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2002 Selected Articles
Suburethral Sling Complications: Recognition
and Management
Peter L. Rosenblatt, MD; Charles R. Rardin,
MD; Neeraj Kohli, MD
It has been estimated that urinary incontinence affects 10%
to 25% of the adult US female population under the age of 65,1and
up to 40% of community-dwelling women aged 65 years or more.2Stress
incontinence (ie, leakage of urine with sudden increases in intraabdominal
pressure) occurs in approximately 6 million Americans. Over the
past decade, there has been a growing interest in innovative
conservative and surgical methods to treat female stress urinary
incontinence. Some 150,000 surgical procedures are performed
annually in the United States for stress incontinence, although
this accounts for only 2% of the population with this condition.3
PATHOPHYSIOLOGY
The most common form of stress urinary incontinence, genuine
stress incontinence (GSI), is due to an anatomic defect in the
endopelvic fascia under the bladder neck, resulting in urethral
hypermobility. Detrusor instability (DI), or involuntary contraction
of the detrusor muscle, is the second most common cause of urinary
incontinence in women. A smaller but significant number of women
with symptoms of severe stress incontinence are found to have
intrinsic sphincter deficiency (ISD). This condition is most
often seen in older women and in those who have undergone multiple
surgical procedures for the treatment of stress urinary incontinence.
In this setting, ISD may result from scarring or denervation
of the urethral sphincter. This compromised sphincter cannot
maintain a water-tight seal at rest, resulting in the classic "lead-pipe" urethra.
Other risk factors for ISD include pelvic x-ray therapy, radical
pelvic surgery, and neurologic conditions such as spinal cord
injury or meningomyelocele.
Based on symptoms alone, it is easy to confuse ISD with both
GSI due to urethral hypermobility (stress incontinence symptoms)
and DI (large-volume urine loss). These conditions can be differentiated
through a careful history, physical examination, and specialized
urodynamic testing. Accurate diagnosis of ISD is essential because
its treatment is considerably different from that of either GSI
with urethral hypermobility or detrusor instability.
SUBURETHRAL SLING
Von Giordano introduced the suburethral sling in 1907, using
gracilis muscle flaps sutured beneath the urethra.4This
was among the first descriptions of a surgical procedure for
stress incontinence. Since then, more than 150 different antiincontinence
procedures have been formally described. Most of these can be
grouped into four general categories: anterior colporrhaphy,
retropubic urethropexy (eg, Burch, Marshall-Marchetti-Krantz),
transvaginal needle suspension (eg, Pereyra, Raz) and suburethral
sling. In 1997, a panel of the American Urological Association
published clinical guidelines for the management of female GSI.5They
concluded that, after 48 months, retropubic suspensions and suburethral
slings appear to be more efficacious than either transvaginal
suspensions or anterior repairs (Table 1).5,6Because
several studies have suggested that slings are associated with
higher complication rates, most US urogynecologists consider
the Burch retropubic urethropexy to be the "gold standard" for
GSI surgery.
|
TABLE 1. Comparison of Urethral
Surgery by Type5,6 |
| Type of Surgery |
Complication
Rate (%)
|
Success
Rate (%)
|
Improvement
Rate (%)
|
| |
AUA
|
AHCPR
|
AUA
|
AHCPR
|
AUA*
|
AHCPR
|
| Anterior repair |
61-85 |
35-91 |
78-95 |
31-98 |
2 |
14 |
| Needle suspension |
65-79 |
74 |
78-82 |
84 |
2 |
|
| Retropubic urethropexy |
84 |
79 |
86-90 |
84 |
2 |
18 |
| Suburethral sling |
82-83 |
78-89 |
85-91 |
84-92 |
4 |
|
AUA = American Urological Association;
AHCPR = Agency for Health Care Policy and Research
*Complications listed as “general medical complications,
significant.” |
|
Women diagnosed with ISD pose a special challenge, however,
because retropubic urethropexy has a high failure rate in these
cases. In a retrospective study of 83 women, Sand found that
patients with a preoperative maximum urethral closure pressure
(MUCP) below 20 cm H2O had a 54% failure rate following
Burch colposuspension compared with an 18% failure rate for women
with an MUCP greater than 20 cm H2O.7In
treating women with ISD, providing partial obstruction of the
urethra (rather than simply stabilizing the urethrovesical junction)
seems to be more effective. For this reason, suburethral slings
have traditionally been used to treat ISD.
Women with recurrent stress incontinence (ie, those who have
failed surgery) and those who lead very active lifestyles or
whose careers require heavy lifting may also be candidates for
sling procedures. Over time, repetitive stress may pull out sutures
and weaken the support from a Burch procedure or other retropubic
suspension. Additionally, women with medical problems leading
to chronically increased intraabdominal pressure (eg, chronic
obstructive pulmonary disorder, asthma, obesity) may be at risk
for failing standard antiincontinence procedures. Therefore,
these women are probably best treated with suburethral sling
surgery.
Because slings have such a high cure rate (81% to 98% in the
literature), some authorities recommend that suburethral slings
be used to treat all stress incontinence, regardless of subtype.8Moreover,
it has been suggested that as many women with urethral hypermobility
do not have stress incontinence, there must be some degree of
intrinsic sphincter incompetence in all women with stress incontinence,
even when urodynamic parameters fail to suggest ISD as the diagnosis.9In
this situation, a sling would provide the suburethral support
and closure required for continence. Although it is widely believed
that slings are associated with higher complication rates compared
with retropubic urethropexies, these studies are biased in favor
of retropubic suspensions, which are often performed on younger
women or less complex cases (eg, no previous bladder-neck surgery).
With proliferating indications for the use of suburethral slings
as well as the increasing use of surgery as a first-line therapy
for stress incontinence, it is likely that the number of sling
procedures will rise substantially over the next few decades.
It is essential that all clinicians who care for women be aware
of these procedures and their potential complications to promote
early recognition and effective management of these problems.
Complications can be divided into those that are common to any
incontinence procedure (eg, injury to the urinary tract, wound
or urinary tract infection, retropubic hematoma, persistent incontinence)
and those that are either specific to or more prevalent in suburethral
sling procedures (eg, erosions, prolonged urinary retention,
voiding dysfunction, new-onset detrusor instability).
Types of Slings
Since its introduction almost a century ago, the techniques
used for suburethral slings have undergone numerous modifications,
including variations in the material used for the sling and the
methods and points of attachment for the sling arms. The development
of postoperative complications seems to depend primarily on the
selection of sling material. Autologous (eg, rectus fascia, fascia
lata), homologous (eg, cadaveric fascia, dermal allograft), heterologous
(eg, porcine intestinal submucosa) and synthetic materials have
all been used as grafts for suburethral slings.
The use of autologous organic tissues (fascia lata, rectus fascia)
continues to be appealing from the standpoint of biocompatibility.
However, the extra surgery required to harvest this tissue is
associated with increased operative time, pain from separate
or enlarged surgical incisions, and higher rates of complications
and morbidity.10
To overcome these issues, many surgeons use banked cadaveric
tissues for slings. These allograft materials are readily available,
do not require intraoperative harvesting, and are specially processed
to reduce tissue reactivity. On the other hand, fascial allografts
may be associated with decreased success rates due to inconsistent
strength and/or weakening of the tissue over time. Chaiken and
Blaivas11describe a case of immediate sling failure
attributed to suture pull-through at both ends of the fascial
sling allograft. FitzGerald and colleagues12describe
a 12% short-term failure rate associated with cadaveric fascia
lata; on reoperation, graft tissue was either "absent" or
markedly attenuated in all cases. Histologic studies confirmed
their surgical findings. Of note, most of the studies on the
problems with cadaveric materials have involved the use of fascia.
More recently, though, dermal grafts have been used for slings
and other pelvic reconstructive procedures, and may represent
a promising alternative to fascia.
Since the 1950s, a variety of synthetic materials (eg, Marlex
mesh, Mersilene mesh, Prolene mesh, Silastic, Gore-Tex) have
been used for suburethral slings. The use of synthetic materials
has several advantages, including uniform sling strength and
decreased morbidity and operative time compared with harvesting
autologous grafts, but may cause erosion over time.
COMPLICATIONS
Sling Erosion
Compared with cadaveric tissue, synthetic slings are associated
with higher rates of erosion and infection. The Female Stress
Urinary Incontinence Clinical Guidelines Panel of the American
Urological Association observed that the use of synthetic material
for slings is associated with an increased complication rate,
including vaginal and urethral erosions and wound sinus formation.5The
risk of these complications depends on the particular material
used, although certainly surgical technique plays a role as well.
While Gore-Tex slings have been associated with a high rate of
erosion, requiring removal of the sling in up to 22% of patients,13other
synthetics (eg, Mersilene mesh) confer a significantly lower
risk of vaginal erosion. In a study of 110 women who underwent
suburethral sling placement using Mersilene mesh, only one patient
(0.9%) required excision of an eroded sling.14Although
the Clinical Guidelines Panel reported that these complications
occurred at rates below 1% (excluding certain high-risk synthetics),
they can be troubling to patient and physician alike. Overall,
serious complications arising from sling erosion into the bladder
or urethra are rare. Sling erosions may occur early in the postoperative
period, with the vaginal wall failing to heal over the sling
due to extensive dissection, local devascularization, or sling
infection. Delayed erosions have also been reported in some series,
with patients presenting up to 3.5 years after sling placement.
Women with vaginal sling erosions may present with persistent
or new-onset vaginal discharge, bleeding (spontaneous or postcoital),
dyspareunia, or vaginal pain. Careful examination of the anterior
vaginal wall in the vicinity of the bladder neck may reveal the
presence of granulation tissue, a sinus tract, or the sling itself
eroded through the mucosa. Colposcopic evaluation may be useful
for visualizing vaginal erosions. In the rare case of sling erosion
into the bladder or urethra, patients may present with recurrent
urinary tract infections, hematuria, or irritative voiding symptoms.
Although bladder and urethral erosions have been reported most
commonly with synthetic slings,15they may also occur
with fascial slings, and should be considered when women present
with repeated urinary retention or irritative symptoms.16Cystoscopy
should be performed if these symptoms are persistent, even if
the test results were normal at the time of the surgery.
The difficulty of sling removal largely depends on the material
used. Silastic and Gore-Tex are generally easy to remove, while
Mersilene mesh may be more difficult or even impossible to remove
completely because of extensive tissue ingrowth. Small vaginal
sling erosions (less than 5 mm) that do not appear to be infected
may respond to conservative treatment with topical estrogen alone,
or with trimming of the visible sling and cauterization of granulation
tissue. Larger erosions may be treated with excision of the exposed
sling and reapproximation of healthy vaginal wall flaps (created
by undermining the epithelium) with absorbable suture.17
In 1997, a woven polyester sling treated with pressure-injected
bovine collagen (ProteGen) was introduced as part of a surgical
kit for stress incontinence. Kobashi and associates18reported
on 34 women who required removal of the ProteGen polyester sling
after the onset of erosion, infection, or pain. The most common
presenting symptoms were delayed vaginal discharge, vaginal pain
or pressure, suprapubic pain, and recurrent urinary tract infection.
These women presented an average of 8 months after sling placement
(range of 1 to 22 months). In this report of complications, 50%
of patients had vaginal erosion of the sling. Less common presenting
problems were urethral erosion (20%), urethrovaginal fistula
(17%), and vaginal sinus tract (0.3%). It should be noted that
as this is simply a report on a group of complications, it is
impossible to determine the true incidence of these problems.
The ProteGen sling was voluntarily recalled by the manufacturer
in 1999.
Because vaginal erosions may occur a year or more after sling
placement, concern has been raised about delayed diagnosis of
this complication. Women presenting to their gynecologists with
abnormal vaginal bleeding or discharge may undergo evaluation
with endometrial biopsy, dilation and curettage, or hysteroscopy.
Others may be treated with multiple courses of hormonal or antibiotic
preparations. Failure to consider sling erosion as a cause of
vaginal bleeding, discharge, or pain or of dyspareunia may subject
women to unnecessary and invasive investigations. Delayed or
incorrect diagnosis can be a source of frustration for women
who experience an erosion of synthetic mesh into the vagina.
More recently, tension-free vaginal tape, TVT, has gained popularity
as a minimally invasive sling procedure that uses Prolene mesh
to support the midurethra. Although long-term data regarding
TVT are lacking, few vaginal erosions have been reported, which
may in part be a function of the minimal dissection (and resultant
minimal devascularization) required to properly place the sling.
Irritative Symptoms
The effect of suburethral slings on preexisting urinary urge
symptoms is variable and unpredictable. Some women experience
resolution of urgency or urge incontinence after surgery, while
others may have persistent irritative symptoms.19In
general, women with mixed incontinence (GSI associated with DI)
should be treated conservatively, with surgery considered only
after resolution or improvement of urgency. In addition, some
women may develop de novo irritative voiding symptoms, eg, urgency,
frequency, urge incontinence, following sling procedures. This
may represent the bladders response to increased outlet
resistance. In any event, the prevalence of irritative symptoms
decreases from 40% to 50% 1 week after surgery to 10% at 10 weeks.20Patients
should therefore be reassured that these symptoms usually resolve
over time. If treatment is required, postoperative DI usually
responds well to anticholinergic agents and bladder retraining
drills.
Voiding Dysfunction
Suburethral slings are associated with a higher risk of postoperative
voiding problems than other operations for stress incontinence.5The
most common cause of voiding dysfunction from sling procedures
is excess tension on the sling or its suspending sutures, which
results in bladder outlet obstruction and the myriad problems
that follow. These include elevated postvoid residual volumes,
hesitancy, decreased urinary stream, irritative symptoms, and
urinary retention.
Successful management of postoperative voiding dysfunction begins
with proper preoperative consent. All women undergoing antiincontinence
surgery should be counseled regarding the risk of voiding problems.
While suburethral sling procedures appear to offer the highest
success rates (particularly for women with ISD), they also appear
to have the highest risk of postoperative voiding dysfunction.
Women who are candidates for sling procedures must understand
before surgery that voiding problems may not be resolved by sling
placement. By the same token, however, they should be encouraged
not to view voiding dysfunction as a sign of therapeutic failure.
The first potential voiding complication likely to be encountered
by a patient after placement of a suburethral sling is incomplete
bladder emptying. The bladder, having grown accustomed to decreased
outlet obstruction, is frequently unable to generate enough pressure
to open the newly suspended urethra, particularly in light of
perioperative swelling and tissue trauma. Postoperative voiding
trials may demonstrate complete retention or high postvoid residual
volumes; even patients who have successful voiding trials after
surgery may present later with urinary retention. These patients
should be provided with some form of bladder drainage until bladder
function is recovered.
Continuous transurethral drainage (Foley catheter) is commonly
used, as it requires minimal patient training. However, surgeons
should consider either clean intermittent self-catheterization
or suprapubic catheter drainage, as both of these methods allow
for bladder filling and spontaneous voiding attempts. These alternative
bladder drainage methods are associated with decreased rates
of urinary tract infections, and the patients progress
can be monitored daily with measurements of both spontaneous
voids and postvoid residual volumes. Certain women are at higher
risk for postoperative voiding dysfunction, including patients
aged 65 years or more, those undergoing other concomitant surgical
procedures, and those demonstrating low peak-flow rates on preoperative
uroflowmetry.21Patients with these risk factors are
excellent candidates for suprapubic tube placement at the time
of surgery. Assisted bladder drainage may be discontinued once
the postvoid residual volumes are less than 20% of the total
starting bladder volume (or less than 100 mL). Urodynamic evaluation
is recommended if postvoid residual volumes remain high 12 weeks
after surgery.20If elevated intravesical pressures
(more than 35 cm H2O) are demonstrated with an inadequate
voiding pattern on pressure-flow studies, it may be necessary
to perform surgery to reduce tension on the sling.
Urethrolysis
A small number of patients undergoing sling procedures will
have voiding dysfunction that is significant, persistent, and
refractory to therapy. The American Urological Association panel
concluded that the overall risk is below 5%, although estimates
range from 1% to 20%.5These patients require some
form of urethrolysis, or surgical release of the sling. One useful
technique involves midline transection of the sling from a vaginal
approach, with additional paraurethral and retropubic dissection
as needed. The exact location of the sling may not always be
evident during dissection. Identifying its location may be facilitated
by placing the sling on tension with the use of a cystoscope
in the urethra while palpating the sling. The morbidity from
this procedure is low, the rates of symptom relief are high,
and most investigators have found that the majority of patients
remain continent, even without resuspension.22A variety
of other techniques for treating obstructive symptoms after sling
procedures have been reported. Brubaker23describes
a technique of releasing the rectus fascia attachments of the
sling sutures. Carr and colleagues24describe vaginal,
retropubic and infrapubic approaches to urethrolysis, while Petrou25describes
a suprameatal, transvaginal approach.
Bone Anchor Complications
Bone anchors were introduced by Leach26in 1988 for
pubic bone fixation of sutures during needle suspension procedures.
It was felt that such a solid suprapubic fixation would improve
the success rate for these procedures by reducing suture pull-through
in the periurethral fascia, and decrease the discomfort associated
with tying sutures over the rectus fascia. Since that time, a
variety of bone anchor designs have been described for both needle
suspensions and slings. Recently, a transvaginal sling procedure
has been introduced that enables surgeons to attach a suburethral
graft to the inferior pubic rami or posterior aspect of the pubis,
thereby eliminating the need for a suprapubic incision. The use
of bone anchors can be complicated by osteomyelitis, especially
when the breach of bone cortex is in close proximity to vaginal
flora. Indeed, there are at least six cases and two case reports
of pubic osteomyelitis in the literature.27,28Although
the incidence of this complication is quite low, osteomyelitis
should be suspected in women who have undergone pubic bone anchor
placement if they present with recurrent or persistent suprapubic
swelling, pain, drainage, or wound infections that are refractory
to conservative treatment. The diagnosis may be confirmed by
blood cultures and bone scans (triple-phase, tagged white blood
cells, or gallium). Aggressive surgical debridement with removal
of the anchors, along with prolonged intravenous antibiotic treatment,
is usually required for successful management.
CONCLUSION
As more antiincontinence procedures are performed, clinicians
must be aware of their potential complications, including those
more commonly seen with sling procedures. Women who have undergone
sling placement may present at any point with a variety of symptoms,
including irritative voiding, vaginal bleeding, and pelvic pain,
which may at first appear unrelated to their surgery. Successful
management depends on the clinician approaching these problems
with an understanding of the procedures and a high index of suspicion.
Peter L. Rosenblatt, MD, is an assistant professor of
obstetrics, gynecology, and reproductive biology at Harvard Medical
School, Boston, Mass, director of urogynecology at Beth Israel
Deaconess Medical Center, Boston, Mass, and co-director of urogynecology
at Mount Auburn Hospital, Cambridge, Mass; Charles R. Rardin,
MD, is a clinical instructor of obstetrics, gynecology, and
reproductive biology at Harvard Medical School, and a clinical
fellow, division of urogynecology at Mount Auburn Hospital; and Neeraj
Kohli, MD, is an assistant professor of obstetrics, gynecology,
and reproductive biology at Harvard Medical School, and co-director
of urogynecology at Mount Auburn Hospital.
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