Minimally Invasive Therapy for Urinary Incontinence and Pelvic Organ Prolapse (Current Clinical Urology) 2014th

18. Pelvic Organ Prolapse: Anterior Compartment—Kits and Customised Repairs

Ajay Rane1 and Jay Iyer1

(1)

Department of Obstetrics and Gynaecology, James Cook University, Townsville, QLD, Australia

Abstract

Genital prolapse requiring surgery occurs roughly in one in ten women. The majority of these surgeries occur in the anterior compartment which is very vulnerable to recurrences. Primary surgery can itself prove problematic because the majority of cystoceles are treated with ‘standard’ midline fascial plication repairs in contrast to the anatomical defects which can be diverse in location (lateral paravaginal, midline fascial or apical). It is little surprise that in the 2001 study published by Weber et.al. comparing three different anterior repair procedures with a 23-month follow-up [1] reported up to a 70 % failure rate after a ‘standard’ anterior repair.

Introduction

Genital prolapse requiring surgery occurs roughly in one in ten women. The majority of these surgeries occur in the anterior compartment which is very vulnerable to recurrences. Primary surgery can itself prove problematic because the majority of cystoceles are treated with ‘standard’ midline fascial plication repairs in contrast to the anatomical defects which can be diverse in location (lateral paravaginal, midline fascial or apical). It is little surprise that in the 2001 study published by Weber et.al. comparing three different anterior repair procedures with a 23-month follow-up [1] reported up to a 70 % failure rate after a ‘standard’ anterior repair.

A robust anterior compartment repair should have the potential to support midline, paravaginal and apical portions of the anterior fascial hammock that support the urinary bladder. Cystocele repairs have traditionally been performed vaginally as these operations are inherently difficult to perform laparoscopically or transabdominally. Midline fascial plication repairs have never been reported via the abdominal route. It is important to appreciate that the results of both ‘augmented’ mesh repair (mesh overlay) and mesh ‘replacement’ (needle kit) grafts are typically encouraging in the short term and only studies with longer than a year’s follow-up reveal the true picture [2].

In view of the high rates of post-operative recurrence with fascial and mesh overlay repairs, there was a genuine need felt to design an operation that could effectively address all ‘parts’ of the anterior hammock with or without the use of graft. This led to the invention of the needle-driven kits like PERIGEE™ (American Medical Systems, MN; Fig. 18.1). The idea was to use helical needles through the obturator foramen and place a new hammock that would effectively address multiple defects in the fascial hammock. Anterior PROLIFT™ (Johnson and Johnson, NJ) worked on a similar principle.

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Fig. 18.1

Perigee system

Indications: Symptomatic/Voiding Dysfunction

The main indication for an anterior repair should be a symptomatic prolapse POP-Q stage 2 or greater. We use mesh kits in our unit only for stage 3 and 4 cystoceles and mainly for recurrences. We tend to avoid use of grafts in smaller cystoceles principally because the defect is small and dissection to the sacrospinous ligament is technically difficult predisposing to cystotomy and bleeding complications. In addition the precut mesh is typically large in surface area relative to the size of the prolapse, which may lead to bunching of mesh edges and symptomatic post-operative complications like mesh exposure and mesh-related pain. A smaller prolapse also indirect indicates partially intact fascial support and is typically best treated with a fascial repair.

Case Selection: Stage 3 and 4 Cystoceles and Recurrences

Cases for mesh repairs should be selected carefully. It is important that a conscious effort be made to ensure that the leading edge of the prolapse is beyond the level of the hymenal ring. We avoid the use of mesh in patients with previous irradiation, in poorly controlled diabetics and patients on high-dose immunosuppressants or corticosteroids. There is a small group of patients who do not want ‘foreign material’ used in their repairs—such patients should never be subjected to a mesh repair.

Special Instruments/Retractors/Suture Materials

In our unit we tend not to use elaborate surgical equipment for either conventional surgery or for transvaginal mesh kit repairs. A Scott retractor is usually very handy. Although in recent times there has been a tendency to use the Lone Star™ Retractor System (Cooper Surgical, CT) for complicated vaginal repairs and mesh surgery, it is our practice to keep instrumentation simple and to a bare minimum. Apart from tissue holding forceps, sharp dissecting scissors and a good needle holder we do not insist upon any other special surgical tools. We also use standardised sutures and closure techniques. Our preference is to use 2/0 Vicryl for vaginal closure after all repairs, reserving 2/0 PDS for fascial repairs and mesh anchoring stitches.

Anaesthesia

The surgical time for most anterior compartment vaginal surgeries is around 30 min hence general anaesthesia is our preferred option. Surgeries under a spinal anaesthetic usually mandate the post-operative placement of an indwelling catheter, which delays our algorithmic ‘trial of void’ protocol and makes it problematic to ensure an ambulatory day surgery ethos [34].

Positioning of Patient: Lithotomy

It is important that the surgeon either supervises or personally arranges the patient position. The use of hydraulic gas-aided stirrups makes adjusting patient position easier but also can lead to an asymmetric positioning of legs or excessive lithotomy.

Surface Anatomy

Following on from patient positioning, it is important to mark surface anatomy of the patient on each side so that asymmetric positioning of ‘Yellow-fin’ stirrups does not adversely affect (appropriate) siting of stab incisions during needle insertion and by corollary cause improper mesh placement.

We have abandoned a standardised approach to siting skin incisions and tend to individually vary them based on particular surgical requirements. The former ostensibly makes the operation appear simpler and more marketable, but the use of surface anatomy markings to individualise placement of incisions helps prevent complications. Using an indelible marker, the marking of the lower border of the adductor longus tendon and the genito-crural fold is outlined. The entry point (the ‘first point’) for the ‘outside-in’ transobturator needles or exit point for the inside-out transobturator tapes is at a point below the adductor longus tendon and medial to the genito-crural fold. This, in our opinion, measurably reduces tendon-related groin pain after surgery. On a related note, the aforementioned point on surface marking also serves as a guide to direct the trajectory of the needle when using ‘minislings’.

The ‘second point’ that needs to be identified is the lowermost portion of the obturator foramen. This is marked by palpating the ischial tuberosity and using one’s fingers to ‘walk up’ from this bony prominence till a distinct ‘give’ of the soft tissue over the obturator foramen is felt. This represents the lowermost portion of the obturator membrane. We tend to utilise this point to easily access the area around the ischial spine; this is useful for guiding transobturator needles mesh kits. By joining the first to the second points outlined above, one begins to appreciate the orientation and margin of the obturator foramen. This is particularly useful in defining the distance of the driving point of the helical needles from the obturator vessels (usually about 4.5 cm) constantly providing a visual feedback (point of reference) to the surgeon. This is especially important in difficult and obese patients when it is all too easy to ‘lose’ the needle when it traverses the obturator fossa. The movement of the needle tips is counter-intuitive; the needle tip moves away from the target location as the external handle is moved towards the surgeon. Needle vacillation is extremely dangerous and a documented cause of major pelvic vascular and visceral laceration. It is therefore imperative that the handle is kept ‘flush’ (in close contact) with the patient’s obturator foramen and an attempt made to ‘visualise’ the three dimensional movement of the needle tip within the confined space between the obturator foramen, the sacrospinous ligament and the lateral pelvic wall.

Finally, prior to making an incision and in order to get a general idea of the topography of the pelvic structures, it is good practice to perform gynecologic pelvimetry, which helps assess the sub-pubic angle for adequacy of access, the accessibility of the ischial spines and the sacrospinous ligaments. These are the important landmarks that need to be identified prior any kind of pelvic floor reconstruction.

Instructions for Use

Stepwise Approach to Any Type of Vaginal Repair Surgery

We recommend the use of hydrodissection in all cases of vaginal repair surgery. This involves the use of Marcaine (0.5 %) with 1 in 200,000 Epinephrine; a volume of 20 millilitres (mL) diluted with 20 mL of normal saline per ‘compartment’. Hydrodissection allows the surgeon to get in the right surgical plane in a bloodless manner (Fig. 18.2). Not only does it help in developing the natural, relatively avascular tissue planes in the pelvic floor, it also facilitates proper mesh placement, reducing the risk of visceral or neurovascular damage. In addition hydrodissection facilitates full thickness vaginal dissection and development of the paravesical space towards the ischial spines and sacrospinous ligaments [5]. We tend to follow the ‘grey bubble’ (Vincent Lucente, personal communication) which is the appearance created by the infiltrated fluid as it dissects the fascia off the viscus helping define the correct plane of dissection (Fig. 18.3). Sharp and blunt dissection is carried out in this plane that lies between the fascia and the serosa of the prolapsing viscus, NOT between the vagina and the fascia (Fig. 18.4). Dissection in the later plane leads to ‘vaginal skinning’ which regrettably, has for many years, been part of the standard technique for fascial repair. In some ways mesh surgery is counter-intuitive involving a degree of relearning, because it does mandate deeper dissection and placement of the mesh on the viscus–fascia interface rather than superficial fascia–vaginal skin plane.

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Fig. 18.2

Hydrodissection

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Fig. 18.3

Follow the ‘grey bubble’

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Fig. 18.4

‘Four point hold’

Full thickness dissection not only permits adequate dissection of the bladder laterally to allow access to the obturator membrane and the sacrospinous ligament, it also allows sufficient dissection of the bladder from its attachment to the cervix or the vaginal vault (Figs. 18.4 and 18.5). This is a critical step for both mesh replacement and native tissue surgery. We employ sharp dissection at the base of the bladder with Metzenbaum scissors prior to the dissection of the tissues lateral to it, using gentle sweeping movements with the index finger from the lateral to medial aspect; keeping the pressure laterally prevents inadvertent bladder trauma. The tissue planes between the viscus and the lateral pelvic wall can usually be developed efficiently with a combination of blunt and sharp dissection. The foregoing techniques are usually sufficient to ensure that the mesh lies directly abutting the serosal surface of the prolapsing viscus, effectively reducing the incidence of vaginal mesh exposure without increasing visceral mesh erosion. In addition this technique meets the core requirement of reducing the prolapse of the affected organ—not of its enveloping fascia/vaginal skin (M. Cosson, personal communication) [5]. A key element in all needle-driven mesh procedures is ‘anchorage’; in the anterior compartment, this takes the form of a ‘four-point anchor’ inserted, respectively, into the obturator internus muscles and sacrospinous ligaments of either side, essentially mimicking the native fascial bladder hammock. This anatomical reproduction of Delancey’s supports has been made possible with mesh surgery and is pivotal to its success (Figs. 18.618.718.8 and 18.9). The sacrospinous ligament forms the cornerstone for mesh surgery in both the anterior and posterior compartments–it is relatively avascular, has a fixed anatomic location with well-circumscribed boundaries, identifiable even in obese women or in the elderly, and acts as a sturdy anchor. The sacrospinous ligament is approached through the ‘anterior approach’, a technique that is essential for mesh surgery in the anterior compartment and which most pelvic floor surgeons can relearn [67].

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Fig. 18.5

Apical anchoring suture

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Fig. 18.6

Sacrospinous anchor loaded on to Orange needle and sheath

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Fig. 18.7

Sacrospinous anchor being inserted (Note: Handle parallel to floor)

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Fig. 18.8

Sacrospinous anchors in place

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Fig. 18.9

Upper anchor in obturator internus muscle

The mesh should be placed in situ in a ‘tension-free’ manner (Fig. 18.10) and there is no need to excise vaginal skin (minor trimming for purposes of aligning the edges is acceptable). Oftentimes after vaginal closure, the operated area appears ‘visually unpleasing’ as if the prolapse has not been reduced at all—this in fact is an indirect indicator of appropriate mesh tensioning (Fig. 18.11) [5]. The beauty of mesh surgery lies in the fact that it factors in the concept of vaginal remodelling that allows surrounding tissues to restructure in much the same way that the vagina involutes to its pre-pregnancy state following vaginal birth [89].

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Fig. 18.10

Mesh locked in place

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Fig. 18.11

Final result—‘visually unpleasing’

It is important to appreciate that every ‘needle’ in every ‘kit’ is different; there is a variety to choose from—helical needles, open curve needles, self-retrieving needles, needles with inner and outer sheaths. It is imperative that surgeons have a detailed knowledge of anatomy to ensure surgical safety and therefore it is recommended that surgeons new to mesh surgery follow a ‘three step training program’ before using mesh. Step 1 usually involves cadaveric dissection and didactic teaching, which is then followed by preceptoring at the trainer’s facility and finally proctoring at the nouveau surgeons operating rooms. Understanding the needle curvatures, the directional reversals of the needle tips with respect to the handles (this tends to be counter-intuitive) and last but perhaps most importantly, appreciating the spatial relationships within the three-dimensionality of female pelvic anatomy is paramount and effectively prevents major visceral and vascular injuries [510]. This relatively new technology has not had the benefit of many robust randomised controlled trials or case-controlled studies done to address the pros and cons [1114]. The proliferation of different types of synthetic and biologic meshes without comprehending their individual biodynamics could lead to delayed complications [1323].

PERIGEE™ (American Medical Systems, MN)

The PERIGEE™ was the first needle-driven mesh replacement system introduced in 2003 to improve upon the results of anterior compartment fascial and mesh-augmented (mesh overlay) repairs. Mesh-augmented surgery was fundamentally inferior because these afforded little or no ‘anchorage’ and failed to provide ‘arcus-to-arcus’ support defined in John Delancey’s seminal work on pelvic organ support [24].

The Superior or Pink Needles

At the commencement of the procedure, an important landmark to look out for is the bladder neck. Surface marking is carried out as discussed earlier. We perform all our anterior compartment repairs belowthe level of the bladder neck. This is marked by identifying the prominent sulcus at the point where the urethra meets the bladder or with the use of a Foley catheter balloon especially if anatomical landmarks are indistinct or have been obscured by previous surgery. In our opinion, avoiding dissection around the bladder neck potentially reduces the incidence of post-operative voiding dysfunction; therefore, a conscious effort needs to be made to stay above it for a sub-urethral sling and below it for an anterior compartment repair. A ‘dry pass’ is made outside the pelvis to get an idea of the position of the needle and its likely range of movement inside the pelvis. The needle is usually held at 45 ° to the vertical and the handle has to be pressed against the skin of the obturator foramen flush with the patient avoiding the tendency to draw the handle towards the operator. This technique ensures that the needle tip remains close to the inner aspect of the obturator internus/membrane rather than going deeper and vacillating in the pelvis around vital structures. The helix further prevents needle vacillation and protects the bladder and the obturator vessels. Tunnels of about 5 mm are created inferior to the ischiopubic rami; this allows palpation of the needles as they exit through the obturator fossa. These tunnels are dissected in a ‘cone’-shape with the base towards the surgeon and the apex at the obturator membrane potentially reducing bleeding from vascular complications and forniceal punctures.

A skin stab incision is made on the external landmark and the needle is passed through the obturator membrane/internus; usually at least one ‘pop’ is felt, if not two. The first pop is through the obturator membrane and the second through the obturator internus. Once the ‘pop’ occurs the tip of the finger inside the tunnel should feel the needle tip and the needle should be brought out with the finger constantly guiding the tip to avoid puncturing the vaginal fornices. Once the tip exits the mesh arm can be attached to it with the connector and the needle is withdrawn in a ‘reverse’-curved motion simultaneously pushing the connector in with the index finger from the vaginal end. This prevents unnecessary tissue distortion during needle withdrawal.

The Inferior or the Grey Needles

The design of these needles was crucial to the next part of the procedure; in order to allow optimal suspension in a ‘hammock-like’ fashion and ensure ‘arcus-to-arcus support’ the needles (and by extension the mesh arms) need to traverse the adductor brevis, adductor magnus, obturator externus, obturator membrane, obturator internus and finally the levator ani close to the ischial spine (about a centimetre medial and cranial). After numerous cadaver testings, two methods were derived for needle placement:

1.

2.

Tunnels of 5 mm are created at the lowermost lateral edge of the bladder dissection—these tunnels can be made bigger even allowing the surgeon to ‘sweep’ the ‘arcus’ if necessary. We do not recommend this for the Perigee operation.

Stab incisions are made on the external surface and the needles are passed as indicated above preferably employing the second technique. The mesh is attached with the connectors and the needles are withdrawn with a reverse motion. The mesh is sited and covers the bladder in a ‘tension-free’ manner. The tail of the Perigee can be trimmed to suit the length of the vault. The mesh is then fixed with a 2-0 PDS suture both at its base and at its cranial portion in the midline below the bladder neck to ensure that the mesh is laid flat. A cystoscopy can be performed at this stage to ensure there has been no bladder trauma or perforation. We then recommend vaginal closure in two layers using 2-0 Vicryl without any vaginal trimming (Fig. 18.12).

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Fig. 18.12

Two-layered closure with 2/0 Vicryl

Tensioning

Once the vagina is closed, we manually reposit the vagina as high as possible; we DO NOT recommend pulling on the mesh arms any further merely to make the operation ‘look good’. A ‘flat’ non-sagging anterior vaginal wall invariably indicates that the mesh is too tight and virtually guarantees post-operative mesh pain in the fornices and predisposes to mesh exposure. Male dyspareunia (‘His’pareunia) is invariably associated with vaginal exposure of mesh whilst female dyspareunia (‘Her’pareunia) seems to be more associated with excessive graft tensioning or with shortening and narrowing of the vaginal canal secondary to skin excision [2527]. We recommend pulling the slack off the mesh arms and then pulling the plastic off without further traction on the limbs. The limbs are then trimmed at skin level and a small dressing is placed on each stab wound.

We do not use an indwelling catheter post-operatively and a vaginal pack is placed only for 2 h. This has been our practice since 2005 and we have performed more than 600 operations (2011) with a readmission rate of 2.9 %.

Anterior Elevate (American Medical Systems, MN)

Following the warning by the FDA in 2008 and 2012, it became important to devise a mesh implantation system that avoided ‘blind’ needle passes in the obturator foramen, which at the same time maintained the success rates of the transobturator procedure. The Anterior Elevate™ transvaginal mesh replacement system was born out this concept (Fig. 2.13). It involves the passage of anchors into the sacrospinous ligament that provide surrogate anchorage for the mesh threaded through it. The system also provides for two additional anchors interwoven into the mesh that deploy into the obturator internus muscle.

Sacrospinous Needles (Orange), Plastic Sheath and Anchors

A full thickness vaginal incision is made below the bladder neck after ensuring adequate hydrodissection with local anaesthetic as described above (Fig. 18.2). A combination of blunt and sharp dissection allows the creation of adequate access laterally to the sacrospinous ligaments. It is very important to dissect the bladder away at the base free of the vaginal vault or cervix (as the case may be) in order to allow for the anchoring suture to be placed at the level of the vault or pericervical ring (Figs. 18.318.4 and 18.13).

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Fig. 18.13

Anchoring suture through peri-cervical ring

The anchors are loaded on to the Orange needles which are then sheathed by the plastic tube. Of note is the design of the tip of the needle that allows the anchor to slot in only one direction. The length of the tip of the needle is unique in that it limits the ‘depth’ to which the anchor treads into the sacrospinous ligament to 22 mm regardless of the driving force applied (Fig. 18.6). This is an important safety feature that protects against needle-induced neurovascular injury within the confines of the pelvis. Another tip to avoid complications is to gently grate the plastic sheath across the sacrospinous ligament about a finger’s breadth medial to the ischial spine; this results in a characteristic ‘grating’ that is fed back to the surgeon’s hand. This technique ensures that the needle driving system with the anchor is perpendicular to the sacrospinous ligament and this is also confirmed by the handle of the needle which lies parallel to the ground when placed correctly (Fig. 18.7). The perpendicular placement of the anchor affords excellent anchorage with pull-out forces of >8 psi and prevents ‘splaying’ of the sacrospinous ligament.

Pink Needle

Again staying clear of the bladder neck two small tunnels are made laterally carrying the dissection below and behind the ischiopubic ramus into belly of the obturator internus muscle. A second anchoring suture is placed just below the bladder neck which along with the other one at the vault helps in laying the mesh flat and prevents the edges from rolling up. These sutures do not in any way contribute to the strength of the repair (Figs. 18.518.6 and 18.9). The ‘tail’ of the mesh is trimmed to size and threaded through the superior suture and tied into place (Fig. 18.14). The pink needles are inserted into the anchors fused with the mesh edges and passed into the obturator internus muscle via the tunnels described above taking care not to perforate the forniceal skin.

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Fig. 18.14

Mesh trimmed to correct ‘dose’

Further Steps

The vault/pericervical ring suture is then passed through the bottom edge of the mesh and tied in place. The vaginal end of the anchors that were placed in the sacrospinous ligament is then threaded through eyelets in the mesh and the mesh is sited in its appropriate position by means of a ‘spoon’ provided in the kit. This also allows for proper tensioning prior to locking the mesh in place with the ‘buttons’ included in the mesh kit (Figs. 18.13 and 18.10). The anchors are cut free and the vagina is closed in two layers using 2/0 Vicryl (Fig. 18.12). As described earlier, the end result of the operation is quite unattractive with a lot of residual laxity of the anterior vaginal wall (Fig. 18.11). This should help reassure the surgeon that the mesh is appropriately tensioned. The 6-week follow-up visit will reveal the true state of affairs as the vagina would have remodelled to a large extent and the perceived laxity that was seen in the immediate post-op period would have all but disappeared.

UPHOLD™ (Boston Scientific, MA)

This mesh kit utilises suture anchorage to the sacrospinous ligament instead of anchors. The Ethibond sutures attached to mesh arms are tacked in place by means of the Capio device which is a needle-driven system that delivers the suture to the appropriate location in the ligament and also retrieves the suture on its return journey. The mesh arms are then pulled through the sacrospinous ligament providing robust anchorage which provides level 1 support and some level 2 support. In cases where a large cystocele coexists with vault/cervical descent the PINNACLE™ device that has a larger mesh with two extra arms may be used. These arms are fixed via the Capio device into the arcus tendineus resulting in good arcus-to-arcus level 2 support like the PERIGEE™ device. Pinnacle has now been withdrawn from the market.

PROSIMA™ (Johnson and Johnson, NJ)

This mesh kit also involves the intravaginal introduction of mesh that is ‘tucked’ into the sacrospinous ligament using a metal carrier device and then held in place by means of inflatable balloon that remains in the vagina for 2 weeks. At the end of 2 weeks, it is expected that the mesh will ‘stick in place’. This product has now been withdrawn from the market.

In our opinion, the Boston devices enshrine the philosophy of minimal mesh area in their kits; AMS kits have moderate mesh volume in their kits with the option of trimming to size whilst the kits by Johnson and Johnson have been relatively larger. So far studies have shown very little difference in clinical outcomes between these various devices. Having said that most studies do not use imaging like 3D/4D ultrasound to observe meshes over a period of time [2829]. It is useful to think of mesh as a medication that needs to be used in the ‘correct dose’—so trim the mesh to meet individual requirements. It is vital that replacement mesh surgery be performed per protocol established by the manufacturer as any deviations from the accepted technique can cause untold damage to the woman besides being medico-legally indefensible.

The introduction of newer meshes that are lighter, softer and less dense has made a discernible change in patient outcomes in a few studies.

Tips and Pearls: Hydrodissection, Full Thickness and Remodelling

The most important lessons we have learnt in our unit over the last 9 years of mesh usage are:

·               Proper patient selection—avoiding use of mesh in small prolapses, appropriate patient counselling before surgery

·               Hydrodissection and full thickness dissection as mentioned before

·               Gentle tissue handling

·               Avoidance of excessive traction to the mesh

·               Avoidance of vaginal trimming

Graft surgery at the end of the operation should not be ‘visually pleasing’ unlike fascial native tissue surgery. This does engender a ‘leap of faith’ and represents a shift in the surgical paradigm. In our experience tension-free placement does prevent mesh complications. The vagina is ‘an innocent victim of prolapse’ and once the proposing organ is supported with the mesh, vaginal remodelling takes over. Indeed a classic example of vaginal remodelling is the postpartum period where the vagina that is stretched to many times its normal size remodels back to its normal calibre (almost!) within 6 weeks.

Post-operative Orders and Management

In our patients the use of local anaesthetic for hydrodissection has reduced the need for post-operative narcotic analgesia to less than 3 %. We advise the use of intraoperative antibiotics like cephalosporins and metronidazole. We also routinely prescribe antibiotics for 5 days post-surgery. Pain relief is achieved by a diclofenac suppository post-surgery and oral ibuprofen, codeine and paracetamol. Patients using codeine are advised to use stool softeners like Lactulose.

All patients undergo a trial of void post-surgery and a post-void residual bladder volume (PVRBV) of <100 mL is our cut-off. We do not routinely use vaginal packing. Our patients are sent home the same day if they are pain-free, are not bleeding excessively and have passed their trial of void, with access to a 24-h hotline number. A nurse calls all patients the next day and performs a visual analogue score for pain, bleeding and bladder function with appropriate referral as necessary.

Results: 5-Year Perigee Data with Data on Mesh Erosion and Sexual Function

Utilising the principles highlighted above, we followed up 350 data sets for a total of 5 years, the results of which were published in 2008 [2]. A total of 350 patients underwent surgery with the Perigee™ system between March 2004 and June 2008. There were no life-threatening complications with the procedure. Thirty-nine (11.1 %) patients were found to have small mesh extrusion through the vagina, and twenty (5.71 %) patients had recurrence of stage 2 cystocele. Of the subset of patients (n = 171) analysed 49.5 % reported no sexual dysfunction, 13.5 % reported no change in sexual function, 29.7 % reported improvement in sexual function whilst 7.2 % reported worsening of dyspareunia (Tables 18.1 and 18.2).

Table 18.1

Numbers sexually active

Status

Number

Percentage

Sexually active

111

 64.91

Not sexually active

 55

 32.16

Not answered

 5

 2.93

Total

171

100

Table 18.2

Outcomes after operation

Dyspareunia

Number

Percentage

None

 55

 49.54

Same

 15

 13.51

Better

 33

 29.72

Worse

 8

 7.23

Total

111

100

A recent audit of 188 of our patients over a 4-year period who had an Apogee and/or Perigee showed 29 (15.4 %) patients in total were diagnosed with mesh exposures. Of the 29 patients, 20 (69 %) patients had Perigee and 9 (31 %) patients had Apogee procedures. Twenty-six patients required surgical management of mesh exposure under general anaesthesia and three patients were treated conservatively. On analysing the trend in occurrence of the mesh exposure, 80 % (16/20) among the Perigee exposure group and 88.9 % (8/9) among the Apogee exposure group had procedures performed at the introduction of the procedure during the years 2005 and 2006. The mesh was changed to InterProlite in 2008. In the following years 2007 and 2008, this significantly declined to 20 % (4/20) and 11.1 % (1/9) among the Perigee and Apogee exposure groups, respectively (Table 18.3).

Table 18.3

Mesh exposures in Perigee and Apogee

Year

Total number of perigee + apogee

Total number of mesh exposure

Percentage

2004

5

0

NA

2005

23

6

26.08

2006

43

18

41.8

2007

56

4

7.14

2008

44

1

2.27

2009

17

0

NA

The time duration between the surgery and the mesh exposure revealed that 55 % had exposures within the first 6 months and 41.4 % had exposures from 6 months to 1 year. The exposure incidence reduced to 10.3 and 6.9 % at the end of second year and >2 years, respectively.

The risk factor parameters included for the analysis of characteristics of patients with mesh exposures included age, smoking, menopausal status, preoperative use of vaginal oestrogen cream, oral hormone replacement therapy, diabetes mellitus and concomitant surgery (Table 18.4). The phenomenon of mesh exposure into the vagina is not, in our opinion, a major worry, and can quite easily be managed either in clinic or in the operating theatre with few recurrences.

Table 18.4

Analysis of mesh erosion data

Characteristics

Case group (total = 29) n (%)

Control group (total = 159) n (%)

P value (Chi squared test)

Age (29–90, mean age 63)

     

<50

7 (24.1)

 26 (16.5)

0.3108

50–70

21 (72.4)

120 (75.4)

0.7265

>80

1 (3.4)

13 (8.2)

0.3725

Diabetes mellitus

4 (13.8)

 17 (10.7)

0.6258

Smoking

4 (13.8)

 20 (12.6)

0.8570

Menopause

23 (79.3)

132 ( 83)

0.6292

Ovestin cream

1 (3.4)

8 (5)

0.71

Oral HRT

6 (20.7)

7 (4.4)

0.0015

Concomitant surgery

14 (48.3) (8/14 posterior repair, 6/14-sus)

 97 (61)

0.1998

The study shows no significant risk factors identified to be associated with mesh exposure. The other significant finding is the dramatic reduction in the trend of incidence of mesh exposure over a period of 4 years since the introduction of the procedure. This can be well attributed to the skin closure technique or change in the type of the mesh used during the procedure.

Conclusion

Anterior compartment surgery is particularly fraught with increased recurrences. A robust surgical operation would be one that addresses all components of the anterior ‘hammock’. The first generation of surgical kits like the PERIGEE™ and PROLIFT™ led the way to radical innovation in transvaginal mesh surgery. Our 5-year follow-up of 350 data sets of the Perigee suggests that careful patient selection is paramount when this modality of treatment is chosen.

Techniques of hydrodissection, full thickness vaginal dissection, anterior access to the sacrospinous ligament, tension-free mesh placement and a two-layered vaginal closure with no vaginal skin trimming have evolved over the years and have contributed significantly to our results. Longer term data continues to show these procedures to be safe, robust and durable particularly in the hands of sub-specialists who routinely perform them. Vaginal mesh exposure is on the decline and poses less of a problem owing to better (‘softer’) meshes, better closure techniques and perhaps a deeper placement of the mesh. Of paramount importance, however, is the change of ‘mindset’ of the surgeon performing mesh surgery.

References

1.

Weber AM, Walters MD, Piedmonte MR, Ballard LA. Anterior colporrhaphy: a randomised trial of three surgical techniques. Am J Obstet Gynecol. 2001;185(185):1299–306.PubMedCrossRef

2.

Rane A, Kannan K, Barry C, Balakrishnan S, Lim Y, Corstiaans A. A prospective study of the Perigee system for the management of cystocoeles—medium-term follow up. Aust N Z J Obstet Gynaecol. 2008;48(4):427–32.PubMedCrossRef

3.

Patwardhan S, Arunkalaivanan AS. Urogynaecology: an ambulatory approach. Br J Hosp Med. 2007;68(8):414–7.

4.

Penketh R, Griffiths A, Chawathe S. A prospective observational study of the safety and acceptability of vaginal hysterectomy performed in a 24-hour day case surgery setting. BJOG. 2007;114(4):430–6.PubMedCrossRef

5.

Muffly TM, Barber MD. Insertion and removal of vaginal mesh for pelvic organ prolapse. Clin Obstet Gynecol. 2010;53(1):99–114.CrossRef

6.

Cespedes RD. Anterior approach bilateral sacrospinous ligament fixation for vaginal vault prolapse. Urology. 2000;56(6 Suppl):70–5.PubMedCrossRef

7.

Rane A, Frazer M, Jain A, Kannan K, Iyer J. The sacrospinous ligament—conveniently effective or effectively convenient? J Obstet Gynaecol. 2011;31(5):366–70.PubMedCrossRef

8.

Alperin M, Moalli PA. Remodeling of vaginal connective tissue in patients with prolapse. Curr Opin Obstet Gynecol. 2006;18(5):544–50.PubMedCrossRef

9.

Kannan K, McConnell A, McLeod M, Rane A. Microscopic alterations of vaginal tissue in women with pelvic organ prolapse. J Obstet Gynaecol. 2011;31(3):250–3.PubMedCrossRef

10.

Moore RD, Miklos JR. Vaginal mesh kits for pelvic organ prolapse, friend or foe: a comprehensive review. Scientific World Journal. 2009;9:163–89.PubMedCrossRef

11.

Davila GW, Drutz H, Deprest J. Clinical implications of the biology of grafts: conclusions of the 2005 IUGA grafts roundtable. Int Urogynecol J Pelvic Floor Dysfunct. 2006;17 Suppl 1:S51–5.PubMedCrossRef

12.

Galloway NT. Words of wisdom. Re: the perils of commercially driven surgical innovation. Eur Urol. 2010;58(1):179.PubMedCrossRef

13.

Ostergard DR. Lessons from the past: directions for the future. Do new marketed surgical procedures and grafts produce ethical, personal liability, and legal concerns for physicians? Int Urogynecol J Pelvic Floor Dysfunct. 2007;18(6):591–8.PubMedCrossRef

14.

Ostergard DR. Vaginal mesh grafts and the Food and Drug Administration. Int Urogynecol J Pelvic Floor Dysfunct. 2010;21:1181–3.CrossRef

15.

FDA public health notification. Serious complications associated with transvaginal placement of surgical mesh in repair of pelvic organ prolapse and stress urinary incontinence health; 2008.

16.

FDA Safety Communication. UPDATE on serious complications associated with transvaginal placement of surgical mesh for pelvic organ prolapse; 2011.

17.

National Institute of Clinical Excellence. Surgical repair of vaginal wall prolapse using mesh. UK; 2008.

18.

Jacquetin B, Cosson M. Complications of vaginal mesh: our experience. Int Urogynecol J Pelvic Floor Dysfunct. 2009;20:893–6.PubMedCrossRef

19.

Rice NT, Hu Y, Slaughter JC, Ward RM. Pelvic mesh complications in women before and after the 2011 FDA public health notification. Female Pelvic Med Reconstr Surg. 2013;19(6):333–8.PubMedCrossRef

20.

Skoczylas LC, Turner LC, Wang L, Winger DG, Shepherd JP. Changes in prolapse surgery trends relative to FDA notifications regarding vaginal mesh. Int Urogynecol J. 2013.

21.

Ellington DR, Richter HE. The role of vaginal mesh procedures in pelvic organ prolapse surgery in view of complication risk. Obstet Gynecol Int. 2013;2013:356960. Epub 2013 Aug 28.PubMedCentralPubMedCrossRef

22.

Nygaard I. Approval process for devices and mesh for surgical treatment of pelvic organ prolapse and urinary incontinence. Clin Obstet Gynecol. 2013;56(2):229–31.PubMedCrossRef

23.

Rogers RG. To mesh or not to mesh: current debates in prolapse repair fueled by the U.S. Food and Drug Administration Safety Notification. Obstet Gynecol. 2011;118(4):771–3.PubMedCrossRef

24.

Wei JT, De Lancey J. Functional anatomy of the pelvic floor and lower urinary tract. Clin Obstet Gynecol. 2008;47(1):3–17.CrossRef

25.

Brubaker L. Editorial: partner dyspareunia (hispareunia). Int Urogynecol J Pelvic Floor Dysfunct. 2006;17(4):311.PubMedCrossRef

26.

Altman D, Elmér C, Kiilholma P, Kinne I, Tegerstedt G, Falconer C. Sexual dysfunction after trocar-guided transvaginal mesh repair of pelvic organ prolapse. Obstet Gynecol. 2009;113(1):127–33.PubMedCrossRef

27.

Feiner B, Maher C. Vaginal mesh contraction: definition, clinical presentation, and management. Obstet Gynecol. 2010;115(2):325–30.PubMedCrossRef

28.

Barry C, Dietz HP. The use of ultrasound in the evaluation of pelvic organ prolapse. Rev Gynaecol Perinat Med. 2005;5(3):182–95.CrossRef

29.

Dietz HP, Lekskulchai O. Ultrasound assessment of pelvic organ prolapse: the relationship between prolapse severity and symptoms. Ultrasound Obstet Gynecol. 2007;29:688–91.PubMedCrossRef