Presentation and management of major complications of midurethral slings: Are complications under‐reported?

Deng, Donna Y.; Rutman, Matthew P.; Raz, Shlomo; Rodríguez, Larissa V.

doi:10.1002/nau.20357

Cited by 222 publications

(146 citation statements)

References 37 publications

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“…Although TVT has become one of the most popular continence operations worldwide because of its efficacy, safety, and the low recurrence rate, major complications such as bowel injury and vascular injury have been reported. 2 Since those complications can be fatal, TOT has been developed to prevent them.…”

Section: Urinary Stress Incontinencementioning

confidence: 99%

“…It also revealed 32 cases of vascular injury, two of them fatal. 2 When major complications were defined as bladder perforation, urethral perforation, nerve injury, and sepsis, in addition to bowel injury and vascular injury, they accounted for 20% of the complications of midurethral slings in the MAUDE database. However, according to published reports, major complications of midurethral slings accounted for 5.2% of all complications, and there were no reports of fatalities.…”

Section: Urinary Stress Incontinencementioning

confidence: 99%

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Female urology: What method will you select?

et al. 2009

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When I was a resident, my leader taught me that the gold standard for patients with stress incontinence is the Marshall-Marchetti-Krantz (MMK) procedure. But a few years later, urologists who could perform advanced techniques showed me needle suspension as the best method at a urological meeting. Fortunately my boss gave me a chance for a hand-to-hand lesson of the stamay procedure by the specialist. Since then, I have been selecting this procedure for a few years. Without doubt, this needle suspension was the gold standard at that time.But now most urologists do not select this technique because of bad results. After I had mastered the technique of tension-free vaginal tape (TVT), I could see the smiling faces of patients after the operation. At that time I believed that TVT would be the gold standard for this condition. But the present status is what you know.Recently most specialists, including myself, believe that using 'mesh' is the best operation for patients with pelvic organ prolapse. Is this tendency good for the patients in the long run? No one can predict the results of this procedure more than ten years from now.God knows what procedure will be the gold standard in the future. Urinary stress incontinenceIs transobturator tape the first choice for surgical treatment of stress urinary incontinence?Transobturator tape (TOT), which was introduced by Delorme 1 in 2001 after the introduction of tension-free vaginal tape (TVT) by Ulmsten in 1996, is also a minimally invasive midurethral sling procedure for stress urinary incontinence (SUI). Although TVT has become one of the most popular continence operations worldwide because of its efficacy, safety, and the low recurrence rate, major complications such as bowel injury and vascular injury have been reported.2 Since those complications can be fatal, TOT has been developed to prevent them.A systematic search of the United States Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience Database (MAUDE), which monitors voluntary reporting of complications of the use of devices in midurethral slings, revealed 33 cases of bowel injury (4.7%), six of them fatal, among 700 major complications following the use of TVT. It also revealed 32 cases of vascular injury, two of them fatal.2 When major complications were defined as bladder perforation, urethral perforation, nerve injury, and sepsis, in addition to bowel injury and vascular injury, they accounted for 20% of the complications of midurethral slings in the MAUDE database. However, according to published reports, major complications of midurethral slings accounted for 5.2% of all complications, and there were no reports of fatalities. In other words, reports of complications have not been made compulsory, and since they are the result of self reports, the complications we were able to learn about from the published reports seem to be the tip of the iceberg in terms of the actual numbers that have occurred. TVT is passed retropubically in a blind manner, whereas TOT is passed via a la...

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Section: Urinary Stress Incontinencementioning

confidence: 99%

Section: Urinary Stress Incontinencementioning

confidence: 99%

Female urology: What method will you select?

et al. 2009

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“…In a meta-analysis of complications reported in 1854 patients, bladder perforation was most common, occurring in 3.5% of retropubic sling insertions and in 0.2% of procedures using the transobturator route [3], although incidences as high as 24% have been reported [4]. Although it has been stated that bladder perforation only occurs during the 'outside-in' technique [2,5], there is at least one report to the contrary [6] and it appears likely that complications are under reported [7].…”

Section: Discussionmentioning

confidence: 99%

“…Several authors have described their approach to this difficult problem (Table 2) [7,11,[18][19][20][21][22] and the approach remains guided by the locally available expertise. For intravesical tape and attendant bladder stone, an open cystotomy may be performed [14,21,[23][24][25].…”

Section: Discussionmentioning

confidence: 99%

Unrecognized bladder perforation with mid‐urethral slings

2010

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Study Type – Therapy (case series) Level of Evidence 4OBJECTIVETo present a series of women with late presentation of mid‐urethral synthetic slings perforating the bladder and their management, this is rare but can lead to significant morbidity with medico‐legal consequences.PATIENTS AND METHODSWe retrospectively reviewed the case notes of nine women with urinary symptoms referred to our unit for further investigation after synthetic mid‐urethral sling placement.RESULTSThe women presented between 8 weeks and 18 months after initial sling placement. Eight patients underwent a tension‐free vaginal tape insertion via the retropubic route and one patient had an ‘outside‐in’ obturator sling with the I‐Stop device (CL Medical, Lyon, France). The frequencies of presenting symptoms were: dysuria in six; recurrent urinary tract infection in four; frequency and urgency in four and pelvic pain in two. Seven of the nine women developed bladder calculi on the exposed sling material, all of which were visible on plain X‐ray. In six women, perforations were present at more than one site; in three urethral perforation had occurred together with an anterolateral bladder injury and in the remaining three there was bilateral bladder perforation. Initial management included cystoscopy and cystolithopaxy followed by transurethral resection (TUR) of the visible prolene mesh into the detrusor muscle. One woman required two TURs to clear all the mesh. Two women required further open surgery to remove all of the remaining mesh, both for ongoing pelvic pain that resolved after revision surgery. All the women had resolution of symptoms but all had recurrent stress urinary incontinence after tape division/excision. We used a novel technique to remove intraurethral mesh using a nasal speculum urethrally and excising the tape under direct vision, where resection proved impossible due to poor endoscopic views, with significant risk of sphincter injury.CONCLUSIONSThe possibility of unrecognized tape perforation or erosion must be considered in women with persistent urinary symptoms, infection or pain after any form of mid‐urethral sling procedure. Bladder stones almost invariably develop if the exposed mesh has been present for >3 months. Most patients can be managed with endoscopic resection to remove all intravesical tape. Cystoscopy should remain a mandatory procedure together with any form of mid‐urethral sling placement but does not prevent unrecognized perforations in inexperienced hands.

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“…Societies should play a major role working on guidelines, defining minimum follow-up before publishing the initial series of patients, selecting acceptable studies, and stimulating publications of data, including complications [8].…”

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confidence: 99%