RSS Urology, Mid Atlantic, Allergan Medical Affairs, 19534, Irvine, CA 92623, USA
Pelvic organ prolapse (POP), with or without stress urinary incontinence (SUI), is a major healthcare problem. Nearly 200,000 women undergo prolapse surgery in the United States every year and the annual cost of pelvic floor surgeries is estimated to be over $1 billion. Olsen et al. reported that the lifetime risk for an American woman to undergo a single operation for prolapse or incontinence is 11.1 % and that a second operation is needed in 29.2 % of cases. However, traditional surgery for POP seems to have limited effectiveness in preventing recurrences, and this disappointing result is due to the poor quality of tissues used. Recently, after the extended use of meshes in abdominal defects and hernias, application of meshed biomaterials for treatment of POP and SUI has been popularized with the hope of defining the most suitable biomaterial for this purpose.
Pelvic organ prolapse (POP), with or without stress urinary incontinence (SUI), is a major healthcare problem. Nearly 200,000 women undergo prolapse surgery in the United States every year  and the annual cost of pelvic floor surgeries is estimated to be over $1 billion . Olsen et al. reported that the lifetime risk for an American woman to undergo a single operation for prolapse or incontinence is 11.1 % and that a second operation is needed in 29.2 % of cases .
However, traditional surgery for POP seems to have limited effectiveness in preventing recurrences, and this disappointing result is due to the poor quality of tissues used. Recently, after the extended use of meshes in abdominal defects and hernias, application of meshed biomaterials for treatment of POP and SUI has been popularized with the hope of defining the most suitable biomaterial for this purpose.
Through the limited evidence available, it seems that the surgical repair of POP using vaginal meshes improves the outcome when compared to repair without the use of a mesh . Maher et al.  suggested in their meta-analysis of the different repair methods that the concept of using a polyglactin mesh for anterior vaginal wall repair decreases the recurrence of cystocele.
In recent years, the use of grafts in gynecological surgery has proven to mandate special considerations when compared to materials used in other surgical procedures. Most relevant of those is the fact that these meshes are required to provide support not only for a herniated sac during rest, but also allow normal, strenuous, and painless sexual activity. Another important factor is the higher risk of infections in these procedures due to the nature of the surgical site in the vagina .
Consequently, surgery for POP aims at restoring physiologic anatomy as well as preserving lower urinary tract, intestinal, and sexual functions. These factors combined together have proven to be a true challenge for the modern urologist.
There are several points of debate within this problem, the most important of which are as follows:
Due to the large number of points and counterpoints in all of those debates, we will focus only on the criteria, types, advantages, and disadvantages of the biomaterials used.
Rationale for Biomaterial Use
In the past, large numbers of POP patients did not seek medical help; however, the number of patients seeking this help is increasing. This is mainly attributed to the improvement in available medical treatments and increased interest in the quality of life . With the recent advances reported in the fields of tissue engineering and regenerative medicine, many technologies have emerged as possible treatment options for POP patients. Biomaterials have been central in those advances whether alone or in combination with cells. All approaches have focused on one of three goals:
There are four main outcomes for the evaluation of prolapse surgery illustrated by the following Venn diagram (Fig. 17.1):
Venn diagram. There are four main outcomes to evaluate prolapse surgery illustrated by the following Venn diagram. (1) Anatomy of the anterior and posterior vaginal walls, vaginal vault, and perineum. (2) Function of bladder and colon, and sexual function. (3) Patient satisfaction and impact on quality of life. (4) Avoidance of complications (From Lee, U. and S. Raz, Emerging concepts for pelvic organ prolapse surgery: What is cure? Curr Urol Rep, 2011. 12(1): p. 62–7, with permission of Springer Science + Business Media)
The successful treatment of POP patients must fulfill all or most of these outcomes to be considered as a viable alternative for management of those patients. The choice of the proper biomaterial is integral to achieving these goals and successful management of POP.
Definition of a Biomaterial
A biomaterial is any natural or synthetic substance that incorporates or integrates into a patient’s tissues during treatment. The ideal compound should be inert, sterile, noncarcinogenic, mechanically durable, noninflammatory, inexpensive, easy to use, and withstand modification by body tissues. The purpose of a biomaterial is to perform, supplement, or replace a natural function that is attenuated or lost .
Criteria of Biomaterials
Cumberland and Scales defined the criteria for an ideal implant material as [9, 10]:
To date, none of the biomaterials available meet all these criteria; however, many come close. The biochemical properties of biomaterials are determined by elasticity, viscosity, and plasticity. The biomaterial is said to be elastic when it regains its original shape after removal of a load without applying another load. When loading occurs for prolonged periods, some elongation of the material or tissue can occur depending on the viscosity of the material .
Difficulties Associated with Detecting the Best Material
In order to estimate the ideal graft characteristics for repair of POP, understanding the biomechanics of the normal patient’s pelvic floor and its supports is useful; however, this is a difficult goal to achieve due to the size of tissue needed for testing. Usually only small biopsies can be obtained from normal women without prolapse and only strips of epithelium may be available from trimming of vaginal tissue as part of prolapse surgery. Also assessing cadaveric tissue has potential limitations such as age of donors, previous medical or surgical history that can affect biomechanical properties, postmortem changes, and potential tissue disintegration .
Additionally, when assessing biomechanical properties of the genital tract alone, other variables such as estrogen status, elastin, collagen, and genetic factors should be considered. Collagen and elastin content in tissue alter biomechanical outcomes. Collagen contributes to tensile strength and preliminary data indicated that collagenase activity was higher in women with SUI leading to increased urinary levels of collagen degradation products. This discovery revealed that the reduced collagen content represents a systemic process in tissues of women with SUI even in other tissues not involved in support of pelvic organs . Elastin on the other hand is important in elasticity of pelvic floor connective tissue, and preliminary data have demonstrated elevated proteolytic activity in skin and endo-pelvic fascia in women with SUI compared to continent women . Selecting a suitable biomaterial for prolapse or incontinence surgery should take these biochemical processes into consideration . As an added level of complexity, the association of SUI with the onset of menopause suggests a role of estrogen . There is also a threefold prevalence of SUI among first degree-related female patients suggesting the potential for predisposing genetic factors [12, 16]. It is also important to note that different studies offer different definitions about “cure” in prolapse surgery. This is mainly due to the variability of symptoms of prolapse and the lack of standardized definitions of “cure” other than depending on improvement of patient’s own symptoms.
Types of Biomaterials
Biomaterials can be classified as either natural or synthetic. Natural biomaterials are typically acellular and may be autologous (harvested from the patient), allogeneic (harvested from cadaveric tissue), or xenogeneic (harvested from animal tissue). Synthetic biomaterials on the other hand differ in their degradation properties (absorbable or nonabsorbable), type of material (polyethylene, polypropylene, polypropylene terephthalate, Gore-Tex), structure (woven, knitted), fiber type (monofilament, multifilament, monofilament/multifilament), pore size, mechanical properties, shape, and surface characteristics .
Natural (Biological) Biomaterials
The potential advantages for biologic materials compared with synthetic meshes include in vivo tissue modeling, histological similarity, and reduced erosion rates. An important problem with some biologic grafts is their rapid degradation and lack of ability to provide long-term support to the grafted tissue [18, 19].
Rectus fascia has remained the reference standard for fascial slings since its reintroduction as a treatment of SUI with reported cure rates of 82–83 % at 3.5–7 years . It remains popular due to its autologous nature, ease of harvest, and durable characteristics. However, disadvantages of using this material include wound infection, increased operative time, patient morbidity associated with graft harvest, limitation of the material size, and susceptibility to degradation if the underlying host pathophysiology is not resolved . One of the studies (Haab et al.)  found that urinary retention was found in 10 % of rectus fascia series slings used in women with SUI. This finding indicates that collagen degradation is systemic and implanted autologous tissue may lose durability over long time.
Fascia lata harvests can provide long specimens that are uniform in thickness while concurrently avoiding abdominal incision and subsequent risk of hernia. However, there is still long operative time, possibility of wound infection, susceptibility to degradation, as well as the possibility of peroneal nerve entrapment. This material also carries the risk of lack of experience of urologists with the harvest area .
The goal of using this material is to decrease the morbidity, operative time, and complications seen with harvesting autologous fascia. Cadaveric fascia and dermis are the two most widely used materials from cadavers.
Strict criteria have to be met before donor harvesting. This usually includes a physical examination, screening for infectious pathogens (hepatitis B and C and human immunodeficiency virus), in addition to a brief medical and social review of the donor and family. The review usually targets previous bacterial sepsis, collagen vascular diseases, rabies, cancer, and intravenous drug abuse . All tissue allografts must be harvested within 24 h of death, as regulated by the Food and Drug Administration (FDA). They must be retrieved under complete aseptic conditions and cultured to rule out bacterial infection before being placed in temporary ice storage .
Although good cure rates (65–98 %) with allograft slings have been reported , several other groups have reported high failure rates, with 20–38 % rate of dissolution of the cadaveric tissue [24, 25]. The reason for this discrepancy could possibly be due to variation in fascia integrity regarding tensile strength, collagen fiber orientation, region of harvest, donor’s age, sex, and genetic background .
To remove the cellular content and sterilize the tissue while retaining structural integrity of the tissue is a multistep process involving irradiation, freeze-drying, or solvent dehydration, as reviewed by Gallentine and Cespedes . However, controversy still exists as to whether irradiation and freeze-drying affect the strength of allograft collagen cross-linking. To date, no difference was noted between irradiated and nonirradiated fascia lata ; however, Lemer et al.  noted that freeze-dried fascia had 25 % less maximal load to failure than autografts or differently prepared allografts. These issues may still present a challenge for the wide use of these materials over larger populations of patients.
These grafts are harvested from animals (mostly porcine) and processed to remove all cellular components. Some examples of these grafts include small intestine submucosa (SIS) and dermis. Xenografts are strictly controlled by the FDA guidelines. These regulations include knowledge of the animal herd, vaccination status, feed source, and bovine spongiform encephalopathy clearance . Surgisis (SIS, cook) and Pelvicol (Acellular Dermis, Bard) are common examples of xenogenic implants. Both products are extracted from porcine donors and undergo rigorous processes to ensure complete decellularization of the materials before human use. Both products claim retention of different growth factors like TGF-beta and FGR-2.
As these products are not cross-linked, they are easily remodeled and gradually replaced by host tissue. The rate of xenograft degradation usually ranges from 4 to 12 weeks and then it is fully replaced by normal regenerated tissue [29–31].
Because of the rapid tissue incorporation and minimal rate of infection, porcine SIS and dermis are promising biomaterials for pelvic floor reconstruction . Collagen and other growth factors act as a signal for local epithelial cells to proliferate, causing a colonization of the SIS graft that promotes tissue healing without scarring. SIS produces the highest stimulus for the formation of collagen fibers around the graft .
Rutner et al.  demonstrated 93 % cure rate using SIS in 152 patients at 4 years, with no graft erosion or infection. A randomized comparison between porcine dermis sling and tension-free vaginal tape (TVT) found SUI cure rates of 85–89 % at 12 months, respectively . However, a study by Ho et al.  indicates a less favorable outcome with SIS. In recent years, there has been more data emerging condemning the use of biomaterials in general (natural and synthetic) into higher rate of serious complications than previously reported. Recently, the FDA has issued a report warning patients against the use of meshes for SUI and POP repair unless highly indicated and with special risk criteria. However, many studies in the recent years have shown that the risks of use of such biomaterials are still acceptable and that when properly indicated, the use of meshes is still the most appropriate procedure for these patients [36–38]. A recently introduced approach makes use of regenerative medicine technologies along with naturally derived biomaterials to create a more biological method of repair for POP patients. The use of regenerative medicine has been popularized and is under investigation in many laboratories across the globe in hopes of creating an appropriately seeded biomaterial that not only repairs but also helps regenerate the area needed for long time success . In the near future, it is expected that regenerative medicine technologies will provide the “perfect” seeded material for management of POP and SUI patients.
Surgical repair for POP patients usually involves repair of defects using native tissues. Due to this fact, failure rates are sometimes high due to the qualitative insufficiency of the tissues used. The native tissue usually shares the same decreased collagen content as the prolapsed tissue making it necessary for re-enforcement using synthetic materials.
These materials enforce the anatomical position, but they also induce an inflammatory reaction which can be chronic and potentially fibrotic . This chronic inflammation results from the persistent remodeling of the connective tissue around the implant. This degree of reaction depends on the chemical and physical structure of the implant, as well as the amount of material and surface of the contact-area with the host; it can vary greatly according to the type of material used .
Thus, biomaterials have been classified into four groups according to pore size :
The pore size allows the host tissue to infiltrate and lay down a new collagen-based scaffold, which proves to be important for graft incorporation, erosion, and infection rates. Based on the previously mentioned classification, type I biomaterials are composed mainly of polypropylene monofilament with pore size more than 75 μm. These materials allow integration of fibroblasts and collagen to anchor the implant within the native tissue and for immune cells to scavenge for bacteria . Type II biomaterials are multifilament with pores less than 10 μm. These materials allow passage of bacteria (usually 2 μm or less) but not leucocytes (9–15 μm) and macrophages (16–20 μm), which are both important for clearing an infection [43–45]. This property renders these materials less likely to be used in cases where infections are expected. Type III biomaterials are composed of polyester multifilaments with microporous components in at least one of the three dimensions, which don’t allow macrophages or polymorph-nuclear cells to enter. Type IV biomaterials are coated with silicone and have pores smaller than 1 μm . Iglesia et al. reported that multifilament polypropylene meshes (pore size < 10 μm) were at higher risk of infection than monofilament polypropylene meshes (pore size > 75 μm) due to difference in pore size of the mesh [46–48]. It has also identified that dead space between the mesh and host tissue, which contributes to seroma formation, is minimized by large pore type I synthetic biomaterials. Thus, type II and III meshes are usually removed in case of infection while with type I biomaterials, infection can be managed by local drainage and secondary healing . One of the strategies implemented to reduce the possibility of infection is the use of a mesh embedded with antimicrobial agents. Such a mesh may prevent bacterial adhesion and colonization with reduction of intraoperative and postoperative infections .
Macroporous (type I) monofilament materials have been preferred in the clinical practice for decades. Polypropylene is the most commonly used fiber to construct strong, inert implants. The majority of clinically available materials are monofilament with limited local side effects such as infection and seroma formation. However, it can also be used to weave other types of fabrics as Surgipro (Tyco), which is a typical monofilament product but is also available as a multifilament mesh (Fig. 17.2).
Surgipro multifilament (top left and right) (×38; Auto Suture European Services Centre, Elancourt, France), and Marlex (a; Bard, Haasrode, Belgium) which is monofilament material; figure (b) shows at larger magnification the effect of multifilament weaving (From Deprest J., C.F., Zheng F., Konstantinovic M., Spelzini F., Guelinckx I., Pottier C., Verbeken E., De Ridder D., Synthetic and biodegradable prostheses in pelvic floor surgery. International Congress Series, 2005. 1279: p. 387–397, with permission)
Synthetic biomaterials can also be classified by their durability into (a) nonabsorbable materials [e.g., Prolene (Ethicon, Somerville, NJ, USA), Marlex (Bard, Cranston, RI, USA), Atrium (Atrium, Hudson, NH, USA), Gortex (Gore, Flagstaff, AZ, USA), Mersilene (Ethicon, Somerville, NJ, USA), and Teflon (DuPont, Wilmington, DE, USA)] and (b) absorbable materials [e.g., Vypro, Vicryl (Ethicon, Somerville, NJ, USA)]. A prospective randomized controlled trial comparing fascia lata and synthetic mesh for sacral colpopexy showed level one evidence for increased durability of POP repair with nonabsorbable meshes .
Other physical properties required in a biomaterial are flexibility and strength. The flexibility of an implant depends on individual stiffness of its yarns, pore size, and knitting procedure of the implant. Implants with larger pores are more flexible than the ones with smaller pores; also multifilament meshes are usually more flexible than monofilament meshes. A stiff non-flexible implant may wrinkle and fold causing local pressure, erosion, and pain which would contradict the original requirement of being biocompatible with the native tissues [51, 52].
Use of Biomaterials in Different Approaches of Surgery for POP
Studies have reported use of prosthetic materials in different approaches (abdominal, vaginal, and laparoscopic) and in different vaginal compartments (anterior, posterior, and apical) for treatment of POP. They have been effectively used for abdominal sacrocolpopexy with minimal side effects. However, a strong debate still exists about their use for transvaginal repair of prolapse. The most recent FDA warning has sparked more active research into the efficacy and safety of using these meshes in patients with POP and SUI.
Abdominal sacrocolpopexy has undergone numerous modifications over the years. Those included the type of prosthesis used and placement onto the anterior and posterior walls of the vagina [48, 53, 54]. In a recent comprehensive review of 98 articles on abdominal sacrocolpopexy, the success rate (when defined as lack of apical prolapse postoperatively) was 78–100 %; however, when it was defined as nopostoperative prolapse, success rate was 58–100 %. The follow-up duration in this study ranged from 6 months to 3 years and the median rate for a second operation was 4.4 % .
Culligan et al.  asserted that polypropylene mesh (91 % cure) was better than cadaveric fascia lata (68 % cure) for abdominal sacrocolpopexy (p = 0.007) at 1 year of follow-up.
FitzGerald et al.  also noted poor anatomic outcomes (a failure rate of 83 % at 17 months) when freeze-dried, irradiated donor fascia lata was used for abdominal sacrocolpopexy as compared to a near perfect success rate of polypropylene meshes.
Vaginal Repair of the Anterior and Posterior Compartments
Most studies reported on the use of synthetic biomaterials in vaginal repair of POP patients have reported good to excellent outcomes. However, most of these have been short-term studies and the rate of complications observed may not represent an accurate figure. A retrospective analysis by Flood et al.  of 142 women using Marlex revealed a success rate of 100 % with mean follow-up of 36 months, with no prosthetic-related complications. On the other hand Dwyer and O’Reilly  used a polypropylene prosthesis (Atrium) in the anterior and posterior compartments and showed a recurrence rate of 6 %.
De Tayrac et al.  reported a recurrence rate of 8 % and erosion rate of 8.3 % using polypropylene prosthesis on 87 women with a mean follow-up of 24 months. Milani et al.  reported a prospective observational cohort of 63 women who had anterior and posterior colporrhaphies using polypropylene mesh with excellent anatomic outcomes after 12 months of surgery but the rates of worsening dyspareunia reached 20 % for those who had anterior mesh repairs and 63 % for posterior mesh repairs.
Based on these results, the use of synthetic biomaterials for POP repair has excellent short-term outcomes; however, long-term studies are required to detect which is the best biomaterial with the least adverse effects and whether biological or synthetic materials are superior for use in treatment of POP.
Complications of Use of Prostheses in Pelvic Reconstructive Surgery
Multiple mesh complications have been reported in the literature that include vaginal wall exposure, vaginal pain, induration, bladder and urethral erosion, dyspareunia, vaginal mesh-related infections (bleeding, discharge, nonspecific pelvic pain, urinary and fecal incontinence), leg pain, neuropathy, and difficulty in walking. These complications have mostly been attributed to age-related changes of the vagina over time . Various factors affect the development of mesh-related infections such as the kind of biomaterial used (pore size, filament structure), type of procedure (abdominal, vaginal, or laparoscopic), the preventive measures taken, age, and associated comorbidities of the patient . Mesh erosion is one of the most important complications in the use of prostheses. The rate of such complication has been much higher in type II and type III (multifilament) synthetic materials reaching up to 20–30 % [60, 61]. On the other hand, the rate of erosion decreases to 0.5–5 % by using type I (monofilament) synthetic materials . The erosion rate has been reported to vary in different materials: 0.5 % for polypropylene, 3.1 % for polyethylene terephthalate (Mersilene; Ethicon, NJ, USA), 3.4 % for Gore-Tex (Gore, Flagstaff, AZ, USA), 5.0 % for polyethylene (Marlex; Bard, Billerica, MA, USA), and 5.6 % for Teflon (DuPont, Wilmington, DE, USA) . These results show that using the proper synthetic biomaterial may drastically decrease the risk of complications and result in very successful repair for the patient. Biological grafts on the other hand have a small risk of prion or viral infection that is estimated to be approximately 1 in 2 million .
Synthetic grafts have an overall higher success rates, but they also have higher erosion rates than biological materials. Current evidence based on available studies suggests that the use of monofilament macroporous polypropylene has the lowest incidence of infection and erosion when compared with other nonabsorbable meshes . Other studies have shown that changing the surgical approach may also affect the rate of erosion even within the same material . Visco et al.  analyzed Mersilene mesh erosion in 273 women who had undergone sacrocolpopexy or sacral colpoperineopexy and found that the risk was 3.2 % for abdominal sacrocolpopexy and 4.5 % for abdominal sacral colpoperineopexy. These results suggest that even though the risk of infection and erosion still exists with the use of synthetic biomaterials, the rate of complications can be drastically reduced by proper patient and biomaterial selections. Level one evidence for the exact rate of complications associated with these materials is still required to make a final decision on the appropriateness of their use [12, 38, 66].
Although several studies have demonstrated that both polypropylene and xenograft are promising materials for pelvic floor reconstruction and SUI treatment, level one evidence and long-term outcomes of prospective randomized trials for the use of biomaterials in pelvic floor prolapse are still needed. To date, no clear results have been reached in published studies about the best biomaterial suitable for any given pelvic floor defect .
Studies concerned with the biomechanical properties of each material have not proven to be sufficient to make this distinction. This is likely due to the fact that the behavior of the graft once implanted is usually different from the ex vivo test results. Another caveat is that studying the implanted material does not take into consideration the effect of regenerated or fibrotic surrounding tissues . A final major issue is the fact that animal models for testing these materials do not test the flexibility needed to prevent vaginal complications once implanted.
The availability of different types of biomaterials, whether natural or synthetic, has expanded the options for management of SUI and POP. However, one has to take into consideration that the ultimate goal of treatment is to restore the physiological anatomy while incurring minimal side effects. The choice of the proper biomaterial is problematic due to the discrepancy of adverse events associated with different biomaterials, including cost, unexpected host response, risk of infection with xenografts , and increased morbidity and operative time for allografts. Other complications such as mesh erosion and dyspareunia are more common in synthetic grafts but can present in all cases on occasion .
The field of regenerative medicine may provide the correct path towards a combination (hybrid) biomaterial that could possess the benefits of both natural and synthetic materials . Some studies have already shown that hybrid biomaterials consisting of type I collagen and PLGA can provide the correct properties of replacement tissues with the suitable biomechanical and biochemical characteristics as well as the feasibility of controlling the fiber diameter according to demand [68, 69].
There still exists a strong need for better and more appropriate biomaterials and identification of the optimal surgical approach. The quest for the ideal biomaterial is far from over and our only hope is to understand the needs of diseased tissue and pursue the right combination of materials to address these needs. Ideally, biomaterial would be developed that would provide the right tensile strength and flexibility while maintaining a natural tissue response that is not harmful to the patient. Longer-term studies are also needed to confirm the suitability of the currently used biomaterials for the management of SUI and POP patients. Until more appropriate level one evidence to the contrary, the use of the currently available biomaterials and meshes will continue to serve as an appropriate method of treatment for these patients [12, 70].
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