**4. Pathophysiology**

244 Urinary Incontinence

A ASYMPTOMATIC

1 A : Abnormal prosthesis or graft finding on clinical examination

3A: Asymptomatic 1-3Aa if no prosthesis or graft related pain

4A: Small intraoperative defect e.g. bladder perforation

5A: Small intraoperative defect (rectal or bowel)

6A: Asymptomatic, abnormal finding or clinical examination

7A: Bleeding complication including hematoma

T2: 48 hours to 2

(meshes, implants, tapes) or graft in female pelvic floor surgery.

S2: Vaginal: away from area of suture line.

months

GENERAL DESCRIPTION

1 VAGINAL: no epithelial separation. Includes prominence (e.g. due to wrinkling or folding), mesh fiber palpation or contraction (shrinkage

2 VAGINAL: Smaller ≤

3 VAGINAL: larger >1 cm

1cm exposure

calculus

exposure, or any extrusion

4 URINARY TRACT: Compromise or perforation including prosthesis(graft) perforation, fistula and

5 RECTAL OR BOWEL: Compromise or perforation including prosthesis(graft) perforation and fistula

7 PATIENT: Compromise including hematoma or systemic compromise

T1: Intraoperative to 48

S1: Vaginal area of suture line

hours

6 SKIN AND/OR MUSCULOSKELETAL Complications including discharge pain lump or sinus tract formation

CATEGORY

B SYMPTOMATIC

1 B: Symptomatic e.g. unusual discomfort/pain; dispareunia (either partner); bleeding

2A : Asymptomatic 2B: Symptomatic 2C: Infection 2D: (+)

3B: Symptomatic 1-3B(b-e) if prosthesis or graft related pain

4B: Other lower urinary tract complication or urinary retention

5B: Rectal injury or compromise

6B: Symptomatic e.g. discharge, pain or lump

7B: Major degree of resuscitation or intensive care

T3: 2 months to 12

S3: Trocar passage Exception: Intraabdominal(S5)

TIME ( CLINICALLY DIAGNOSED)

SITE

Table 3. A Classification of complications related directly to the insertion of prosthesis

months

C INFECTION

1C: Infection (suspected or actual)

3C: Infection 1-3C/1-3D (b-e) if prosthesis or graft related pain

4C: Ureteric or upper urinary

complication

5C: Small or large bowel injury or compromise

6C: Infection e.g. sinus tract formation

7C: Mortality\* \*additional complication \*no site applicable-S0)

T4: Over 12 months

S4: Other skin or musculoskeletal site

tract

D ABSCESS (+)

1D: (+)

3D: (+)

5D (+)

6D (+)

Jeffry et al (2001) reported that the bladder lesion rate due to perforation, increased in patients who had a prior anti-incontinence surgical procedure, this is due to the retropubic scarring process, and they also observed that the bladder perforation site is greater on the opposite side of the surgeon's dominating hand.

Is a bladder lesion never observed during cystoscopy? Not really. Buchsbaum et al in (2004) reported that when they discarded the presence of bladder lesion after a cystoscopy, they found fluid leak through the incision or through the trocar path. Therefore, it is important to perform an appropriate bladder distension in order to separate the bladder folds and discard or confirm this complication appropriately. If necessary, methylene blue or indigo carmine can be used.

What is the anatomical relationship between vascular anatomy and placement of trocars in the insertion of a TVT? Muir et al (2003) did an anatomical dissection in cadavers and found that the TVT trocar goes through at an average distance of 4.9 cm from the external iliac artery and 3.2 cm from the obturator vessels, therefore, when the trocar goes in deviated laterally, it can cause an injury to the external iliac artery or vein. An inadequate technique when the trocar is inserted can cause severe complications.

Is the patient's position as well as position of the legs important to avoid complications? Yes. Whiteside et al (2004) reported the anatomy of the neurovascular bundle in relation to the obturator fossa when the TOT is placed; the trocar goes through at a 1.1 ± 0.4 cm average distance from the medial branch of the obturator vessels and the average distance to the obturator nerve is 2.5 ± 0.7 cm. Hubka et al (2010) reported in a study of 14 embalmed bodies with poor position of the legs (group 1), 5 fresh frozen bodies with poor leg position (group 2) and 5 fresh frozen bodies with the proper leg position (group 3). After dissection, they measured the rami of the obturator nerve; in group 1, the average distance of the anterior ramus of the obturator nerve was at 8.4 mm (left) and at 8.9 mm (right). In group 2 the average was 5 mm (left) and at 8 mm (right) and the posterior ramus of the obturator nerve was at 5 mm (left) and 8 mm (right) respectively. In group 3, the average distance of the anterior ramus of the obturator nerve was 24mm (left) and 23 mm (right). Therefore, the correct position of the patient and of the legs ensures proper placement of the TVT-O.

Several factors have been proposed for complications with these kits: broad dissection with devascularization of the vaginal tissue, estrogen deficiency, excess tension, and presence of subclinical or overt infection before surgery, poor placement of the patient's legs during surgery, poor knowledge of the surgical technique to place the kits and smoking.

Surgical Complications with Synthetic Materials 247

management of each complication and the patient outcomes. Of the 241 patients, complications during surgery were bladder perforation in 48 patients (5.8%). Andonian et al (2005) compared SPARC with TVT reporting a similar percentage in both groups 24% and 23% respectively. Kristensen et al (2010) reported that out of 778 patients there was bladder perforation in 51 (6.6%). Lee et al (2010) reported 141 patients, with 9 patients (6.4%) having bladder perforation. When Novara et al (2010) in a systematic review of pubovaginal sling, retropubic tape (RT) and transobturator tape (TOT), made a comparison between procedures they reported that the TOT has less risk of bladder or vaginal perforation (OR: 2.5 IC: 1.75-3.57; p<0.00001); but Revicky et al (2011) reported in 342 women with TVT, that the incidence of bladder lesion was 4.7% (16/342). Pushkay et al (2011) reported in 577 patients a high incidence of bladder perforation in the TVT group vs. the TVO-O group (5.4% vs. 0.6%; p=0.001) George et al (2010) reported bladder perforation in 1.3% of the TVT group and none in the TOT group. Barry et al (2011) in a multicentric, randomized trial comparing TVT- Monarc at 3 months follow up, report a bladder lesion in 7/140 patients with TVT and 0/140 patients with Monarc. Rajendra et al (2011) reported 419 patients with stress urinary incontinence at 3 years follow up, 2 patients (0.5%) with bladder perforation. Latthe et al (2010) in his systematic review of 4 articles, report that bladder lesions with the TOT procedure have an OR 0.11 (IC 95% 0.05-0.25) and TVTO has an OR of 0.15 (IC 95%

Bladder perforation during surgery due to the trocars is reported at 1.3% by George et al (2010) and up to 22% during the learning curve phase as described by Lebret et al (2001).

Alvárez-Bandrés et al (2010) reported complications with the mini-sling system (50 patients with TVT-secur and 105 with Miniarc), there were bladder perforations in 0.64% total in

Primicero et al (1999) reported one lesion of the external iliac vein in a patient with TVT which had to be repaired through laparotomy; Zilbert and Farrel (2001) reported one patient with laceration of the external iliac artery and a neurovascular bundle lesion of the obturator ramus when the TVT was applied. Kuuva and Nilssons (2002) reported in 1455 patients a lesion incidence of large vessels and nerves in 2 patients (0.1%). Flock et al (2004) reported in 7 patients with TVT, blood loss quantified at 250 to 400 ml (2.1%); Abouassaly et al (2004) reported major bleeding of 500 ml in 16 women (2.5%) (16/421) with TVT. Kristensen et al (2010) in 778 patients with TVT reported hemorrhage that needed transfusion in 5 patients (0.6%), Barry et al (2011) observed that bleeding is minor in the group of patients with Monarc, 49 ml; in the TVT group it was 64 ml (p < 0.05), likewise surgical time was 14.6 min with Monarc and 18.5 min with TVT (p < 0.001). Rajendra et al (2011) reported that of 419 patients with TVT-O, 3 patients (0.8%) had a blood loss over 200 ml. Dunn et al (2004)

Brink (2000) reported one case of intestinal lesion that was repaired with a good outcome for the patient. Although we have minimally invasive procedures, these also pose arterial complications as Jung et al (2010) reported in a patient with TVT-secur who presented a

both groups which were resolved with conservative bladder drainage management.

Up to date there have been no reports of uretheral lesion during surgery.

reported 30 cases with vascular injury including 2 fatalities.

0.06-0.35).

**6. Bleeding** 

Atis et al (2009) did an assessment in rats to see the reaction produced by the materials of the different slings in the bladder through histopathology (TVT, Vypro mesh, intravaginal plastic sling: IVS); they studied 30 rats with a similar control group, through laparotomy they placed a 0.5 to 1 cm mesh on the anterior bladder wall; after 12 weeks they did a hystopathological test of the bladder. They found signs of inflammation, reaction to a foreign body, subserous fibrosis, necrosis and different degrees of collagen deposits. The Kruskal-Wallis and Posthoc Dunn tests were performed, observing that the inflammatory process was greater in the IVS (p= 0.001) group than in the TVT (p= 0.006) group, and Vypro (p=0.031); this IVS group also showed greater subserous fibrosis (p=0.0001); reaction to a foreign body (p=0.0001) and more collagen deposit (p=0.0001). The bladder showed a greater inflammatory response in the IVS group than in the TVT and Vypro (p=0.041, p=0.028) groups. This can play an important role in the results or complications of the slings.

But et al (2005) reported the probability of the mesh migrating and thus presenting some of the complications mentioned above. We should recall that meshes are a foreign object in the body and there may be a response to these.

Other causes may be that the kit is placed with greater tension than necessary, the quality of the tissue may be poor for several reasons such as: estrogen deficiency or due to poor dissection that leaves tissue with significant devascularization and thus with less blood irrigation which causes a deficiency in the fibroblast migration, in angiogenesis and therefore complications may arise. Surgeons who are going to place any of these devices should be well aware of the neurovascular anatomy of the pelvis as well as of the recommendations to place the chosen device.

Letouzey et al (2011) in an experimental study in rats, used macropore and multifilament polypropylene mesh contaminated with Escherichia Coli, removing it after 30 days. They concluded that the mesh infection forms a bacterial film that acts as a lining and this may be associated to prosthetic erosion without observing changes in the polymer of the mesh. Same results have Mamy et al (2011) highlights a link between infection and shrinkage in the model used (rats).

Withagen et al (2011) reported the risk factors associated to mesh exposure after insertion of the TVT in patients with pelvic organ prolapse; 12 months later only 294 (79%) patients were studied. The risk factors identified were smoking with a RR of 3.08 (IC 95% 1.09-8.72); the surgeons lack of experience (< than 10 years) RR 0.49 (IC 95% 0.29-0.83) and placement of a total Prolift RR 2.95 (IC 95% 1.24-7.01) although this is prolapse information, the TVT mesh was used.
