**5. Complications**

We will divide complications into: intra-operative and post-operative (immediate and late).

#### **5.1 Intra-operative complications**

#### **5.1.1 Bladder and urethral lesions**

Abouassaly et al (2004) analyzed surgical complications of the tension free tape (TVT) in six institutions; the procedures were carried out by 6 different urologists. They checked the

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

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

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

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

We will divide complications into: intra-operative and post-operative (immediate and late).

Abouassaly et al (2004) analyzed surgical complications of the tension free tape (TVT) in six institutions; the procedures were carried out by 6 different urologists. They checked the

body and there may be a response to these.

recommendations to place the chosen device.

the model used (rats).

**5. Complications** 

**5.1 Intra-operative complications 5.1.1 Bladder and urethral lesions** 

was used.

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% 0.06-0.35).

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).

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

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 both groups which were resolved with conservative bladder drainage management.
