Pelvic Floor Disorders: Surgical Approach

27. Synthetic and Biological Meshes for Pelvic Floor Disorders

Gabriele Böhm 

(1)

Department of General and Visceral Surgery, Katholische Stiftung Marienhospital, Teaching Hospital University RWTH Aachen, Aachen, Germany

Gabriele Böhm

Email: GabrieleBoehm@gmx.net

Abstract

New innovative surgical procedures will achieve general acceptance and change former standards if they have the capacity to improve clinical outcome.

27.1 Introduction

New innovative surgical procedures will achieve general acceptance and change former standards if they have the capacity to improve clinical outcome.

An improvement in the outcome in surgery for pelvic organ prolapse (POP) was sought, as re-operation rates after traditional POP and urinary incontinence surgery were high [1], with 60% of female patients undergoing re-intervention at the same anatomical site, and 32% of females developing a hidden support defect requiring additional intervention at a different pelvic site. The recurrence rate following pelvic surgery within the anterior compartment has been shown to be 40% [2]. These recurrence rates were observed with the traditional plication-type surgical techniques, particularly for the anterior compartment. As a result, in the hope of reducing such high recurrence rates, novel techniques for POP repair were described and disseminated within the surgical community.

The idea of adding graft augmentation to the traditional plication-type technique was in agreement with the aim of tissue reinforcement and the improvement of outcomes achieved by mesh augmentation for abdominal wall hernia repair [34]. Within the field of POP surgery, the use of graft reinforcement has gained wide acceptance and the burning question is now: which graft is best to use?

Biological meshes are currently very much in vogue within the surgical community. There is nothing new about ‘biologicals’: in the 1960s, fascia lata was used regularly as a material for hernia repair, for example to cover congenital diaphragmatic defects. It had a convincing haptic and was easy to insert. Why then, was there a powerful search for new synthetic materials?

The main advantage of biologic mesh is its supposedly superior role within contaminated areas and resistance to infection. But is this proclaimed advantage scientifically sufficiently supported?

What are the pros and cons of biologic and synthetic mesh? There is some good new research that may lead us in the right direction. And within the context of rather extreme warnings from the US Food and Drug Administration with regard to the use of synthetics in the urogynecological field, one should read the evidence rather carefully [56].

Warnings were issued about transperineal or transvaginal insertion of synthetic meshes with regard to reported rates of complications such as mesh extrusion or viscous erosion. Studies highlighted the fact that the type of surgical insertion technique (blind insertions via trocars) might have more effect on the outcome than the type of mesh used [7]. In other studies, the complication rates of extrusion or erosion were found to be similar or higher with biological mesh compared with synthetic mesh [6].

The decision for or against one particular mesh material becomes more and more difficult given the vast amount of different materials on the market. Factors influencing the decision are the biology of the patient, the anatomical location and its role for functional improvement, the anatomical insertion site, a contaminated or noncontaminated operative area, and financial considerations.

The requirements of any biomaterial for the use in humans are:

·               Elasticity according to its surrounding needs

·               Structural stability (e.g., form, surface, three-dimensional construction)

·               Resistance to degradation by host cells for at least 1 year or longer (depending on its supposed function: e.g., permanent support material or temporary scaffold for tissue regeneration in its place)

·               Biocompatibility

·               Nontoxic, nonteratogenic, noninfectious, hypoallergic

·               Integration within its new surrounding tissue

Additional future benefits are likely to include:

·               Stimulation of tissue regeneration in its place

·               Anti-adhesive toward cavities such as the abdominal or thoracic cavity

·               Surface modification according to needs, e.g., pharmaceuticals, active agents influencing the inflammatory reaction, and agents promoting tissue regeneration

·               Surface modification for the visualization of the inserted material

There is a plea for more preclinical research in the field of pelvic floor surgery before the launch of new mesh designs [89]. We fully support this plea and support the tendency towards more physiological, mechanical, and biomolecular research of the pelvic floor. The standardization of measuring parameters is a requirement that is long overdue.

For many years, synthetic as well as biological mesh materials were inserted and studied at different hernia locations, mostly the groin and abdominal wall. Knowledge from these locations can be partially used for other applications such as hiatus hernia, diaphragmatic hernia, urogenital prolapse and rectal prolapse, or pelvic diaphragmatic insufficiencies.

When choosing the right mesh, the surgeon has to consider the following:

·               Mesh material

·               Required durability of the material

·               Elasticity

·               Adjacent organ involvement

·               Movement rate and likelihood of side-effects due to friction

·               Pressure necrosis

·               Contact with the peritoneal cavity

·               Bacterial contamination

·               Surgical insertion site

Meshes can be of biological or synthetic material.

Biological mesh materials can be classified into three groups:

·               Autologous material

·               Allografts (human acellular cadaveric materials)

·               Xenografts (animal acellular cadaveric materials).

It is important that these materials are chemically processed in different ways. First, they have to be devitalized. This can be achieved in different ways. The chemicals used might have an effect on the functional quality of the product as well as on the host that will receive the implant. For further information we refer to chemical information sites. Box 27.1 gives some examples of biological materials.

Box 27.1

Examples of biological materials

Autologous grafts:

   Fascia lata

   Rectus fascia

Allografts:

   Human cadaveric dermis:

    AlloDerm (LifeCell Corporation, Branchburg, New Jersey, USA)

    FlexHD (Ethicon, Cornelia, Georgia, USA)

   Cadaveric fascia lata:

    Suspend Tutoplast (Mentor Corporation, Santa Barbara, California, USA)

    FasLata (CR Bard, Covington, Georgia, USA)

Xenografts:

   Porcine dermis:

    Cross-linked:

     Permacol (Covidien, Mansfield, Massachusetts, USA)

     Collamend (Davol, Warwick, Rhode Island, USA)

     Pelvicol Acellular Collagen Matrix (CR Bard)

     PelviSoft BioMesh (like the above, only with perforations)

     (CR Bard)

    Non-cross-linked:

     Strattice (LiefeCell Corporation)

     XenMatrix (Davol)

   Porcine small intestinal submucosa:

    Surgisis (Cook Surgical, Bloomington, Indiana, USA)

   Bovine dermis:

    Xenform Soft-Tissue Repair Matrix (Boston Scientific, Natick, Massachusetts, USA)

    SurgiMend (TEI Biosciences, Boston, Massachusetts, USA)

   Bovine pericardium:

    Veritas (Synovis Surgical Innovation, St Paul, Minnesota, USA)

    Tutomesh (RTI Biologics, Alachua, Florida, USA)

Some biomaterials are cross-linked in order to render the biomaterial less vulnerable to rapid breakdown of collagens and proteins by collagenases and other proteinases. The amount of cross-linking defines the time required for degradation of these biomaterials. For example, 100% cross-linking may render the material impenetrable by host cells and therefore not degradable. The latter goes often hand in hand with encapsulation of the material and isolation from normal tissue turnover. This is not an ideal situation.

Synthetic materials can be classified into absorbable and nonabsorbable, monofilament and multifilament, knitted or woven, microporous and macroporous, and heavyweight and lightweight meshes. Box 27.2gives some examples of synthetic materials.

Box 27.2

Examples of synthetic meshes

Absorbable:

   GORE®BIO-A® Tissue reinforcement (polyglycolic acid:trimethylene)

   carbonate (PGA:TMC) fibers (Gore & Associates, Inc., Newark, Delaware, USA)

Nonabsorbable:

   Gynemesh (polypropylene) (Ethicon, Norderstedt, Hamburg)

   Smart Mesh (polypropylene, light weight) (Coloplast, Orton, Peterborough, UK)

   ePTFE (polytetrafluorethylene) (Gore & Associates, Inc., Newark, Delaware, USA)

   PVDF (polyvinylidene difluoride) (Dahlhausen GmbH & FEG Textiltechnik Aachen, Germany)

   Parietex Prosup (polyester, large pore, heavyweight)(Tyco Healthcare, Gosport, Hampshire, UK)

Mixed, partially absorbable:

   Vypro® (polypropylene plus polyglactin) (Ethicon, Norderstedt, Hamburg)

   Ultrapro® (polypropylene plus polyglecaprone-25, large pore, lightweight) (Ethicon, Norderstedt, Hamburg)

Mixed, nonabsorbable:

   Dynamesh IPOM (Polypropylene plus polyvinylidinchloride at abdominal side)

   (Dahlhausen GmbH & FEG Textiltechnik)

Additional surface modifications:

   Proceed® (Polypropylene plus polydioxanone and cellulose)(Ethicon, Norderstedt, Hamburg)

   Parietene composite: polypropylene plus collagen/polyethylenglycol/glycerol coating) (Covidien, Mansfield, Massachusetts, USA)

27.2 Biological Materials

Lyophilized bovine dura mater was used regularly for congenital diaphragmatic hernia repair. The surgical haptic was good, and the material was flexible enough to fit into a dome-shaped form. With the occurrence of BSE (bovine spongiform encephalopathy) and possible transmission of Creutzfeldt-Jakob disease, bovine neuron-related materials were withdrawn from the market after 1992. Despite new avitalization processes, a residual small risk of prion or viral transmission cannot be excluded. Examples of substitutes for neuron-based materials include bovine pericardium [10], porcine pericardium, bowel wall, or fascia; however, the available size of these materials is not always sufficient for repair of large hernias. Large surface area materials, such as dermal matrix or small bowel mucosa, chemically processed and reconstituted, are used for this purpose.

27.2.1 Acellular Biological Materials

Examples of two prototypes of acellular biological materials are discussed: Surgisis® and Permacol®.

Surgisis (Cook Surgical, Bloomington, Indiana, USA) was produced following studies by Hodde et al. [11] describing the development of an extracellular matrix (ECM) made from sterilized porcine small bowel mucosa with its ECM components. Related studies by Cook Surgical postulated complete new tissue regeneration, which was qualitatively similar to the surrounding tissue [12]. As yet, there have been no long-term randomized studies to prove its superior quality. Clinical results comparing Surgisis with other meshes for use in diaphragmatic hernia demonstrated a similarly high recurrence rate of 50% [13]. Our own animal studies demonstrated that 4 months after insertion Surgisis had disintegrated and had been substituted by lower-quality scar tissue, resulting in inferior mechanical quality compared with a polypropylene mesh [1417]. No improvement of tissue tensile strength was found when comparing animals implanted with Surgisis with control animals without mesh [18]. In a rat model, animals with Surgisis had a much lower tensile strength compared with polypropylene [19].

Surgisis did not show any convincing advantage compared with synthetic materials with respect to seroma formation, adhesions, tensile strength [20], shrinkage [21], and recurrence rates following hernia repair [22].

In summary, the insufficient mechanical strength of Surgisis renders it unsuitable for any application where mechanical support is essential [23], e.g., pelvic prolapse surgery.

Permacol (acellular cross-linked porcine dermal matrix) is another type of biomaterial that is regularly inserted in different hernia locations, including parastomal hernias, and plevic prolapse surgery [24]. Within this group of crosslinked meshes, collagen molecules are covalently bound to each other following chemical processing. This protects the material to a certain degree against degradation by host tissue collagenases. In a study, Permacol showed satisfactory tensile strength over 6 months and better mechanical properties compared with other cross-linked materials [20]. Another study demonstrated a lower hernia recurrence rate with Permacol compared with polytetrafluoroethylene (PTFE) [25]; however, the follow-up time was short and patient numbers were small. In prolapse surgery, clinical short-term results were shown to be promising [26].

However, several recent studies have revealed problems with the use of biological meshes. In a long-term follow-up study using different materials for abdominal incisional hernia repair, Permacol did not show an advantage compared with synthetic meshes [25]. In a clinical study, the recurrence rate of incisional hernia at 18 months using Permacol was 15%, with a complication rate of 35% (e.g., wound infection) [27]. This is no improvement on currently used synthetic meshes. The fistula rate following the use of Permacol intra-abdominally is low, but not unheard of; equally, bowel adhesions with the need for re-intervention have been described [6].

Additionally, Permacol has shown a marked inflammatory response in rats up to 40 days postimplantation, and no ingrowth of skeletal muscle cells [28].

The cross-linked Permacol has demonstrated better mechanical qualities compared with non-cross-linked materials [20], but inferior qualities compared with synthetic meshes. Similar findings were shown in an animal study comparing Pelvicol® with Pelvisoft®, Gynemesh®, and Surgisis. The polypropylene-based Gynemesh showed the highest tensile strength and least stiffness compared with the cross-linked Pelvicol. In addition, Pelvicol showed encapsulation after 3 months insertion time, whereas Gynemesh was found to be incorporated [29]. A clinical study using Surgisis or Pelvicol for sacrocolpopexy at 2 years follow-up found the anatomical recurrence rate to be very high (70%), with a functional recurrence rate of 40% [30].

These results compare very badly with studies on prolapse surgery using synthetic meshes. On the other hand, long-term clinical follow-up results on the use of synthetic mesh for laparoscopic anterior rectopexy for rectal prolapse describe very low recurrence rates of no more than 5% [3132].

Additionally, the hope for superior behavior of biological materials within a contaminated area is contradicted by multiple studies. Following inoculation of meshes with bacteria, findings have indicated a possible higher tendency of infection when using biological materials [33]. Additionally, inoculation seems to weaken the tensile strength of the biological mesh [34].

In summary, biological materials have not shown convincing superiority compared with synthetic nonabsorbable meshes in hernia repair [3536], or in prolapse/pelvic floor surgery [3739]. Another disadvantage with biomaterials is their inconsistent ECM composition (e.g., type and amount of collagen). Therefore, their functional outcome is not predictable, plus, this inconsistency renders them unsuitable for surface modulation.

27.3 Synthetic Meshes

Synthetic meshes are frequently used in hernia surgery, in the knowledge that they produce good long-term results. Typical qualities include good biocompatibility, reproducibility, and consistency. The concept of lightweight and heavyweight meshes is well established [40]. The basis for this concept was the finding that the host inflammatory response depends on the material density and pore size of the mesh construct. A lightweight and large-pore-size mesh is more suitable than a heavyweight and small-pore-size mesh.

However, a limited inflammatory reaction is tolerated and is required for tissue remodeling and adequate scar formation [41]. Therefore the density of the material was reduced and the pore size was enlarged, which led to optimal tissue incorporation of the mesh and avoidance of biofilm production [4245], with no impact on the good mechanical qualities of the material [4649].

Mesh shrinkage of synthetic meshes is in the range of 3–30%, depending on their location, textile structure, and weight [50]. In hernia surgery, this is compensated by mesh overlap.

For the intra-abdominal application of meshes, anti-adhesive materials are added to the mesh. For example, Proceed® has a cellulose cover on its abdominal side [5152]. Studies comparing polypropylene meshes with different covers suggest that there is room for further improvement [5253].

Ultrapro® (polypropylene plus polyglecaprone-25) has demonstrated superior biocompatibility in animal studies in comparison with other synthetic materials [54], and is one of the most frequently used materials in hernia surgery [55].

PTFE was known for its lack of elasticity and tendency toward encapsulation and failed tissue integration [21]. It was hoped that there would be an improvement in these properties in the expanded version of PTFE: ePTFE. In one study, it showed fewer adhesions compared with polypropylene in the intra-abdominal position, but it also showed a shrinkage rate of 30% [51].

Another advantage of synthetic meshes, is the possibility of surface modulation [5657].

27.3.1 Surface-modulated Meshes

The search for the ideal mesh is ongoing. The advantage of synthetic meshes is the possibility of modifying the surface of currently available commercial meshes (Fig. 27.1) [5659]. It is possible to add active agents such as antibiotics, protein- repellent substances, and inflammatory response proteins. Also, one can configure a three-dimensional scaffold that allows cell inoculation according to the required needs. Ongoing in vitro research is attempting to establish a system in order to test cell interaction with different biomaterials [6064]. Controlled release of active substances (e.g., antibiotics, cytokines, growth hormones) bound to the mesh is also easily achieved [65].

A978-88-470-5441-7_27_Fig1_HTML.jpg

Fig. 27.1

Electronmicroscopy of a surface-modified mesh: electrospun absorbable nanoweb on Ultrapro® mesh. PLGA (polylactide glycolic acid) with NCO-sP(EO-stat-PO) as a possible carrier for active substances

27.4 Summary

In summary, the individual needs of the patient, the target location and its required function, and the insertion route [66] plus its surrounding communicating tissue [67] will decide whether a biological or synthetic, absorbable or nonabsorbable material, is most suitable.

The main advantage of synthetic material is its precise reproducibility, absent infectious risk, and possibility for surface modification, and addition of active agents such as inflammatory modulators or stem cell inoculation. Mechanical qualities of different synthetic meshes have been studied and the surgeon has to decide whether a stiffer or more elastic material is needed. For prolapse surgery, a more elastic mesh such as Ultrapro or smart mesh seems advisable, considering the proximity to the rather vulnerable vaginal tissue [67]. In order to avoid mesh erosion into or constriction of viscous organs (rare, but devastating for the patient when it happens) we would recommend use of as little implant material as possible, never surrounding an organ completely, and covering the material with a good amount of the patients’ own tissue as a barrier. These recommendations are fulfilled, for example, in the anterior rectocolposuspension technique described by D’Hoore and Penninckx [68], using a small strip of mesh and covering it completely with peritoneum and fat.

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