Skip to main content
Erschienen in: Current Bladder Dysfunction Reports 1/2016

01.03.2016 | Stress Incontinence and Prolapse (R Dmochowski, Section Editor)

Lessons Learned from Mesh Litigation for Prolapse and Incontinence

verfasst von: Elizabeth Timbrook Brown, Joshua A. Cohn, Melissa R. Kaufman, W. Stuart Reynolds, Roger R. Dmochowski

Erschienen in: Current Bladder Dysfunction Reports | Ausgabe 1/2016

Einloggen, um Zugang zu erhalten

Abstract

Pelvic organ prolapse (POP) and stress urinary incontinence (SUI) can cause significant impairment in quality of life and lead many women to seek surgical correction. These procedures are often performed using polypropylene mesh. The Food and Drug Administration (FDA) issued a Public Health Notification to inform patients of adverse events related to the use of mesh placed in these repairs. Since this time, there have been almost 50,000 legal proceedings related to complications of polypropylene mesh in the urogynecology setting. Currently, the FDA is conducting further studies to evaluate the safety and efficacy of polypropylene mesh, but it is still available for use in the repair of SUI and POP. Thus, patients should be carefully selected and counseled appropriately regarding conservative management options and alternative surgical therapies prior to mesh placement. As a result of the FDA recommendations, researchers are currently trying to develop a treatment alternative to mesh.
Literatur
1.
Zurück zum Zitat Togami J, Brown E, Winters JC. Vaginal mesh-the controversy. F1000 Med Rep. 2012;2:21. Togami J, Brown E, Winters JC. Vaginal mesh-the controversy. F1000 Med Rep. 2012;2:21.
2.
Zurück zum Zitat Mock S, Angelle J, Reynolds WS, et al. Contemporary comparison between retropubic midurethral sling and autologous pubovaginal sling for stress urinary incontinence after the FDA advisory notification. Urology. 2015;85:321–25.CrossRefPubMed Mock S, Angelle J, Reynolds WS, et al. Contemporary comparison between retropubic midurethral sling and autologous pubovaginal sling for stress urinary incontinence after the FDA advisory notification. Urology. 2015;85:321–25.CrossRefPubMed
3.
Zurück zum Zitat Sivaslioglu A, Unlubilgin E, Dolen I. A randomized comparison of polypropylene mesh surgery with site specific surgery in the treatment of cystocele. Int Urogynecol J. 2008;19:467–71.CrossRef Sivaslioglu A, Unlubilgin E, Dolen I. A randomized comparison of polypropylene mesh surgery with site specific surgery in the treatment of cystocele. Int Urogynecol J. 2008;19:467–71.CrossRef
5.
Zurück zum Zitat Kuhlmann-Capek M, Kilic G, Shah A, et al. Enmeshed in controversy: use of vaginal mesh in the current medicolegal environment. Female Pelv Med Reconstr Surg. 2015;21(5):241–3.CrossRef Kuhlmann-Capek M, Kilic G, Shah A, et al. Enmeshed in controversy: use of vaginal mesh in the current medicolegal environment. Female Pelv Med Reconstr Surg. 2015;21(5):241–3.CrossRef
6.
Zurück zum Zitat Drutz HP, Alarab M. Pelvic organ prolapse: demographics and future growth prospects. Int Urogynecol J Pelvic Floor Dysfunct. 2006;17 Suppl 1:S6.CrossRefPubMed Drutz HP, Alarab M. Pelvic organ prolapse: demographics and future growth prospects. Int Urogynecol J Pelvic Floor Dysfunct. 2006;17 Suppl 1:S6.CrossRefPubMed
7.
Zurück zum Zitat Koski M, Rovner E. Implications of the FDA statement on transvaginal placement of mesh: the aftermath. Curr Urol Rep. 2014;15:380.CrossRefPubMed Koski M, Rovner E. Implications of the FDA statement on transvaginal placement of mesh: the aftermath. Curr Urol Rep. 2014;15:380.CrossRefPubMed
10.
Zurück zum Zitat Chapple C, Raz S, Brubaker L, et al. Mesh sling in an era of uncertainty: lessons learned and the way forward. Eur Urol. 2013;64:525–29.CrossRefPubMed Chapple C, Raz S, Brubaker L, et al. Mesh sling in an era of uncertainty: lessons learned and the way forward. Eur Urol. 2013;64:525–29.CrossRefPubMed
17.
Zurück zum Zitat Koski M, Chamberlain J, Rossof J, et al. Patient perception of transvaginal mesh and the media. Urology. 2014;84:575–82.CrossRefPubMed Koski M, Chamberlain J, Rossof J, et al. Patient perception of transvaginal mesh and the media. Urology. 2014;84:575–82.CrossRefPubMed
18.
Zurück zum Zitat Brown LK, Fenner DE, Berger MB, et al. Defining patients’ knowledge and perceptions of vaginal mesh surgery. Female Pelvic Med Reconstr Surg. 2013;19(5):282–7.CrossRefPubMedPubMedCentral Brown LK, Fenner DE, Berger MB, et al. Defining patients’ knowledge and perceptions of vaginal mesh surgery. Female Pelvic Med Reconstr Surg. 2013;19(5):282–7.CrossRefPubMedPubMedCentral
19.
Zurück zum Zitat GoogleTM search term “transvaginal mesh” performed September 26, 2015. GoogleTM search term “transvaginal mesh” performed September 26, 2015.
20.
Zurück zum Zitat Sadiq A, Mitchell S, Rosenblum N, et al. YouTube as a source for vaginal mesh information. J Urol. 2014;191(4S):e783.CrossRef Sadiq A, Mitchell S, Rosenblum N, et al. YouTube as a source for vaginal mesh information. J Urol. 2014;191(4S):e783.CrossRef
21.
Zurück zum Zitat Tenggardjaja C, Moore C, Vasavada S, et al. Evaluation of patients’ perceptions of mesh usage in female pelvic medicine and reconstructive surgery. Urology. 2015;85:326–32.CrossRefPubMed Tenggardjaja C, Moore C, Vasavada S, et al. Evaluation of patients’ perceptions of mesh usage in female pelvic medicine and reconstructive surgery. Urology. 2015;85:326–32.CrossRefPubMed
22.
Zurück zum Zitat Yanagisawa M, Rhodes M, Zimmern P. Mesh social networking: a patient-driven process. BJUI. 2011;108:1539–43.CrossRef Yanagisawa M, Rhodes M, Zimmern P. Mesh social networking: a patient-driven process. BJUI. 2011;108:1539–43.CrossRef
24.
Zurück zum Zitat Scott v. Kannappan, S-1500-CV-266034-WDE, Superior Court for Kern County, California. Scott v. Kannappan, S-1500-CV-266034-WDE, Superior Court for Kern County, California.
25.
Zurück zum Zitat Nosti P, Iglesia C. Medicolegal issues surrounding devices and mesh for surgical treatment of prolapse and incontinence. Clin Obset Gyn. 2013;56(20):221–28.CrossRef Nosti P, Iglesia C. Medicolegal issues surrounding devices and mesh for surgical treatment of prolapse and incontinence. Clin Obset Gyn. 2013;56(20):221–28.CrossRef
28.•
Zurück zum Zitat American Urologic Association (AUA) position statement on the use of vaginal mesh for the surgical treatment of stress urinary incontinence. 2012[www.auanet.org/education/vaginal-mesh-for-sui.cfm]. This is the AUA position statement continuing to support the use of multi-incision mesh slings stating that there is good evidence for their use. American Urologic Association (AUA) position statement on the use of vaginal mesh for the surgical treatment of stress urinary incontinence. 2012[www.​auanet.​org/​education/​vaginal-mesh-for-sui.​cfm]. This is the AUA position statement continuing to support the use of multi-incision mesh slings stating that there is good evidence for their use.
29.•
Zurück zum Zitat Miller D, Milani AL, Sutherland SE. Informed surgical consent for a mesh/graft-augmented vaginal repair of pelvic organ prolapse. Consensus of the 2nd IUGA grafts roundtable: optimizing safety and appropriateness of graft use in transvaginal pelvic reconstructive surgery. Int Urogynecol J. 2012;23(supp 1):33. This outlines the IUGA consensus regarding informed consent and implantation practices.CrossRef Miller D, Milani AL, Sutherland SE. Informed surgical consent for a mesh/graft-augmented vaginal repair of pelvic organ prolapse. Consensus of the 2nd IUGA grafts roundtable: optimizing safety and appropriateness of graft use in transvaginal pelvic reconstructive surgery. Int Urogynecol J. 2012;23(supp 1):33. This outlines the IUGA consensus regarding informed consent and implantation practices.CrossRef
30.
Zurück zum Zitat Clemons JL, Weinstein M, Guess MK, 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):191–8.CrossRefPubMed Clemons JL, Weinstein M, Guess MK, 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):191–8.CrossRefPubMed
31.
Zurück zum Zitat American College of Obstetricians and Gynecologists. Committee opinion no. 513: vaginal placement of synthetic mesh for pelvic organ prolapse,”. Obstet Gynecol. 2011;118(6):1459–64.CrossRef American College of Obstetricians and Gynecologists. Committee opinion no. 513: vaginal placement of synthetic mesh for pelvic organ prolapse,”. Obstet Gynecol. 2011;118(6):1459–64.CrossRef
32.
Zurück zum Zitat Menefee SA, Dyer KY, Lukacz ES. Colporrhaphy compared with mesh or graft-reinforced vaginal paravaginal repair for anterior vaginal wall prolapsed: a randomized controlled trial. Obstet Gynecol. 2011;118:1337–44.CrossRefPubMed Menefee SA, Dyer KY, Lukacz ES. Colporrhaphy compared with mesh or graft-reinforced vaginal paravaginal repair for anterior vaginal wall prolapsed: a randomized controlled trial. Obstet Gynecol. 2011;118:1337–44.CrossRefPubMed
33.
Zurück zum Zitat Maher C, Feiner B, Bassler K, et al. Surgical management of pelvic organ prolapse in women: the updated Cochrane summary review. Int Urogynecol J. 2011;22:1455–57. Maher C, Feiner B, Bassler K, et al. Surgical management of pelvic organ prolapse in women: the updated Cochrane summary review. Int Urogynecol J. 2011;22:1455–57.
34.
Zurück zum Zitat Murphy M, Hozberg A, van Raalte H, et al. Time to rethink: an evidence-based response from pelvic surgeons to the FDA Safety Communication: “UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse”. Int Urogynecol J. 2012;23:5–9.CrossRefPubMed Murphy M, Hozberg A, van Raalte H, et al. Time to rethink: an evidence-based response from pelvic surgeons to the FDA Safety Communication: “UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse”. Int Urogynecol J. 2012;23:5–9.CrossRefPubMed
Metadaten
Titel
Lessons Learned from Mesh Litigation for Prolapse and Incontinence
verfasst von
Elizabeth Timbrook Brown
Joshua A. Cohn
Melissa R. Kaufman
W. Stuart Reynolds
Roger R. Dmochowski
Publikationsdatum
01.03.2016
Verlag
Springer US
Erschienen in
Current Bladder Dysfunction Reports / Ausgabe 1/2016
Print ISSN: 1931-7212
Elektronische ISSN: 1931-7220
DOI
https://doi.org/10.1007/s11884-016-0353-8

Weitere Artikel der Ausgabe 1/2016

Current Bladder Dysfunction Reports 1/2016 Zur Ausgabe

Overactive Bladder (U Lee, Section Editor)

Impact of Caffeine on Overactive Bladder Symptoms

Overactive Bladder (U Lee, Section Editor)

The Role of Mindfulness in Urinary Urgency Symptoms

Stress Incontinence and Prolapse (R Dmochowski, Section Editor)

Urinary Tract Infections in Women: Pathogenesis, Diagnosis, and Management

Stress Incontinence and Prolapse (R Dmochowski, Section Editor)

Bladder Outlet Obstruction After Incontinence Surgery

Viel pflanzliche Nahrung, seltener Prostata-Ca.-Progression

12.05.2024 Prostatakarzinom Nachrichten

Ein hoher Anteil pflanzlicher Nahrung trägt möglicherweise dazu bei, das Progressionsrisiko von Männern mit Prostatakarzinomen zu senken. In einer US-Studie war das Risiko bei ausgeprägter pflanzlicher Ernährung in etwa halbiert.

Darf man die Behandlung eines Neonazis ablehnen?

08.05.2024 Gesellschaft Nachrichten

In einer Leseranfrage in der Zeitschrift Journal of the American Academy of Dermatology möchte ein anonymer Dermatologe bzw. eine anonyme Dermatologin wissen, ob er oder sie einen Patienten behandeln muss, der eine rassistische Tätowierung trägt.

Hypertherme Chemotherapie bietet Chance auf Blasenerhalt

07.05.2024 Harnblasenkarzinom Nachrichten

Eine hypertherme intravesikale Chemotherapie mit Mitomycin kann für Patienten mit hochriskantem nicht muskelinvasivem Blasenkrebs eine Alternative zur radikalen Zystektomie darstellen. Kölner Urologen berichten über ihre Erfahrungen.

Ein Drittel der jungen Ärztinnen und Ärzte erwägt abzuwandern

07.05.2024 Klinik aktuell Nachrichten

Extreme Arbeitsverdichtung und kaum Supervision: Dr. Andrea Martini, Sprecherin des Bündnisses Junge Ärztinnen und Ärzte (BJÄ) über den Frust des ärztlichen Nachwuchses und die Vorteile des Rucksack-Modells.

Update Urologie

Bestellen Sie unseren Fach-Newsletter und bleiben Sie gut informiert.