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The Use of Mesh in Pelvic Reconstructive Surgery
LetterS to the Editor
REFERENCES 1. Thiel J. It sounded like a good idea at the time. J Obstet Gynaecol Can 2012;34(7):611–2. 2. Tone A, McAlpine J, Finlayson S, Gilks CB, Heywood M, Huntsman D, et al. It sounded like a good idea at the time [Letter to the Editor]. J Obstet Gynaecol Can 2012;34(12):1127–9. 3. Morelli M, Venturella R, Mocciaro R, Di Cello A, Rania E, Lico D, et al. Prophylactic salpingectomy in premenopausal low-risk women for ovarian cancer: primum non nocere. Gyn Oncol 2013 Apr 2. [Epub ahead of print] DOI: 10.1016/j.ygyn0.2013.03.023. 4. Crum CP, Drapkin R, Kindelberger D, Medeiros F, Miron A, Lee Y. Lessons from BRCA: the tubal fimbria emerges as an origin for pelvic serous cancer. Clin Med Res 2007;5:35–44. 5. Kurman RJ, Shih Ie M. The origin and pathogenesis of epithelial ovarian cancer: a proposed unifying theory. Am J Surg Pathol 2010;34:433–43. 6. Parker WH, Broder MS, Chang E, Feskanich D, Farquhar C, Liu Z, et al. Ovarian conservation at the time of hysterectomy and long-term health outcomes in the nurses’ health study. Obstet Gynecol 2009;113:1027–37. 7. Vang R, Shih IeM, Kurman RJ. Fallopian tube precursors of ovarian low- and high-grade serous neoplasms. Histopathology 2013;62:44–58. J Obstet Gynaecol Can 2013;35(6):505–506
The Use of Mesh in Pelvic Reconstructive Surgery To the Editor: Recently, the use of mesh in pelvic reconstructive surgery has received increased attention in the literature and in the lay press. The use of abdominally placed artificial materials including mesh for apical vaginal support has been established as the “gold standard” for over 50 years.1 Ten years ago, level I evidence supported the use of vaginally placed mesh for stress urinary incontinence (SUI).2 Placement of transvaginal mesh (TVM) for pelvic organ prolapse (POP) followed during the last decade, in response to a desire to reduce the failure rate associated with repairs using only native tissue. The purpose of this letter is to summarize the official notices from the Food and Drug Administration in the United States (FDA) and from Health Canada, and to refer to relevant articles that help to put efficacy and safety issues into perspective. Members of the SOGC urogynaecology sub-committee published a statement on the introduction of new surgical devices in 20083 and emphasized the need for Health Canada, industry, surgeons, patients, health institutions, and professional societies to be vigilant about demanding proof of safety and efficacy before adoption of new technologies (including TVM). The FDA issued a public health notification 506 l JUNE JOGC JUIN 2013
(PHN) later in 2008,4 which emphasized that complications of mesh insertion for POP and SUI were not as rare as previously reported, and that several conditions must be met before their use. These included having sufficient surgical training, improved disclosure to the patient of the risks and benefits of artificial versus native material used in repairs, and creation of a better adverse outcomes reporting system. Two articles published in the BC Medical Journal5 by a urologist and two gynaecologists drew attention to the FDA PHN and helped to put these concerns into perspective. They included a summary of the background to the motivation to develop TVM and a statement that the clinical concerns regarding adverse outcomes were essentially related to mesh inserted vaginally for POP. Smaller mesh slings for SUI had not been associated with the same degree or frequency of complications. Health Canada issued a notice to hospitals in 20106 that made recommendations that were essentially similar to the FDA PHN: namely, reviewing labelling of devices, requiring informed consent, exerting vigilance to identify complications, and promoting appropriate training and case selection for mesh insertion for SUI and POP. The SOGC sub-committee issued a technical update7 focused mainly on TVM placement for POP, as this was the new technology of concern. Recommendations were similar to those of the PHN and to the notice to hospitals with particular emphasis on the necessity of full informed consent and adequacy of surgical training. The FDA released a further PHN in July 20118 and followed this with Committee Opinion No. 513.9 These emphasized the need for appropriate training of physicians, the importance of surgeons being aware of the risks of these procedures, the need to be vigilant for adverse events, and the need for patients to be informed about the permanent nature of these products, that additional surgery may be required, and that this surgery may not correct the complication. They also stressed that the patient should be informed that her quality of life may be affected if a complication occurs and that she should be offered a written copy of the patient labelling on her mesh. In addition to the already required reporting of serious adverse events or death, hospitals were encouraged to report lesser forms of complications to MedWatch (the FDA safety information and adverse event reporting program). In the September meeting of the College Committee of the FDA, the consensus concluded that the efficacy of TVM for POP has not been clearly established, that TVM should be reclassified as a Class III product that requires pre-market studies with a control arm before release of product, and
LETTERS TO THE EDITOR
that post-market studies should be performed involving those with existing TVM for POP. In this same review, the consensus stated that retropubic and transobturator mesh for SUI are not the subject of the same concern as TVM for POP. Post-market studies are not to be required, although better reporting of life-altering (but rare) adverse events could be considered. The newer single incision slings should be compared with the established retro-pubic or transobturator slings, and the FDA plans to address this using the 510(k) pre-market notification pathway. Studies of these slings should cover a three- to five-year period. Of note, the FDA wrote a warning letter to Johnson and Johnson Gynecare division expressing its concerns about complications of mesh used for vaginal prolapse repair.10 On June 6, 2012, this company voluntarily withdrew four mesh products (principally their transvaginal mesh kits for prolapse support). This notice does not appear on the company’s website but is referred to on numerous public awareness and legal firms’ websites.11 In summary, the events of the last decade have illustrated the strengths and weaknesses of the way the public is protected by federal health agencies, health care institutions, and health care providers. The criteria to permit licensing of a new or modified surgical device have been less onerous than the approval process for a new pharmaceutical. The FDA and Health Canada have notified hospitals, health care providers and, more recently, the public about risks of transvaginally implanted materials in urogynaecology. There is agreement that there may be a role for TVM; however, more work is required in areas of defining patient selection, informed consent, training of surgeons, and reporting of outcome. The safety and efficacy of mesh for sacral colpopexy and mid-urethral support in treatment of SUI is not controversial, as they have been proven in long-term clinical trials. Retropubic or transobturator placement of mid-urethral mesh slings have become the standard of care for SUI. Single incision slings are a promising modification in this area, but longer outcome results are required before they are to become interchangeable with the other established slings for SUI. David Wilkie, MD, FRCSC Clinical Professor, University of British Columbia, Vancouver BC, for the SOGC Urogynaecology Committee
REFERENCES 1. Nygard IE, McCreery R, Brubaker L, Connolly A, Cundiff G, Weber AM, et al. For the Pelvic Floor Disorders Network. Abdominal sacral colpopexy: a comprehensive review. Obstet Gynecol 2004:104:805–23. 2. Ward K, Hilton P; United Kingdom and Ireland Tension-free Vaginal Tape Trial Group. Prospective multicentre randomised trial of tension-free vaginal tape and colposuspension as primary treatment for stress incontinence. BMJ 2002;325:67. 3. Ross S, Robert M, Harvey M-A, Farrell S, Schulz J, Wilkie D, et al. Ethical issues associated with the introduction of new surgical devices, or just because we can, doesn’t mean we should. J Obstet Gynaecol Can 2008;30:508–13. 4. United States Food and Drug Administration. Public Health Notification. Serious complications associated with transvaginal placement of surgical mesh in repair of pelvic floor prolapse and stress incontinence. 2008. Available at: http://www.fda.gov/medicaldevices/safety/ alertsandnotices/publichealthnotifications/ucm061976.htm. Accessed April 24, 2013. 5. Fenster HN, Cundiff GW, Wilkie D. Complications of surgical mesh for pelvic organ prolapse and stress incontinence: FDA notifications worth heeding. Putting the FDA notifications in perspective. BCMJ 2008;51(8):350–3. 6. Health Canada notice to hospitals. Health Canada issued important safety information on surgical mesh for stress urinary incontinence and pelvic floor prolapse; February 4, 2010. Available at: http://www.healthycanadians.gc.ca/ recall-alert-rappel-avis/hc-sc/2010/14626a-eng.php. Accessed April 24, 2013. 7. Walter J-E; SOGC Urogynaecology Committee. Transvaginal mesh procedures for pelvic organ prolapse. SOGC Technical Update, no. 254, February 2011. J Obstet Gynaecol Can 2011;33:168–74. 8. United States Food and Drug Administration. FDA safety communication: UPDATE on serious complications associated with transvaginal placement of surgical mesh for pelvic organ prolapse. July 13, 2011. Available at: http://www.fda.gov/medicaldevices/ safety/alertsandnotices/ucm262435.htm. Accessed April 24, 2013. 9. United States Food and Drug Administration Obstetrics and Gynecology Devices Panel. September 8–9, 2011. 24-hr Summary-Ob/Gyn Devices Panel September 8–9, 2011. Available at: http://www.fda.gov/medicaldevices/safety/ alertsandnotices/ucm262435.htm. Accessed April 24, 2013. 10. United States Food and Drug Administration. Inspections, Compliance, Enforcement, and Criminal Investigations. Johnson & Johnson Pharmaceutical Research & Development, LLC 8/10/09. Warning letter. Available at: http://www.fda.gov/ ICECI/EnforcementActions/WarningLetters/ucm177398.htm. Accessed April 24, 2013. 11. PR Web. Johnson & Johnson’s Ethicon Division to Stop Selling Gynecare Vaginal Mesh Systems. Available at: http://www.prweb.com/releases/2012/6/prweb9578109.htm. Accessed April 24, 2013. J Obstet Gynaecol Can 2013;35(6):506–507
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REFERENCES 1. Thiel J. It sounded like a good idea at the time. J Obstet Gynaecol Can 2012;34(7):611–2. 2. Tone A, McAlpine J, Finlayson S, Gilks CB, Heywood M, Huntsman D, et al. It sounded like a good idea at the time [Letter to the Editor]. J Obstet Gynaecol Can 2012;34(12):1127–9. 3. Morelli M, Venturella R, Mocciaro R, Di Cello A, Rania E, Lico D, et al. Prophylactic salpingectomy in premenopausal low-risk women for ovarian cancer: primum non nocere. Gyn Oncol 2013 Apr 2. [Epub ahead of print] DOI: 10.1016/j.ygyn0.2013.03.023. 4. Crum CP, Drapkin R, Kindelberger D, Medeiros F, Miron A, Lee Y. Lessons from BRCA: the tubal fimbria emerges as an origin for pelvic serous cancer. Clin Med Res 2007;5:35–44. 5. Kurman RJ, Shih Ie M. The origin and pathogenesis of epithelial ovarian cancer: a proposed unifying theory. Am J Surg Pathol 2010;34:433–43. 6. Parker WH, Broder MS, Chang E, Feskanich D, Farquhar C, Liu Z, et al. Ovarian conservation at the time of hysterectomy and long-term health outcomes in the nurses’ health study. Obstet Gynecol 2009;113:1027–37. 7. Vang R, Shih IeM, Kurman RJ. Fallopian tube precursors of ovarian low- and high-grade serous neoplasms. Histopathology 2013;62:44–58. J Obstet Gynaecol Can 2013;35(6):505–506
The Use of Mesh in Pelvic Reconstructive Surgery To the Editor: Recently, the use of mesh in pelvic reconstructive surgery has received increased attention in the literature and in the lay press. The use of abdominally placed artificial materials including mesh for apical vaginal support has been established as the “gold standard” for over 50 years.1 Ten years ago, level I evidence supported the use of vaginally placed mesh for stress urinary incontinence (SUI).2 Placement of transvaginal mesh (TVM) for pelvic organ prolapse (POP) followed during the last decade, in response to a desire to reduce the failure rate associated with repairs using only native tissue. The purpose of this letter is to summarize the official notices from the Food and Drug Administration in the United States (FDA) and from Health Canada, and to refer to relevant articles that help to put efficacy and safety issues into perspective. Members of the SOGC urogynaecology sub-committee published a statement on the introduction of new surgical devices in 20083 and emphasized the need for Health Canada, industry, surgeons, patients, health institutions, and professional societies to be vigilant about demanding proof of safety and efficacy before adoption of new technologies (including TVM). The FDA issued a public health notification 506 l JUNE JOGC JUIN 2013
(PHN) later in 2008,4 which emphasized that complications of mesh insertion for POP and SUI were not as rare as previously reported, and that several conditions must be met before their use. These included having sufficient surgical training, improved disclosure to the patient of the risks and benefits of artificial versus native material used in repairs, and creation of a better adverse outcomes reporting system. Two articles published in the BC Medical Journal5 by a urologist and two gynaecologists drew attention to the FDA PHN and helped to put these concerns into perspective. They included a summary of the background to the motivation to develop TVM and a statement that the clinical concerns regarding adverse outcomes were essentially related to mesh inserted vaginally for POP. Smaller mesh slings for SUI had not been associated with the same degree or frequency of complications. Health Canada issued a notice to hospitals in 20106 that made recommendations that were essentially similar to the FDA PHN: namely, reviewing labelling of devices, requiring informed consent, exerting vigilance to identify complications, and promoting appropriate training and case selection for mesh insertion for SUI and POP. The SOGC sub-committee issued a technical update7 focused mainly on TVM placement for POP, as this was the new technology of concern. Recommendations were similar to those of the PHN and to the notice to hospitals with particular emphasis on the necessity of full informed consent and adequacy of surgical training. The FDA released a further PHN in July 20118 and followed this with Committee Opinion No. 513.9 These emphasized the need for appropriate training of physicians, the importance of surgeons being aware of the risks of these procedures, the need to be vigilant for adverse events, and the need for patients to be informed about the permanent nature of these products, that additional surgery may be required, and that this surgery may not correct the complication. They also stressed that the patient should be informed that her quality of life may be affected if a complication occurs and that she should be offered a written copy of the patient labelling on her mesh. In addition to the already required reporting of serious adverse events or death, hospitals were encouraged to report lesser forms of complications to MedWatch (the FDA safety information and adverse event reporting program). In the September meeting of the College Committee of the FDA, the consensus concluded that the efficacy of TVM for POP has not been clearly established, that TVM should be reclassified as a Class III product that requires pre-market studies with a control arm before release of product, and
LETTERS TO THE EDITOR
that post-market studies should be performed involving those with existing TVM for POP. In this same review, the consensus stated that retropubic and transobturator mesh for SUI are not the subject of the same concern as TVM for POP. Post-market studies are not to be required, although better reporting of life-altering (but rare) adverse events could be considered. The newer single incision slings should be compared with the established retro-pubic or transobturator slings, and the FDA plans to address this using the 510(k) pre-market notification pathway. Studies of these slings should cover a three- to five-year period. Of note, the FDA wrote a warning letter to Johnson and Johnson Gynecare division expressing its concerns about complications of mesh used for vaginal prolapse repair.10 On June 6, 2012, this company voluntarily withdrew four mesh products (principally their transvaginal mesh kits for prolapse support). This notice does not appear on the company’s website but is referred to on numerous public awareness and legal firms’ websites.11 In summary, the events of the last decade have illustrated the strengths and weaknesses of the way the public is protected by federal health agencies, health care institutions, and health care providers. The criteria to permit licensing of a new or modified surgical device have been less onerous than the approval process for a new pharmaceutical. The FDA and Health Canada have notified hospitals, health care providers and, more recently, the public about risks of transvaginally implanted materials in urogynaecology. There is agreement that there may be a role for TVM; however, more work is required in areas of defining patient selection, informed consent, training of surgeons, and reporting of outcome. The safety and efficacy of mesh for sacral colpopexy and mid-urethral support in treatment of SUI is not controversial, as they have been proven in long-term clinical trials. Retropubic or transobturator placement of mid-urethral mesh slings have become the standard of care for SUI. Single incision slings are a promising modification in this area, but longer outcome results are required before they are to become interchangeable with the other established slings for SUI. David Wilkie, MD, FRCSC Clinical Professor, University of British Columbia, Vancouver BC, for the SOGC Urogynaecology Committee
REFERENCES 1. Nygard IE, McCreery R, Brubaker L, Connolly A, Cundiff G, Weber AM, et al. For the Pelvic Floor Disorders Network. Abdominal sacral colpopexy: a comprehensive review. Obstet Gynecol 2004:104:805–23. 2. Ward K, Hilton P; United Kingdom and Ireland Tension-free Vaginal Tape Trial Group. Prospective multicentre randomised trial of tension-free vaginal tape and colposuspension as primary treatment for stress incontinence. BMJ 2002;325:67. 3. Ross S, Robert M, Harvey M-A, Farrell S, Schulz J, Wilkie D, et al. Ethical issues associated with the introduction of new surgical devices, or just because we can, doesn’t mean we should. J Obstet Gynaecol Can 2008;30:508–13. 4. United States Food and Drug Administration. Public Health Notification. Serious complications associated with transvaginal placement of surgical mesh in repair of pelvic floor prolapse and stress incontinence. 2008. Available at: http://www.fda.gov/medicaldevices/safety/ alertsandnotices/publichealthnotifications/ucm061976.htm. Accessed April 24, 2013. 5. Fenster HN, Cundiff GW, Wilkie D. Complications of surgical mesh for pelvic organ prolapse and stress incontinence: FDA notifications worth heeding. Putting the FDA notifications in perspective. BCMJ 2008;51(8):350–3. 6. Health Canada notice to hospitals. Health Canada issued important safety information on surgical mesh for stress urinary incontinence and pelvic floor prolapse; February 4, 2010. Available at: http://www.healthycanadians.gc.ca/ recall-alert-rappel-avis/hc-sc/2010/14626a-eng.php. Accessed April 24, 2013. 7. Walter J-E; SOGC Urogynaecology Committee. Transvaginal mesh procedures for pelvic organ prolapse. SOGC Technical Update, no. 254, February 2011. J Obstet Gynaecol Can 2011;33:168–74. 8. United States Food and Drug Administration. FDA safety communication: UPDATE on serious complications associated with transvaginal placement of surgical mesh for pelvic organ prolapse. July 13, 2011. Available at: http://www.fda.gov/medicaldevices/ safety/alertsandnotices/ucm262435.htm. Accessed April 24, 2013. 9. United States Food and Drug Administration Obstetrics and Gynecology Devices Panel. September 8–9, 2011. 24-hr Summary-Ob/Gyn Devices Panel September 8–9, 2011. Available at: http://www.fda.gov/medicaldevices/safety/ alertsandnotices/ucm262435.htm. Accessed April 24, 2013. 10. United States Food and Drug Administration. Inspections, Compliance, Enforcement, and Criminal Investigations. Johnson & Johnson Pharmaceutical Research & Development, LLC 8/10/09. Warning letter. Available at: http://www.fda.gov/ ICECI/EnforcementActions/WarningLetters/ucm177398.htm. Accessed April 24, 2013. 11. PR Web. Johnson & Johnson’s Ethicon Division to Stop Selling Gynecare Vaginal Mesh Systems. Available at: http://www.prweb.com/releases/2012/6/prweb9578109.htm. Accessed April 24, 2013. J Obstet Gynaecol Can 2013;35(6):506–507
JUNE JOGC JUIN 2013 l 507