Trans-Vaginal Mesh Revision: A Comprehensive Review on Etiologies and Management Strategies with Emphasis on Postoperative Pain Outcomes

Transcription

1 LUTS (2014) 6, REVIEW ARTICLE Trans-Vaginal Mesh Revision: A Comprehensive Review on Etiologies and Management Strategies with Emphasis on Postoperative Pain Outcomes Stephen MOCK, William S. REYNOLDS, and Roger R. DMOCHOWSKI Department of Urologic Surgery, Vanderbilt University Medical Center, Nashville, Tennessee, USA The use of polypropylene mesh to augment surgery aimed to correct pelvic organ prolapse and stress urinary incontinence stems largely from the high recurrence rates of native tissue repairs. While objective outcomes were improved, mesh related complications began to emerge that included mesh exposures, extrusions, dyspareunia and other pain issues. However, the indication for and benefit of surgical intervention(s) to address these complications are lacking. We aim to review to current literature regarding postoperative pain outcomes following vaginal mesh revision. Evidence based literature indicates that mesh complications are not rare and surgery that aims to address them generally have an overall benefit. However, studies available are generally small case series of a retrospective nature with short follow up. Some themes are evident: there is a long lag period from mesh insertion to removal; there is a lack of a true denominator of total mesh insertions making it hard to gauge the real scope of the problem; mesh material found not along the expected trocar path or coursing close to neurovascular structures thus raises the possibility of technical errors during insertion. Transvaginal mesh revision(s) for mesh complications generally have a positive effect on pain outcomes, but better controlled studies are needed. Additionally, since technical issues may be a factor in the development of mesh complications, rigorous training and sufficient surgical case volume should be emphasized. Key words dyspareunia, pelvic organ prolapse, trans-vaginal mesh 1. INTRODUCTION Pelvic organ prolapse (POP) and urinary incontinence (UI) are common conditions that may have a negative impact on a woman s quality of life. Based on the large Women s Health Initiative Trial, POP occurs in 41% of postmenopausal women as assessed by pelvic examination. 1 By the year 2050, this is estimated to increase by 46% in the United States. 2 UI is estimated to affect up to 50% of women. 3 The estimated lifetime risk by age 80 years to undergoing surgery for UI or POP was 11.1% in a large managed care population in Oregon. Among these cases, 29% were reoperations. 4 This stems largely from the high recurrence rates of up to 40% from traditional anatomic transvaginal repairs which uses the patient s own weakened tissue. 5 To improve upon this, surgeons began incorporating biologic graft materials to reinforce the repairs, but the success of these grafts decreases over time due to unpredictable tissue incorporation, decreased tensile strength and graft contraction. 6 The use of synthetic polypropylene mesh to augment POP repairs was adopted. The rationale for these augmented repairs was extrapolated from success of synthetic mesh augmented abdominal and inguinal hernia repair. The first transvaginal prolapse mesh kit was introduced in Likewise, Ulmsten et al. introduced a procedure that involved the placement of a retropubic midurethral mesh sling for stress UI (SUI) in 1995 largely due to poor results and durability with traditional repairs such as Burch colposuspension. 8 Due to the theoretic improvement, ease of use of the mesh kits, and strong commercial advertising directed at physicians and patients, these kits become widely used and commonplace. 2. FOOD AND DRUG ADMINISTRATION WARNING The Food and Drug administration (FDA) issued a public health notification (PHN) in 2008 to inform patients of adverse events related to placement of surgical mesh in the urogynecological setting. Continued monitoring via the manufacturer and user facility device experience (MAUDE), a database that houses medical device reports (MDR) of suspected device associated deaths, serious injuries and malfunctions submitted to the FDA by mandatory reporters (manufacturers, importers, and device user facilities), and voluntary reporters such as health care professionals, patients and Correspondence: Stephen Mock, MD, Department of Urologic Surgery, Vanderbilt University Medical Center, A1302 Medical Center North, Nashville, TN 37232, USA. Tel: ; Fax: Stephen.mock@vanderbilt.edu Received 15 December 2013; revised 24 January 2014; accepted 2 February 2014 DOI: /luts.12055

2 70 Stephen Mock et al. consumers, raised concerns. The number of MDRs for the POP indication increased from 303 in 2008 to 620 in Erosion accounted for 35.1% of adverse events while pain/dyspareunia made up nearly 40%. For the SUI indication, there were 368 MDRs in 2008 and increasing to 490 in Rates of erosion and pain were similar. Citing this along with increasing peer reviewed scientific literature on mesh, the FDA issued an update in 2011 and identified safety concerns specifically with transvaginal mesh for POP, and not for SUI, and its potentially life altering sequelae, including erosion and long term pain issues requiring further procedure(s) for removal. At the same time, the FDA commented that while mesh repair may restore pelvic viscera to more anatomic locations, clinical benefit and symptomatology has not been demonstrated to be improved over traditional non-mesh repair. Without conclusive evidence of improved clinical outcomes with mesh repair and the greater risk exposure to patients, the FDA issued recommendations to providers and patients that encourage dialogue and to weigh the risk and benefits seriously prior to making a decision. 9 While not a ban on mesh use, multiple vendors have withdrawn mesh kits and usage of mesh by surgeons have dramatically plummeted. 10,11 As a result of the FDA s PHN, multiple professional organizations have issued statements that advised restraint and further study. In their response letter, the Society of Urodynamics, Female pelvic medicine, and Urogenital reconstruction (SUFU) unequivocally supported the FDA s comments regarding rigorous training in mesh implantation techniques and proper informed consent between the surgeon and patient on the risks and benefits of the procedure. The letter did stress, however, that while prolapse mesh repair is associated with complications, many of these complications including dyspareunia, injury to urinary tract and pain occur with non-mesh procedures as well. In summary, they state that SUFU is unable to make universal recommendations for or against the utilization of vaginal mesh based on the scientific evidence base currently available, and there exists a population of patients for whom mesh has potential benefit. 12 In an article by Murphy et al. and endorsed by over 600 members of the Pelvic Surgeons Network, they highlight certain points in response: (i) complications attributed to mesh occur in traditional non-mesh surgery as well; (ii) only one of seven RCTs that compared mesh vs. non-mesh anterior POP repair incorporated subjective outcomes (which at one year statistically favored the mesh group), which makes the FDA comment on anatomic benefit not result(ing) in better symptomatic results highly questionable; and (iii) the high rates of failure in traditional repairs, and which can vary based on various parameters, require individualized assessment and in some cases the benefits of mesh may outweigh the risks MESH COMPLICATIONS Mesh exposure is the most common mesh-related complication following vaginal POP repair and the second most common for SUI. Reported rates vary between 0 and 25% and usually occur within the first year of intervention. 14 Complicating this is the widespread use of the term erosion, a generic term whose medical definition is the state of being worn away, as by friction or pressure. 15 In the joint statement by International Urogynecological Association/International Continence Society (IUGA/ICS), they recommend avoiding its use and to be replaced by terms with greater physical specificity and clarity, such as separation, exposure, extrusion and perforation. 16 Exposure can result in serious complications unique to mesh procedures not experienced by patients who undergo traditional repair. Additionally, mesh exposure and shrinkage of fibrous tissue around the mesh may result in pelvic pain and dyspareunia in the longer term. It can be life-altering for women since removal may require multiple procedures, sometimes including abdominal approaches, sequelae may persist, and the primary indication for the index procedure may recur. Attributing pain to the actual implantation of mesh is problematic and often difficult. However, findings that are suggestive of mesh-related pain include: pain that persists or is de novo past the normal predicted postoperative course; pain associated with findings of mesh exposure or extrusion; and physical exam findings positive for hypertonia or tenderness along the surgical tract. The major argument in favor of the pathogenic role of mesh implantation is the temporal association of the pain occurring rapidly after placement and not resolving with time. The differential diagnosis of persistent pain after mesh implantation includes muscle strain, osteitis pubis, abscess, mesh contraction, inflammation and edema, nerve entrapment or direct injury, and structural adhesions. Muscle strain and osteitis pubis should resolve with rest, ice, and non-steroidal anti-inflammatory drugs within 3 months postoperatively. Abscess is usually accompanied by vaginal exposure of the mesh. Mesh contraction results from periprosthetic retraction phenomena and inflammation reactions, resulting in increased prosthesis tension and pulling on surrounding pelvic structures, which results in symptoms of pain. Physical exam findings of prominent and tense focal area of mesh underlying the vaginal epithelium with reproducible symptoms on palpation makes one suspicious of mesh contraction. 17 When performed correctly, the obturator or pudendal neurovascular bundles should not be in contact with the mesh, but there exists variability in pelvic anatomic structures such that blind trocar passage can result in chronic neuralgias as a result of either direct damage to the nerves or entrapment. Additionally, cadaveric studies evaluating trocar trajectories demonstrate wide variability in their course, which can also be influenced by patient position during sling insertion. 18 In these cases of neural origin of pain, steroid and/or anesthetic injection helps make the diagnosis. Pain may also be non-neural in etiology and may be due to tension secondary to activity, which could lead to abnormal distortion or pulling of the tissue in the groin and pain. 19 The incidence is hard to pinpoint but is generally reported in the range of 0 30%. 20 How many

3 Trans-Vaginal Mesh Revision 71 TABLE 1. Representative manuscripts on pain outcomes following mesh revision References No. patients Mesh indication Indication for revision Median follow up Pain resolution/ improvement (%) Notes Misrai et al SUI Multiple 6 months 100 Rigaud et al SUI Pelvic/perineal pain 10 months 68 88% of TVT group with arms noted very laterally Reynolds et al SUI Pelvic pain 6 months 63 Mesh located more lateral and anteriorly Feiner et al POP Pain 24 months 88 Skala et al POP Pain (67%); erosion (56%) 3 months 53 Tijdink et al POP/SUI Pain (77%); erosion (76%) 6 months 92 Lee et al POP/SUI Extrusion (74%); dyspareunia (72%) 13 months 86 Voiding dysfunction rate of 63% suggest possible technical errors with implantation Danford et al. 233 POP/SUI Pain 12months 73 POP, pelvic organ prolapse; SUI, stress urinary incontinence; TVT, tension-free vaginal tape. patients end up needing subsequent surgery and how they do postoperatively is limited to small series in the published literature (see Table 1 for representative studies). The purpose of this review is to analyze subsequent operations following initial mesh surgery and to focus on pain outcomes following mesh excision. 4. MIDURETHRAL SLING Midurethral slings (MUS) are considered the gold standard for surgical management of female SUI owing to its technical ease and long-term success rates. 22 The retropubic tension-free vaginal tape (TVT) was the first procedure launched and was performed extensively until the transobturator approach (TOT) was introduced. Due to its avoidance of the retropubic space and avoidance of viscera in proximity, the transobturator approach became popular and led to a decrease in TVT usage. 27 While both are considered safe, a growing number of postoperative complications are emerging and are difficult to address, especially in the pain domain. The 2-year follow up study of the landmark Trial of Midurethral Slings (TOMUS) trial revealed a pain per patient report > 6 weeks post-operation at around 2% for both the retropubic and transobturator groups. Additionally, neurologic symptoms defined as new paresthesias or alterations in motor function, which may be hard to distinguish from perceived pain, was present in 5% for the retropubic group and 9.7% in the transobturator group. 19 Furthermore, the proportion of patients who went on to further surgery to alleviate these symptoms was not reported. Misrai reported on 75 women who had mesh removal after MUS. Fifty-eight cases (77.3%) were TVT and the remaining was TOT. There were 16 isolated cases of mesh extrusion, eight isolated cases of mesh erosion, 29 women developed bladder outlet obstruction, 16 women had isolated chronic pelvic pain (12 from TVT, four from TOT) and nine had de novo urinary incontinence and urgency. Most had failed initial therapy, which included a trial of anticholingergic drugs, steroid and/or analgesic blocks, vaginal closures, and partial sling excision based on complaints and findings. The surgical extent of removal was at the surgeon s discretion but special consideration was given to complete mesh removal if there was prior attempts at surgical removal, if there was a suspicion of sling infection or if pelvic pain and symptoms could be triggered by bladder filling during cystoscopy, since this would make it difficult to isolate the location of the pain and restrict it to particular areas. Complete resection for the TVT group required laparoscopy, which was performed extraperitoneally while the TOT group required obturator foramen dissection via a separate incision in addition to the vaginal one. All cases of partial resections were done via a transvaginal approach. The mesh was completely excised in approximately 40% of cases. No standardized pain questionnaire was administered, but at the 6-month follow-up, all patients reported a total decrease in pain. 21 Rigaud et al. retrospectively reviewed 32 patients who underwent removal of MUS for chronic pelvic and perineal pain. Fifteen cases were TOT and 17 were TVT. In every case, the pain was poorly defined and diffuse and the time to onset of pain after tape insertion was within 10 days after sling insertion, but the mean delay between sling placement and removal was nearly 37 months. A majority had a response from anesthetic nerve blocks, but pain recurred after the effect of the anesthetic wore off. Pain was inducible at palpation of the sling or the obturator muscle in 56% of patients. One third had attempted mesh excision prior to referral. The operative approach differed between the two groups. In the TVT group, mesh removal was performed via a trans-peritoneal laparoscopic approach and was completely dissected in the retropubic space with the limbs of the sling removed from the posterior surface of the rectus abdominis muscle to the lateral border of the urethra. The hemi-circumference of the portion of the sling posterior to the urethra was left in place in an effort to prevent recurrence of incontinence. In the TOT group, a solely transvaginal approach that extended from one obturator internus muscle to the other was performed initially (seven patients) but the latter cases involved obturator foramen dissection via a proximal thigh incision to remove the portion of the sling situated in the adductor muscle compartment. In cases of

4 72 Stephen Mock et al. lateralized pain, unilateral thigh dissection was performed (five patients). In the patients with complaints of obturator neuralgia, they underwent laparoscopic neurolysis as well (three for TVT group and seven for TOT group). At a mean follow up of 10 months, 68% of patients had pain improvement (defined as 50% improvement in VAS score) with 15.6% having complete pain resolution. Those with persistent pain were referred to a pain management specialist. The effect on pain improvement was immediate and noted during the hospitalization in a majority of cases. In the TVT group, 88% demonstrated the sling in an abnormal position with the sling noted far more laterally in the levator ani muscle and/or bladder wall but without crossing the bladder mucosa. For those who had obturator neuralgia, a majority had compression of the obturator nerve in the obturator foramen from hypertonia of the obturator internus muscle but without direct nerve injury. The authors theorized that this muscle hypertonia was induced by sling passage through the muscle either in an incorrect position or due to excessive tension of the tape. No difference in outcome was noted between the TVT and TOT group or by the extent of sling removal in the TOT group. Since a great majority of these patients presented with pain in the immediate postoperative period, the article highlighted the benefit of immediate mesh removal (though they did not take advantage of this), a time prior to formation of fibrosis and when the procedure would be simpler. Additionally technical considerations may in part be responsible given the great majority of patients in the TVT group had the sling arms in abnormal positions. 22 Recalcitrant cases may require more extensive excision. Reynolds et al. reported on eight patients who underwent bilateral obturator foramen dissection for intractable pain in the area of the obturator foramen and/or medial groin and thigh after transobturator mesh placement. Five patients had mesh placed for SUI only, two were for SUI and POP, and one was for POP only. It was performed through a lateral groin incision directly over the inferior pubic ramus at the level of the obturator foramen. Seven of eight patients had already undergone 1 2 previous transvaginal excisions or explorations. The average interval between mesh placement and obturator dissection was 23.1 months. In all cases, residual mesh was identified and excised. At a mean follow-up of 6 months, 5 of 8 patients (63%) were cured of pain and/or infection while the remaining three had varying degrees of symptomatic improvement. There was no patient reported new onset gait or hip impairment after surgery. In all cases, mesh was noted to be located more lateral and anterior than expected from common placement techniques and more closely associated to or traversing the adductor longus muscle and tendon. In one case, the mesh was intimately associated with the neurovascular bundle. As a result, these complications may have been a result of technical error. 18 Along the same lines, in our own unpublished data, trocar injury at the time of surgery is associated with an increased risk of later mesh perforation (odds ratio 15.7). This provides additional evidence that technical issues play a role in mesh exposure and/or pelvic pain. In the current environment and controversy surrounding transvaginal mesh, rigorous training and proper operative technique are being emphasized and will continue to be stressed moving forward, especially in light of the mentioned papers that surmise breaks in techniques may contribute to the complications of mesh usage. 5. TRANSVAGINAL MESH PROLAPSE REPAIR A recent updated Cochrane review of 56 randomized controlled trials that involved a total of greater than 5900 patients examined the surgical management of POP in women. For the anterior compartment, it demonstrated a higher recurrence rate from native repair compared with a repair supplemented with mesh, a reduced objective prolapse outcome with a relative risk of 3.15 but no difference in quality of life data or re-operative rates for recurrent prolapse. This is at the expense of higher rates of surgical complications and postoperative adverse events. The risk of subsequent surgery was significantly higher for the mesh group (10 vs. 5%), with mesh erosion as the event that was more common and leading to the higher re-operative rates. Overall, the mesh erosion rate was 11.4%, and surgical intervention to correct mesh erosion occurred in 6.8%. Vaginal pain and dyspareunia did not factor much in this review as only 0.5% had mesh excision for this indication. 10 This is in contrast to the 2011 FDA report on transvaginal mesh that had vaginal pain and dyspareunia accounting for nearly 40% of complaints. 9 Feiner et al. retrospectively reviewed 17 women who underwent mesh removal for the primary indication of mesh contraction. Mesh contraction was defined by clinical examination and included any focal or diffuse tenderness, increased mesh tension or the presence of prominent bands under the vaginal mucosa. Eleven of the 17 women had mesh placed for the POP indication. No woman had prior attempts at excision. Severe vaginal pain was present in all women and all sexually active women experienced severe dyspareunia. On physical examination, all women had prominent tense focal areas of mesh palpable under the vaginal epithelium which, on palpation, reproduced the pain experienced with movement and intercourse. Erosion was noted in nine patients (53%). Median time from mesh implantation to seeking medical care for symptomatic mesh contraction was 20 weeks. The extent of mesh removal was proportional to the severity of symptoms and physical findings. At a median follow up of 24 weeks, 88 and 64% of women reported a substantial reduction in vaginal pain and dyspareunia, respectively. Three women had persistent symptoms and underwent a second intervention. Pain was surmised to be secondary to the tension that ensued after shrinkage of the main body of the mesh against the arms that remained fixated and unmovable in the tissue. An alternative explanation and one that has been emphasized in this review relates to technical factors, namely in this case, excessive tensioning or bunching of the mesh at the initial time of implantation. Either one could also explain the high erosion rate in this

5 Trans-Vaginal Mesh Revision 73 series compared with published rates. There are little data on the prevalence of asymptomatic contraction, making it difficult to draw linear conclusions from this retrospective study. 23 Translabial sonography, which has been used to estimate the amount of mesh contraction and has been published in the literature, 28 is lacking here. Marcus-Braun reported on a cohort of 83 women who underwent 104 procedures for removal of transvaginal mesh for mesh-related complications. The indications for mesh removal were multiple and included erosion (44), infection (30), incomplete voiding (17), and pain (9). Included in this report is the distribution of indications for mesh removal stratified by time from the primary operation. Interestingly, a large proportion of patients presented for removal after 2 years, specifically, 41% of erosion cases, 67% of infection cases, and 78% of pain. While this may be a function of this institution s tertiary care referral status and potential delay to referral from the community, it also highlights the importance of continued follow up since these patients can present late, in some cases greater than 4 years later. This report followed patients to the 6-month visit and focused on recurrence of POP or SUI after mesh removal and no mention was made of resolution rates in terms of pain, but only one patient underwent a repeat excision for the indication of pain. 29 In a later published article, this same group, using the same methodology, focused on a cohort of 10 women who had mesh removal for the primary sole indication of pelvic pain, which accounted for about 10% of cases. Eight patients had mesh placement for the SUI indication (five for the TOT group, three for the TVT group) and the remaining two were for POP. Six patients had obturator neuralgia, two had pudendal neuralgia, one had dyspareunia, and another with nonspecific pelvic pain. Sling section (two), partial mesh removal (one), complete mesh removal (four), and laparoscopic (two) were performed. A majority had neurolysis of the involved nerve in addition to mesh removal. Five patients (50%) had complete pain relief at the 6 month follow-up, two had partial relief of pain while three had ongoing pain requiring referral to pain specialists. 30 Lee et al. retrospectively reviewed all cases of mesh removal for transvaginal POP mesh kits between 2006 and Fifty-eight women met the inclusion criteria, 45 of which underwent anterior compartment mesh repair alone (78%), which the remaining had both anterior/posterior mesh repair. Sixty percent had undergone concurrent synthetic MUS. The patients all underwent maximal excision of mesh to the lateral-most extension. Thirty six percent had undergone initial mesh removal attempts prior to referral. Most women had multiple complaints, the most frequently being mesh extrusion (74%). Most also reported pain with 72% experiencing dyspareunia and 45% reporting pelvic and/or buttock pain. Mean interval from mesh insertion to referral was 21 months. Seventeen women (29%) required re-excision of residual anterior mesh. Sling takedown was performed concurrently with prolapse mesh excision in 43% who had voiding dysfunction. At the mean follow-up of 13 months, most women reported resolution or improvement in dyspareunia, with an overall subjective cure/improvement rate of 86%. Chronic pelvic pain resolved in 19.2%, improved in 57.8%, and was unchanged in 23%. Sling takedown at the time of mesh excision did not affect the outcome. 26 An editorial comment for this manuscript cited the high voiding dysfunction rate of 63% suggest a possible etiology of technical issues with implantation. The editor cites further evidence by highlighting higher complications in the early learning curve, the lack of training in the use of these mesh kits and low volume at which they are performed by the vast majority of surgeons. Thus separating the complications resulting from the mesh from those related to technique and surgeon inexperience is key. 31 In our own unpublished series of 233 patients who underwent mesh revision, removal or urethrolysis for the primary indication of pain, at a median follow up of 12 months, 73% of patients reported that their pain improved or resolved, 19% were unchanged, while 8% reported worsening of pain. One hundred and thirty-one patients also had mesh erosion, of which the vagina (103), bladder (14) and urethra (14) were involved. Extent of excision was predicated on physical examination and extensiveness of exposure. Pre-operative variables were explored to predict failure to relieve pain postoperatively and a prior history of chronic pelvic pain was associated with an increased risk (RR 0.28, P = 0.003). There was no increased risk of failure in those with a history of fibromyalgia, interstitial cystitis or site of erosion. This is consistent with data published by Withagen et al. who in a prospective observational study of 374 women who underwent trocar guided tension free vaginal mesh surgery for POP, pain and dyspareunia before surgery were independent risk factors for these symptoms after surgery MANAGEMENT Padmanabhan et al. provided a management strategy based on their experience and outcomes in dealing with iatrogenic foreign bodies in the female lower urinary tract (LUT) and vagina placed for either SUI and/or POP. In general the clinical circumstances and patient findings direct the operative approach. Conservative management for vaginal extrusion with estrogen therapy generally have not been successful for this group but can be attempted if present early in the postoperative period, particularly with vaginal wound dehiscence. If this fails, more aggressive techniques are used and involve mesh excision up to the level of the endopelvic fascia bilaterally with simple vaginal closure. For LUT involvement, while endoscopic simple excision can be attempted for small exposures, the authors usually perform a transvaginal urethrotomy with mesh removal along with a tension free two layer closure. Interpositional graft is considered if urethral tissue is not robust or if SUI is present, a rectus fascia pubovaginal sling. In those with bladder mesh extrusions, management is aimed firstly at complete excision prior to reconstruction. Endoscopic treatments can be attempted if a single suture and its likely accompanying calcification

6 74 Stephen Mock et al. is that which is exposed. Those with large extrusions are recommended to undergo cystorrhaphy or partial cystectomy through an abdominal incision. The possibility of ureteral reimplantation should be discussed with patients, especially if the site of exposure is at the trigone. Patients should be made aware that multiple procedures may be needed to address mesh exposure/extrusion. Urinary diversion should be reserved as a last resort for those with a devastated urethra or bladder. 32 In those whose primary complaint is pain and/or dyspareunia, a similar stepwise approach can be employed to guide management. Assuming the temporary association of development of pain after mesh placement is accurate, physical exam and cystoscopy are vital to rule out mesh exposure/extrusion. Once ruled out, and if physical exam is inconclusive, a period of rest and as needed NSAIDs (non-steroidal anti-inflammatory drugs) would be appropriate as a large percentage of these complaints are self-limited. If, on the other hand, physical exam is positive for tenderness to palpation along with a focal area of tension, mesh contraction should be considered. All areas of tenderness should be accurately mapped out while the patient is awake so as to direct the surgical approach. A mesh incision to release the tension may relieve the symptom of pain. If tenderness can be elicited and reproducible along the distribution of the obturator or pudendal nerve, anesthetic injection would provide the proof of concept. An attempt at mesh excision should be made and a period of time should be allowed to see if there is symptomatic relief. If no relief is evident and if pain is still consistent with obturator or pudendal neuralgia, more aggressive therapy in the form of obturator foramen dissection with neurolysis or transabdominal neurolysis would be warranted. If no relief is attained with surgical therapy, referral to pain management specialists would be warranted. 7. CONCLUSIONS Pelvic organ prolapse and urinary incontinence are common conditions that can adversely affect a woman s quality of life. Traditional native tissue repairs yielded high recurrence rates and as a result, augmented repairs using synthetic polypropylene mesh were adopted. This resulted in improved objective anatomic cure rates and lower recurrence rates, but at the expense of a greater number of complications associated with mesh insertion, namely extrusion/exposure and pain/dyspareunia issues. But the indication for and benefit of surgical removal are lacking. In this review of pain outcomes after mesh removal, the literature available provides some guidance on treatment course, but is generally hampered by small case series of a retrospective nature. Additionally, there is poor consensus on the quantification of pain across studies as well as a lack of standardization of surgical approach, making comparison across studies difficult. But, some points deserve emphasis: (i) there is a long lag period from mesh insertion to removal; (ii) the lack of a true denominator of total mesh insertions makes it is hard to gauge the real scope of the problem; (iii) mesh excision provides symptomatic relief in a majority (iv) follow up in the available literature is generally short; and (v) multiple studies have found mesh material not along the expected trocar path or coursing close to neurovascular structures, thus raising the possibility of technical errors during insertion. In an effort to provide appropriate patient counseling and high quality care, the FDA approval process should be re-evaluated and strengthened to improve the safety profile of the medical implants. The surgeon should have thorough training in the use of the product and with appropriate proctorship prior to usage. He or she should maintain a sufficient case volume to keep skills current. If complications arise postoperatively, it is prudent to pursue conservative measures first in an effort to avoid the morbidity of additional surgery, but the surgeon should maintain a high degree of suspicion for the potential for intervention. It should be done in a timely manner so as to minimize prolonged patient suffering. Solace to both clinicians and patients can be found in the fact that a majority do attain symptomatic relief after surgical removal, though it may take multiple procedures. There should also be a mandatory national registry of complications of mesh insertion so it can be honestly analyzed and information can be disseminated to clinicians for treatment guidance. In the end, open and honest dialogue between provider and patient is paramount in improving care and minimizing morbidity. Disclosure The authors declare no conflict of interest. REFERENCES 1. Hendrix SL, Clark A, Nygaard I et al. Pelvic organ prolapse in the women s health initiative: gravity and gravidity. Am J Obstet Gynecol 2002; 186: Wu JM, Hundley AF, Fulton RG et al. Forecasting the prevalence of pelvic floor disorders in U.S. women: 2010 to Obstet Gynecol 2009; 114: Melville JL, Katon W, Delaney K et al. Urinary incontinence in US women: a population-based study. Arch Intern Med 2005; 165: Olsen AL, Smith VJ, Bergstrom JO et al. Epidemiology of surgically managed pelvic organ prolapse and urinary incontinence. Obstet Gynecol 1997; 89: Nguyen JN, Burchette RJ. Outcome after anterior vaginal prolapse repair: a randomized controlled trial. Obstet Gynecol 2008; 111: Chen CC, Ridgeway B, Paraiso MF. Biologic grafts and synthetic meshes in pelvic reconstructive surgery. Clin Obstet Gynecol 2007; 50: De Tayrac R, Gervaise A, Chauveaud A et al. Tension-free polypropylene mesh for vaginal repair of anterior vaginal wall prolapse. J Reprod Med 2005; 50: Ulmsten U, Petros P. Intravaginal slingplasty (IVS): an ambulatory surgical procedure for treatment of female urinary incontinence. Scand J Urol Nephrol 1995; 29: CDRH. Urogynecologic Surgical Mesh: Update on the Safety and Effectiveness of Transvaginal Placement for Pelvic Organ Prolapse, [Cited 15 Nov 2013.] Available from URL: AlertsandNotices/UCM pdf. 10. Maher C, Feiner B, Baessler K et al. Surgical management of pelvic organ prolapse in women. Cochrane Database Syst Rev 2013; 4: Art. No.: CD doi: / CD pub5.

7 Trans-Vaginal Mesh Revision Skoczylas LC, Turner LC, Wang L et al. Changes in prolapse surgery trends relative to FDA notifications regarding vaginal mesh. Int Urogynecol J 2013; (October epub ahead of print). 12. Society for Female Urology and Urodynamics (SUFU) Response: FDA Safety Communication: UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse, July [Cited 15 Nov 2013.] Available from URL: sufuorg.com/docs/news/sufu-fda-response. aspx. 13. Murphy M, Holzberg A, van Raalte H et al. Time to rethink: an evidence based response from pelvic surgeons to the FDA safety communication: update on serious complications associated with transvaginal placement of surgical mesh for pelvic organ prolapse. Int Urogynecol J 2012; 23: Withagen MI, Vierhout ME, Hendriks JC et al. Risk factors for exposure, pain, and dyspareunia after tension free vaginal mesh procedure. Obstet Gynecol 2011; 118: XXXX. Stedman s Medical Dictionary, 28th edn. Baltimore: Lippincott Williams and Wilkins, Haylen BT, Freeman RM, Swift SE 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. Neurourol Urodyn 2011; 30: Roth TM. Management of persistent groin pain after transobturator slings. Int Urogynecol J 2007; 18: Reynolds WS, Kit LC, Kaufman MR et al. Obturator foramen dissection for excision of symptomatic transobturator mesh. JUrol2012; 187: Brubaker L, Norton PA, Albo ME et al. Adverse events over two years after retropubic or transobturator midurethral sling surgery: findings from the trial of midurethral slings (TOMUS) study. Am J Obstet Gynecol 2011; 205: 498e Latthe PM, Foon R, Toozs-Hobson P. Transobturator and retropubic tape procedures in stress urinary incontinence: a systemic review and meta-analysis of effectiveness and complications. BJOG 2007; 114: Misrai V, Roupret M, Xylinas E et al. Surgical resection for suburethral sling complications after treatment for stress urinary incontinence. JUrol2009; 181: Rigaud J, Pothin P, Labat J et al. Functional results after tape removal for chronic pelvic pain following tension free vaginal tape or transobturator tape. JUrol2010; 184: Feiner B, Maher C. Vaginal mesh contraction: definition, clinical presentation, and management. Obstet Gynecol 2010; 115: Skala CE, Renezeder K, Albrich S et al. Mesh complications following prolapse surgery: management and outcome. Eur J Obstet Gynecol Reprod Biol 2011; 159: Tijdink MM, Vierhout ME, Heesakkers JP et al. Surgical management of mesh-related complications after prior pelvic floor reconstructive surgery with mesh. Int Urogynecol J 2011; 22: Lee D, Dillon B, Lemack G et al. Transvaginal mesh kits-how serious are the complications and are they reversible? Urology 2013; 81: Delorme E, Droupy S, de Tayrac R et al. Transobturator tape (Uratape): a new minimally invasive procedure to treat female urinary incontinence. Eur Urol 2004; 45: Svabik K, Martan A, Masata J et al. Ultrasound appearances after mesh implantation evidence of mesh contraction or folding? Int Urogynecol J 2011; 22: Marcus-Braun N, von Theobald P. Mesh removal following transvaginal mesh placement: a case series of 104 operations. Int Urogynecol J 2010; 21: Marcus-Braun N, Bourret A, von Theobald P. Persistent pelvic pain following transvaginal mesh surgery: a cause for mesh removal. Eur J Obstet Gynecol Reprod Biol 2012; 162: Badlani G. Editorial comment on Transvaginal mesh kits-how serious are the complications and are they reversible?. Urology 2013; 81: Padmanabhan P, Hutchinson RC, Reynolds WS et al. Approach to management of iatrogenic foreign bodies of the lower urinary tract following reconstructive pelvic surgery. JUrol2012; 187: