Mesh in Prolapse Surgery



Fig. 16.1
Perigee system



In response to safety concerns raised by the US Food and Drug Administration (FDA) advisory statement [6, 7], first-generation mesh kits that involved relatively blind needle passes, resulting in uncommon but serious neurovascular complications, were modified in search of safer alternatives. The second-generation mesh kits use a single vaginal incision for both dissection and introducing the mesh device. These mesh kits use trocar-less delivery systems and lighter meshes and include the Elevate™ system (American Medical System) (Fig. 16.2) and Pinnacle™ (Boston Scientific). These mesh devices obviate the need to use blind needle pass and thereby reduce complication rates related to insertion.

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Fig. 16.2
Elevate system


Principles in Mesh Repair


The first principle in mesh repair is the recognition that in most cases, POP can be treated successfully without mesh, thus avoiding the risk of mesh-related complications. Mesh surgery is chosen only after weighing the risks and benefits of surgery with mesh versus all surgical and nonsurgical alternatives [68]. The specific technique with each of the mesh kits is beyond the scope of this chapter, but the general guiding principles are discussed below.

Appropriate positioning of the patient is important to have adequate access for needle insertions and movement of trocars. It is incumbent on the surgeon to ensure correct patient positioning. There are no requirements for any special instruments and it is preferable to keep instrumentation simple and to bare minimum. Usually, a Scott retractor or the Lone Star retractor is helpful.

With trocar-based kits, it is good practice to mark the surface anatomy of the obturator foramen, adductor longus tendon, pubic tubercle, ischiopubic ramus and ischial tuberosities before the incision. Additionally, it is useful to mark the bladder neck. Incising below the bladder neck potentially reduces the incidence of postoperative voiding dysfunction. In addition, a gynecologic pelvimetry helps to assess the subpubic angle for adequacy of access and the accessibility of the ischial spines and the sacrospinous ligaments. These are the important landmarks that need to be identified prior to any kind of pelvic floor reconstruction.

Procedure usually starts with hydrodissection with local anesthetic (Marcaine 0.5 %) mixed with diluted epinephrine (1 in 200,000). This helps in developing the natural avascular tissue plane and facilitates full-thickness vaginal dissection. Fluid in the space between the viscus and vaginal wall helps to define the correct plane of dissection (Fig. 16.3). A combination of sharp and blunt dissection carried out in this plane ensures the fascia is left attached to the vaginal wall rather than to the viscus [9]. This ensures that the mesh lies directly in apposition with the prolapsing organ, reducing the chance of vaginal mesh extrusion.

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Fig. 16.3
Hydro-dissection and site of incision

Anchorage of the mesh to a strong pelvic floor support is pivotal to the success of mesh replacement surgery. The sacrospinous ligament fulfills the role of an “anchor,” being relatively avascular, sturdy, with a fixed anatomical location and a well-circumscribed boundary, identifiable even in obese women. The sacrospinous ligament is approached anteriorly in mesh kits and this requires some degree of relearning and is a key skill in mesh repair [10]. To ensure a “four-point anchorage” in the anterior compartment, the needle is inserted through the obturator internus muscles and sacrospinous ligaments on either side, essentially mimicking the original “arcus-to-arcus” support of fascial bladder hammock. Intraoperative cystourethroscopy should be performed as a part of the standard operating protocol to detect inadvertent needle injury or mesh placement.

In posterior mesh placement, needle is inserted via incisions posterior to the anus, passed through ischiorectal fossa and directed towards the ischial spine to be anchored to the sacrospinous ligament complex. Rectal examination is done to rule out rectal injury, following trocar insertion and repeated at the end of the surgery.

It is recommended the mesh is trimmed to the size of the prolapse (Fig. 16.4) and placed in a “tension-free” manner. This reduces the risk of pain-related complications with mesh contracture. There is no need to excise vaginal skin prior to vaginal closure in mesh surgery. Minor trimming for purposes of aligning the edges is acceptable. A two-layered vaginal closure can make vaginal mesh exposure less likely and reduce dead space preventing hematomas. (Rane A., personal communication, 2010).

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Fig. 16.4
Mesh trimmed to correct “dose”

At the end of the mesh repair, there may be considerable residual laxity of the vaginal skin unlike in native tissue repairs. This in fact denotes appropriate mesh tensioning [9, 11, 12]. Mesh surgery factors in the concept of “vaginal remodeling” that allows surrounding tissues to restructure in much the same way as the vagina involutes following vaginal birth [11].

The major issue with mesh repair is its use without adequate training. Proper training in the use of mesh devices is ideally a three-staged procedure: didactic training and cadaveric workshops, followed by preceptor training at the trainer’s operating facility, and finally proctoring at the trainee’s own hospital. Reference to the local college/Urogynecological society guidelines will ensure ongoing training, quality control, audit, and peer review. It is also important that mesh surgery be performed as per protocol established by the manufacturer, as any deviations from the accepted technique can cause complications and is medicolegally indefensible.


Surgical Outcomes


Several initial prospective and retrospective cohort studies using mesh kits, showed good anatomical success rates in the range of 80–100 % with follow-up over 3–24 months [1317]. Studies with medium- and long-term follow-up and randomized controlled trials (RCT) comparing mesh versus fascial repair, showed variable results. In an one year RCT, comparing objective outcomes of mesh versus fascial repair of all compartments, there was an overall recurrence of 63 % in mesh compared to 70 % with no mesh. Most recurrences occurred in the anterior compartment – 46 % in mesh and 60 % with native tissue [18]. In a RCT comparing anterior colporraphy with mesh, objective assessment at the end of a year showed a success rate of 61 % with mesh and 35 % with colporraphy [19]. Other RCTs comparing the mesh with standard colporraphy have shown failure rates in the range of 9–28 % with mesh [20, 21]. In one long-term outcome analysis of vaginal mesh with native tissue repair in the anterior compartment, the 5-year cumulative risk of any repeat surgery was significantly higher for vaginal mesh, 15.2 % compared to 9.8 %, but risk of surgery for recurrent prolapse was similar [22]. In the posterior compartment, fascial repairs have been shown to give excellent results and there is no evidence to support the use of mesh in posterior repair [23].

The secondary outcomes of cohort studies and RCTs started to highlight the complications rates with mesh. In the RCT by Sokol et al., mesh exposure was reported in 15 % and no statistically significant difference between mesh and native tissue with respect to new-onset dyspareunia [18]. In the study by Altman, the rates of bladder perforation and intraoperative bleed were higher in the mesh group, with mesh exposure rate of 3.2 % [19]. It was the complication profile with mesh repair, lack of evidence for optimal management of these complications and long-term sequelae related to mesh complications that constrained its use. In view of the increasing concerns about mesh-related complications, the US FDA issued statements related to mesh use in prolapse surgery [6, 7].



Complications of Mesh Surgery



Intraoperative



Cystotomy and Urethral Injury


If cystotomy occurs during dissection and is central and accessible, repair of it does not pose a problem. A single- or two-layered closure with 2/0 polyglactin should suffice and a layer of fascia could be interposed over the cystotomy to bolster the repair. It would be usual to continue with the dissection; however, opinion is divided on whether it would be safe to use mesh after a cystotomy. Some surgeons argue that a “clean” midline cystotomy, if adequately repaired, does not contraindicate mesh placement [24]. Most surgeons however would defer mesh in this scenario. More commonly cystotomies occur in the lateral “tunnels” while accessing the sacrospinous ligaments and lateral pelvic wall. Risk is increased in patients with previous surgery and almost always due to improper surgical techniques. These cystotomies are difficult to repair, and the consensus in such cases would be to avoid using mesh and resort to a fascial repair instead. Urethral trauma by needles may occur with the upper needle passes into the obturator foramen with mesh kits. Performing an intraoperative cystourethroscopy is the only reliable method of detecting this complication.


Rectal Injury


If rectal/anal injury was encountered during dissection, standard practice would dictate repair of the laceration and abandonment of mesh repair. A standard fascial repair should be considered in these patients. Rectal injury if unrecognized can lead to rectovaginal fistula.


Fornix Tear


Forniceal puncture is not unusual in women with deep lateral fornices and results during the passage of the anchors into the obturator internus muscle. Creating an adequate subcutaneous tunnel along the length of the fornix, until the ischiopubic ramus reduces this risk. The technique of directing the needle posteriorly along the length of the tunnel before changing direction under the ramus also helps. If fornix tear is identified after the passage of the anchor/mesh, it is reasonable to undermine the vaginal skin at the site of puncture and close vaginal skin over the mesh.


Bleeding


Brisk bleeding can be encountered during dissection, after mesh insertion or while deploying the anchor. Sustained pressure with a pack and gauze usually suffices, as it is usually a venous bleed. In rare occasions, using hemostatic agent like FlosealTM (Baxter, IL) may be needed. Retroperitoneal hemorrhages with large hematoma have been reported with transvaginal mesh surgeries [25]. If a major vessel laceration is suspected, help from a vascular surgeon or an interventional radiologist may be indicated. Heavy bleeding from the iliac vessels can be life-threatening, necessitating a laparotomy and surgical vascular control.


Late Complications



Vaginal Mesh Exposure


Vaginal mesh exposure occurs in about 13–15 % of cases [18, 24]. The mean timing of exposure is around 234 days (range of 45–1040 days) [26]. Mesh exposure risk is not limited to vaginal mesh placement and has been reported with mesh use in abdominal sacrocolpopexy (ASC) as well. With anterior mesh, the risk of exposure is 9 %, with posterior mesh 8 % and with ASC risk is around 3 % [26]. The risk of vaginal mesh exposure is higher if the mesh is sutured vaginally during sacrocolpopexy [24]. Vaginal mesh exposure is possibly a healing abnormality when it occurs early, along the suture line and with no signs of infection. It can also be detected in the lateral vaginal wall or fornices. In a proportion of patients where mesh exposure is small (<0.5 cm) and asymptomatic, it can be managed with vaginal estrogen with or without mesh excision as an outpatient procedure. The vast majority, however, need to be reoperated with excision of mesh and fascial repair over the defect. Reoperation rate for mesh exposure is quoted between 8 and 36 % [24].


Visceral Mesh Extrusion


Bladder, urethral and rectal mesh extrusions have been reported after both vaginal mesh surgery and ASC. Bladder extrusion can present with hematuria, recurrent UTI, pain or fistula. Patients who have constant urinary or fecal incontinence immediately after surgery should be evaluated for vesicovaginal or rectovaginal fistula. Treatment involves removal of the entire mesh from the viscus, repair of the visceral defect and closure of vaginal defect. This can be done vaginally, but more often an open abdominal approach is needed. Laparoscopic and cystoscopic transurethral removals have been reported and the important principle is to remove the mesh completely. Urethral erosions are managed with urethrolysis, graft explanation and multilayer closure with Mauritius flap reinforcement.


Pain


The most troublesome and concerning complication of mesh is the pain resulting from contraction and/or hardening of the mesh, leading to dyspareunia and chronic pelvic pain. Feiner et al. defined mesh contraction as an adverse outcome following polypropylene mesh repair where patients experience vaginal pain with movement and dyspareunia [27]. Contraction typically occurs along the fixation arms of the mesh and rarely does the entire implanted mesh contracts. On examination, patient can have localized areas of prominent, tense and tender mesh under the vaginal epithelium. The reported rate of polypropylene mesh-related pain, ranges between 4 and 11 % according to the definition used [24].

Management usually involves meticulous history taking, mapping of the pain with accurate charting of the trigger points and extensive counseling. In-office trigger-point injection of bupivacaine with triamcinolone is useful to accurately identify the location of pain that is causing dyspareunia. After injection, the patient is asked to return home and resume sexual intercourse. If dyspareunia diminishes, surgical removal of the involved mesh segment is likely to ameliorate symptoms. If dyspareunia persists after injection, the problem may not be related to the mesh. This can be helpful in counseling the patient prior to mesh excision.

Mesh contraction should be managed by a surgeon who is experienced in extensive deep pelvic dissection, which is necessary to remove the mesh arms. Complete excision of mesh should be attempted only by experienced surgeons. The most troublesome segments can be excised with full-thickness vaginal dissection. Symptomatic relief is noted in over 90 % of patients, but sadly a few patients may never be cured completely [27]. Therefore, it is essential that women are adequately counseled before primary surgery and particularly prior to reoperation to treat complications.

Diffuse vaginal pain after mesh implantation is unusual and in these patients, the report of pain has been preceded by an underlying pelvic pain syndrome. Management of such pain is controversial and many patients may not be cured even after the entire graft is removed. An existing pelvic pain syndrome should ideally be elicited in patients where mesh repair is considered.

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Jul 5, 2017 | Posted by in UROLOGY | Comments Off on Mesh in Prolapse Surgery

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