**2. History**

The first to use synthetic material for a female urethral sling were Williams and Te Linde in 1962, followed by Ridley in 1966 and Morgan in 1970, using a polypropylene Marlex mesh for recurrent stress urinary incontinence. Subsequently, Morgan and colleagues (1985) reported at least a 5 year follow-up of patients with a 77.4% success rate. The complications

Surgical Complications with Synthetic Materials 243

Lapitan et al (2009), in their systematic Cochrane review, evaluated the different treatments for urinary incontinence: open retropubic vaginal suspension, among others, and the tension-free vaginal tape. This review included 46 articles for a total of 4738 women. The total cure rate for open retropubic vaginal suspension was 68.9% to 88%. When open retropubic vaginal suspension is compared to the tension-free tape in 12 studies, there is no difference in the success rate throughout the follow-up time. The available evidence according to Lapitan´s report is that there is no high morbidity or complication rate

Several commercial houses have started to change the mesh placement, with different access

Haylen et al (2011) in The Standardization and Terminology Committees of the International Urogynecological Association (IUGA) and the International Continence Society (ICS) and the joint IUGA/ICS working group on Complications Terminology seek to provide a terminology and a standardized classification for those complications arising directly from the insertion of prostheses and graft in female pelvic floor surgery. A significant increase in the use of an ever widening array of prostheses and graft has occurred in female pelvic floor surgery over the last 30 years. Terminology involved in the classification (Table 2), Classification of complications

PROSTHESIS A Fabricated substitute to assist a damaged body part or to augment or stabilize a hypoplastic structure

A flat strip of synthetic material GRAFT Any tissue or organ for transplantation. This term will refer to biological materials inserted.

From post-mortem tissue banks

PROMINENCE Parts that protrude beyond the surface (e.g. due to wrinkling or folding with no epithelial separation)

EXPOSURE A condition of displaying, revealing, exhibiting or making accessible

intestine, bovine pericardium COMPLICATION A morbid process or event that occurs during the course of a

SEPARATION Physically disconnected (e.g. vaginal epithelium)

EXTRUSION Passage gradually out of a body structure or tissue

DEHISCENCE A bursting opening or gaping along natural or sutured line

PERFORATION Abnormal opening into a hollow organ or viscus

A (prosthetic) network fabric or structure A surgically inserted or embedded prosthesis

From the woman's own tissues e.g. dura mater, rectus sheath or

From other species e.g. modifies porcine dermis, porcine small

e.g. vaginal mesh visualized through separated vaginal epithelium

surgery that is not an essential part of that surgery

routes, either inside-out or outside-in; with suprapubic or transobturator approach.

related directly to the insertion of prosthesis (Table 3) and Grades of pain (Table 4)

fascia lata

CONTRACTION Shrinkage or reduction in size

COMPROMISE Bring into danger

Table 2. Terminology involved in the Classification.

difference between these two surgical procedures.

TERMS USED DEFINITION

**3. Classification** 

a. Mesh b. Implant c. Tape(sling)

a. Autologous Grafts

b. Allografts c. Xenografts

of this procedure include bladder neck obstruction and chronic cystitis. Subsequently, his patients had problems of erosion, infection and fistula formation

Vervigni and Natale (2001) described the three most important components for the use of a mesh in urological reconstructive surgery: the pore size, the type of fiber and its inflexibility. The pore size and the type of fiber may be used to classify mesh in 4 types: Mesh type 1, such as prolene, which is very soft (Ethicon, Endosurgery Inc, Summerville) and Marlex, having a long pore (>75μg) and usually made of polypropylene. This pore size allows macrophages to cross over and there is growth of fibroblasts (fibroplasias), as well as blood vessels (angiogenesis), and collagen deposits; White (1988) reported that because of these features, the mesh leads to changes to prevent infections and fibrous connective tissue grows around the tissue. Type II mesh such as Gore-tex (WL Gore & Associates Inc; Flagstaff, AZ) has a pore size under 10 μg in each one of its three dimensions (micropore). Mesh type III, such as Mersilene, is a macropore shaped naturally, but with micropore components that often include braided material and one/or multiple filaments. Mesh type IV has material with a pore size under a micron, and it is not used as a sling for urinary incontinence surgical procedures. (Table 1). Another important property is fiber composition: polypropylene mesh is made of monofilament and there are others made of multiple filaments which are commonly used. Multiple filament mesh often has a hole less than 10 μg wide, allowing small bacteria to infiltrate and proliferate. In theory, this small hole does not allow macrophages (16 to 20 μg) or white cells (9 a 15 μg) to pass through to kill bacteria, resulting in potential risk of infections. Flexibility or inflexibility of the mesh is another important feature. Prolene has a pore size twice as big as Marlex (1500 μg vs. 600 μg) and is much more flexible. Considering all of these properties, theoretically, prolene may have the lowest rate of erosion on the vagina and adjacent organs.


Table 1. Classification of Mesh Types

Ulmsten et al (1996) were the first to use a tension-free polypropylene mesh (TVT) to repair female stress urinary incontinence. They used a prolene mesh to support the mid urethra. The procedure needs to be performed with cystoscopy. This procedure was designed to avoid excessive tension and the kit is adjusted according to a cough test. The authors do not report any complication during surgery and they conclude that the procedure has a good success rate. This surgical procedure was known worldwide and surgeons started to use it, however some time later, complications were reported in publications. Primicero et al (1999) used the device in 24 patients, reporting a case of a patient with perforation of the external iliac vein and needing surgical repair. Brink (2000) reported a case of intestinal injury. Already in the year 2005 Atherton and Stanton reported that the bladder perforation rate with this kit has a 4.4% incidence in up to 71% of cases, but these were not the only complications. Delorme et al (2204) was the first to use the approach through the obturator hole. In this procedure it is not necessary to use cytoscopy. But some time later, urinary tract injuries were also documented.

Lapitan et al (2009), in their systematic Cochrane review, evaluated the different treatments for urinary incontinence: open retropubic vaginal suspension, among others, and the tension-free vaginal tape. This review included 46 articles for a total of 4738 women. The total cure rate for open retropubic vaginal suspension was 68.9% to 88%. When open retropubic vaginal suspension is compared to the tension-free tape in 12 studies, there is no difference in the success rate throughout the follow-up time. The available evidence according to Lapitan´s report is that there is no high morbidity or complication rate difference between these two surgical procedures.

Several commercial houses have started to change the mesh placement, with different access routes, either inside-out or outside-in; with suprapubic or transobturator approach.
