Abstract
Purpose
In this review, we explore the evidence behind mid-urethral sling (MUS) surgery, review the rising reports of complications and the subsequent US Food and Drug Administration (FDA) and society statements, and evaluate risk perception and communication with patients, doctors, governing bodies, manufacturers and insurance companies. Our aim was to explore the pitfalls in communication that may be contributing to the decline in MUS use, and develop strategies to make MUS surgery safer.
Methods
We searched the English language literature using PubMed for articles related to the management of stress urinary incontinence (SUI), MUS, safety and monitoring of transvaginal mesh (TVM), and reviewed all online FDA publications and international position statements regarding MUS for SUI.
Results
Polypropylene mesh has been used in MUS since the 1990s, with robust evidence to support its use. There has been a decline in the use of MUS ever since the FDA notifications. In response to the controversy surrounding TVM, position statements have been released portending the safety of, and advocating for the continued use of, MUS for the management of SUI.
Conclusions
MUS is a viable, effective and safe treatment for SUI management. Physicians should obtain and document informed consent, be adequately trained, and monitor and report their outcomes using registries. With publication of registry results and ongoing health advocacy, the perception of the safety of MUS can improve and MUS can still be offered as a treatment option for SUI.
Similar content being viewed by others
References
Abrams P et al (2018) 6th International consultation on incontinence. Recommendations of the International Scientific Committee: EVALUATION AND TREATMENT OF URINARY INCONTINENCE, PELVIC ORGAN PROLAPSE AND FAECAL INCONTINENCE. Neurourol. Urodyn. 37(7):2271–2272
Petros PE, Ulmsten UI (1993) An integral theory and its method for the diagnosis and management of female urinary incontinence. Scand. J. Urol. Nephrol. Suppl. 153:1–93
Ford AA et al (2017) Mid-urethral sling operations for stress urinary incontinence in women. Cochrane Database Syst. Rev. 7:Cd006375
Nilsson CG (1998) The tensionfree vaginal tape procedure (TVT) for treatment of female urinary incontinence. A minimal invasive surgical procedure. Acta Obstet. Gynecol. Scand. Suppl. 168:34–37
Khan AA, Brucker RN, Nitti V (2017) Changes in management of stress urinary incontinence following the 2011 FDA Health Notification. J Clin Urol 10(5):440–448
Keltie K et al (2017) Complications following vaginal mesh procedures for stress urinary incontinence: an 8 year study of 92,246 women. Sci Rep 7(1):12015
Lavelle ES, Zyczynski HM (2016) Stress urinary incontinence: comparative efficacy trials. Obstet Gynecol Clin N Am 43(1):45–57
Deng DY et al (2007) Presentation and management of major complications of midurethral slings: are complications under-reported? Neurourol. Urodyn. 26(1):46–52
Barber MD, Maher C (2013) Epidemiology and outcome assessment of pelvic organ prolapse. Int. Urogynecol. J. 24(11):1783–1790
Larouche M, Geoffrion R, Walter JE (2017) No. 351-transvaginal mesh procedures for pelvic organ prolapse. J Obstet Gynaecol Can 39(11):1085–1097
Shah AD et al (2008) The age distribution, rates, and types of surgery for pelvic organ prolapse in the USA. Int Urogynecol J Pelvic Floor Dysfunct 19(3):421–428
Altman D et al (2011) Anterior colporrhaphy versus transvaginal mesh for pelvic-organ prolapse. N. Engl. J. Med. 364(19):1826–1836
Iyer S, Botros SM (2017) Transvaginal mesh: a historical review and update of the current state of affairs in the United States. Int. Urogynecol. J. 28(4):527–535
Maher C et al (2016) Surgery for women with anterior compartment prolapse. Cochrane Database Syst. Rev. 11:Cd004014
Bjelic-Radisic V et al (2014) Vaginal prolapse surgery with transvaginal mesh: results of the Austrian registry. Int. Urogynecol. J. 25(8):1047–1052
Withagen MI et al (2011) Risk factors for exposure, pain, and dyspareunia after tension-free vaginal mesh procedure. Obstet. Gynecol. 118(3):629–636
Heneghan CJ et al (2017) Trials of transvaginal mesh devices for pelvic organ prolapse: a systematic database review of the US FDA approval process. BMJ Open 7(12):e017125
BMJ (2018) Investigation exposes ‘scandal’ that has left thousands of women irreversibly harmed. Medical Devices and Surgical Technology Week. https://www.bmj.com/company/newsroom/investigation-exposes-vaginal-mesh-scandal-that-has-left-thousands-of-women-irreversibly-harmed/. Accessed 2 Feb 2019
Notification FPH (2008) Serious complications associated with transvaginal placement of surgical mesh in repair of pelvic organ prolapse. Issued: 20 October 2008. http://www.fda.gov/medicaldevices/safety/alertsandnotices/publichealthnotifications/ucm061976.htm. Accessed 2 Feb 2019
Bako A, Dhar R (2009) Review of synthetic mesh-related complications in pelvic floor reconstructive surgery. Int Urogynecol J Pelvic Floor Dysfunct 20(1):103–111
Administration F (2011) Urogynecologic surgical mesh: update on the safety and effectiveness of transvaginal placement for pelvic organ prolapse. http://www.fda.gov/downloads/medicaldevices/safety/alertsandnotices/UCM262760.pdf. Accessed 2 Feb 2019
Administration, U.S.F.a.D (2016) FDA Strengthens requirements for surgical mesh for the transvaginal repeair of pelvic organ prolapse to address safety risks. Silver Springs, MD: US Food and Drug Administration; 2016. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm479732.htm. Accessed 2 Feb 2019
Orders. https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/PostmarketSurveillance/ucm134497.htm. Accessed 28 May 2019
TGA. TGA actions after review into urogynaecological surgical mesh implants [Online]. https://www.tga.gov.au/alert/tga-actions-after-review-urogynaecological-surgical-mesh-implants. Accessed 2 Feb 2019
TGA. Australian Government response to the Senate Community Affairs References Committee report: The number of women in Australia who have had transvaginal mesh implants and related matters [Online]. https://www.tga.gov.au/australian-government-response-senate-community-affairs-references-committee-report. Accessed 2 Feb 2019
Stephen Unterberg TG (2019) Mesh in urological surgery in the UK—background, reviews and current status. https://www.urologynews.uk.com/features/features/post/mesh-in-urological-surgery-in-the-uk-background-reviews-and-current-status. Accessed 28 May 2019
Administration, U.S.F.a.D (2019) FDA takes action to protect women’s health, orders manufacturers of surgical mesh intended for transvaginal repair of pelvic organ prolapse to stop selling all devices. https://www.fda.gov/news-events/press-announcements/fda-takes-action-protect-womens-health-orders-manufacturers-surgical-mesh-intended-transvaginal?utm_source=AAGL&utm_campaign=d741db6fc7-EMAIL_CAMPAIGN_2018_04_30_COPY_01&utm_medium=email&utm_term=0_528024759c-d741db6fc7-95019183. Accessed 26 May 2019
Koski ME, Rovner ES (2014) Implications of the FDA statement on transvaginal placement of mesh: the aftermath. Curr Urol Rep 15(2):380
Reuters (2015) The Lien Machine. New breed of investor profits by financing surgeries for desperate women patients [Online]. https://www.reuters.com/investigates/special-report/usa-litigation-mesh/. Accessed 2 Feb 2019
Souders CP et al (2018) The truth behind transvaginal mesh litigation: devices, timelines, and provider characteristics. Female Pelvic Med Reconstr Surg 24(1):21–25
Rogo-Gupta L et al (2013) Trends in the surgical management of stress urinary incontinence among female Medicare beneficiaries, 2002–2007. Urology 82(1):38–41
Wang LC et al (2015) Trends in mesh use for pelvic organ prolapse repair from the Medicare database. Urology 86(5):885–891
Pierson B (2019) Doctor, medical funder charged in New York in transvaginal mesh fraud. https://news.yahoo.com/doctor-medical-funder-charged-york-transvaginal-mesh-fraud-212145151–finance.html. Accessed 26 May 2019
Brown LK et al (2013) Defining patients’ knowledge and perceptions of vaginal mesh surgery. Female Pelvic Med Reconstr Surg 19(5):282–287
Chapple CR et al (2017) Consensus statement of the European Urology Association and the European Urogynaecological Association on the use of implanted materials for treating pelvic organ prolapse and stress urinary incontinence. Eur. Urol. 72(3):424–431
Koski ME et al (2014) Patient perception of transvaginal mesh and the media. Urology 84(3):575–582
Tenggardjaja CF et al (2015) Evaluation of patients’ perceptions of mesh usage in female pelvic medicine and reconstructive surgery. Urology 85(2):326–331
Cobb WS, Kercher KW, Heniford BT (2005) The argument for lightweight polypropylene mesh in hernia repair. Surg Innov 12(1):63–69
Scott N, Go PM, Graham P, McCormack K, Ross SJ, Grant AM (2001) Open Mesh versus non-Mesh for groin hernia repair. Cochrane Database Syst Rev. https://doi.org/10.1002/14651858.CD002197
AUGS (2016) Position statement: mesh midurehtral slings for stress urinary incontinence [Online]. https://www.augs.org/assets/1/6/AUGS-SUFU_MUS_Position_Statement.pdf. Accessed 2 Feb 2019
Rac G et al (2017) Stress urinary incontinence surgery trends in academic female pelvic medicine and reconstructive surgery urology practice in the setting of the food and drug administration public health notifications. Neurourol. Urodyn. 36(4):1155–1160
Clemons JL et al (2013) 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 19(4):191–198
Mathieson R, Kippern R, Brennan J (2019) Stress Urinary Incontinence in the mesh litigation era: a trend towards alternative treatments in Australia. BJU Int 123:4–28
SGS (2016) Groups reaffirm position on use of vaginal mesh for surgical treatment of stress urinary incontinence [Online]. https://www.sgsonline.org/assets/docs/Special_Reports/jointmeshstatement_final%208%2016%2016.pdf. Accessed 2 Feb 2019
Lucas MG, Berghmans LC et al. (2015) Guidelines on Urinary Incontinence, 2015 edition [Online]. http://uroweb.org/wp-content/uploads/20-Urinary-Incontinence_LR1.pdf. Accessed 2 Feb 2019
USANZ (2017) Position statement on the use of mid-urethral slings (MUS) in the surgical management of female stress urinary incontinence (SUI) [Online]. https://www.usanz.org.au/uploads/65337/ufiles/Patients__GPs/Attachment_1_USANZ_PositionPaper_MUS_-_Copy.pdf. Accessed 2 Feb 2019
Care, A.C.o.S.a.Q.i.H (2018) Treatment options for stress urinary incontinence. www.safetyandquality.gov.au. Accessed 2 Feb 2019
Lee D, Zimmern PE (2015) Management of complications of mesh surgery. Curr. Opin. Urol. 25(4):284–291
MRHA, M.a.H.P.R.A (2014) A summary of the evidence on the benefits and risks of vaginal mesh implants. 2014 [Online]. https://www.fda.gov/downloads/UCM270402.pdf
Chermansky CJ, Winters JC (2012) Complications of vaginal mesh surgery. Curr. Opin. Urol. 22(4):287–291
Weber LeBrun EE (2016) Registries as tools for clinical excellence and the development of the pelvic floor disorders registry. Obstet Gynecol Clin N Am 43(1):121–130
MP, T.H.G.H (2019) $2.3 million to improve safety of pelvic floor surgery. MEDIA RELEASE 2019. https://beta.health.gov.au/ministers. Accessed 5 May 2019
AUA. AUA Position Statement on the Use of Vaginal Mesh for the Surgical Treatment of Stress Urinary Incontinence (SUI). [Online]. https://www.auanet.org/guidelines/use-of-vaginal-mesh-for-the-surgical-treatment-of-stress-urinary-incontinence. Accessed 2 Feb 2019
Author information
Authors and Affiliations
Contributions
SE: literature review and manuscript writing/editing. JB: data contribution/analysis. RM: data collection. BN: literature review. MC: manuscript editing. CD: manuscript writing/editing.
Corresponding author
Ethics declarations
Conflict of interest
None to declare.
Research involving human participants and/or animals
Not applicable.
Informed consent
Not required.
Additional information
Publisher's Note
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
Rights and permissions
About this article
Cite this article
Elmer, S., Brennan, J., Mathieson, R. et al. Making surgery safer through adequate communication with the stakeholders: vaginal slings. World J Urol 38, 1351–1358 (2020). https://doi.org/10.1007/s00345-019-02859-8
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s00345-019-02859-8