**2.4 Complications of synthetic midurethral slings**

Although midurethral slings are minimally invasive procedures with high efficacy, however they result in bothersome complications which should not be minimized. The reported complication rates for midurethral slings ranged from 4.3% to 75.1% for TVT and 10.5% to 31.3% for TOT **(Daneshgari et al, 2008).** Awareness of these complications should encourage improvements in patient counseling as well as further investigation of the underlying mechanisms. Summary of the complications of midurethral sling procedures (table 6):


Table 6. Summary of the complications of midurethral sling procedures.

With regard to complications, most of the complications reported were intraoperative minor ones, with little or no disabling effects provided they are recognized and treated intraoperatively. A very limited number of major complications (e.g. bowel, vascular, and nerve injuries, necrotizing fasciitis, ischiorectal abscess, urethrovaginal fistulas, sepsis, and patient deaths) have been reported after placement of midurethral slings. Deng et al reported on the prevalence of major complications in the US Food and Drug Administration's Manufacturer and User Facility Device Experience database, identifying 32 cases of vascular injuries, 33 bowel injuries, and 8 patient deaths after TVT placement **(Deng et al, 2007)**.

A new terminology and classification system has been developed by the International Urogynecological Association (IUGA) and the International Continence Society (ICS) for full description of all possible physical complications related directly to the insertion of prostheses (meshes, implants, tapes) & grafts in female pelvic floor surgery (figure 4). A key advantage of a standardized classification is that all parties involved in female pelvic floor surgery including surgeons, physicians, nurses, allied health professionals and industry will be referring to the same clinical issue. It is anticipated that a category (C), time (T), and site (S) - (CTS) codified table of complications will be a necessary part of reports of surgical procedures relevant to this document. With a standardized classification in place, quicker assessment of adverse events will be achieved together with uniform reporting of prosthetic-related complications **(Haylen et al, 2011)**.


Fig. 4. A classification by category (C), time (T), and site (S) of complications directly related to the insertion of prostheses (meshes, implants, tapes) or grafts in female pelvic floor surgery **(Haylen et al, 2011).** 

Although midurethral slings are minimally invasive procedures with high efficacy, however they result in bothersome complications which should not be minimized. The reported complication rates for midurethral slings ranged from 4.3% to 75.1% for TVT and 10.5% to 31.3% for TOT **(Daneshgari et al, 2008).** Awareness of these complications should encourage improvements in patient counseling as well as further investigation of the underlying mechanisms. Summary of the complications of midurethral sling procedures (table 6):

> Nerve injuries. Gut lesions. - Minor: Bladder injury. Urethral injury.




**a) Intraoperative complications:** - Major: Vascular lesions.

**b) Early postoperative complications:** - Retropubic haematoma.

**c) Late postoperative complications:** - Transient urinary retention.

Table 6. Summary of the complications of midurethral sling procedures.

prosthetic-related complications **(Haylen et al, 2011)**.

With regard to complications, most of the complications reported were intraoperative minor ones, with little or no disabling effects provided they are recognized and treated intraoperatively. A very limited number of major complications (e.g. bowel, vascular, and nerve injuries, necrotizing fasciitis, ischiorectal abscess, urethrovaginal fistulas, sepsis, and patient deaths) have been reported after placement of midurethral slings. Deng et al reported on the prevalence of major complications in the US Food and Drug Administration's Manufacturer and User Facility Device Experience database, identifying 32 cases of vascular

injuries, 33 bowel injuries, and 8 patient deaths after TVT placement **(Deng et al, 2007)**.

A new terminology and classification system has been developed by the International Urogynecological Association (IUGA) and the International Continence Society (ICS) for full description of all possible physical complications related directly to the insertion of prostheses (meshes, implants, tapes) & grafts in female pelvic floor surgery (figure 4). A key advantage of a standardized classification is that all parties involved in female pelvic floor surgery including surgeons, physicians, nurses, allied health professionals and industry will be referring to the same clinical issue. It is anticipated that a category (C), time (T), and site (S) - (CTS) codified table of complications will be a necessary part of reports of surgical procedures relevant to this document. With a standardized classification in place, quicker assessment of adverse events will be achieved together with uniform reporting of

**2.4 Complications of synthetic midurethral slings** 

Futuristic Concept in Management

suburethral tape transaction.

respectively **(Costantini et al, 2007)**.

material also plays an important role in this complication.

months after surgery but they can also happen much later.

removal and tissue reconstruction with a Martius flap.

of Female SUI: Permanent Repair Without Permanent Material 301

**Bladder Outlet Obstruction:** Postoperative obstruction is another challenging complication after a mid urethral sling procedure which varies from urinary retention (temporary or permanent), difficulty emptying or a weak urinary stream. Obstruction usually arises from excessive tension placed over the midurethra by the tape. The reported rates of postoperative obstruction after TVT range from 1.9% to 19.7% **(Abouassaly et al, 2004; Barber et al, 2006)**, and after TOT the rates actually vary from 0% to 15.6% **(Fischer et al, 2005; Delorme et al, 2004)**. Although urine retention and voiding dysfunction are thought to be less common after TOT approach, a recent multicenter randomized trial did not reveal significant differences in postoperative urinary retention between the TVT and TOT (6% and 3%, respectively) **(Barber et al, 2008).** Early postoperative transient urinary retention could be treated with intermittent sterile self-catheterisation or indwelling catheter and usually resolve spontaneously within 12 wk with restoration of complete bladder emptying in the majority of cases. If no improvement occur, early simple sling lysis should be considered or

**Genitourinary erosion:** it is the most frequent and distressing complication after synthetic midurethral sling operations. Costantini and colleagues reported erosion rates after midurethral sling operations based on ranges as reported in the literatures a range from 0.7% - 33%, 2.7% - 33% and 0.5% - 0.6% for vaginal, urethra and urinary bladder erosion

The etiology of the erosion is multifactorial and includes inadequate closure of vaginal wall incision, extensive or incorrect plane of dissection, wound infection, mesh rejection, early sexual activity, tape rolling and abnormal vaginal epithelium i.e. atrophic, scarred or otherwise compromised vaginal mucosa as in post-menopausal women or after previous vaginal surgery and unrecognized vaginal laceration injury during trocar passage. The sling

Patients with genitourinary erosion may be asymptomatic discovered on routine follow-up or presented with a group of symptoms which raise the suspicion of its diagnosis such as pain, dyspareunia, dysuria, discharge and/or bleeding from the urethra or vagina or tape palpable to the patient or partner. Hammad et al, reported that 35% of vaginal erosions were asymptomatic and erosion was discovered on routine follow-up **(Hammad et al, 2005)**. Kobashi et al seemed to confirm these data. In > 90 women who received a polypropylene mesh for the treatment of SUI, 3 developed vaginal erosion, but only 1 had symptoms such as pain, discomfort during sexual activity, and vaginal discharge and erosion was discovered during a routine check-up **(Kobashi et al, 2003)**. Most cases occur in the first few

Mesh erosion may be treated with conservative measures or surgically treated depends on the erosion site and size, mesh material, and local tissue condition. Surgical approach ranges from partial simple excision of the exposed mesh to surgical exploration for total graft

Conservative management with observation might be a viable option if erosion is limited to the vagina and the sling were made of autologous, allograft and new, loosely woven polypropylene material because the latter provides large interstices, which favour tissue ingrowth and healing **(Duckett and Constantine, 2000)**. While some authors stated that

### **2.4.1 Intraoperative and early postoperative complications**

**Bladder perforation:** occur during trocar passage in the retropubic space, it is a common intraoperative complication with reported rates of 0.7% to 24%. **(Laurikainen et al, 2007; Andonian et al, 2005)**. Incidence of perforation increases with poor surgeon experience with the procedure or in recurrent cases. Bladder perforation is suspected intraoperatively by observation of hematuria after trocar passage and diagnosed by cystoscopy. Perforation is easily treated by correct reinsertion of the trocar and catheter drainage for 2–4 days. TOT avoids the needle passage in the retropubic space, and hence bladder perforation is much lower than that of TVT.

**Bleeding and retro-pubic hematoma:** ranges from 0.7% to 8% **(Laurikainen et al, 2007; Rezapour et al, 2001c)** and in majority of cases minor bleeding occur during vaginal dissection and easily controlled. Sometimes excessive bleeding may lead to retropubic hematoma formation usually arises from pelvic floor veins, epigastric, external iliac or obturator vessels injury due to inadvertent trocar passage if laterally directed or externally rotated during the course of insertion. Hematomas size < 100 ml usually asymptomatic, between 100 - 200 ml cause moderate pain, while those >300 ml associated with severe pain and require surgical evacuation of Retzius space **(Flock et al, 2004)**. As perforation, bleeding is not a common complication in TOT procedures, with reported rate 0% to 2% **(Barber et al, 2006; Costa et al, 2004)**.

**Bowel perforation:** a very rare (< 0.007%) **(Costantini et al, 2007)** but serious complication and may be fatal. A recent review revealed 7 deaths that occurred after TVT placement of which 6 were associated with bowel injury **(Nygaard and Heit, 2004)**. Bowel perforation is not reported with TOT procedures. Risk factors for bowel injury include previous pelvic and abdominal surgery due to presence of adhesions in the retropubic space.

#### **2.4.2 Late postoperative complications**

**De novo urgency:** The rate of de novo urgency after midurethral slings placement as reported in literature ranges from 7.2% to 25% **(Costantini et al, 2007).** The mechanisms of de novo urgency after midurethral slings procedures are poorly understood. Combined outlet obstruction and urethral irritation by the sling has commonly been used as an explanation. TOT procedure is usually associated with a lower rate of de novo urgency than TVT **(Juanos et al, 2011)**. Meanwhile, such complication usually does not improve by time. Holmgren et al reported 14.5% of de novo urgency after long term follow-up of 5.2 years after TVT **(Holmgren et al, 2007)**.

**Groin and thigh pain:** On the other hand, TOT procedure has a significant risk of postoperative groin and thigh pain. This pain was observed with range of 5% to 26%. **(Meschia et al, 2007; Dobson et al, 2007)**. However, the pain is usually transient and resolves spontaneously within a few months in most of cases. The exact etiology of this pain remains unknown but it may be related to the tape's presence in the adductor muscles or the foreign body reaction to the tape lying in proximity to peripheral obturator nerve branches or secondary to the trauma to the obturator membrane and muscles during the procedure.

**Bladder perforation:** occur during trocar passage in the retropubic space, it is a common intraoperative complication with reported rates of 0.7% to 24%. **(Laurikainen et al, 2007; Andonian et al, 2005)**. Incidence of perforation increases with poor surgeon experience with the procedure or in recurrent cases. Bladder perforation is suspected intraoperatively by observation of hematuria after trocar passage and diagnosed by cystoscopy. Perforation is easily treated by correct reinsertion of the trocar and catheter drainage for 2–4 days. TOT avoids the needle passage in the retropubic space, and hence bladder perforation is much

**Bleeding and retro-pubic hematoma:** ranges from 0.7% to 8% **(Laurikainen et al, 2007; Rezapour et al, 2001c)** and in majority of cases minor bleeding occur during vaginal dissection and easily controlled. Sometimes excessive bleeding may lead to retropubic hematoma formation usually arises from pelvic floor veins, epigastric, external iliac or obturator vessels injury due to inadvertent trocar passage if laterally directed or externally rotated during the course of insertion. Hematomas size < 100 ml usually asymptomatic, between 100 - 200 ml cause moderate pain, while those >300 ml associated with severe pain and require surgical evacuation of Retzius space **(Flock et al, 2004)**. As perforation, bleeding is not a common complication in TOT procedures, with reported rate 0% to 2% **(Barber et al,** 

**Bowel perforation:** a very rare (< 0.007%) **(Costantini et al, 2007)** but serious complication and may be fatal. A recent review revealed 7 deaths that occurred after TVT placement of which 6 were associated with bowel injury **(Nygaard and Heit, 2004)**. Bowel perforation is not reported with TOT procedures. Risk factors for bowel injury include previous pelvic and

**De novo urgency:** The rate of de novo urgency after midurethral slings placement as reported in literature ranges from 7.2% to 25% **(Costantini et al, 2007).** The mechanisms of de novo urgency after midurethral slings procedures are poorly understood. Combined outlet obstruction and urethral irritation by the sling has commonly been used as an explanation. TOT procedure is usually associated with a lower rate of de novo urgency than TVT **(Juanos et al, 2011)**. Meanwhile, such complication usually does not improve by time. Holmgren et al reported 14.5% of de novo urgency after long term follow-up of 5.2 years

**Groin and thigh pain:** On the other hand, TOT procedure has a significant risk of postoperative groin and thigh pain. This pain was observed with range of 5% to 26%. **(Meschia et al, 2007; Dobson et al, 2007)**. However, the pain is usually transient and resolves spontaneously within a few months in most of cases. The exact etiology of this pain remains unknown but it may be related to the tape's presence in the adductor muscles or the foreign body reaction to the tape lying in proximity to peripheral obturator nerve branches or secondary to the trauma to the obturator membrane and muscles

abdominal surgery due to presence of adhesions in the retropubic space.

**2.4.1 Intraoperative and early postoperative complications** 

lower than that of TVT.

**2006; Costa et al, 2004)**.

**2.4.2 Late postoperative complications** 

after TVT **(Holmgren et al, 2007)**.

during the procedure.

**Bladder Outlet Obstruction:** Postoperative obstruction is another challenging complication after a mid urethral sling procedure which varies from urinary retention (temporary or permanent), difficulty emptying or a weak urinary stream. Obstruction usually arises from excessive tension placed over the midurethra by the tape. The reported rates of postoperative obstruction after TVT range from 1.9% to 19.7% **(Abouassaly et al, 2004; Barber et al, 2006)**, and after TOT the rates actually vary from 0% to 15.6% **(Fischer et al, 2005; Delorme et al, 2004)**. Although urine retention and voiding dysfunction are thought to be less common after TOT approach, a recent multicenter randomized trial did not reveal significant differences in postoperative urinary retention between the TVT and TOT (6% and 3%, respectively) **(Barber et al, 2008).** Early postoperative transient urinary retention could be treated with intermittent sterile self-catheterisation or indwelling catheter and usually resolve spontaneously within 12 wk with restoration of complete bladder emptying in the majority of cases. If no improvement occur, early simple sling lysis should be considered or suburethral tape transaction.

**Genitourinary erosion:** it is the most frequent and distressing complication after synthetic midurethral sling operations. Costantini and colleagues reported erosion rates after midurethral sling operations based on ranges as reported in the literatures a range from 0.7% - 33%, 2.7% - 33% and 0.5% - 0.6% for vaginal, urethra and urinary bladder erosion respectively **(Costantini et al, 2007)**.

The etiology of the erosion is multifactorial and includes inadequate closure of vaginal wall incision, extensive or incorrect plane of dissection, wound infection, mesh rejection, early sexual activity, tape rolling and abnormal vaginal epithelium i.e. atrophic, scarred or otherwise compromised vaginal mucosa as in post-menopausal women or after previous vaginal surgery and unrecognized vaginal laceration injury during trocar passage. The sling material also plays an important role in this complication.

Patients with genitourinary erosion may be asymptomatic discovered on routine follow-up or presented with a group of symptoms which raise the suspicion of its diagnosis such as pain, dyspareunia, dysuria, discharge and/or bleeding from the urethra or vagina or tape palpable to the patient or partner. Hammad et al, reported that 35% of vaginal erosions were asymptomatic and erosion was discovered on routine follow-up **(Hammad et al, 2005)**. Kobashi et al seemed to confirm these data. In > 90 women who received a polypropylene mesh for the treatment of SUI, 3 developed vaginal erosion, but only 1 had symptoms such as pain, discomfort during sexual activity, and vaginal discharge and erosion was discovered during a routine check-up **(Kobashi et al, 2003)**. Most cases occur in the first few months after surgery but they can also happen much later.

Mesh erosion may be treated with conservative measures or surgically treated depends on the erosion site and size, mesh material, and local tissue condition. Surgical approach ranges from partial simple excision of the exposed mesh to surgical exploration for total graft removal and tissue reconstruction with a Martius flap.

Conservative management with observation might be a viable option if erosion is limited to the vagina and the sling were made of autologous, allograft and new, loosely woven polypropylene material because the latter provides large interstices, which favour tissue ingrowth and healing **(Duckett and Constantine, 2000)**. While some authors stated that

Futuristic Concept in Management

**(Haylen et al, 2011)** 

**3.1 Introduction** 

**3. Use of biodegradable materials** 

of Female SUI: Permanent Repair Without Permanent Material 303

Fig. 6. A 47-year-old woman underwent a transoburator tape for USI. At 5 months followup, she reported vaginal discharge. Clinically she was febrile at 38°C with a large sling

Fig. 7. 65-year-old with urinary incontinence underwent a multifilament transobturator sling. At 14 months follow up, she experienced severe pelvic pain and vaginal discharge. Clinical examination revealed hyperthermia to 40°C, (i) sling exposure at right vaginal sulcus and (ii) severe cellulitis in the genito-crural fold. Classification: 3C T4 S2; (ii) 6C T4 S3

The perfect implant material currently is not available yet, but in general surgery there is now a consensus, that low weight, large pore (macroporus), monofilament synthetic materials are preferable. However, still serious local complications (e.g. erosion and infection) may occur and related to an increased foreign body reaction. Subsequently,

extrusion as depicted. Classification: 3C T3 S1 **(Haylen et al, 2011)** 

polypropylene tape erosion should be treated with complete mesh removal, without regard to erosion site, size, or local tissue condition **(Sweat et al, 2002)**. Vaginal erosion of synthetic materials, such as polyester and silicone slings, should also be treated with mesh removal because epithelialisation over these materials is unlikely **(Duckett and Constantine, 2000; Stanton, Brindley and Holmes, 1985).**

If the vaginal erosion is small (1 cm) and local tissue does not appear infected, spontaneous healing by epithelialisation may occur in 6 to 12 weeks with pelvic rest alone **(Kobashi and Govier, 2003)**. If conservative management is unsuccessful or the erosion is (1 cm), the exposed mesh may be excised with the patient under local anesthesia with vaginal closure after the edges have been freshened. Erosions with copious vaginal discharge or if local tissue appears to be infected may require more extensive resection of the mesh. Surgery is recommended when erosion involves the lower urinary tract (bladder or urethra), independently of sling materials **(Clemens et al, 2000; Duckett and Constantine, 2000)**. A recent meta-analysis of polypropylene midurethral slings revealed a possible trend toward increased erosion rates after TOT approach (OR 1.5, 95% CI 0.51– 4.4) **(Latthe et al, 2007)**.

Although rare, erosion of mesh into the urethra can occur. A recent large retrospective series of TVT revealed urethral erosion in 0.3% of cases **(Karram et al, 2003)**.

With the new classification system of IUGA and ICS the description of the complications related to midurethral slings especially genitourinary erosion now become standardized and easy as shown in some the following reported cases of complication related to the use of midurethral tapes (figures 5, 6, 7)

Fig. 5. 52 year old female underwent a transobturator tape. At 6 weeks, she was cured of her USI and reported no vaginal discharge. Vaginal examination revealed a smaller mesh exposure away from vaginal suture line. Classification: 2A T2 S2 **(Haylen et al, 2011)** 

polypropylene tape erosion should be treated with complete mesh removal, without regard to erosion site, size, or local tissue condition **(Sweat et al, 2002)**. Vaginal erosion of synthetic materials, such as polyester and silicone slings, should also be treated with mesh removal because epithelialisation over these materials is unlikely **(Duckett and Constantine, 2000;** 

If the vaginal erosion is small (1 cm) and local tissue does not appear infected, spontaneous healing by epithelialisation may occur in 6 to 12 weeks with pelvic rest alone **(Kobashi and Govier, 2003)**. If conservative management is unsuccessful or the erosion is (1 cm), the exposed mesh may be excised with the patient under local anesthesia with vaginal closure after the edges have been freshened. Erosions with copious vaginal discharge or if local tissue appears to be infected may require more extensive resection of the mesh. Surgery is recommended when erosion involves the lower urinary tract (bladder or urethra), independently of sling materials **(Clemens et al, 2000; Duckett and Constantine, 2000)**. A recent meta-analysis of polypropylene midurethral slings revealed a possible trend toward increased erosion rates after TOT approach (OR 1.5, 95% CI 0.51–

Although rare, erosion of mesh into the urethra can occur. A recent large retrospective series

With the new classification system of IUGA and ICS the description of the complications related to midurethral slings especially genitourinary erosion now become standardized and easy as shown in some the following reported cases of complication related to the use of

Fig. 5. 52 year old female underwent a transobturator tape. At 6 weeks, she was cured of her USI and reported no vaginal discharge. Vaginal examination revealed a smaller mesh exposure away from vaginal suture line. Classification: 2A T2 S2 **(Haylen et al, 2011)** 

of TVT revealed urethral erosion in 0.3% of cases **(Karram et al, 2003)**.

**Stanton, Brindley and Holmes, 1985).**

4.4) **(Latthe et al, 2007)**.

midurethral tapes (figures 5, 6, 7)

Fig. 6. A 47-year-old woman underwent a transoburator tape for USI. At 5 months followup, she reported vaginal discharge. Clinically she was febrile at 38°C with a large sling extrusion as depicted. Classification: 3C T3 S1 **(Haylen et al, 2011)** 

Fig. 7. 65-year-old with urinary incontinence underwent a multifilament transobturator sling. At 14 months follow up, she experienced severe pelvic pain and vaginal discharge. Clinical examination revealed hyperthermia to 40°C, (i) sling exposure at right vaginal sulcus and (ii) severe cellulitis in the genito-crural fold. Classification: 3C T4 S2; (ii) 6C T4 S3 **(Haylen et al, 2011)** 
