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Volume 63, Number 4

OBSTETRICAL AND GYNECOLOGICAL SURVEY


Copyright © 2008
by Lippincott Williams & Wilkins CME REVIEWARTICLE 11
CHIEF EDITOR’S NOTE: This article is part of a series of continuing education activities in this Journal through which a total
of 36 AMA/PRA Category 1 CreditsTM can be earned in 2008. Instructions for how CME credits can be earned appear on the
last page of the Table of Contents.

Biologic and Synthetic Graft Use in


Pelvic Surgery: A Review
Sharon M. Jakus, MD, MPH,* Alex Shapiro, MD,† and
Cynthia D. Hall, MD‡
*Fellow, Urogynecology and Pelvic Reconstructive Surgery, Cedars-Sinai Medical Center, Los Angeles,
California; †Fellow, Urogynecology and Pelvic Reconstructive Surgery, Women’s Hospital Memorial Medical
Center, Long Beach, California; and ‡Director, Division of Urogynecology and Pelvic Reconstructive Surgery,
Co-Director, Center for Women’s Continence and Pelvic Health, Cedars-Sinai Medical Center and Assistant
Professor, David Geffen School of Medicine at UCLA, Los Angeles, California

Urinary incontinence and pelvic organ prolapse are some of the most commonly treated condi-
tions in postmenopausal women. Surgical cure rates vary greatly depending on surgical technique
and the type of materials used, if any, to supplement the native tissue. Traditional colporrhaphy
relies on adequate tissue for a successful repair. The main concern associated with traditional
plication or needle suspension type repairs is that the use of intrinsic attenuated tissue may provide
a weak, constricted, or an anatomically incorrect result. Graft use allows for a broader base of
support and eliminates the need to rely on the existing weakened fascia and musculature. A review
of the existing literature on success rates and complications with various synthetic and biologic
graft materials yielded the following conclusions. The superiority of graft use over traditional suture
suspensions for abdominal sacrocolpopexy and suburethral sling procedures has clearly been shown
in the literature. Macroporous monofilament synthetic grafts and non-cross-linked biologic grafts
appear to have the best integration into native tissues. Solvent dehydration and irradiation of biologic
grafts may weaken the integrity of the material and may prevent proper tissue integration. Technical
factors related to surgical technique may impact success rates, such as tension on suture line or failure
to use vaginal packing. The perfect graft material has not yet been created. Suggestions for further
research include more prospective, randomized trials comparing synthetic and biologic grafts, tension-
free versus secured mesh, and absorbable versus nonabsorbable mesh.
Target Audience: Obstetricians & Gynecologists, Family Physicians
Learning Objectives: After completion of this article, the reader should be able to recall how common
urinary incontinence is, explain the historical considerations for diagnosis and treatment, and summarize
the updated methods of treatment based upon anatomical structures and pathophysiology.

Pelvic organ prolapse is a common condition af- this puts strain on the surrounding connective tissue.
fecting 15% to 30% of women over the age of 50 (1). The endopelvic fascia provides a continuous frame-
The likelihood of undergoing prolapse or inconti- work of support, including the pubocervical fascia
nence surgery in the United Sates is quoted as 1 in 11 for the anterior vaginal wall and the rectovaginal
with up to a 30% recurrence rate (2). fascia for the posterior vaginal wall. Reconstructive
Normal pelvic anatomy relies upon muscular sup- pelvic floor surgery is based on the anatomic princi-
port and intact endopelvic fascia. The levator ani ple of repairing defects in the endopelvic fascia or
musculature is tonically contracted to close the gen- compensating for these defects (3). Historically,
ital hiatus and provides support to the pelvic organs. these defects were classified as a distension type
When neuromuscular injury weakens the levators, defect (stretching or attenuation of the pubovaginal
253
254 Obstetrical and Gynecological Survey

or rectovaginal fascia) or a displacement type defect identified as “fascia” at the time of colporrhaphy may
(detachment from the arcus tendineus). The Del- actually consist of part of the vaginal wall, possibly
ancey Classification delineates the contribution of an artifact of the surgical dissection itself (12).
connective tissue attachments to pelvic organ sup- Risk of reoperation after failed prolapse surgery
port. “Level I” refers to the upper one-fourth of the has been quoted as high as 29.2% (2). Another con-
vagina, which is suspended by the uterosacral/cardi- cern of traditional repairs is that the surgeon may
nal ligament complex maintaining the cervix above attempt to use stronger lateral or nonanatomic tissues
the level of the ischial spines. Lateral paravaginal for repair and suspension, which can result in con-
support to the arcus tendineus fascia pelvis provides striction or foreshortening of the vagina. This in turn
support to “Level II,” the middle one-half of the may result in pelvic pain, dyspareunia, and urinary
vagina, which keeps the vagina midline over the retention. Furthermore, the wisdom of relying on
rectum. The most distal or inferior level, “Level III” native tissue that has already failed the patient in
or the lower one-fourth of the vagina, is supported by providing adequate support is questioned by some
the perineal body, perineal membrane, superficial authors (3).
and deep perineal muscles, and endopelvic fascia. Graft use allows for a broader base of support and
The latter attachments maintain the normal position eliminates the need to be dependent on existing
of the lower vagina and are critical to the proper weakened fascia and musculature. The use of grafts
function of the anal canal. to augment pelvic reconstructive surgery must be
Cure rates and mesh-related complications have been tailored to maintain continence, vaginal capacity, and
described for many urogynecologic procedures, such as coital function in addition to pelvic organ support.
suburethral slings, anterior and posterior repairs, and Some proposed criteria for graft use are: patients who
abdominal sacrocolpopexies (ASCs). Long-term suc- have failed previous reconstructive surgery, those in
cess rates with biologic or synthetic mesh vary from whom intraoperative dissection reveals inadequate
61% to 100% for suburethral slings, from 68% to 100% tissue, and patients with congenital collagen defi-
for ASCs, and from 84% to 100% for posterior repairs ciency (13). Relative contraindications to the use of
(4–6). Anterior repairs, however, have more inconsis- grafts include: history of previous irradiation; severe
tent results (37%–100%) (6). Superior success rates urogenital atrophy; immunosuppressed patient; ac-
with graft use have been confirmed by meta-analysis tive pelvic or vaginal infection; systemic steroid use;
for ASCs and suburethral slings (7–11). and conditions which impair healing, such as morbid
Traditionally, surgical correction of stress urinary obesity, poorly controlled diabetes, and heavy ciga-
incontinence involves reinforcing the periurethral tis- rette smoking (14).
sue, such as with a Kelly plication, and providing Cure rates and mesh-related complications have
support to the suburethral hammock, such as with a been described for various urogynecologic proce-
needle suspension or a Burch procedure. Traditional dures, such as suburethral slings, anterior and poste-
anterior or posterior colporrhaphy relies on adequate rior repairs, and ASCs. Long-term success rates of
tissue for a successful repair. There are 2 main con- suburethral slings with synthetic mesh vary from
cerns associated with traditional plication type re- 61% to 100% (5). Long-term outcomes for ASCs and
pairs. One is that the use of intrinsic attenuated tissue posterior repairs with synthetic grafts are similarly
may provide a weak repair. Indeed, histologic exam- favorable (68%–100% and 84%–100%, respectively)
ination in at least one study demonstrated that tissue (5,15–17). Anterior repairs, however, seem to have
The authors have disclosed that they have no financial relation-
more inconsistent results, between 37% and 100%
ships with or interests in any commercial companies pertaining to (6). Technical factors related to surgical technique
this educational activity. such as tension on the suture line or failure to use
The Faculty and Staff in a position to control the content of this vaginal packing may impact success rates.
CME activity have disclosed that they have no financial relation- Overall, there are few prospective, randomized tri-
ships with, or financial interests in, any commercial companies
pertaining to this educational activity.
als addressing the success rates and complications of
Lippincott CME Institute, Inc. has identified and resolved all graft use in pelvic reconstructive surgery. Most of the
faculty and staff conflicts of interest regarding this educational existing literature consists of retrospective case series
activity. with small numbers and inconsistent outcome mea-
Reprint requests to: Cynthia D. Hall, MD, Division of Urogyne- sures. There is also considerable variation in the way
cology and Pelvic Reconstructive Surgery, Department of Obstet-
rics and Gynecology, Cedars-Sinai Medical Center, 8635 West 3rd
that prolapse and success rates are defined. The 2
Street, Suite 160W, Los Angeles, CA 90048. E-mail: hallc@cshs. standard means of objectively quantifying pelvic or-
org. gan prolapse are: the Baden-Walker Half-Way
Biologic and Synthetic Grafts in Pelvic Surgery Y CME Review Article 255

Graded System and the International Continence So- (20). However, with vaginal reconstructive surgeries,
ciety Pelvic Organ Questionnaire (POP-Q) Stages. there are additional hurdles to overcome, such as the
Outcomes are often described as “recurrence” or proximity to bladder and bowel, and the pliability nec-
“failures” if found to be stage II or grade II on essary for coital function.
follow-up examination, although some studies only
use “anatomic success” (without specific docu-
IMMUNOLOGIC RESPONSE TO GRAFTS
mented measurements) or need for reoperation in the
assessment of their results. Multiple validated quality The ideal prosthesis should incur minimal initial
of life questionnaires can also be used to quantify the inflammatory and cellular reactions followed by vas-
impact of these surgeries on activities of daily living, cular and fibroblastic ingrowth. The inflammatory
recurrence of incontinence or prolapse symptoms, process is different in response to synthetic versus
and sexual function. Unfortunately, however, many biologic grafts. Biologic grafts induce a T helper type
studies omit these questionnaires and instead only 2 (Th2) humoral immune response. Th2 pathways
report subjective patient impressions (6,18). Mesh- typically correspond to a graft acceptance type reac-
related complications are also not always reported tion in transplant patients (21). Synthetic grafts acti-
and often are not clearly defined. The literature con- vate leukocytes and generate a cytokine profile
tains terminology that varies from mesh “exposure” largely consisting of tumor necrosis factor (TNF)-␤,
and “extrusion” to “erosion” or “rejection.” interferon (IFN)-␥, and interleukin (IL)-12, which is
This review will begin with an overview of the classified as a T helper type 1 (Th1) response. These
properties of the grafts available for use in pelvic cytokines are proinflammatory with the activation of
surgery, including ideal characteristics of grafts as macrophages that may then initiate a rejection pro-
well as the biomechanics of existing biologic and cess. The time sequence of the histologic response to
synthetic grafts. This will be followed by an account grafts is classically described in stages. Stage 1, the
of current experience with graft use for particular first 7 days, includes intense inflammation with the
pelvic reconstructive surgeries, including suburethral infiltration of capillaries, granular tissue, and giant
slings, ASC, anterior and posterior repairs, and total cells. In stage 2, after 14 days, granular tissue persists
vaginal mesh repairs. Finally, an evidence-based and the number of giant cells increases. In stage 3,
summary and recommendations will be provided for after 28 days, the acute phase reaction ends and
the use of grafts in urogynecologic surgery. histiocytes and giant cells predominate. Finally, stage
4 begins with the presence of giant cells and dense
fibrous tissue on the external surface of the implant.
IDEAL GRAFTS Wound healing is characterized by collagen deposi-
tion with tissue integration (resulting in good long-
The principle of using grafts in reconstructive sur- term durability). Encapsulation of grafts with fibrous
gery is to reinforce existing tissue with a material that tissue alone can result in hardening, shrinkage, and
is safe, biologically compatible, and provides an an- erosion, which may result in dyspareunia, alteration
atomically appropriate result. The ideal graft should of normal anatomy, and increased failure rates (14).
be inert, noncarcinogenic, have tensile strength and
flexibility, nonallergenic, noninflammatory, able to
BIOLOGIC GRAFTS
be sterilized, nonmodifiable by body tissue, and con-
venient and affordable (19). However, no existing Biologic grafts, whether autografts, allografts, or
graft has all of these properties. Natural biologic xenografts, have several theoretical advantages and
graft materials, including autographs, allographs, and disadvantages. Due to histologic similarities with
xenographs, can be costly or in limited supply and native tissues at the surgical site, the grafts are more
may carry risks of perioperative morbidity or, theo- likely to undergo tissue remodeling and less likely to
retically, disease transmission. Concerns regarding cause erosion. Biologic grafts may be preferred for
synthetic mesh center on the risk of erosion, encapsu- patients with severe vaginal atrophy, history of local
lation, and poor tissue function. Both natural and bio- radiation, or immunosuppression because of their in-
logic materials have long been employed successfully creased risk of delayed healing or infection. Drawbacks
for hernia and prolapse surgeries. Mesh-augmented re- of biologic grafts are limited availability; high cost;
pairs have become the accepted standard of care for inconsistent strength between specimens; possible at-
inguinal hernia repairs with clearly demonstrated im- tenuation due to chemical processing; and concerns for
provement in success rates over suture repair alone disease transmission via viruses, prions, or zoons.
256 Obstetrical and Gynecological Survey

Harvesting of autologous grafts, such as fascia lata, weeks and a full healing time of 13 weeks with
rectus fascia, or skin graft (such as Repliform™; conservative management using vaginal estrogen
Boston Scientific, Natick, MA) increases operative (34). In a study of ASC, Culligan reported 11% of
time and carries a risk of increased perioperative patients in the fascia lata arm with wound break
morbidity and incisional hernia. It may also result in down but no erosions (35). In a similar study, Greg-
poor cosmesis at the harvesting site. However, they ory had no mesh-related complications (36).
are well incorporated into the native tissues and are Some xenograft materials have also been shown to
less likely to cause a foreign body reaction. These have favorable results with efficacy similar to autol-
grafts may also be the safest for use in an infected ogous fascia (37). Xenografts can be prepared from
area. The durability of autologous grafts may be porcine dermis (Pelvicol™ and Pelvisoft™; CR
limited, given the intrinsic strength of this tissue, the Bard, Branston, RI), porcine small intestinal submu-
physiologic absorption process, and eventual re- cosa (SIS™; Cook Medical Inc., Bloomington, IN)
placement with local connective tissue. or bovine pericardium (Veritas™; Synovis Surgical,
Allografts can be taken from dura matter, rectus St Paul, MN). Porcine collagen has a 95% homology
sheath, or fascia lata. Several techniques are used to human collagen and is easy to handle because it
in the preparation of allograft specimens includ- rehydrates rapidly. Xenograft degradation, with
ing: ethanol extraction, high-pressure agitation, respect to both integrity and strength, has been
lyophilization (freeze-drying), and gamma irradia- noted after implantation in human studies (26).
tion. Allografts, such as dermis and cadaveric fas- Similar to human allografts, xenografts are strictly
cia, have been shown to have similar tensile regulated by the FDA.
strength and tissue stiffness to fresh, unprocessed
tissue if processed by solvent dehydration (22).
SYNTHETIC GRAFTS
The risk of HIV transmission from allografts has
been estimated at 1 in 1.67 million, although in Historically, the use of prosthetic materials in pel-
actuality there have been no reported cases of vic surgery dates back to the turn of the century.
transmission in the literature (23). The freeze- Silver mesh was used as early as 1903, followed by
drying technique was designed to decrease the the introduction of nylon in the 1938, Dacron (Mer-
antigenicity of the tissue, but has also been shown silene™; Ethicon, Somerville, NJ) in the 1956,
to result in a graft that is weaker than solvent- polypropylene (Marlex™; CR Bard) in 1958, and
dehydrated fascia (24,25). Cross-linkage of bio- most recently absorbable products such as polygla-
logic grafts may also result in decreased durability ctin 910 (Vypro I and II™; Ethicon) (38). Synthetic
due to decreased potential for collagen ingrowth, mesh is typically classified by filament number and
limited revascularization, and an increased risk of pore size (Table 1) with tensile strength dependent on
encapsulation (14). fiber type, weight-to-area ratio and the weave (39).
The proposed mechanism of allograft breakdown is Type I meshes [e.g., Marlex, Atrium™ (American
a graft-versus-host type autolysis reaction caused by Medical Systems, Minnetonka, MN), Gynemesh™
residual antigenicity of the graft. Some early failure (Ethicon), Pelvitex™ (CR Bard)] are polypropylene,
rates due to autolysis with cadaveric fascia lata slings monofilament meshes that are macroporous (⬎75
have been quoted as high as 20% (26). A small, ␮m). Type II (e.g., Gore-tex™; WL Gore Associates,
retrospective comparison of autologous pubovaginal Flagstaff, AZ) and type III [e.g., Teflon™ (DuPont
slings (N ⫽ 17) to solvent-dehydrated allograft slings de Nemours, Wilmington, DE), Mersilene, IVS™
(N ⫽ 12) found similar rates of subjective improve- (TYCO Healthcare, Michelin, Belgium)] meshes are
ment in stress incontinence (92.3% vs. 90.5%) al- both multifilamentous, although type II are micro-
though a significant number of allograft patients porous (⬍10 ␮m) and type III have both macro-
(41.7%) had positive urodynamic findings of stress porous and microporous components. Type IV
incontinence that was not seen at all in the autolo- meshes, polypropylene sheets, have a pore size ⬍1
gous graft patients (9). Although most studies ob- micrometer [e.g., Silastic™ (CR Bard) Cellgard™
served no erosion or graft-related complications with (Hoechst Cellanese Corp., NY)]. Mechanical and
use of biologic grafts in the anterior or posterior biologic properties of mesh types I, II, and III were
compartments (27–33), one study by Drake et al studied by Brun et al, and found to be comparable
reported an extrusion rate of 10.9% using a dermal with similarly high tensile strengths (⬎50 N) (40).
allograft for anterior and posterior colporrhaphies. The surgical literature reveals improved success rates
This study reported a median time to discovery of 4 with low weight, large pore monofilament meshes
Biologic and Synthetic Grafts in Pelvic Surgery Y CME Review Article 257

TABLE 1
Graft and mesh characteristics
Rigidity Thickness
Type of Mesh Material Trade Name Manufacturer Knitted (mg/cm) (cm)
I. Monofilament Polypropylene Marlex CR Bard, Branston, RI Yes 540 0.066
macroporous Atrium American Medical Systems, Yes 185 0.048
Minnetonka, MN
Prolene Ethicon, Somerville, NJ Yes 465 0.065
Gynemesh Ethicon, Somerville, NJ Yes 177 0.041
Pelvitex CR Bard, Branston, RI Yes ? 0.04
Multifilament Polyglactin 910 Vicryl/VyproI, II Ethicon, Somerville, NJ Yes ? 0.49
II. Multifilament Polytetrafluoroethylene Goretex WL Gore Associates, No ? 1.1
microporous Flagstaff, AZ
III. Multifilament macro- ⫹ Polyethylene Terephthalate Mersilene Ethicon, Somerville, NJ Yes 17 0.025
microporous Polytetrafluoroethylene Teflon DuPont de Nemours, Yes ? 0.068
Wilmington, DE
Polypropylene IVS TYCO Healthcare Yes ? 0.04
International, Mechelin,
Belgium

with elasticity between 20% and 35% (21). This monofilaments whose interstices are smaller, akin
degree of elasticity matches the compliance of sur- to those a microporous mesh. The number, size and
rounding tissues. Marlex, a type I mesh, is stiffer shape of the pores also correlate with the develop-
than several of the type II meshes, Mersilene and ment of collagen and fibrous tissue. Monofilament
Teflon, could increase the risk of injury to surround- macroporous grafts permit collagen deposition be-
ing tissues (41). Atrium polypropylene mesh is more tween fibers whereas multifilament microporous
pliable and lighter than Marlex or Prolene™ (5). grafts are more likely to engender encapsulation of
High erosion rates have been reported for vaginally the entire graft with collagen (49). This may be
placed mesh, ranging from 9% to 11% for polypro- due to a shorter lasting acute inflammatory re-
pylene mesh (42,43) to 25% for Marlex mesh (44) in sponse to multifilament materials that results in a
anterior repairs and up to 40% with the use of Mer- more pronounced chronic inflammatory response
silene and Goretex mesh in posterior repairs (45). as compared to the reaction to monofilament ma-
One study comparing abdominally and vaginally terials. Heavier meshes, such as Prolene (85 g/m2)
placed mesh also reported a significantly greater and Marlex (95 g/m2), have a greater weight and
erosion rate with the vaginal route (3%–4% for the tighter weave than lighter meshes, such as Gy-
abdominal route vs. 16%–40% for the transvaginally nemesh (43 g/m2) and Polyform™ (Boston Scien-
placed mesh) (45). Experience with the use of syn- tific) (40 g/m2).
thetic materials for suburethral slings illustrates the Other newer light meshes with combined absorb-
impact of the biomechanical properties of the mesh able and nonabsorbable components have also been
on postoperative morbidity. Erosion rates with the introduced recently. For example, Vypro I and II
polypropylene mesh used for a transvaginal tape meshes contain 50% Polyglactin 910 (absorbable,
(TVT) (⬍1%) are lower than those reported with used for abdominal hernia repairs) and 50% Polypro-
Goretex (6%–12%) (46), Mersilene (4%–6%) (47) or pylene with the addition of a combined polyglactin-
Marlex (3%) (48). polypropylene violet thread for added stiffness in
Monofilament macroporous type I meshes have the Vypro II. Lym et al looked at 78 patients who un-
lowest reported incidence of infection and erosion. derwent posterior colporrhaphy with Vypro II, and
This supports the theory that the small interstices found an unacceptably high rate of complications
of multifilament meshes (⬍10 ␮m) that are the at 3 years of follow-up with 27% de novo dyspa-
root of the problem. Small interstices permit the reunia and 30% of mesh erosion (16). De Tayrac
entry of bacteria (⬍1 ␮m), but block the migration cites experience in the posterior compartment with
of larger macrophages (16–20 ␮m) and polymor- a light (38 g/m2), macroporous (1.5 mm) polyester
phonuclear leukocytes (9–15 ␮m) that might coun- mesh, Ugytex™ (Sofradim, Rhone-Alps, France)
teract bacterial colonization. It also seems best to coated with collagen, polyethylene and glycol.
select knitted monofilament prosthesis over woven Mesh erosion is cited at 6.3% and de novo dyspa-
258 Obstetrical and Gynecological Survey

reunia at 12.8%. However, this author also reports some patients due to suture placement in the perios-
a high anatomical success rate of 92% at 10 teum of the pubic symphysis.
months after surgery (50). Retrospective studies have shown autologous grafts
have better success rates with pubovaginal slings than
allografts. In one case control study, patients who re-
GRAFTS IN SPECIFIC GYNECOLOGIC ceived autologous fascial slings (N ⫽ 39) had similar
PROCEDURES quality of life measures to those patients who received
a Tutoplast™ (Tutogen Medical, Neunkiichen, Ger-
The following sections will review the current pub-
many), a solvent-dehydrated fascial sling; however, the
lished experience with biologic and synthetic grafts
rate of objective stress incontinence symptoms was
for particular urogynecologic procedures, including
much higher in the allograft group (42% vs. 0%, re-
suburethral slings, ASC, anterior repair, posterior
spectively) (9). A second retrospective study found
repair, and total vaginal mesh. Level I and II evi-
higher failure rates (recurrent findings of stress incon-
dence to support the use of graft materials in pelvic
tinence at 6 months on urodynamics) in patients who
reconstructive surgery exists for both suburethral
received allografts (67%) compared to those who re-
slings and ASCs. A Cochrane review by Maher et al
ceived autologous grafts (11).
illustrates the significant benefits of graft use for
There is also a long history of the use of synthetic
continence procedures (with a RR of 5.5 for recurrent
slings for the treatment of stress urinary incontinence
stress urinary incontinence after endofascial plication
(Table 2). The first synthetic materials used for blad-
compared to TVT sling) and ASC (RR ⫽ 0.23 for
der neck suspensions were Mersilene by Williams in
recurrent prolapse of the vaginal vault with ASC
1962 and Marlex mesh by Morgan et al in 1970
compared to vaginal sacrospinous fixation) (6). The
(48,53). With these early slings, high rates of ero-
published literature on anterior and posterior colpor-
sions, infections, and fistula formation were noted.
rhaphy is mixed with respect to success rates and
For example, Mersilene mesh use for suburethral
complications and does not conclusively support the
slings has a high reported success rate of 93% at 30
use of grafts over site-specific or plication-type re-
months, but is complicated by a 4% erosion rate (47).
pair with native tissues. The Cochrane review re-
The “tension-free” mid-urethral slings, made of
ported a RR of 1.39 for cystocele recurrence after a
polypropylene mesh, were first introduced by Ulm-
simple plication repair compared to a repair with
sten and Petros in the late 1990s (54). These were
mesh and a RR of 0.24 for rectocele recurrence with
placed with an introducer and a plastic overlying
a transvaginal repair compared to a transanal repair
sheath, and were made of a stretchy 1-cm wide
(there was insufficient evidence for a comparison
segment of polypropylene which did not move ap-
with and without mesh) (6). Finally, there are no
preciably in the tissues once the overlying sheath was
peer-reviewed studies on the use of total vaginal
removed. The design allowed for minimal dissection,
mesh procedures. Acquiring Level II evidence with
no need to anchor the sling, and the potential added
sufficient power to demonstrate the superiority of
benefit of the sheath protecting the sling itself from
mesh use is most challenging for rectocele repair due
contamination. Multicenter randomized studies com-
to the high success rates (80%–90%) with traditional
paring the TVT to the Burch procedure show com-
plication and site-specific repair (10).
parable results with the added benefit of decreased
morbidity and hospitalization rates with the TVT
(55). Long-term follow-up data for the TVT sling
Suburethral Slings
show high success rate (84.7%) at 56 months (56).
The original, gold-standard urethral suspension In 2001, Delorme first described the transobturator
procedures were developed by Marshall, Marchetti, suburethral tape (TOT) placement with a 90% cure
and Krantz (MMK) in the 1950s and Burch in the rate and no perioperative complications or voiding
1960s. The first use of a sling suspension was de- dysfunction (57). The theoretical advantages of the
scribed by Aldridge in the 1940s using autologous TOT are the avoidance of intrapelvic and retropubic
rectus fascia. High cure rates were reported with both passage of the instruments (thereby decreasing the
the Burch procedure and fascial slings, although complication rate) and decreased postoperative void-
postoperative voiding dysfunction was less common ing dysfunction (due to a more transverse mesh
with the Burch procedure (51,52). MMK procedures placement compared to the TVT). In one study by
had similar success rates, but fell out of favor with DeTayrac et al (2004), TOT procedures had lower
most gynecologists after reports of osteitis pubis in mean operative time, no bladder injury, decreased
Biologic and Synthetic Grafts in Pelvic Surgery Y CME Review Article 259

TABLE 2
Slings
Follow-Up Cure Rate
Author Yr No. Patients Type of Mesh (mo) (%) Complications
Nilsson (56) 2001 85 TVT (Prolene) 56 84.7
Young (47) 2001 136 Mersilene 30 93 4% erosion
McBride (9) 2005 39 Autologous 24 100
32 Allograft 24 58
Meschia (60) 2006 95 TVT (Prolene) 24 87 No erosions
95 IVS (Prolene—Multifilament) 24 78 9% erosions
Soergel (11) 2001 33 Autologous 33 78.8
12 Allograft 12 33
deTayrac (50) 2004 31 TVT (Prolene) 12 83.9 No erosions
30 TOT (Prolene) 12 90 No erosions
Moore (59) 2005 5 TOT (Prolene) after failed TVT 17 100 No erosions
Meschia (60) 2006 95 TVT 24 87 None
95 IVS tape 24 78 9% erosion
Yamada (63) 2006 67 Mentor ObTape 36 13.4% erosion
56 Monarc None

postoperative urinary retention, and similar rates of Abdominal Sacrocolpopexies


cure (90%), improvement, and failures compared to
ASCs are currently the gold standard to correct
the TVT group (50).
apical vaginal prolapse and may also correct high
The TOT has also been shown to have a signifi-
cantly lower rate of de novo detrusor overactivity cystoceles or rectoceles. The most common tech-
compared to a retropubic approach such as the TVT nique involves mesh sewn to both the anterior and
or SPARC sling (8% vs. 33% and 17%, respectively) posterior walls of the vagina and anchored to the
(58). A recent study has reported that failure rates for anterior sacrum. A review article by Nygaard et al
TOT slings may be higher for patients with intrinsic reported an average follow-up of 6 months to 3 years
sphincter deficiency. Failures may be corrected by with success rates of 78% to 100%, a reoperation rate
subsequent placement of a TVT sling (59). of 4.4%, mesh erosion rate of 3.4%, and an incidence
Even with similar technique, different materials of small bowel obstruction of 1.1% requiring reop-
may yield different erosion rates. One prospective, eration (7). Long-term follow-up up to 13.7 years
randomized study of TVT (monofilament, macro- after ASC maintained a 74% success rate (8). In
porous mesh) versus IVS (microporous, multifila- terms of technique, concurrent hysterectomy may be
ment mesh) showed similar efficacy in the treatment a risk factor for mesh erosion, particularly if a total
of SUI. However, the IVS tape had a lower incidence hysterectomy is performed (64) with erosion rates
of postoperative voiding dysfunction but a higher increased up to 27% compared to 1.3% without a
rate (9%) of vaginal erosion (60). Another study hysterectomy (35). However, another retrospective
showed similar rates of erosion (7.5%) and need for study did not support this finding (65). Some surgeons,
reoperation (7%) due to postoperative symptoms of therefore, advocate supracervical hysterectomy at the
stress and urge incontinence (61). The severe mesh time of ASC in the absence of cervical dysplasia or a
complications with the IVS tape are even more con- malignancy. Enterocele and abdominal paravaginal re-
cerning. Indications for mesh removal with the IVS pair at the time of ASC have not been shown to con-
tape listed in the literature include intractable mesh sistently improve outcomes. The median rate of bowel
infections, retropubic abscesses, cutaneous and vesi- obstruction requiring surgery after an ASC without
covaginal fistulas, voiding difficulties, and chronic reperitonealization of mesh is only 1.1% (7). A recent
pain syndrome (62). Comparison of the Mentor Ob- case series report also showed no increased risk of
Tape™ (a nonwoven minimally elastic, microporous, bowel complications up to 19 months of follow-up with
monofilament polypropylene mesh) with the Monarc ASC not accompanied by burial of mesh (66).
Sling™ (a woven, elastic, macroporous, monofila- Allogenic graft material use in ASC is complicated
ment polypropylene mesh), similarly revealed a by high short-term failure rates (26). A case series
marked difference in erosion rates (13.4% vs. 0%, report by Fitzgerald et al describes a 12% reoperation
respectively) (63). rate for ASC using freeze-dried fascia lata allografts
260 Obstetrical and Gynecological Survey

with failure evident at a mean time of 7 to 11 months. Anterior Repairs


Histologic analysis of the retrieved material demon-
The earliest described anterior vaginal wall repair,
strated areas of disorganized remodeling, graft de- designed to correct stress incontinence, was the Kelly
generation, and some instances of immune reactions plication of the urethral sphincter muscle in 1913.
(26). The same author was only able to actually Anterior colporrhaphy to correct primary and recur-
locate the remains of the fascia in 3 of the 21 repeat rent cystoceles have traditionally involved a similar
sacrocolpopexies. type of plication technique. One of the earlier reports
There are prospective trials that have compared of an anterior repair augmented by prosthesis was
synthetic and biologic meshes for ASC (Table 3). described by Julian in 1996 (44). This prospective
Culligan et al compared 54 patients who underwent study randomly allocated 24 patients to anterior
ASC with Trelex polypropylene mesh to 46 patients repair alone or with the addition of Marlex monofil-
who received solvent-dehydrated fascial grafts. Fail- ament polypropylene mesh. This prosthesis was an-
ure rates (prolapse greater than stage II, by POP-Q chored proximally to the vaginal apex and to the
quantification) 6 months postoperatively were signif- levator fascia as lateral attachments over the standard
icantly higher in the allograft group (32%) than in fascial repair. The success rate for the correction of
those who received mesh (9%) (35). The superiority prolapse (defined as less than grade I) was higher in
of synthetic mesh for ASC was also confirmed by a those patients with the graft (100%) compared to
retrospective cohort study comparing synthetic mesh 66% at 24 months. Compared to the use of synthetic
to freeze-dried cadaveric fascia with higher optimal meshes for ASC, however, vaginal placement of
surgical outcomes by POP-Q examination when synthetic mesh seems to have a much higher rate of
mesh was used (89%) compared to when the fascia erosions in most studies (25% in Julian’s study) (44).
was used (61%) (36). Another retrospective cohort Another polypropylene mesh, Gynemesh, was stud-
study by Altman et al also found a trend toward ied by DeTayrac in a larger patient sample (87
increased rate of recurrence by anatomic and subjec- women) with a similarly high success rate of 92% at
tive measures with porcine dermal grafts compared 24 months and a lower erosion rate of 8.3% (70). A
prospective, observational study by Milani et al had
to synthetic mesh (29% vs. 24%, respectively) (67).
a 94% success rate with Prolene mesh in 63 patients
Similar to the experience with other procedures,
at a 17-month follow-up examination, but was ac-
erosion rates with synthetic mesh used for ASC vary companied by an erosion rate of 13% (71). There has
by the properties of the mesh used. Vaginal mesh been at least one retrospective case series, however,
erosion has been reported in 2% of patients who showing a 100% success rate with Marlex mesh in
received polypropylene mesh (66,68). These rates are 142 patients at 3 years with a low incidence of
higher (up to 11%) with microporous multifilament erosion (2%) (72) (Table 4).
meshes, such as Gore-Tex and Mersilene (69). The In addition to the high risk of erosion, functional
treatment of vaginal mesh erosion varies from trans- outcomes may also be worse with the use of nonab-
vaginal excision plus antibiotics for monofilament sorbable mesh during anterior repair. Salvatore et al
macroporous meshes to complete abdominal and reported not only an erosion rate of 13% using Pro-
vaginal excision for infected multifilament micro- lene mesh, but also an increase in overactive bladder
porous meshes (4,9). symptoms (28%–⬎56%) and an increase in dyspa-

TABLE 3
Abdominal sacrocolpopexy
Author Follow-Up Cure Rate
(Biologic vs. Synthetic) Yr No. Patients Type of Mesh (mo) (%) Complications
Gregory (36) 2004 28 Marlex/Mersilene 26.3 89
Culligan (35) 2005 54 Polypropylene 12 91 26% graft complications
46 Fascia lata 68 15% graft complications
Altman (67) 2006 25 Prolene 7.4 24
27 Porcine collagen 7.1 29
Fitzgerald (26) 2004 67 Freeze-dried fascia 12 57 ?
Elneil (66) 2005 128 Prolene
Biologic and Synthetic Grafts in Pelvic Surgery Y CME Review Article 261

TABLE 4
Anterior repair
Follow-Up Cure Rate
Author Yr No. Patients Type of Mesh (mo) (%) Complications
Synthetic
Sand (15) 2004 161 Polyglactin 910 13 75
Dwyer (49) 2004 64 Atrium polypropylene 29 94 9% erosion
Milani (71) 2005 32 Prolene 17 94 13% erosion
20% dyspareunia
Julian (44) 1996 24 Marlex 12 100 25% erosion
Flood (72) 1998 142 Marlex 38 100 2% erosion
Weber (74) 2001 26 Polyglactin 23.3 42
Tension free
Eglin (87) 2003 103 Polypropylene 16 97 ⬍1% erosion
DeTayrac (70) 2005 87 Polypropylene 24 92 8.3% erosion
Bader (86) 2004 40 Polypropylene 16 95 ⬍1% erosion
Biologic
Gandhi (31) 2005 76 Fascia lata 13 79
Gomellski (75) 2004 70 Porcine dermis 24 91 1.4% wound separation
Groutz (32) 2001 21 Solvent-dehydrated fascia 20 100
Salomon (33) 2004 27 Porcine 14 81

reunia (18%–⬎78%) (73). In general, nonabsorbable Ghandi et al performed a prospective, randomized


mesh use for anterior repairs seems to result in high trial revealing a trend toward decreased recurrence
success rates when combined with traditional fascia rates with the use of cadaveric fascia lata versus
repair, but may be accompanied by unacceptably standard colporrhaphy to repair recurrent anterior
high erosion rates. vaginal wall prolapse (21% vs. 29%, respectively) at
Absorbable mesh use was adopted in order to at- 13 months (31). A retrospective case series of high-
tempt to achieve equivalent success rates with fewer grade cystocele repair with porcine dermis similarly
complications. Polyglactin 910 is an absorbable showed an 87% success rate at 24 months (75).
mesh that has been studied in several large, prospec- Transobturator placement of a porcine collagen im-
tive, randomized controlled trials. In one study by plant showed an 81% anatomic cure rate at 14-month
Sand et al, the mesh was used as a patch on top of the follow-up, with concomitant improvement in quality
standard fascial repair in 161 patients (21 with recur- of life and urinary discomfort scores (33). Finally, a
rent cystoceles) with a significantly decreased recur- small, prospective series of anterior repairs with
rence rate at 12 months compared to the suture-only solvent-dehydrated fascia-lata grafts did not docu-
controls (25% vs. 43%) (15). A review by Maher et ment any recurrences at a follow-up of 20 months
al reported similar success rates with Polyglactin 910 (32). These studies seem to support higher success
compared to fascial repair alone (75% vs. 57%) at rates using biologic grafts to augment anterior repair,
1-year follow-up (17). Another large, prospective, although none was a comparative trial.
randomized study compared 3 different techniques,
Posterior Repairs
including standard anterior colporrhaphy, ultralateral
anterior repair with dissection to the lateral pubic Posterior repairs should correct associated symptoms
ramus, and anterior repair reinforced with Polygla- of defecatory dysfunction in addition to prolapse symp-
ctin 910 use, showed no significant differences in toms. Rectocele repair has been performed with varied
recurrence rates or mesh complications among the approaches from transanal to transvaginal placation re-
different groups at a 2-year follow-up (74). It is pairs, site-specific repair of the rectovaginal fascia, to
important to note, however, that this study was not plication of both the rectovaginal fascia and levator
powered for a ⬍30% difference in success rates. muscles. Randomized controlled trials have confirmed
The best available level I and II evidence indicates the superiority of transvaginal repairs over transanal
that anterior repair with the addition of any mesh is procedures (76). Traditional levator ani plication has
more effective than anterior repair alone, but that ab- been shown to have good anatomic success rates (76%–
sorbable mesh may have lower complication rates (6). 96%), but can be complicated by dyspareunia up to
Biologic grafts have shown good success rate for 50% of the time (6). One retrospective, observational
anterior repairs with virtually no mention of erosions. study of posterior colporrhaphy reported a success
262 Obstetrical and Gynecological Survey

rate of 76% at 42 months, but was associated with without mesh and the authors reported no adverse
an increase in dyspareunia (18%–⬎27%), consti- events (15) (Table 5).
pation (22%–⬎33%), incomplete bowel emptying Biologic grafts for rectocele repair have produced
(27%–⬎38%), fecal incontinence (4%–⬎11%), inconsistent results with many of the same compli-
and sexual dysfunction (18%–⬎27%) (77). In the cations seen with nonabsorbable synthetic meshes.
mid 1990s, site-specific repairs became popular in One prospective study using a porcine collagen xeno-
an attempt to lessen dyspareunia by theoretically re- graft without underlying plication or repair of native
storing normal anatomy. Early studies seemed to sup- tissues had a high rate of recurrence, 38% at 1-year
port this contention (3,78,79). However, a retrospective follow-up and 41% at 2 years, with a 13% reopera-
comparison of site-specific repair and fascial reapproxi- tion rate and ⬍50% of patients reporting relief of
mation indicates a significantly higher recurrence rate rectal trapping. Although Altman theorized that the
with site-specific repair (44% vs. 18%, respectively) at high rate of failure with this xenograft might result
1 year (80). A recent prospective, randomized study, from premature degradation of the biologic grafts, he
however, found similar anatomic and functional out- concluded that the addition of site-specific repair
comes comparing traditional posterior repair, site- might improve the success rate when biologic grafts
specific rectocele repair, and posterior repair with are used (30). Another prospective, observational
porcine graft at up to 18 months average follow-up (81). study combining site-specific repair with a dermal
Although the baseline success rates of posterior allograft showed a success rate of 93% at 12 months
repairs are reasonably good, the addition of a graft or without any documented complications (28). Finally,
mesh might ameliorate shortening or narrowing of a second prospective, observational series combining
the vagina that could contribute to dyspareunia. Syn- site-specific repair with a porcine acellular collagen
thetic mesh use for posterior repairs maintains high matrix had a high wound separation rate of 15% (29).
anatomic cure rates, but has been associated with a The authors concluded that devascularization of the
significant incidence of dyspareunia and vaginal ero- vaginal mucosa and lack of contact with the under-
sion when nonabsorbable meshes are used. A retrospec- lying rectovaginal septum may have contributed to
tive, observational study with Atrium polypropylene the high degree of wound breakdown. The addition
mesh had a 100% success rate at 29 months with mesh of fenestrations to the graft may increase the surface
erosion in 9% of patients (42). An ambiperspective area in contact with the vaginal mucosa and improve
(retrospective chart review and prospective observa- outcomes. One study using a fenestrated graft (Pel-
tional) study with combined vicryl/Prolene mesh had an visoft) did indeed find less sloughing of the vaginal
83.9% cure rate at 6 months with mesh protrusion in mucosa and quicker healing (29).
12.9% at 6 months (82). One prospective, observational
study by Milani using Prolene mesh demonstrated a
TENSION-FREE PLACEMENT OF
6.5% erosion rate and an alarming 63% increase in
GRAFTS VAGINALLY
dyspareunia (71). On the other hand, a prospective,
randomized trial with polyglactin 910 absorbable mesh There has been a literal explosion of new products
had an anatomic cure rate (90%) equivalent to repairs which utilize grafts (mostly synthetic nonabsorbable)

TABLE 5
Posterior repair
Cure Rate
Author Yr No. Patients Type of Mesh Follow-Up (%) Complications
Synthetic
Lim (82) 2005 90 Vicryl-Prolene 6 mo–1 yr 83.9 7.8% erosion
Sand (15) 2001 161 Polyglactin 910 13 mo 90
Dwyer (49) 2004 50 Atrium polypropylene 29 mo 100 9% erosion
Milani (71) 2005 31 Prolene 17 mo 94 6.5% erosion
Biologic
Kohli (13) 2003 30 Dermal allograft 12.9 mo 93
Dell (29) 2005 35 Pelvisoft 12 mo
Altman (30) 2005 33 Porcine collagen 12 mo 61
Tension free
Farnsworth (84) 2002 IVS Tunneler 91
Biertho (85) 2004 34 IVS Tunneler 12 mo 92.2 2.9% erosion
Biologic and Synthetic Grafts in Pelvic Surgery Y CME Review Article 263

placed with a “tension-free” technique, having exten- prolapse, respectively, using this technique with a
sions that pass through the obturator space or the macroporous polypropylene mesh. Posterior dissec-
pararectal space and are not secured with any sutures. tion must proceed to the level of the ischial spines
The first such procedure was the posterior intravag- with an introducer needle inserted inferior and lateral
inal slingplasty (IVS) introduced by Petros in 1997 to the anus. The 2 anterior support extensions are
for the treatment of vault prolapse (83). The IVS passed through the obturator membrane. There is
Tunneller™ (Tyco Healthcare) is used to insert an some data on tension-free support of the anterior
8-mm polypropylene tape (not a macroporous vaginal wall. Several prospective, observational se-
polypropylene mesh) between the perineum and the ries using polypropylene meshes have shown high
vaginal vault. It was not attached to another graft that success rates of 91% to 97% and moderate erosion
covered the posterior or anterior wall. The thin syn- rates 5% to 8.3% at 16 to 24-month follow-up
thetic strip of mesh acts like an artificial ligament to (50,86,87). The data on posterior intravaginal sling-
reinforce weakened uterosacral ligaments. A small, plasty is limited by small numbers and short
prospective, observational study by Farnsworth et al follow-up periods. One retrospective study assessing
describes a symptomatic prolapse cure rate of 91% posterior IVS combined with posterior repair had a
(84). Another small, prospective series described an high recurrence rate of 29% with a reoperation rate of
8.8% recurrence rate over a 1-year follow-up period 14%. The erosion rate was not reported (88). A
(85). Potential complications with this procedure short-term follow-up study showed a low erosion rate
and/or this particular mesh were elucidated in a case of 2.9% with a moderate rate of recurrence of 8.8%
series by Baessler et al describing mesh infections, (85). The ProLift™ (Gynecare/Ethicon) system con-
retropubic abscesses, vesicovaginal fistulas, intraves- sists of a complete vaginal mesh with 3 sets of
ical mesh, voiding difficulties, and pain syndromes in extensions. We have some older data on total vaginal
patients requiring sling removal at 24-months post- mesh repair using Marlex (without the tension-free
operatively from the IVS procedure (62). extensions) that showed a 10% reoperation and 5%
Since then, other procedures have been developed mesh erosion rate during 10 years of follow-up (89).
which utilize these same tension-free extensions but However, there are currently only a few case series
connected to other graft materials. The Apogee™ evaluating this newer technique. One case series re-
and Perigee™ devices (American Medical Systems) porting the experience with total vaginal mesh, using
were designed to correct posterior/apical and anterior Marlex, over a 10-year period cited a 5% erosion rate

TABLE 6
Summary of findings
1) Synthetic grafts have been shown to be superior to biologic grafts for abdominal sacrocolpopexy and suburethral sling
procedures in the literature through prospective randomized trials and prospective case series.
2) Macroporous monofilament synthetic grafts and non-cross linked biologic grafts appear to have the best integration into native tissues.
Microporous synthetic grafts are more likely to become infected.
3) Solvent dehydration and irradiation of biologic grafts appear to weaken the integrity of the material and may prevent proper
tissue integration.
4) Technical factors related to surgical technique may impact success rates, such as tension on suture line or failure to use
vaginal packing.
5) Level I and II data seem to support the use of grafts (biologic or synthetic) for anterior repair but erosion rates are higher,
especially with the non-absorbable meshes.
6) There is no conclusive data to recommend the use of grafts posteriorly or the new “tension-free” vaginal mesh procedures.

TABLE 7
Recommendations for future research
1) Classification of graft-related healing abnormalities, because the current terminology of “erosion”, “rejection” and “exposure” are
non-specific.
2) Standardized outcome measures for all studies, using quality-of-life (QOL) validated questionnaires, urodynamic (UDS)
parameters, and pelvic-organ-prolapse-quantification (POPQ) measurements.
3) Consideration of the long-term implications of graft implantation, particularly following total graft suspensions (with respect to
erosion rates and management of erosion).
4) Comparison of synthetic and biologic meshes in prospective randomized studies.
5) Prospective comparison of tension-free vs. secured mesh.
6) Prospective comparison of absorbable vs. non-absorbable mesh.
264 Obstetrical and Gynecological Survey

and high rates of reoperation, 36% for bladder func- absorbable mesh (Table 7). These studies should also
tion and 28% for anorectal function, although with standardize outcome measures based on pelvic exami-
reported high patient satisfaction rates, as much as nation and validated questionnaires. Finally, long-term
74% (89). A retrospective chart review of polypro- implications of graft implantation, particularly total
pylene mesh over a shorter period of time of 2.5 graft suspensions, need to be further studied.
years showed a recurrence rate of 5.2% and a 7%
erosion rate (90).
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