Fig. 14.1
IUGA/ICS joint terminology and classification of the complications related directly to the insertion of prostheses. (Reprinted with permission of John Wiley and Sons from Haylen BT, Freeman RM, Swift ST, et al. An international urogynecological association (IUGA)/international continence society (ICS) joint terminology and classification of the complications related directly to the insertion of prostheses (meshes, implants, tapes) and grafts in female pelvic floor surgery. Neurourology and Urodynamics 2011 Jan;30(1):2–12)
Evaluation of Patient
Evaluation of a patient with vaginal, suprapubic, or thigh pain after transvaginal mesh placement starts with a thorough history and physical exam. During the history, it is important to determine if the patient had any chronic pain prior to mesh placement as this is important in counseling about success after any mesh removal . Obtaining details regarding the original surgery as well as any prior excisions is important. Reviewing the prior operative notes, if they can be obtained, is critical. Descriptive information regarding location of pain, type of pain, and any alleviating or aggravating factors should be well documented.
On physical exam, a thorough abdominal exam, vaginal exam, and thigh exam as indicated is important. Assessing for any pain or tenderness along the expected trajectory of any mesh placed should be done with palpation. Often exposures are best detected with finger palpation although visualization can be helpful also. The levator muscles should also be palpated to try to differentiate levator spasm from pain related to the mesh, although the former could develop in reaction to the latter. Rectal exam should be performed to assess tone and evaluate for pain or mesh perforation. Cystoscopy may be utilized to rule out bladder or urethral perforation. Urodynamics may be indicated depending on the other presenting symptoms; however, if mesh excision is planned for pain, then urodynamics may not be indicated.
Vaginal Pain and Dyspareunia
Synthetic Midurethral Slings
Vaginal exposure, vaginal pain , dyspareunia , and sexual function outcomes after midurethral sling placement are extremely intertwined and difficult to tease out in the literature. Overall rates of exposure after sling placement range from 1.7 to 12.1% [5, 6]. The most recent Cochrane review reports an overall exposure rate of 2.09% [7]. The 5-year data from the TOMUS trial showed no difference in exposure rate between retropubic and transobturator slings [5].
Dyspareunia rates range from 4.3% in larger reviews [6] to 14.5% in smaller series [8]. One finding after TOT sling that has been reported is paraurethral banding. Some have thought that this could lead to worsening pain and dyspareunia ; however, this has not been supported in the literature [9–11].
Sexual function generally improves after sling placement, although this can be related to improved coital incontinence [12]. However, de novo dyspareunia and urgency incontinence negatively impact sexual function [12, 13]. Some studies have shown similar improvement in sexual function after both retropubic and transobturator slings; however, the 5-year data from the TOMUS trial shows greater improvement in sexual function after transobturator sling [5, 13].
Transvaginal Mesh for Pelvic Organ Prolapse Repair
Rates of vaginal exposure after TVM/POP vary; however, in the Cochrane Review from 2011, the overall mesh vaginal exposure rate was 10% [14] but has been quoted as high as 20% in some series [15]. Vaginal exposure does not always correlate with dyspareunia or vaginal pain . Bontje and colleagues reported their series of 84 patients who underwent a Prolift® (Ethicon, Somerville, NJ, USA) graft. None of the patients with dyspareunia had a mesh exposure [16]. Other studies have also found that dyspareunia was more common in patients without mesh exposure [15]. De novo dyspareunia rates after TVM/POP vary, ranging from 2.5 to 16.7% [17, 18]. According to the Cochrane Review, there is no difference in dyspareunia rates between suture-based repairs and TVM/POP [19].
The effect of TVM/POP on overall sexual function is controversial. Altman and colleagues reported on a series of 261 patients who underwent an anterior, posterior or total Prolift mesh prolapse repair. Of the 105 who were sexually active prior to the procedure, overall sexual function declined; however, dyspareunia rates were not significantly changed. The decline in sexual function was related to more behavioral or emotional domains. The authors also found that anatomic success did not correlate with improved sexual function [20]. Others have found no effect on sexual function [21].
Risk Factors
Vaginal pain and dyspareunia after transvaginal mesh placement can be related to mesh exposure or may present without any mesh exposure. Separating this causality in the literature is difficult. However, risk factors for mesh exposure include increased blood loss intraoperatively [22], lower BMI [22], and smoking [23]. Sirls and colleagues performed a retrospective review of 335 women who underwent mesh augmented prolapse repair to assess for risk factors for mesh exposure. Overall exposure rate was 8.1% with median time to detection of exposure of 96 days. Lower BMI and increased blood loss were associated with mesh exposure but no other risk factors were identified including age, smoking history, menopause, diabetes, steroids, past surgery, or prolapse stage [22].
There has been an assumption that postmenopausal status would lead to worsening pain after mesh placement. The literature on this is limited; however, Long and colleagues examined the effect of menopausal status on changes in sexual function after mesh augmented prolapse repair. Contrary to the expected outcome, they found that sexual function worsened in the premenopausal group compared to the postmenopausal group and that anatomic success was not correlated with improvements in sexual function. However, it should be noted that there was a significant minority of patients in the postmenopausal group on estrogen replacement. In addition, although most of the total patients were postmenopausal, only 30% of the postmenopausal group was sexually active and completed follow-up compared to 89% of the premenopausal group [24].
Another concern brought up in the FDA communication was regarding the role that mesh contraction plays. Some have found that mesh length in the patients who reported vaginal pain and de novo OAB was significantly decreased by about 1 cm compared to patients without these complaints [25]. However, it is important to remember that several series including the most recent Cochrane review found no difference in dyspareunia rates after mesh or native tissue prolapse repair [19, 26]. Other studies have shown more dyspareunia after mesh augmented prolapse repair compared to native tissue repair. Anger and coworkers utilized a 5% random sample of Medicare beneficiaries who underwent prolapse repairs with and without mesh from 2007 to 2008. These were compared to patient who underwent prolapse repair without mesh from 1998 to 2000. They found that failures within 1 year requiring reoperation were higher in the nonmesh group; however, the mesh group was more likely to report dyspareunia and pelvic pain [27].
Prevention
While nothing can completely prevent complications from occurring, a number of strategies can help minimize the risk of pain after mesh surgery. Dissection must be carried out in the proper plane. If the dissection is too superficial, then the patient is at increased risk of exposure and potentially for vaginal pain . The mesh should be placed to avoid any tension on the mesh body or arms. Good hemostasis is also important as hematoma formation and drainage can lead to wound separation and exposure. Knowledge of the anatomic borders and staying within them is vital.
Treatment
Treatment depends somewhat on whether there is vaginal pain and dyspareunia (or partner-related pain) with or without a vaginal exposure. However, overall treatment options include medical management, physical therapy, and surgical intervention.
To treat vaginal pain and dyspareunia without vaginal exposure, NSAIDS, pain medications, neuroleptics, and muscle relaxants can be utilized alone or with pelvic floor physical therapy. Botulinum toxin A has been used to improve pain related to levator spasms; however, insurance coverage can be difficult in some cases as it is not an FDA-approved treatment for pelvic pain . Local anesthetic can also be injected to relieve pain. Pudendal nerve blocks can be performed in patients with pudendal neuralgia.
If a patient fails more conservative treatment options, then mesh excision can be performed. Typically in the face of pain and vaginal exposure, excision is favored; however, topical estrogen cream and other more conservative treatments can be attempted depending on the size of exposure and degree of pain .
Technique for Mesh Excision
Typical mesh excision can be performed transvaginally as previously described [28] although in the case of ureteral involvement or bladder perforation transabdominal repair may be necessary. Typically, if the excision is done for pain then a wider excision is performed than for vaginal exposure alone; however, the focus of dissection should be on the areas that cause pain with palpation as determined on physical exam. Further details of transvaginal mesh removal are contained in another chapter.
Outcomes of Surgical Excision
Resolution rates of vaginal pain and dyspareunia vary in the literature. Many series quote a resolution rate around 50%; however, this varies from 13 to 100% resolution [29–32]. The series, which showed resolution of dyspareunia in only 13% after mesh excision, found on multivariant analysis that complete excision, de novo overactive bladder symptoms after initial placement and obesity correlated with improvement in symptoms. Patient who developed de novo OAB symptoms after the original surgery did show improvement of these symptoms. As far as the relationship between obesity and improved symptoms, the authors proposed a possible role of elevated estrogen from peripheral conversion in the adipose tissue as leading to improved healing [31]. One series found that patients who had mesh exposure were more likely to have improvements in pain after excision but the difference was not statistically significant. The authors also found that a history of chronic pain led to a higher risk of worsening or unchanged symptoms [33].
Recurrence of SUI after excision for pain ranges from 24 to 37.8% [34, 35]. Recurrence of prolapse occurs in 5–29% with higher rates of recurrence after complete excision [36]. Some series report low complications rates after transvaginal excision; however, others report slightly higher complication rates. Tijdink and coworkers performed a retrospective series of 73 patients who underwent mesh excision. Overall, intraoperative and postoperative complication rates were 5% and 16%, respectively. Intraoperative complications included three bowel injuries and one case of bilateral ureteral injury which was diagnosed postoperatively with anuria. The patient underwent bilateral ureteral reimplantation after diagnosis [36]. Counseling the patient is very important, including possible lack of improvement in pain, possibly worsening symptoms, recurrent incontinence, or prolapse depending on type and degree of mesh excised, visceral injury, significant bleeding, ureteral injury requiring abdominal surgery, and fistula formation.
Suprapubic Pain
Risk Factors
Fisher and coworkers performed anatomic dissection to illustrate possible nerve injuries that are at risk with TVT placement. The ilioinguinal and iliohypogastric nerves can be injured if the trocar is passed too laterally. The ilioinguinal nerve is involved in sensation to the skin over the pubic symphysis, groin, labia, and inner thigh. The iliohypogastric has similar sensory function over the pubic symphysis and groin. The pudendal nerve has branches under the pubic bone and if one passes the trocar scraping the edge of the pubic bone (often done to avoid bladder injury), these branches can be involved. Injury to the pudendal branches can lead to localized pain or perineal pain [37]. In addition, obturator neuralgia has been reported from a lateral passage of TVT trocar [38]. Therefore, it appears that suprapubic pain after retropubic sling placement can be reduced by proper passage of the trocars.
Treatment
Overall, rates of persistent suprapubic pain after sling placement appear low around 2.3% [39]. However, when pain persists, treatment options include NSAIDS, pain medications, and neuroleptics. Local anesthetic injection can be utilized. If a patient fails more conservative treatment options, then mesh excision can be performed. If there is concurrent vaginal pain , a vaginal excision alone may be considered first. However, if this does not relieve the suprapubic pain or if there is isolated suprapubic pain, then excision of the suprapubic arms can be performed either open or laparoscopically [38, 40].
Technique for Suprapubic Dissection
Suprapubic dissection can be performed open, laparoscopically or robotically. If performed open, the dissection is extraperitoneal; however, if done laparoscopically or robotically, either an extraperitoneal or intraperitoneally approach can be done.
Open excision can be done through an infraumbilical or Pfannenstiel incision. The rectus muscles are split, and the space of Retzius is developed. The mesh arm is localized by palpation and visualization in the expected location of passage. The arm can then be dissected off the pubic bone down through the endopelvic fascia and then in the opposite direction out to the level of the skin. Bladder injury should be avoided; however, if a bladder injury occurs during dissection, it can be repaired from this approach.
For a laparoscopic or robotic-assisted approach, a midline periumbilical camera port can be placed as well as two working ports, each about 8 cm lateral and 2 cm caudal to the midline port. Additional assistant ports can also be utilized. The approach is similar to the open technique; however, with an intraperitoneal approach, the space of Retzius must be exposed. This is done by incising the peritoneum above the pubic symphysis and then dividing the median umbilical ligaments and the urachus. The bladder can then be dropped down to obtain adequate exposure. To perform the surgery via an extraperitoneal approach, balloon dilation must be done first to develop the space of Retzius.
An alternative approach can be done if a vaginal dissection is performed concomitantly. The vaginal arms can be dissected through the endopelvic fascia. Then with an instrument on the mesh, the tip of the instrument can be advanced around the pubic bone towards the prior suprapubic incision. Next, through a smaller suprapubic incision, the tip of the instrument can be found and the mesh can be dissected free. Cystoscopy is prudent after excision to rule out any bladder injury.
Thigh Pain
Transobturator Sling
The risk of persistent thigh pain is higher after transobturator slings compared to retropubic slings. In the TOMUS trial , at the 12-month follow-up, neurologic symptoms were higher in the transobturator group compared to the retropubic group (9.4% vs. 4.0%) [41]. At 5-year follow-up, two women in the transobturator group reported persistent thigh pain [22]. Others have reported rates of persistent thigh pain at 5 years of 32.8% [42].
Risk Factors
Two main factors that may contribute to the development of persistent thigh pain are patient positioning at time of sling placement and technique of transobturator sling placement. Two cadaver studies have emphasized the importance of proper patient positioning to increase the distance between mesh placement and the branches of the obturator nerve. Hinoul and coworkers showed in a cadaveric study that the exit site of the TVT-O is variable and affected by the positioning of the legs during trocar placement. They recommended hyperflexion to maximize trocar distance from the obturator nerve branches [43].
Hubka and coworkers also analyzed the effect of leg position during TVT-O procedure on proximity to the branches of the obturator nerve in both properly positioned and malpositioned cadavers. The malpositioned bodies were placed with the legs at 30° to the horizontal plane versus the properly positioned bodies with legs at 90° to the horizontal plane. All the legs were abducted 30° to the sagittal plane. In the malpositioned group of both formalin-embalmed bodies and fresh frozen bodies, the mean distance from all the branches of the obturator nerve was less than 1 cm, and there was direct contact with the nerve noted three times in this group of 19 bodies. In the properly positioned fresh frozen bodies, the mean distance from the obturator nerve was over 2 cm and no direct contact with the nerve was noted [44].