- Email: [email protected]
INCONTINENCE
0022-5347/05/1744-1175/0 THE JOURNAL OF UROLOGY® Copyright © 2005 by AMERICAN UROLOGICAL ASSOCIATION
Vol. 174, 1175–1176, October 2005 Printed in U.S.A.
DOI: 10.1097/01.ju.0000179193.02838.60
INCONTINENCE Recently Thom et al presented the national trends in the evaluation and treatment of women with urinary incontinence, finding that in the United States we are treating more women for urinary incontinence, and increasingly with nonautologous slings.1 Reporting that slings have increased from 621/100,000 procedures in 1995 to 2,776/100,000 in 1998, coupled with a marked increase in outpatient procedures for stress urinary incontinence, arguably then the majority of outpatient sling procedures are being performed with newer polypropylene synthetic meshes. Given the plethora of these procedures and the increasing number of reports on the associated complications, 2 more articles on the common complications of intravesical and vaginal erosions of polypropylene mesh materials are published in this issue of The Journal. Giri et al (page 1306) present 3 cases of symptomatic intravesical presentations of either polypropylene suture or mesh after anti-incontinence procedure successfully excised using a holmium laser fiber through a flexible cystoscope. Siegel et al (page 1308) present 17% vaginal erosion rate at a single center occurring with a multifilament synthetic mesh. The majority of patients with mesh erosion after pelvic procedure with synthetic mesh present with 1 or more local symptoms, such as vaginal drainage, fistulas, pelvic pain or various voiding dysfunctions, including retention, irritative voiding symptoms, hematuria or urinary tract infections.2, 3 Patients may present with simultaneous erosions either from multiple procedures4 or from the same procedure.5 Occasionally, the presenting symptoms will be that of bacteremia. The incidence of erosion varies with operative experience, the procedure and the center reporting. There is a learning curve with operative procedures reflected most cogently by the intraoperative bladder perforation rate.6 Recognized by the American Urological Association, efforts are increasingly directed at establishing volume of urological cases required for competency. In single center experiences (thereby obviating a referral bias) the incidence of vaginal erosion is in the range of 10% to 15%,6, 7 similar to the data presented by Siegel et al for the intravaginal slingoplasty sling. These more contemporary rates are far higher than earlier published ranges of 0% to 12%. Clearly the risk of synthetic erosion is much higher than the less than 1% risk of erosive or infectious complications with autologous material. Wide speculation as to cause of mesh erosion ranges from tension of the mesh inciting an increased inflammatory reaction,8 compromise of the vascularity of the underlying tissue2, 8 or of the various mesh materials themselves. Pore size of a monofilament mesh is critical.9 Multifilament mesh, woven materials and silicone coating are even at higher risk as suggested by others10 –12 and as reported by Siegel et al. Antibiotic use during these procedures is prudent and has been reported to reduce the risk of erosion.13 Regardless, once mesh is exposed, the infectious process begins by establishing a bacterial biofilm,14 made all the easier on materials with low porosity, woven or of multifilaments, each of which limits the salutary inflammatory response. The diagnosis of erosion is largely made by cystoscopy and vaginoscopy with further imaging dictated by the clinical situation. Methods of minimally invasive approaches to partial excision of either intravesical or intraurethral mesh include extraperitoneal laparoscopic assisted excision,15 or transurethral cutting of the tape with endoscopic scissors16 or with the holmium laser fiber (Giri et al). Vaginal erosion without abscess formation can be initially managed with local excision, antibiotic irrigation and re-closure. While local excision
usually allows for maintenance of continence, it will unfortunately be insufficient in many cases of synthetic erosion. Complete explantation is necessary, particularly if the erosion and/or abscess formation is associated with virulent organisms, such as Staphylococcus aureus or Candida.17 Inadequate drainage is associated with progression of the infectious process and risks far more significant complications. Extraction of the mesh and reconstruction can be complicated,3, 9 and expert immediate repair of any associated injuries to the urethra, bladder neck and bladder is necessary. Furthermore, each of our reported patients undergoing complete extraction required further surgery to restore continence.3 Importantly, erosions and secondary infection of the mesh material can present as late as 18 years after the procedure,18 such that wisdom dictates a high degree of suspicion when a patient presents with irritative or possibly infectious symptoms even years after pelvic mesh procedure. When incomplete removal is associated with persistence of symptoms, one is risking progression of the infectious process. Other caveats should be known in the long-term health care of these patients. Mesh will complicate future operative procedures in the area, just as reported with radical prostatectomy and prior inguinal mesh herniorrhaphy.19 Little known is that synthetic mesh can complicate imaging with positron emission tomography used increasingly in the evaluation and staging of malignant disease.20 No blame should be placed on any particular contemporary procedure. Mesh associated erosions are not limited to certain types of pelvic procedures but are reported with all minimally invasive, tension-free procedures as well as laparoscopic and open pelvic procedures whether for incontinence, prolapse or hernia. Erosion also occurs without violation of the retropubic space with transobturator tape procedures. This certainly does not imply a bias that mesh is a poor material for pelvic floor reconstruction, but it does mean that a cavalier attitude towards a simple outpatient procedure is unacceptable. The financial costs are unknown, but of 15,000 penile prosthesis implanted each year in the United States 450 are removed at an estimated average cost per case of $35,000.17 This would likely underestimate the costs associated with synthetic mesh erosions for stress incontinence, as complete mesh extraction often requires secondary reconstructive and or incontinence procedures.
1175
Deborah J. Lightner Department of Urology Mayo Clinic Rochester, Minnesota REFERENCES
1. Thom, D. H., Nygaard, I. E. and Calhoun, E. A.: Urologic Diseases in America Project: urinary incontinence in women— national trends in hospitalizations, office visits, treatment and economic impact. J Urol, 173: 1295, 2005 2. Kobashi, K. C. and Govier, F. E.: Management of vaginal erosion of polypropylene mesh slings. J Urol, 169: 2242, 2003 3. Sweat, S. D., Itano, N. B., Clemens, J. Q., Bushman, W., Gruenenfelder, J., McGuire, E. J. and Lightner, D. J.: Polypropylene mesh tape for stress urinary incontinence: complications of urethral erosion and outlet obstruction. J Urol, 168: 144, 2002 4. Gerstenbluth, R. E. and Goldman, H. B.: Simultaneous urethral erosion of tension-free vaginal tape and woven polyester pubovaginal sling. J Urol, 170: 525, 2003
1176
INCONTINENCE
5. Kenton, K., FitzGerald, M. P. and Brubaker, L.: Multiple foreign body erosions after laparoscopic colposuspension with mesh. Am J Obstet Gynecol, 187: 252, 2002 6. Bodelsson, G., Henriksson, L., Osser, S. and Stjernquist, M.: Short term complications of the tension free vaginal tape operation for stress urinary incontinence in women. Int J Obstet Gynaecol, 109: 566, 2002 7. Domingo, S., Alama, P., Ruiz, N., Perales, A. and Pellicer, A.: Diagnosis, management and prognosis of vaginal erosion after transobturator suburethral tape procedure using a nonwoven thermally bonded polypropylene mesh. J Urol, 173: 1627, 2005 8. DiVita, G., Milano, S., Frazzetta, M., Patti, R., Palazzolo, V., Barbera, C. et al: Tension-free hernia repair is associated with an increase in inflammatory response markers against the mesh. Am J Surg, 180: 203, 2000 9. Blaivas, J. G. and Sandhu, J.: Urethral reconstruction after erosion of slings in women. Curr Opin Urol, 14: 335, 2004 10. Bafghi, A., Benizri, E. I., Trastour, C., Benizri, E. J., Michiels, J. F. and Bongain, A.: Multifilament polypropylene mesh for urinary incontinence: 10 cases of infections requiring removal of the sling. Int J Obstet Gynaecol, 112: 376, 2005 11. Kobashi, K. C., Dmochowski, R., Mee, S. L., Mostwin, J., Nitti, V. W., Zimmern, P. E. et al: Erosion of woven polyester pubovaginal sling. J Urol, 162: 2070, 1999 12. Comiter, C. V. and Colegrove, P. M.: High rate of vaginal extrusion of silicone-coated polyester sling. Urology, 63: 1066, 2004
13. Persson, J., Iosif, C. and Wolner-Hanssen, P.: Risk factors for rejection of synthetic suburethral slings for stress urinary incontinence: a case-control study. Obstet Gynecol, 99: 629, 2002 14. Darouiche, R. O.: Device-associated infections: a macroproblem that starts with microadherence. Clin Infect Dis, 33: 1567, 2001 15. Kielb, S. J. and Clemens, J. Q.: Endoscopic excision of intravesical tension-free vaginal tape with laparoscopic instrument assistance. J Urol, 172: 971, 2004 16. Werner, M., Najjari, L. and Schuessler, B.: Transurethral resection of tension-free vaginal tape penetrating the urethra. Obstet Gynecol, 102: 1034, 2003 17. Darouiche, R. O.: Treatment of infections associated with surgical implants. N Engl J Med, 350: 1422, 2004 18. Giles, D. L. and Davila, G. W.: Suprapubic-vaginocutaneous fistula 18 years after a bladder-neck suspension. Obstet Gynecol, 105: 1193, 2005 19. Cooperberg, M. R., Downs, T. M. and Carroll, P. R.: Radical retropubic prostatectomy frustrated by prior laparoscopic mesh herniorrhaphy. Surgery, 135: 452, 2004 20. Aide, N., Deux, J. F., Peretti, I., Mabille, L., Mandet, J., Callard, P. et al: Persistent foreign body reaction around inguinal mesh prostheses: a potential pitfall of FDG PET. AJR Am J Roentgenol, 184: 1172, 2005
Vol. 174, 1175–1176, October 2005 Printed in U.S.A.
DOI: 10.1097/01.ju.0000179193.02838.60
INCONTINENCE Recently Thom et al presented the national trends in the evaluation and treatment of women with urinary incontinence, finding that in the United States we are treating more women for urinary incontinence, and increasingly with nonautologous slings.1 Reporting that slings have increased from 621/100,000 procedures in 1995 to 2,776/100,000 in 1998, coupled with a marked increase in outpatient procedures for stress urinary incontinence, arguably then the majority of outpatient sling procedures are being performed with newer polypropylene synthetic meshes. Given the plethora of these procedures and the increasing number of reports on the associated complications, 2 more articles on the common complications of intravesical and vaginal erosions of polypropylene mesh materials are published in this issue of The Journal. Giri et al (page 1306) present 3 cases of symptomatic intravesical presentations of either polypropylene suture or mesh after anti-incontinence procedure successfully excised using a holmium laser fiber through a flexible cystoscope. Siegel et al (page 1308) present 17% vaginal erosion rate at a single center occurring with a multifilament synthetic mesh. The majority of patients with mesh erosion after pelvic procedure with synthetic mesh present with 1 or more local symptoms, such as vaginal drainage, fistulas, pelvic pain or various voiding dysfunctions, including retention, irritative voiding symptoms, hematuria or urinary tract infections.2, 3 Patients may present with simultaneous erosions either from multiple procedures4 or from the same procedure.5 Occasionally, the presenting symptoms will be that of bacteremia. The incidence of erosion varies with operative experience, the procedure and the center reporting. There is a learning curve with operative procedures reflected most cogently by the intraoperative bladder perforation rate.6 Recognized by the American Urological Association, efforts are increasingly directed at establishing volume of urological cases required for competency. In single center experiences (thereby obviating a referral bias) the incidence of vaginal erosion is in the range of 10% to 15%,6, 7 similar to the data presented by Siegel et al for the intravaginal slingoplasty sling. These more contemporary rates are far higher than earlier published ranges of 0% to 12%. Clearly the risk of synthetic erosion is much higher than the less than 1% risk of erosive or infectious complications with autologous material. Wide speculation as to cause of mesh erosion ranges from tension of the mesh inciting an increased inflammatory reaction,8 compromise of the vascularity of the underlying tissue2, 8 or of the various mesh materials themselves. Pore size of a monofilament mesh is critical.9 Multifilament mesh, woven materials and silicone coating are even at higher risk as suggested by others10 –12 and as reported by Siegel et al. Antibiotic use during these procedures is prudent and has been reported to reduce the risk of erosion.13 Regardless, once mesh is exposed, the infectious process begins by establishing a bacterial biofilm,14 made all the easier on materials with low porosity, woven or of multifilaments, each of which limits the salutary inflammatory response. The diagnosis of erosion is largely made by cystoscopy and vaginoscopy with further imaging dictated by the clinical situation. Methods of minimally invasive approaches to partial excision of either intravesical or intraurethral mesh include extraperitoneal laparoscopic assisted excision,15 or transurethral cutting of the tape with endoscopic scissors16 or with the holmium laser fiber (Giri et al). Vaginal erosion without abscess formation can be initially managed with local excision, antibiotic irrigation and re-closure. While local excision
usually allows for maintenance of continence, it will unfortunately be insufficient in many cases of synthetic erosion. Complete explantation is necessary, particularly if the erosion and/or abscess formation is associated with virulent organisms, such as Staphylococcus aureus or Candida.17 Inadequate drainage is associated with progression of the infectious process and risks far more significant complications. Extraction of the mesh and reconstruction can be complicated,3, 9 and expert immediate repair of any associated injuries to the urethra, bladder neck and bladder is necessary. Furthermore, each of our reported patients undergoing complete extraction required further surgery to restore continence.3 Importantly, erosions and secondary infection of the mesh material can present as late as 18 years after the procedure,18 such that wisdom dictates a high degree of suspicion when a patient presents with irritative or possibly infectious symptoms even years after pelvic mesh procedure. When incomplete removal is associated with persistence of symptoms, one is risking progression of the infectious process. Other caveats should be known in the long-term health care of these patients. Mesh will complicate future operative procedures in the area, just as reported with radical prostatectomy and prior inguinal mesh herniorrhaphy.19 Little known is that synthetic mesh can complicate imaging with positron emission tomography used increasingly in the evaluation and staging of malignant disease.20 No blame should be placed on any particular contemporary procedure. Mesh associated erosions are not limited to certain types of pelvic procedures but are reported with all minimally invasive, tension-free procedures as well as laparoscopic and open pelvic procedures whether for incontinence, prolapse or hernia. Erosion also occurs without violation of the retropubic space with transobturator tape procedures. This certainly does not imply a bias that mesh is a poor material for pelvic floor reconstruction, but it does mean that a cavalier attitude towards a simple outpatient procedure is unacceptable. The financial costs are unknown, but of 15,000 penile prosthesis implanted each year in the United States 450 are removed at an estimated average cost per case of $35,000.17 This would likely underestimate the costs associated with synthetic mesh erosions for stress incontinence, as complete mesh extraction often requires secondary reconstructive and or incontinence procedures.
1175
Deborah J. Lightner Department of Urology Mayo Clinic Rochester, Minnesota REFERENCES
1. Thom, D. H., Nygaard, I. E. and Calhoun, E. A.: Urologic Diseases in America Project: urinary incontinence in women— national trends in hospitalizations, office visits, treatment and economic impact. J Urol, 173: 1295, 2005 2. Kobashi, K. C. and Govier, F. E.: Management of vaginal erosion of polypropylene mesh slings. J Urol, 169: 2242, 2003 3. Sweat, S. D., Itano, N. B., Clemens, J. Q., Bushman, W., Gruenenfelder, J., McGuire, E. J. and Lightner, D. J.: Polypropylene mesh tape for stress urinary incontinence: complications of urethral erosion and outlet obstruction. J Urol, 168: 144, 2002 4. Gerstenbluth, R. E. and Goldman, H. B.: Simultaneous urethral erosion of tension-free vaginal tape and woven polyester pubovaginal sling. J Urol, 170: 525, 2003
1176
INCONTINENCE
5. Kenton, K., FitzGerald, M. P. and Brubaker, L.: Multiple foreign body erosions after laparoscopic colposuspension with mesh. Am J Obstet Gynecol, 187: 252, 2002 6. Bodelsson, G., Henriksson, L., Osser, S. and Stjernquist, M.: Short term complications of the tension free vaginal tape operation for stress urinary incontinence in women. Int J Obstet Gynaecol, 109: 566, 2002 7. Domingo, S., Alama, P., Ruiz, N., Perales, A. and Pellicer, A.: Diagnosis, management and prognosis of vaginal erosion after transobturator suburethral tape procedure using a nonwoven thermally bonded polypropylene mesh. J Urol, 173: 1627, 2005 8. DiVita, G., Milano, S., Frazzetta, M., Patti, R., Palazzolo, V., Barbera, C. et al: Tension-free hernia repair is associated with an increase in inflammatory response markers against the mesh. Am J Surg, 180: 203, 2000 9. Blaivas, J. G. and Sandhu, J.: Urethral reconstruction after erosion of slings in women. Curr Opin Urol, 14: 335, 2004 10. Bafghi, A., Benizri, E. I., Trastour, C., Benizri, E. J., Michiels, J. F. and Bongain, A.: Multifilament polypropylene mesh for urinary incontinence: 10 cases of infections requiring removal of the sling. Int J Obstet Gynaecol, 112: 376, 2005 11. Kobashi, K. C., Dmochowski, R., Mee, S. L., Mostwin, J., Nitti, V. W., Zimmern, P. E. et al: Erosion of woven polyester pubovaginal sling. J Urol, 162: 2070, 1999 12. Comiter, C. V. and Colegrove, P. M.: High rate of vaginal extrusion of silicone-coated polyester sling. Urology, 63: 1066, 2004
13. Persson, J., Iosif, C. and Wolner-Hanssen, P.: Risk factors for rejection of synthetic suburethral slings for stress urinary incontinence: a case-control study. Obstet Gynecol, 99: 629, 2002 14. Darouiche, R. O.: Device-associated infections: a macroproblem that starts with microadherence. Clin Infect Dis, 33: 1567, 2001 15. Kielb, S. J. and Clemens, J. Q.: Endoscopic excision of intravesical tension-free vaginal tape with laparoscopic instrument assistance. J Urol, 172: 971, 2004 16. Werner, M., Najjari, L. and Schuessler, B.: Transurethral resection of tension-free vaginal tape penetrating the urethra. Obstet Gynecol, 102: 1034, 2003 17. Darouiche, R. O.: Treatment of infections associated with surgical implants. N Engl J Med, 350: 1422, 2004 18. Giles, D. L. and Davila, G. W.: Suprapubic-vaginocutaneous fistula 18 years after a bladder-neck suspension. Obstet Gynecol, 105: 1193, 2005 19. Cooperberg, M. R., Downs, T. M. and Carroll, P. R.: Radical retropubic prostatectomy frustrated by prior laparoscopic mesh herniorrhaphy. Surgery, 135: 452, 2004 20. Aide, N., Deux, J. F., Peretti, I., Mabille, L., Mandet, J., Callard, P. et al: Persistent foreign body reaction around inguinal mesh prostheses: a potential pitfall of FDG PET. AJR Am J Roentgenol, 184: 1172, 2005