Opinion on suburethral tapes

"Declaration on promoting the use of midurethal sling in surgical treatments for stress urinary incontinence - on behalf of the International Urogynecological Society"


This global statement aims to further promote the use of midurethral sling (MUS) in surgical treatments for stress urinary incontinence (SUI), a disease that makes life difficult for one in three women worldwide.

MUS was developed in the 1990s and has been widely used since then. Being a mini-invasive method requiring day care, it is an effective surgical solution to the SUI problem. This technique uses a narrow strip of monofilament tape, which is inserted through the vagina under the middle urethra with two small outlets in the suprapubic or groin area.

SUI refers to involuntary leakage of urine due to coughing, sneezing or physical exertion caused by weakening of the urethra and pelvic floor. It is often a debilitating condition that can significantly reduce a woman's quality of life1. In the treatment of SUI, non-surgical solutions such as maintaining a healthy lifestyle, behavioral modification and pelvic floor muscle exercises should be the first choice. However, they may be ineffective, so many women with severe incontinence opt for surgery2.

The International Society of Urogynecology stresses the importance of distinguishing between surgical, vaginally placed nets for the treatment of pelvic organ prolapse, and straps used to treat SUI. Governmental authorities in Scotland and the European Union now recommend that nets be used to treat pelvic organs only after careful consultation and careful consideration of the individual circumstances of each patient.

We believe that international media attention has resulted in confusion, concern, and an unbalanced negative perception of MUS as an SUI treatment. As a result, unfortunately, some women postpone or refuse interventions and decide to deal with the problem, for example, with incontinence pads. However, the international medical community does not share these concerns, and the vast majority of women who received MUS treatment were satisfied with it. This method is also endorsed by the Food and Drug Administration of the United States of America (FDA), claiming that "the safety and efficacy of multi-incision tape has been well established in clinical trials" 4,5.

We fully support recent government statements, including the statements of the European Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) 2015, the Scottish Independent Research 2017 and the Australian Senate Declarations 2018, all of which confirm the need for adequate MUS training and long-term collection data with feedback to help control. They also emphasize the fact that women must be fully informed and aware of all potential risks before surgery7,8,9. A small percentage of women suffer from pain after MUS procedures. It is important to address these symptoms and take proper care of women.

Justification of the statement

1. Polypropylene is a safe and effective material

Polypropylene has been used in most areas of surgery (general surgery, cardiovascular surgery, transplant surgery, ophthalmology, ENT, gynecology and urology) for over 50 years in millions of patients worldwide. Durable insulated fibers are widely used as a sewing material. Polypropylene mesh is the leading material used in hernia surgery6,10 and has a very positive effect on the results of the surgery. Macroporous monofilament polypropylene exhibits long-term durability, safety and efficacy for up to 17 years in SUI treatment11.

2. MUS monofilament polypropylene tape is the most researched treatment for incontinence.

Numerous evidence suggests favoring MUS as a method of SUI treatment, including studies published in reputable journals12. More than 2000 publications have already dealt with this topic. These studies, published in peer-reviewed journals, are based on numerous scientific evidence. The use of MUS has been studied in virtually all types of patients with and without co-morbidities, and in all types of SUI. Randomized controlled trials comparing different types of MUS interventions as well as MUS with other established SUI therapies have shown efficacy and patient satisfaction11,12,13,14,15. In the past, MUS interventions and follow-up examinations have received the same attention as other methods, and have shown an excellent level of safety and efficacy11,14. No other SUI treatment has been extensively studied.

3. MUS is a first-line treatment for SUI and is a great advance for our patients.

Since the publication of countless randomized level 1 comparative studies, MUS has been the most common surgical SUI solution in developed countries. It essentially replaced the open and trans vaginal suspension in SUI without complications. There are more than 100 surgical procedures that SUIs deal with. Compared to the methods used in the last century, MUS procedures are associated with less pain, shorter hospitalization, faster recovery and return to normal life and reduced costs.Transobturator and retropubic tapes have been extensively investigated, are safe and effective compared to other methods and remain the leading method and gold standard for the treatment of SUI17. MUS has been implanted more than 10 million patients worldwide.

4. The FDA has declared polypropylene MUS to be a safe and effective method of treating SUI.

Midterm sling was not the subject of the 2001 FDA Safety Notice "Surgical Mesh in Urogynecology: Updating the Safety and Efficacy of Vaginal Implants in Pelvic Organ Prolapse" 3. In this document it was explicitly stated that "the FDA will continue to evaluate the results of the use of surgical nets in the treatment of SUIs and deliver conclusions at a later date". In 2013, the FDA made clear on its website that "the safety and efficacy of multi-incision tape has been well established in clinical trials" 5.

5. The European Commission Declaration (SCENHIR) on the safety of surgical nets recommends the use of synthetic sling for SUI treatment.

In 2015, SCENHIR concluded that interventions using MUS to treat SUI are an established method with proven safety and efficacy in most patients with moderate to severe SUI, provided that they are performed by an experienced and properly trained surgeon7.

Conclusion

Polypropylene MUS helps millions of women fight SUI by undergoing a simple one-day procedure that gives them the chance to return to normal life. Confirmed efficacy and safety have allowed many more women to undergo treatment. In the past, worries about failure and complications have resulted in many incontinence women not being treated. One consequence of the current controversy on surgical nets was an attempt to prevent women from undergoing any surgical procedure for the treatment of SUI18. The most significant progress in SUI treatment over the past 50 years has been fully supported by the global urogynecological community, which has consistently been committed to improving the standard of living of women with SUI.

Resources

1. Imamura, M., et al., Systematic review and economic modelling of the effectiveness and cost- effectiveness of non- surgical treatments for women with stress urinary incontinence. Health Technol Assess, 2010. 14(40): p. 1-188, III-IV.
2. Labrie, J., et al., Surgery versus physiotherapy for stress urinary incontinence. N Engl J Med, 2013. 369(12): p. 1124-33.
3. FDA, Urogynecologic Surgical Mesh: Update on the Safety and Effectiveness of Vaginal Placement for Pelvic Organ Prolapse http://www.fda.gov/downloads/medicaldevices/safety/alertsandnotices/UCM262760.pdf, 2011.
4.  FDA,    FDA   Safety    Communication:    UPDATE    on   Serious   Complications   Associated    with    Transvaginal Placement       of       Surgical       Mesh       for       Pelvic       Organ       Prolapse       http://wayback.archive-it.org/7993/20170722150848/https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm262435.htm, 2011.
5. FDA, Considerations about Surgical Mesh for SUI.
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/UroGynSurgicalM esh/ucm345219.htm, 2013.
6. Cobb, W.S., K.W. Kercher, and B.T. Heniford, The argument for lightweight polypropylene mesh in hernia repair. Surg Innov, 2005. 12(1): p. 63-9.
7. European Commission Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR), Opinion on the efficacy and safety of vaginal meshes used in urogynaecological surgery, https://ec.europa.eu/health/scientific_committees/emerging/docs/scenihr_o_049.pdf, 2015 (December).
8.  The Scottish Independent Review of the Use, Safety and Efficacy of Transvaginal Mesh Implants in the Treatment of Stress Urinary Incontinence and Pelvic Organ Prolapse in Women: Final report http://www.gov.scot/Publications/2017/03/3336/0, 2017
9.     The    Senate    Women’s    Affairs    Reference    committee     Number     of    women    in    Australia who have had transvaginal mesh implants and related          matters, https://www.aph.gov.au/Parliamentary_Business/Committees/Senate/Community_Affairs/MeshImplants/Report
10. Scott, N.W., et al., Open mesh versus non-mesh for repair of femoral and inguinal hernia. Cochrane Database Syst Rev, 2002(4): p. CD002197.
11. Nilsson, C.G., et al., Seventeen years' follow-up of the tension-free vaginal tape procedure for female stress urinary incontinence. Int Urogynecol J, 2013. 24(8): p. 1265-9.
12. Ogah, J., J.D. Cody, and L. Rogerson, Minimally invasive synthetic sub urethral sling operations for stress urinary incontinence in women. Cochrane Database Syst Rev,2009(4): p. CD006375.
13. Novara, G., et al., Updated systematic review and meta-analysis of the comparative data on colposuspensions, pubovaginal slings, and mid urethral tapes in the surgical treatment of female stress urinary incontinence. Eur Urol, 2010. 58(2): p. 218-38.
14.  Ward, K. and P. Hilton, Prospective multicentre randomised trial of tension-free vaginal tape and colposuspension as primary treatment for stress incontinence. BMJ, 2002. 325(7355):p. 67.
15. Richter, H.E., et al., Retropubic versus transobturator mid urethral slings for stress incontinence. N EnglJ Med, 2010. 362(22): p. 2066-76.
16. Fusco F, Abdel-Fattah M, Chapple CR, Creta M, La Falce S, Waltregny D, et al. Updated Systematic Review and Meta-analysis of the Comparative Data on Colposuspensions, Pubovaginal slings, and Mid urethral tapes in the Surgical Treatment of Female Stress Urinary Incontinence. Eur Urol, 2017 72(4):567-591
17.Cox, A., S. Herschorn, and L. Lee, Surgical management of female SUI: is there a gold standard? Nat Rev Urol, 2013. 10(2): p. 78-89.
18. Clemons, J.L., et al., Impact of the 2011 FDA transvaginal mesh safety update on AUGS members' use of synthetic mesh and biologic grafts in pelvic reconstructive surgery. Female Pelvic Med Reconstr Surg, 2013. 19(4): p. 191-8.

 

- Document released in July 2018 -

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