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Erschienen in: World Journal of Urology 6/2020

04.07.2019 | Topic Paper

Making surgery safer through adequate communication with the stakeholders: vaginal slings

verfasst von: Sandra Elmer, Janelle Brennan, Rebecca Mathieson, Briony Norris, Marcus Carey, Caroline Dowling

Erschienen in: World Journal of Urology | Ausgabe 6/2020

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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.
Literatur
1.
Zurück zum Zitat 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):2271–2272PubMedCrossRef 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):2271–2272PubMedCrossRef
2.
Zurück zum Zitat 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. 153:1–93PubMed 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. 153:1–93PubMed
3.
Zurück zum Zitat Ford AA et al (2017) Mid-urethral sling operations for stress urinary incontinence in women. Cochrane Database Syst. Rev. 7:Cd006375PubMed Ford AA et al (2017) Mid-urethral sling operations for stress urinary incontinence in women. Cochrane Database Syst. Rev. 7:Cd006375PubMed
4.
Zurück zum Zitat 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. 168:34–37PubMed 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. 168:34–37PubMed
5.
Zurück zum Zitat 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):440–448CrossRef 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):440–448CrossRef
6.
Zurück zum Zitat 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):12015PubMedPubMedCentralCrossRef 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):12015PubMedPubMedCentralCrossRef
7.
Zurück zum Zitat Lavelle ES, Zyczynski HM (2016) Stress urinary incontinence: comparative efficacy trials. Obstet Gynecol Clin N Am 43(1):45–57CrossRef Lavelle ES, Zyczynski HM (2016) Stress urinary incontinence: comparative efficacy trials. Obstet Gynecol Clin N Am 43(1):45–57CrossRef
8.
Zurück zum Zitat Deng DY et al (2007) Presentation and management of major complications of midurethral slings: are complications under-reported? Neurourol. Urodyn. 26(1):46–52PubMedCrossRef Deng DY et al (2007) Presentation and management of major complications of midurethral slings: are complications under-reported? Neurourol. Urodyn. 26(1):46–52PubMedCrossRef
9.
Zurück zum Zitat Barber MD, Maher C (2013) Epidemiology and outcome assessment of pelvic organ prolapse. Int. Urogynecol. J. 24(11):1783–1790PubMedCrossRef Barber MD, Maher C (2013) Epidemiology and outcome assessment of pelvic organ prolapse. Int. Urogynecol. J. 24(11):1783–1790PubMedCrossRef
10.
Zurück zum Zitat Larouche M, Geoffrion R, Walter JE (2017) No. 351-transvaginal mesh procedures for pelvic organ prolapse. J Obstet Gynaecol Can 39(11):1085–1097PubMedCrossRef Larouche M, Geoffrion R, Walter JE (2017) No. 351-transvaginal mesh procedures for pelvic organ prolapse. J Obstet Gynaecol Can 39(11):1085–1097PubMedCrossRef
11.
Zurück zum Zitat 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):421–428PubMedCrossRef 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):421–428PubMedCrossRef
12.
Zurück zum Zitat Altman D et al (2011) Anterior colporrhaphy versus transvaginal mesh for pelvic-organ prolapse. N. Engl. J. Med. 364(19):1826–1836PubMedCrossRef Altman D et al (2011) Anterior colporrhaphy versus transvaginal mesh for pelvic-organ prolapse. N. Engl. J. Med. 364(19):1826–1836PubMedCrossRef
13.
Zurück zum Zitat 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):527–535PubMedCrossRef 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):527–535PubMedCrossRef
14.
Zurück zum Zitat Maher C et al (2016) Surgery for women with anterior compartment prolapse. Cochrane Database Syst. Rev. 11:Cd004014PubMed Maher C et al (2016) Surgery for women with anterior compartment prolapse. Cochrane Database Syst. Rev. 11:Cd004014PubMed
15.
Zurück zum Zitat Bjelic-Radisic V et al (2014) Vaginal prolapse surgery with transvaginal mesh: results of the Austrian registry. Int. Urogynecol. J. 25(8):1047–1052PubMedCrossRef Bjelic-Radisic V et al (2014) Vaginal prolapse surgery with transvaginal mesh: results of the Austrian registry. Int. Urogynecol. J. 25(8):1047–1052PubMedCrossRef
16.
Zurück zum Zitat Withagen MI et al (2011) Risk factors for exposure, pain, and dyspareunia after tension-free vaginal mesh procedure. Obstet. Gynecol. 118(3):629–636PubMedCrossRef Withagen MI et al (2011) Risk factors for exposure, pain, and dyspareunia after tension-free vaginal mesh procedure. Obstet. Gynecol. 118(3):629–636PubMedCrossRef
17.
Zurück zum Zitat 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):e017125PubMedPubMedCentralCrossRef 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):e017125PubMedPubMedCentralCrossRef
20.
Zurück zum Zitat Bako A, Dhar R (2009) Review of synthetic mesh-related complications in pelvic floor reconstructive surgery. Int Urogynecol J Pelvic Floor Dysfunct 20(1):103–111PubMedCrossRef Bako A, Dhar R (2009) Review of synthetic mesh-related complications in pelvic floor reconstructive surgery. Int Urogynecol J Pelvic Floor Dysfunct 20(1):103–111PubMedCrossRef
28.
Zurück zum Zitat Koski ME, Rovner ES (2014) Implications of the FDA statement on transvaginal placement of mesh: the aftermath. Curr Urol Rep 15(2):380PubMedCrossRef Koski ME, Rovner ES (2014) Implications of the FDA statement on transvaginal placement of mesh: the aftermath. Curr Urol Rep 15(2):380PubMedCrossRef
30.
Zurück zum Zitat Souders CP et al (2018) The truth behind transvaginal mesh litigation: devices, timelines, and provider characteristics. Female Pelvic Med Reconstr Surg 24(1):21–25PubMedCrossRef Souders CP et al (2018) The truth behind transvaginal mesh litigation: devices, timelines, and provider characteristics. Female Pelvic Med Reconstr Surg 24(1):21–25PubMedCrossRef
31.
Zurück zum Zitat Rogo-Gupta L et al (2013) Trends in the surgical management of stress urinary incontinence among female Medicare beneficiaries, 2002–2007. Urology 82(1):38–41PubMedPubMedCentralCrossRef Rogo-Gupta L et al (2013) Trends in the surgical management of stress urinary incontinence among female Medicare beneficiaries, 2002–2007. Urology 82(1):38–41PubMedPubMedCentralCrossRef
32.
Zurück zum Zitat Wang LC et al (2015) Trends in mesh use for pelvic organ prolapse repair from the Medicare database. Urology 86(5):885–891PubMedCrossRef Wang LC et al (2015) Trends in mesh use for pelvic organ prolapse repair from the Medicare database. Urology 86(5):885–891PubMedCrossRef
34.
35.
Zurück zum Zitat 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):424–431PubMedCrossRef 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):424–431PubMedCrossRef
36.
Zurück zum Zitat Koski ME et al (2014) Patient perception of transvaginal mesh and the media. Urology 84(3):575–582PubMedCrossRef Koski ME et al (2014) Patient perception of transvaginal mesh and the media. Urology 84(3):575–582PubMedCrossRef
37.
Zurück zum Zitat Tenggardjaja CF et al (2015) Evaluation of patients’ perceptions of mesh usage in female pelvic medicine and reconstructive surgery. Urology 85(2):326–331PubMedCrossRef Tenggardjaja CF et al (2015) Evaluation of patients’ perceptions of mesh usage in female pelvic medicine and reconstructive surgery. Urology 85(2):326–331PubMedCrossRef
38.
Zurück zum Zitat Cobb WS, Kercher KW, Heniford BT (2005) The argument for lightweight polypropylene mesh in hernia repair. Surg Innov 12(1):63–69PubMedCrossRef Cobb WS, Kercher KW, Heniford BT (2005) The argument for lightweight polypropylene mesh in hernia repair. Surg Innov 12(1):63–69PubMedCrossRef
41.
Zurück zum Zitat 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):1155–1160PubMedCrossRef 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):1155–1160PubMedCrossRef
42.
Zurück zum Zitat 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):191–198PubMedCrossRef 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):191–198PubMedCrossRef
43.
Zurück zum Zitat 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 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
48.
Zurück zum Zitat Lee D, Zimmern PE (2015) Management of complications of mesh surgery. Curr. Opin. Urol. 25(4):284–291PubMed Lee D, Zimmern PE (2015) Management of complications of mesh surgery. Curr. Opin. Urol. 25(4):284–291PubMed
50.
Zurück zum Zitat Chermansky CJ, Winters JC (2012) Complications of vaginal mesh surgery. Curr. Opin. Urol. 22(4):287–291PubMedCrossRef Chermansky CJ, Winters JC (2012) Complications of vaginal mesh surgery. Curr. Opin. Urol. 22(4):287–291PubMedCrossRef
51.
Zurück zum Zitat 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):121–130CrossRef 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):121–130CrossRef
Metadaten
Titel
Making surgery safer through adequate communication with the stakeholders: vaginal slings
verfasst von
Sandra Elmer
Janelle Brennan
Rebecca Mathieson
Briony Norris
Marcus Carey
Caroline Dowling
Publikationsdatum
04.07.2019
Verlag
Springer Berlin Heidelberg
Erschienen in
World Journal of Urology / Ausgabe 6/2020
Print ISSN: 0724-4983
Elektronische ISSN: 1433-8726
DOI
https://doi.org/10.1007/s00345-019-02859-8

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