EUF-160; No. of Pages 4 EUROPEAN UROLOGY FOCUS XXX (2016) XXX–XXX

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Clinical Consultation Guide

How to Deal with Pain Following a Vaginal Mesh Insertion Konstantinos Giannitsas a, Elisabetta Costantini b,* a

Urology Department, Patras University Hospital, Patras University, Patras, Greece; b Urology and Andrology Clinic, Department of Surgical and Biomedical

Sciences, University of Perugia, Perugia, Italy

Over the past 20 yr, there has been a massive uptake of surgical mesh ‘‘kits’’ in urogynecologic surgery. A significant number of complications related to these kits was soon noticed, leading to the well-known 2008 and 2011 US Food and Drug Administration (FDA) warnings. These complications include injuries to the pelvic organs; infection; urinary problems; exposure or extrusion of mesh through the vaginal, bladder or urethral epithelium; and pain. What do we mean by ‘‘pain following a vaginal 1. mesh insertion’’? Postoperative pain is usually mild and self-limited after vaginal mesh surgery for either stress urinary incontinence (SUI) or pelvic organ prolapse (POP) and may occasionally require use of analgesics to increase patient comfort. Pain reported following mesh insertion merits special attention when it is severe or debilitating, becomes long term, or redevelops or worsens after a period with no or mild pain. Pain with such characteristics is discussed in this guide, with a primary focus on pain after mesh surgery for SUI. Pain following mesh-augmented POP surgery is also discussed. Pain following vaginal mesh insertion is quite variable: It can be spontaneous or provoked by vaginal examination, sexual intercourse (dyspareunia), or physical activity and can be localized in the vagina, vulva, groin or thigh, or buttocks or diffused in the pelvis. Chronic forms of sexual pain, including vulvar pain and its localized forms vestibulodynia and clitorodynia, may present in women following vaginal mesh insertion, but their complex pathophysiology has not been specifically linked to mesh surgery in the current literature.

A significant effort to classify pain and other complications related to vaginal mesh insertion has been done with the joint International Urogynecological Association and International Continence Society report [1]. In a very recent report of 445 women who underwent surgical removal of sling, transvaginal mesh, and sacrocolpopexy for meshrelated complications [2], the most common complication categories, according to the above mentioned report, were spontaneous pain (1Be: 32.5%) and dyspareunia (1Bc: 14.7%), without any vaginal epithelial separation. Unfortunately, this terminology is not always adopted, and the term pain is generically used. How common is pain after a vaginal mesh 2. insertion? The prevalence of pain following vaginal mesh surgery decreases with time. In a systematic review and metaanalysis of the effectiveness and complications of suburethral sling procedures for the treatment of SUI [3], pain was present in 16% of the patients at 2 mo but in only 3% at 1 yr after surgery. Chronic pain, conventionally defined as pain persisting >6 wk, is not common. A significant consideration in the epidemiology of pain following vaginal mesh insertion is whether pain is isolated or combined with other complications, especially mesh exposure or infection. This differentiation has profound implications for the presumed pathophysiology and, consequently, management of the condition. It appears that pain more commonly accompanies other complications, mesh exposure in particular, and its incidence is higher in vaginal mesh POP repairs compared with suburethral sling procedures [4].

* Corresponding author. Urology and Andrology Clinic, Department of Surgical and Biomedical Sciences, University of Perugia, Perugia, Italy. Tel. +39 075 5783743; Fax: +39 075 5784416. E-mail address: [email protected] (E. Costantini). http://dx.doi.org/10.1016/j.euf.2016.04.011 2405-4569/# 2016 European Association of Urology. Published by Elsevier B.V. All rights reserved.

Please cite this article in press as: Giannitsas K, Costantini E, How to Deal with Pain Following a Vaginal Mesh Insertion. Eur Urol Focus (2016), http://dx.doi.org/10.1016/j.euf.2016.04.011

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Next we try to focus on the pathophysiology and management of pain as an isolated complication. 3.

Etiology and pathophysiology of the pain

The etiopathogenesis of pain as an isolated complication after a vaginal mesh insertion is not well understood. Endopelvic hematoma formation, infection, nerve injury, and muscle injury from inappropriately positioned mesh have been implicated as etiologic factors in cases in which no mesh exposure or pelvic organ injury was detected. The finding of postoperative hematoma formation on imaging in some cases has suggested a possible etiologic relation, but magnetic resonance imaging studies have demonstrated similar pain scores in patients with and without hematoma, thus challenging the association [5]. Infection may contribute to pain etiology, and evidence suggests that it may be present even in cases in which it is not clinically apparent [6]. In a large series of tape excision due to pain [7], an abnormal tape position was demonstrated in as many as 88% of cases of midurethral slings: The tape was in the levator ani, in the bladder wall but not through the mucosa, or directly affected the obturator nerve. The authors noted that obturator nerve lesions were more frequently due to a ‘‘myofascial syndrome,’’ with muscle hypertonia induced by passage of the tape through the muscle rather than due to direct injury of the nerve by the tape. This theory of direct or indirect nerve damage is in accordance with the clinical observation of, for example, higher risk of groin or thigh pain with transobturator slings compared with retropubic or single-incision slings [3,8]. A special type of mesh-related complication characterized by severe and debilitating pain is mesh contraction. This condition, previously described after laparoscopic intraperitoneal onlay mesh, appeared in the urogynecologic literature in 2010 [9] and is also referred to as vaginal scarring/shrinkage in the 2011 FDA warning. It is characterized by severe pelvic pain and dyspareunia, whereas on clinical examination, there is focal or diffuse tenderness, increased mesh tension, or the presence of prominent mesh bands under the vaginal mucosa. Whether this is due to true in vivo mesh shrinkage or inappropriate tensioning of the mesh that creates folds during insertion it is not well understood. 4. Management of pain following a vaginal mesh insertion The first step in dealing with pain is to understand its pathophysiology. A thorough evaluation of the patient aiming primarily at detecting any concomitant complications is mandatory. A careful physical examination, endoscopy of the lower urinary tract, and imaging of the pelvis usually suffice to exclude or diagnose such complications. If they are detected, they should be managed accordingly. In the absence of other complications, pain can be attributed to mesh insertion. Unfortunately, on most occasions, the best proof of a link between the tape and the pain is time: Pain appears soon after mesh insertion and persists.

4.1.

Conservative management

Pain management is initially conservative with oral analgesics, either anti-inflammatory drugs or opioids. Local anesthetics and steroids have shown efficacy in small series or case reports [10], and transcutaneous electrical nerve stimulation has been used to control pain and reduce analgesic requirements [11]. 4.2.

Surgical management (partial or complete removal of

mesh)

Surgical removal of the mesh material is a treatment option whenever pain is attributed to its presence. Nevertheless, questions regarding the time, approach, and technical details of the intervention have not been adequately addressed. As far as time of intervention is concerned, early mesh removal could, at least theoretically, avoid nerve sensitization and neuropathic sequelae. Another reason for early removal would be the lack of fibrosis formation postoperatively, which would permit easier removal of the material. An argument against early removal is the spontaneous resolution of pain in the majority of patients initially reporting it. Another important question is whether to remove the entire mesh or just part of it. As a general rule, when pain is localized and provoked, partial removal of the mesh or even dissection around and loosening of the mesh may be efficacious, especially when another complication such as exposure is present. Nevertheless, in the majority of cases, complete removal is attempted for persistent spontaneous pain. Route of access depends heavily on how much mesh needs to be excised. The suburethral portion of the sling can be accessed vaginally with a midline or inverted U incision. Groin or thigh incision is used to remove the lateral part of the mesh in transobturator slings. Laparoscopy represents an excellent option for accessing mesh in the retropubic space. In many instances, multiple operations are required to achieve complete mesh removal. Meticulous technique is important to avoid further tissue and nerve damage. 4.3.

Results of mesh removal

One of the first large series of tape excision [7] included 32 patients who originally had a transobturator tape (TOT; n = 15) or tension-free vaginal tape (TVT; n = 17). All patients had chronic pelvic pain, refractory to standard treatments, as an isolated complication. Decision for tape removal was based on a consensus concerning the potential role of the suburethral tape in the pathogenesis of pain. In the TVT group, the tape was removed laparoscopically, whereas the TOTs were removed via a transvaginal approach with unilateral or bilateral extension into the thigh. Sixty-eight percent of patients showed >50% improvement in pain on a visual analog scale (0–10). Mean visual analog score before surgery was 7.3 (standard deviation [SD] 1.5), and after surgery this figure decreased to 3.4 (SD 3). The effect of pain was immediate, but no further improvement was noted. Recurrence of incontinence was observed in 22% of cases.

Please cite this article in press as: Giannitsas K, Costantini E, How to Deal with Pain Following a Vaginal Mesh Insertion. Eur Urol Focus (2016), http://dx.doi.org/10.1016/j.euf.2016.04.011

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Table 1 – Summary of mesh revision and excision trials reporting on pain outcomes Publication

n

Mesh inserted

Reason for removal

Surgical technique

Pain outcome Cured

Hammett et al. [13]

57

Unger et al. [14]

52

Crosby et al. [15]

84

Hou et al. [16]

Agnew et al. [17] Danford et al. [18] Feiner and Maher [9]

123

47 233 17

26 midurethral slings, 23 vaginal (POP), 9 mesh sacrocolpopexy Any mesh for POP or SUI Various mesh kits for POP repairs 69 prolapse kits, 54 suburethral slings Variety of suburethral slings 80% sling, 20% sling and prolapse Prolift, Perigee, Apogee

SUI or POP recurrence

Improved

Other

Mesh exposure; 55,6% had chronic pelvic pain

Complete removal





95% complete or partial resolution

NR

Mesh complications; 30 had pain Mesh complications; 59 with pain (not isolated) Pain

Revision or excision As much as possible



63%

NR





7% no change, 30% worse 51% persistence

NR

Partial removala

67% (mesh), 81% (slings)b





NR

83% extrusion with or without pain, 17% pain Pain

49% complete removal Revision or excision Partial or total (3 of 17)

100%





29%c



73%

NR



88% vaginal pain, 64% dyspareunia

No change 19%, worsening 8% –

Mesh contraction

1 POPd

NR = not reported; POP = pelvic organ prolapse; SUI = stress urinary incontinence. Pain free status defined as visual analog scale (0–10) score 0. For suburethral slings, lateral arms in the obturator or suprapubic space were left intact. For prolapse, as much as possible was removed transvaginally. c 29% of those who did not have concomitant anti-incontinence procedure. d After complete mesh removal. a

b

At the same time as the above-mentioned trial, a series of complete laparoscopic TVT removal reported a 67% incontinence recurrence rate [12]. Since then, the number of publications on the efficacy of mesh removal in alleviating symptoms related to mesh complications has been steadily increasing. High percentages of pain improvement are reported. Unfortunately, pain is usually reported in association with other complications,

complete or partial mesh removal is attempted to treat these complications at surgeons’ discretion, different means of assessing and reporting pain are used, and recurrence of POP or SUI is not always evaluated. As a result, grouping of these series is not feasible. The largest series of mesh removal reporting on pain published in the last 2 yr are summarized in Table 1 [9,13–18].

Fig. 1 – Proposed algorithm for the management of pain following vaginal mesh insertion.

Please cite this article in press as: Giannitsas K, Costantini E, How to Deal with Pain Following a Vaginal Mesh Insertion. Eur Urol Focus (2016), http://dx.doi.org/10.1016/j.euf.2016.04.011

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5.

Conclusions

[6] de Tayrac R, Letouzey V. Basic science and clinical aspects of mesh infection in pelvic floor reconstructive surgery. Int Urogynecol J

The management of chronic pain after vaginal mesh insertion is complex, and no consensus has been reached. Surgical removal of the mesh offers complete or partial resolution of pain in the majority of cases, but the best time, route of access, and completeness of removal are factors that merit further investigation. A simplified algorithm for the management of pain related to mesh insertion is presented in Figure 1. In difficult cases, a multidisciplinary pain management approach is advised to reduce distress and disability, resulting in an improvement in quality of life. Conflicts of interest: The authors have nothing to disclose.

2011;22:775–80. [7] Rigaud J, Pothin P, Labat JJ, et al. Functional results after tape removal for chronic pelvic pain following tension-free vaginal tape or transobturator tape. J Urol 2010;184:610–5. [8] Mostafa A, Lim CP, Hopper L, Madhuvrata P, Abdel-Fattah M. Singleincision mini-slings versus standard midurethral slings in surgical management of female stress urinary incontinence: an updated systematic review and meta-analysis of effectiveness and complications. Eur Urol 2014;65:402–27. [9] Feiner B, Maher C. Vaginal mesh contraction: definition, clinical presentation, and management. Obstet Gynecol 2010;115:325–30. [10] Roth TM. Management of persistent groin pain after transobturator slings. Int Urogynecol J Pelvic Floor Dysfunct 2007;18:1371–3. [11] Hazewinkel MH, Hinoul P, Roovers JP. Persistent groin pain following a trans-obturator sling procedure for stress urinary incontinence: a diagnostic and therapeutic challenge. Int Urogynecol J

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Please cite this article in press as: Giannitsas K, Costantini E, How to Deal with Pain Following a Vaginal Mesh Insertion. Eur Urol Focus (2016), http://dx.doi.org/10.1016/j.euf.2016.04.011

How to Deal with Pain Following a Vaginal Mesh Insertion.

Pain as an isolated complication of vaginal mesh insertion is uncommon, and its pathophysiology not well understood. Management is complex and involve...
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