Review of synthetic mesh-related complications in pelvic floor reconstructive surgery

Review Article

Abstract

There is significant risk of re-operation after pelvic reconstructive surgery. In an attempt to improve outcome, synthetic materials are increasingly being used to augment pelvic organ prolapse repair despite lack of strong evidence to support their routine use. The use of synthetic mesh to correct apical, anterior and posterior vaginal wall prolapse is not without complications. This review aims to evaluate the long-term complications of synthetic mesh in pelvic reconstructive surgery.

Keywords

Mesh complications Pelvic organ prolapse Synthetic mesh 

Introduction

About 50% of parous women have some degree of pelvic organ prolapse [1] although only 10% are symptomatic [2, 3]. Oslen et al. [2] reported an 11–12% risk of surgery for prolapse in women reaching 79 years of age. Over the years, several surgical procedures have been described to correct pelvic organ prolapse (POP). Despite improvement in the knowledge of pelvic anatomy and advances in surgical techniques, the success rates of traditional pelvic reconstructive surgical procedures are variable and sometime disappointing [4]; indeed, when the surgical outcome is described as being successful, it has not been long lasting which is significant in an ageing population. A re-operation rate of nearly 30% has been reported [2, 5]. Some studies quote a recurrence risk as high as 33–45% [6, 7].

Traditional surgical procedures can take a long time to perform, result in long hospital stay, long time to recover and return to daily activities [8] resulting in higher cost to the health service and the society. The need to improve the outcome of traditional surgical treatment of pelvic organ prolapse has led to increased use of graft materials in pelvic reconstructive surgery. The aim of using mesh in pelvic reconstructive surgery is to result in repairs that are safe, effective and durable.

Whilst on the one hand, sub-urethral sling procedures using synthetic meshes are now the gold standard for the surgical management of stress urinary incontinence with a success rate of around 81% at 7-year follow-up [9]. There is paucity of high quality evidence to support the routine use of synthetic meshes for augmentation of anterior and posterior vaginal wall and apical repairs [8, 10, 11]. Based on the experience of using synthetic materials in abdominal hernia surgery and possibly commercial interest, there is increasing use of synthetic mesh in pelvic organ reconstruction. However, the 4th International Consultation for Incontinence Committee for Pelvic Organ Prolapse review concluded that there are insufficient data to make any definitive conclusions with regard to the role of biologic or synthetic prosthetic materials in primary or recurrent prolapse surgery [10].

The objective of using mesh in pelvic reconstructive surgery includes: substitution or replacement of lacking supportive tissue, reinforcement of weak or defective supportive tissues or induction of new supportive tissue and consolidation to compliment traditional surgical techniques [3]. It is important to note that the use of synthetic mesh is not without complications and mesh-related complications could have significant impact on the quality of life of sufferers, limit their use [12] and add to the cost of health service. It is sometimes not very clear whether complications associated with the use of mesh in pelvic reconstructive surgery are caused by the surgical technique or by the synthetic mesh utilised. Nevertheless, clinicians’ understanding of mesh-related complications and their proper management, combined with careful case selection, would result in improved outcome.

The aim of this article is to evaluate the various long-term complications associated with synthetic mesh, their predisposing factors, their incidence, early recognition and management. Recommendations would be made for the identification, prevention and management of these complications. Recurrence of POP following mesh repair will not be explored because it is not very clear whether the recurrence is due to the operative technique such as method of placement or the characteristics of the mesh employed. Intra-operative complications, such as bleeding, haematoma, injury to organs during placement of mesh [13, 14, 15, 16] etc., will also not be explored. We reviewed the literature to synthesise the evidence regarding the complications related to the use of synthetic mesh in pelvic reconstructive surgery. We searched Medline (OVID 1996 version), PubMed, Cochrane, current contents and references of initially identified relevant articles and extracted data regarding the incidence, clinical manifestation and management of mesh-related complications. Our search terms combination included anterior vaginal wall prolapse, posterior vaginal wall prolapse, vaginal vault prolapse, apical prolapse, mesh and complication.

Types of synthetic mesh [11, 17]

Amid in 1997 [18], categorised synthetic materials used in abdominal hernia based on their properties including pore size and fibre type. Deprest et al. [19] published a detail review of the physical properties and host response to implants in pelvic organ prolapse repair. Unique mesh characteristics that are necessary in pelvic organ reconstruction include ease of use, the capability of host tissue to incorporate the mesh with reduced risk for erosion, infection and extrusion and non-carcinogenic. There is need for pelvic surgeons to become familiar with the molecular and biomechanical properties and the differences between different grafts prior to graft selection [20]. Grafts differ in their sources (synthetic or biological), composition (mono-filament or multi-filament), pore size, flexibility and architecture (knitted or woven).

Type I: macro-porous mesh

Type I mesh has a pore size of >75 μm. The large pore size facilitates infiltration of the mesh by macrophages, fibroblast and blood vessels; host tissue in growth is promoted resulting in good support and lower risk of infection [6, 21, 22]. Examples include polypropylene mesh (Atrium, Atrum Medical; Marlex, CR Bard; Prolene, Ethicon) and polyvinylidene fluoride mesh such as Gynemesh, Ethicon.

Type II: micro-porous mesh

Type II mesh has a pore size of <10 μm. Due to the pore size, bacteria are able to infiltrate the mesh; however, angiogenesis and fibropasia are prevented because macrophage infiltration of the mesh and fibroblast incorporation is deterred. These results in higher risk of infection that is difficult to treat. Example includes polytetrafluoroethylene mesh (Gore-tex, WL Gore).

Type III: macro-porous mesh with multi-filamentous or micro-porous components

Type III mesh has large pores with small interstices and a large surface area. Due to its characteristics, bacteria invasion is possible; however, macrophage infiltration is restricted. The adherence of bacteria appears to be dependent on the increase surface area of type III mesh. Examples include polyethylene tetraphthalate mesh (Mersilene, Ethicon; Teflon, CR Bard).

Type IV: sub-microporous mesh

These meshes are coated biomaterials with pores of <1 μm. Example includes polyester–silicone-coated mesh (Intermesh, AMS). These are rarely used in pelvic reconstructive surgery.

Absorbable mesh

Mesh of this type dissolve in 30–90 days and this property of rapid loss of tensile strength might be a disadvantage in pelvic reconstructive surgery. Their characteristics favour low erosion rates and absorbable mesh has not been shown to promote infection. Commonly used absorbable meshes are polyglactin 910 (e.g. Vicryl, Ethicon) and polyglycolic acid (Dexon, Davis and Geck).

Mixed (absorbable and non-absorbable) mesh

These are meshes made of absorbable and non-absorbable materials such as polyglactin 910 and polypropylene. They are multi-filamentous type III mesh type. The multi-filamentous component favours infection. Example includes Vypro II (Ethicon).

Multi-filament or mono-filament

The composite structure of the mesh is also important. Within the filamentous fibres of some synthetic meshes are interstices. Multi-filament meshes have interstices that are <10 μm and bacteria (<1 μm) can replicate within these interstices. However, access to macrophages and ability to fight bacterial colonisation within the interstices is impaired [11]. Mono-filamentous meshes do not have small interstices and the risk of mesh infection is reduced with their use (Table 1).
Table 1

Synthetic mesh types and characteristics

Type

Mesh material

Example (brand)

Manufacturer

Characteristics

Non-absorbable

 I

Polypropylene

Atrium

Atrum Medical, Hudson, NH

Mono-filament

 I

Gynemesh

Ethicon, Somerville, NJ

Mono-filament

 I

Marlex

Davol/Bard, Cranston, RI

Mono-filament

 I

Prolene

Ethicon, Somerville, NJ

Mono-filament

 III

Surgipro

Synecture/US Surgical, Norwalk, CT

Mono-filament knitted

 I

Trelex

Boston Scientific, Natick, MA

Mono-filament knitted

 III

Polyester

Mersilene

Ethicon, Somerville, NJ

Multi-filament woven dacron

 III

PTFE

Teflon

Davol/Bard, Cranston, RI

Multi-filament

 II

Gore-Tex

WL Gore, Flagstaff

Multi-filament

Absorbable

Polyglactin 910

Vicryl

Ethicon, Somerville, NJ

Multi-filament (woven or knitted)

Polygycolic acid

Dexon

Synecture/US Surgical, Norwalk, CT

Multi-filament

Mixed (non-absorbable and absorbable)

 III

Polyglactin 910 and polypropylene

Vypro II

Ethicon, Norderstedt, Germany

Multi-filament

 I

Poliglecaprone and polypropylene

Ultrapro

Ethicon, Somerville, NJ

Mono-filament

PTFE Polytetrafluoroethylene

Mesh-related complications

There are few randomised controlled trials exploring the use of synthetic mesh in pelvic reconstructive surgery; most of the reported studies are either retrospective series or uncontrolled with short-term follow-up with consequent liability to bias. It is difficult to compare these studies because of variable methodology such as quantification method of pelvic organ prolapse, size and type of synthetic mesh utilised, method of placement and anchorage of mesh, duration of follow-up and use of validated questionnaires [11]. There is also no robust evidence on the best cost-effective strategies of managing mesh-related complications.

Mesh erosion

Mesh erosion is defined as any visible mesh exposure identified on vaginal examination or visualised on cystoscopy or rectosigmoidoscopy. Mesh may erode the vagina, urethra, bladder or bowel. The presenting symptoms vary depending on the organ involved. For example, vaginal mesh erosion may result in vaginal bleeding, abnormal discharge, dyspareunia or vaginal pain. Symptoms of mesh erosion into the bladder/urethra include painful voiding, urinary frequency, urgency, haematuria, recurrent urinary tract infection, urinary calculi and urinary fistula.

There is variation in the timing of mesh erosion. Mesh erosion has been reported as early as 6 weeks and as late as 7 years after surgery [22, 23, 24]. Reported incidence of mesh erosion varies because most of the published studies have variable methodology, operative techniques of placement, type of synthetic mesh and reported length of follow-up.

Anterior vaginal wall prolapse

A randomised controlled trial exploring the use of non-absorbable synthetic mesh in anterior vaginal wall prolapse repair in post-menopausal women by Hiltunen et al. [25] found mesh erosion in 17.3% of the women in the mesh arm. An earlier randomised controlled trial by Weber et al. [26] reported one case of mesh erosion after a median follow-up of 23 months in women who had anterior repair with polyglactin 910 absorbable mesh.

Placement of Marlex mesh in anterior vaginal wall prolapse surgery was associated with an erosion rate ranging from 2% (Flood et al. [27]) to 25% (Julian [28]). Tension-free insertion of synthetic mesh does not appear to eliminate the risk of erosion. Tension-free polypropylene mesh placement for anterior vaginal wall repair was reported to be associated with an erosion rate of 8.3% in 84 women [29]. Natale et al. [30] reported on ‘tension-free cystocele repair’ using a Prolene mesh in a double-wing shape placed between pubocervical fascia and vaginal epithelium without suture. After a mean follow-up period of 18 months, 13 mesh erosions were reported in 138 patients (9.4%). Other authors reported mesh erosion rates of 8–24% [22, 28, 29, 31, 32] (Table 2).
Table 2

Complications of synthetic meshes in anterior vaginal wall repair

Author

Mesh type

No. of patient

Duration of follow-up (median) months

Complications

Milani et al. [22]

Polypropylene

32

17

Mesh erosion—13%

Detrusor overactivity—34%

De novo dyspareunia—4 cases

Hiltunen et al. [25]

Polypropylene

104

12

Mesh erosion—17.3%

De novo SUI—23%

Weber et al. [26]

Polyglactin 910

35

23

Mesh erosion—1 case

Flood et al. [27]

Marlex

142

38.4

Mesh erosion—2%

Julian [28]

Marlex

12

24

Mesh erosion—25%

de Tayrac et al. [29]

Polypropylene

87

24

Mesh erosion—8.3%

De novo SUI—7%

Natale et al. [30]

Polypropylene

138

18.7

Mesh erosion—13 cases

Dyspareunia—9 cases

de Tayrac et al. [31]

Polypropylene with absorbable film

143

13

Mesh erosion—6.3%

De novo dyspareunia—9%

Deffieux et al. [32]

Gynemesh and Gynemesh soft

138

32.1

Mesh erosion—20%

Achtari et al. [42]

Atrium and Vypro II

90

6

Mesh erosion—6 cases

Hung et al. [51]

Polypropylene

38

21

Mesh erosion—10.5%

De novo SUI—16.7%

Dwyer and O’Reilly [52]

Polypropylene

64

29

Mesh erosion—4.6%

SUI Stress urinary incontinence

Posterior vaginal wall prolapse

There are presently limited long-term data supporting the use of synthetic materials in posterior vaginal wall repairs [12]. The reported erosion rate after posterior vaginal wall repair with synthetic mesh also varies depending on the characteristics, method of placement of the synthetic mesh and whether other concomitant surgery were undertaken. In reviewing surgical repair of posterior compartment, Culligan [33] concluded that synthetic mesh erosions through the vagina are difficult to predict but seem to be correlated with the amount of mesh placed, especially when a vaginal incision is used. Milani et al. [22] reported mesh erosion rate of 6.5% after posterior prolene mesh repair (after a mean follow-up of 17 months) and de Tayrac et al. [34] reported an erosion rate of 12% in a case series of 36 women who had combined sacrospinous suspension and polypropylene mesh placed in the posterior vaginal wall to treat rectocele (mean follow-up of 22 months).

Two small earlier observational studies of four and nine patients reported no erosion after a median follow-up interval of 14 and 29 months, respectively [35, 36]. However, Lim et al. [37] found a mesh erosion rate of 12.9% in a follow-up study of 31 consecutive patients 6 months after rectocele repair with Vypro II mesh (combination of Vicryl and Prolene; Table 3).
Table 3

Complications of synthetic meshes in posterior vaginal wall repair

Author

Mesh type

No. of patient

Duration of follow-up (median) months

Complications

Milani et al. [22]

Polypropylene

31

17

Mesh erosion—6.5%

Pelvic abscess—1 case

De novo fecal incontinence—1 case

Dyspareunia—69%

de Tayrac et al. [34]

Polypropylene

36

22

Mesh erosion—12%

De novo dyspareunia—7.7%

Parker an Phillips [35]

Marlex

4

14

Mesh erosion—none

Watson et al. [36]

Polypropylene

9

29

Mesh erosion—none

Lim et al. [37]

Mixed (polyglactin 910 and polypropylene)

90

6

Mesh erosion—12.9%

Dyspareunia—3%

Achtari et al. [42]

Atrium and Vypro II

76

6

Mesh erosion—7 cases

Mercer-Jones et al. [48]

Prolene

14 of 22

12.5

Mesh erosion—none

Vypro II

8 of 22

 

De novo dyspareunia—4.5%

   

Deep infection—4.5%

Apical vaginal wall prolapse

The rate of mesh erosion following the use of synthetic mesh to provide apical support in abdominal repair has been reported as 3.4% by Nygaard et al. [38] and 9% by Iglesia et al. [39] although the mesh type and placement method were different. Other authors reported different erosion rates: 16% by Valatis and Stanton [6], 3.4% by Timmons and Addison [5] and 12% by Kohli et al. [7].

Insertion of synthetic mesh to support apical prolapse with concomitant vaginal and perineal incisions is associated with increased erosion rate. A retrospective analysis of 273 women who had sacral colpopexy or sacral colpoperineopexy by Visco et al. [40] found an overall mesh erosion rate of 3.2% for abdominal sacral colpopexy and 4.5% for sacral colpoperineopexy (introducing the graft and sutures abdominally). Erosion rate increased to 16% if sutures were placed vaginally and attached to an abdominally introduced mesh during sacral colpoperineopexy. If the mesh was introduced vaginally, the mesh erosion rate was 40% (Table 4).
Table 4

Complications of synthetic meshes in apical vaginal wall repair

Author

Mesh type

No. of patient

Duration of follow-up

Complications

Valatis and Stanton [6]

Teflon

43

3–19 months

Mesh erosion—16%

Sepsis—1 case

Kohli et al. [7]

Polypropylene

57

19.9

Mesh erosion—12%

Creighton and Stanton [23]

Mersilene

23

17.1

Sinuses—2 case

Voiding difficulty—1 case

Visco et al. [40]

Mersilene

155—abdominal sacrocolpopexy

16

Mesh erosion—3.2% for abdominal sacrocolpopexy and 4.5% for abdominal sacrocolpoperineopexy

88—abdominal sacrocolpoperineopexy

12

Iosif [45]

Marlex—25 cases

40 (total)

12–120 months

Draining sinus—1 case

Goretex—15 cases

Elneil et al. [47]

Polypropylene

128

19

Mesh erosion—3 cases

De novo SUI—3%

Baessler et al. [49]

Polypropylene (multi-filament)

19

24

Dyspareunia—10 cases

Vesicovaginal fistula—1 case

Intractable infection—6 cases

Risk factors

There are no studies powered to look at the risk factors for mesh erosion following pelvic reconstructive surgery with synthetic mesh. It would appear that patient’s characteristics such as age and estrogen deficiency, type and size of synthetic mesh, route of surgery/placement, method of fixation, type and concomitant surgeries are risk factors for mesh erosion [21, 40, 41].

In a retrospective analysis of 138 consecutive cases of transvaginal repair of cystocele using Gynemesh or Gynemesh-Soft synthetic mesh, multi-variate analysis revealed that age >70 years was an independent predictive factor of vaginal erosion (odds ratio 3.6, 95% confidence interval 1.3–9.7, p = 0.010 [32]). Achtari et al. [42] reported that surgeon’s experience and patient’s age were associated with mesh erosion when they reviewed women who underwent transvaginal repair of pelvic organ prolapse with Atrium or Vypro II mesh. Synthetic meshes other than type I mesh appear to be associated with higher erosion rate. de Tayrac et al. [29] reported that the use of type II and type III synthetic mesh in pelvic reconstructive surgery was reported to be associated with higher erosion rates. The use of combine synthetic and absorbable mesh does not appear to reduce mesh erosion rate. A 7% erosion rate was found for polypropylene as well as for composite polypropylene and polyglactin [42]. After a median follow-up of 13 months, de Tayrac et al. [31] reported a mesh erosion rate of 6.3% in 143 women who underwent anterior or posterior repair with placement of low-weight polypropylene mesh coated with an absorbable film.

The effect of concomitant hysterectomy appears to be conflicting. Concurrent hysterectomy seems to be a risk factor according to Collinet et al. [43] and Baessler and Maher [3]; however, Deffieux et al. [32] did not find hysterectomy to be an independent risk factor. The use of a low-weight, mono-filament, large-pore size polypropylene mesh coated with a hydrophilic film (Pelvitex, Bard) for vaginal prolapse repairs was associated with a 10% erosion rate when concomitant hysterectomy or trachelectomy was performed and a 4% erosion rate if the uterus was preserved or if the procedure was performed after previous hysterectomy [34].

Mesh-related infection

The incidence of mesh-related infections ranged from 0% to 8% [29, 32, 44]. Various factors influence the development of vaginal mesh-related infection such as the characteristics of the synthetic mesh material (filament structure, pore size), size of mesh, the type of procedure, the peri-operative preventive measures taken and the age and underlying co-morbidity of the treated women [11]. The route of placement, extensive dissection, improper placement and increased tension might promote ischaemia [21] and increase the risk of bacterial colonisation.

Presentation

Non-specific pelvic pain, dyspareunia and persistent vaginal discharge and or bleeding are common manifestation of vaginal mesh-related infection [44]. Occasionally, patients may present with fistulae, pelvic abscess and vertebral osteomyelitis [11]. Draining sinus has been reported as an infection-related complication of synthetic mesh [45]. Clinical examination may reveal induration of the vaginal incision, vaginal granulation tissue, draining sinus tracts and mesh erosion. Various microbiological organisms have been identified, including Gram-positive and Gram-negative aerobic and anaerobic bacteria [44].

Management of mesh erosion and infection

There are limited data on the optimal cost-effective management of mesh erosion and infection. Most of the evidence are based on case series and include antibiotic treatment, local oestrogen treatment and surgical treatment which involves drainage of abscesses, partial or complete removal of the mesh and suturing of vaginal skin over exposed mesh [11, 20, 32, 44]. Generally, mesh erosion into the bladder or urethra or bowel needs surgical removal [11].

Up to 52% of erosions associated with infection do not require surgery [32]. A conservative treatment strategy should be attempted initially especially in small vaginal mesh erosion. Patients are advised to abstain from intercourse. Achtari et al. [42] recommend that failure to resolve in 2 months necessitate return to theatre for excision of the mesh and re-suturing of the vagina. Even so, most patients only require partial excision of the mesh [32, 42] and suturing of vaginal skin over exposed mesh. South et al. [46] described three techniques of excising mesh erosion after abdominal sacrocolpopexy. These include transvaginal, endoscopic-assisted transvaginal and laparotomy. It would be pragmatic to rule out simultaneous erosion into urethra or bladder by cystoscopy [11].

Prevention of mesh erosion and infection

Because of the significance of the impact of mesh erosion and infection on the quality of life of the sufferers, it is important to employ preventive strategies. Anchoring the mesh may be associated with a lower mesh erosion rate by preventing ‘puckering’, movement and extrusion through the vaginal incision. Limited dissection with gentle handling of tissue, meticulous attention to haemostasis, would discourage haematoma formation and colonisation by bacteria. Peri-operative antibiotics, thorough antisepsis of the perineum, vulva and vagina and covering the anus at surgery are important infection prevention strategies. There is no strong evidence that embedding the mesh in anti-septic solution may play a crucial role.

On the basis of the characteristics of the different synthetic mesh, it is preferable to choose a synthetic material that will promote fibrosis and angiogenesis and discourage bacterial colonisation. Vaginal meshes with mono-filament and large pore size (>75 μm) are known to be associated with reduced risk of infection. There is conflicting evidence on risk of mesh erosion by performing concomitant hysterectomy during placement of synthetic mesh in pelvic reconstructive surgery [3, 32, 43]. The role of re-peritonealisation in abdominal sacrocolpopexy remains unclear since there are no randomised controlled trials powered to explore this variable. However, Elneil et al. [47] reviewed 128 patients who underwent apical prolapse surgery with prolene mesh without re-peritonealisation of the mesh. After a median follow-up period of 19 months, 2.3% mesh erosion rate was reported.

Other mesh-related complications

Other mesh-related complications include foreign body reaction, fibrosis, tissue calcification, pain syndromes [48] and recurrent urinary tract infection. Mesh erosions, mesh shrinkage and extensive fibrosis may lead to pain, dyspareunia and dyschezia. Posterior intra-vaginal sling operations are associated with buttock or rectal pain. Posterior intra-vaginal sling resulted in buttock/rectal pain aggravated by sitting, defecation or sexual intercourse [49]. These symptoms have been known to improve with removal of the slings and the main indication for removal of the posterior intra-vaginal slings was severe pain, especially during defecation and sexual intercourse [49]. The exact origin of this pain syndrome is not clear, but the lack of plastic deformation or high stiffness [50] of the intra-vaginal sling and the marked fibrosis surrounding the mesh might contribute.

De novo stress urinary incontinence

Interestingly, an increased rate of post-operative stress urinary incontinence was seen in women who had anterior repair with mesh augmentation [25, 50]. Hiltunen et al. [25] reported de novo stress urinary incontinence in 23% of patients who had mesh repair compared with 10% in patients who underwent traditional anterior repair. Previously, Hung et al. [51] reported de novo stress urinary incontinence in 16.7% of women after anterior repair reinforced with polypropylene mesh. A lower rate of de novo stress incontinence (3%) was reported by Elneil et al. [47] in women who had apical prolapse repair with prolene mesh (open abdominal or laparoscopic; a median follow-up of 19 months). An increase in detrusor overactivity was observed in 34% of women after anterior vaginal wall prolapse repair with prolene mesh [22]; these were women who agreed to have urodynamics 6 months after their repair. The same authors reported recurrent urinary tract infection in 20% of women after anterior vaginal wall prolapse repair with prolene mesh (all the women had normal cystoscopy).

De novo faecal incontinence

De novo faecal incontinence following mesh repair of posterior vaginal wall repair was reported by Milani et al. [22] in a series of women who had posterior vaginal wall repair with synthetic mesh.

Dyspareunia

It is not very clear whether dyspareunia is caused by the size, type, site and route of placement of mesh or by the repair technique and, indeed, it is not clear if validated questionnaires were used to evaluate functional outcome in some of the reported series [12]. Dyspareunia rate of up to 38% has been reported with vaginally introduced mesh for pelvic organ prolapse repair [3]. Following anterior repair with prolene mesh, Milani et al. [22] reported four cases of de novo dyspareunia amongst a series of 17 women who were sexually active pre-operatively, but Dwyer and O’Reilly [52] had a much better experience. De novo dyspareunia was reported in 3% of 90 consecutive patients who had rectocele repair with a combination of Vicryl and Prolene (Vypro II) mesh [53]. Maher et al. [54] in a randomised study comparing abdominal sacrocolpopexy to vaginal sacrospinous suspension found that the incidence of dyspareunia pre- and post-operatively in the abdominal mesh group (20% vs. 13%) was similar to the sacrospinous non-mesh vaginal group (20% vs. 14%).

Women may develop de novo dyspareunia without mesh erosion. In a retrospective analysis of 138 consecutive cases of transvaginal repair of cystocele using synthetic mesh, the incidence of de novo dyspareunia was equal in patients with vaginal erosion and in patients without erosion (9% and 11%, respectively) [32]. Having concomitant operation may be a confounding factor in the development of dyspareunia. Of the 26 women who had rectocele repair with sacrospinous ligament fixation attached to polypropylene mesh, 7.7% developed de novo dyspareunia [34]. Dyspareunia was the indication for removal of mesh in ten out of 19 women who had posterior intra-vaginal slingplasty [49]. In a study of gastrointestinal complications of abdominal sacrocolpopexy, Whitehead [55] noted that pain syndromes and dyspareunia are rarely reported. The outcome data of our unit’s experience with synthetic mesh in pelvic reconstructive surgery is under preparation.

Conclusion

The use of synthetic meshes has been an advance and exciting new development in the surgical management of women with pelvic organ prolapse. The effectiveness of synthetic mesh has been demonstrated in abdominal sacrocolpopexy [10, 54]. However, there is lack of strong evidence to support its routine use in anterior and posterior pelvic reconstructive surgery [8, 10]. There is insufficient good evidence on the long-term safety of synthetic mesh in pelvic reconstructive surgery; therefore, its medicolegal place is yet to be defined clearly. There are few randomised controlled studies comparing mesh augmentation techniques with traditional repairs for anterior and posterior vaginal wall prolapse; most of the reported studies are retrospective series or uncontrolled studies [17]. NICE in England and Wales [56] recommends that these procedures should only be used with special arrangements for clinical governance, consent and audit or research.

It is difficult to generalise about the long-term safety of synthetic mesh in pelvic reconstructive surgery because of variable study design and different length of follow-up of reported studies. Some of the patients underwent concomitant procedures and there is inconsistency in the use of validated questionnaire to evaluate functional outcomes such as dyspareunia and pelvic pain. There is no ideal synthetic mesh. It is still unclear which specific synthetic mesh is best, as synthetic meshes have not been compared in a randomised controlled trials [12]. Available evidence would suggest that type II and III micro-porous and multi-filament meshes are not recommended because of the higher rates of mesh erosion and foreign body reaction compared with type I macro-porous mono-filament mesh. Randomised controlled trials are needed on the safety and efficacy of synthetic mesh in pelvic reconstructive surgery using validated tools to measure anatomic and functional outcomes including quality of life. Due to the paucity of evidence, we would recommend that re-peritonealisation during abdominal sacrocolpopexy be performed pending the outcome of randomised controlled trials.

De novo SUI is an important complication following the use of synthetic mesh in pelvic reconstructive surgery because of its impact on the quality of life of sufferers. Similarly, de novo dyspareunia is a significant complication of vaginal mesh repair. Available evidence shows that it is relatively rare after abdominal sacrocolpopexy [55]. It is pertinent that clinicians are aware of the various potential mesh-related complications and are able to recognise and manage them. This is important because of the increasing use of synthetic mesh in POP surgery.

There is need for large randomised controlled trials with long follow-up evaluating the effectiveness and complications of synthetic mesh in pelvic organ prolapse surgery. There is also the need for studies evaluating the impact of mesh-related complications on the quality of life of patients following mesh augmentation in pelvic reconstructive surgery. Routine use of synthetic mesh in vaginal reconstructive surgery outside of clinical trials cannot be recommended until robust data on its safety and efficacy emerge [8, 10]. There is an exciting possibility that stem cells and gene therapy are likely to play a role in future management of pelvic organ prolapse [12].

Notes

Acknowledgments

Conflicts of interest

None.

Funding

Manufacturers did not sponsor this review.

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Copyright information

© The International Urogynecological Association 2008

Authors and Affiliations

  1. 1.Department of Obstetrics and GynaecologyDerby City General HospitalDerbyUK

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