation to incontinence that patients would be exposed to more complex procedures with a greater complication rate because they would no longer have access to synthetic slings. The two synthetic sling procedures performed for stress urinary incontinence (SUI) are the tension-free vaginal tape (TVT) retropubic and the TVT obturator. Recently, these two devices have been referred to in the press interchangeably. The devices are made from identical mesh and are the same in their composition, size and the amount that is embedded in the patient, with similar success rates. However, that is where the similarity ends. So how did the two types of synthetic tapes become the Jekyll and Hyde of continence surgery? The Scottish review of the use of transvaginal mesh implants found greater adverse effects with obturator synthetic tapes than with retropubic tapes (https://www.gov.scot/publications/scottish-independent-review-use-safety-efficacy-transvaginal-mesh-implants-treatment-9781786528711/). The review also identified a greater need for repeat SUI surgery following the transobturator approach beyond 12 months. In addition, the number of cases under review for litigious reasons was three times greater in the obturator group than in the retropubic group. In the 2006 National Institute of Health and Care Excellence (NICE) clinical guidance (CG 40) on the management of urinary incontinence, there was only a brief mention of obturator tapes and the advice was to make women aware of the ‘lack of long term data’. When this guidance was updated in 2013 (CG 171), this advice remained unchanged. In the recent NICE consultation document published in October 2018, the advice is more directive: ‘do not offer a transobturator approach unless there are specific clinical circumstances (for example, multiple previous abdominal procedures) in which the retropubic approach should be avoided’. Obturator tapes were developed to reduce the risk of bladder injury but have been associated with groin pain and obturator neuropathies. These present as pain and restricted mobility of the thigh and hip adduction, along with sensory loss and pain across the anterior thigh. Foot drop is another rare presentation. However, the greatest problem with obturator tapes is the difficulty of complete removal, which is hampered by their placement deep in the obturator foramen, requiring dissection of the groin (usually by a plastic surgeon). In the largest series of vaginal mesh removals for all indications, the commonest type of mesh removed was the obturator tape for incontinence (Miklos Surg Technol Int 2016;29:185–9) and the removal of these meshes also had the highest complication rates. Clinicians who traditionally undertook obturator tape placement should be aware that even if the temporary ban is lifted, they will have to change their practice, as this procedure has acquired the mantle of Mr Hyde and will be off limits in most future circumstances. None declared. Completed disclosure of interests form available to view online as supporting information. Please note: The publisher is not responsible for the content or functionality of any supporting information supplied by the authors. Any queries (other than missing content) should be directed to the corresponding author for the article.

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