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Current Urology Reports

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01.02.2014 | Female Urology (K Kobashi, Section Editor)

Implications of the FDA Statement on Transvaginal Placement of Mesh: The Aftermath

verfasst von: Michelle E. Koski, Eric S. Rovner

Erschienen in: Current Urology Reports | Ausgabe 2/2014

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Abstract

The release of the U.S. Food and Drug Administration (FDA) safety communication on the use of transvaginal mesh (TVM) for pelvic organ prolapse (POP) has resulted in changes in the pelvic reconstruction community. This monograph reviews the implications of the FDA statements over the last 18–24 months. Recent findings show that there have been significant developments in the areas of regulatory mandates, media and medico-legal activity, and statements from surgical societies. In summary, well-publicized communications from the FDA and major medical organizations are defining a change in the use of TVM for POP.

Drutz HP, Alarab M. Pelvic organ prolapse: demographics and future growth prospects. Int Urogynecol J Pelvic Floor Dysfunct. 2006;17 Suppl 1:S6.PubMedCrossRef

2.••

Urogynecologic Surgical Mesh: Updated on the Safety and Effectiveness of Transvaginal Placement for Pelvic Organ Prolapse. July 2011. Federal Drug Administration. Available at: http://www.fda.gov/downloads/MedicalDevices/Safety/AlertsandNotices/UCM262760.pdf. This document delineates the summary of the MAUDE database reports, the FDA literature review, and the FDA activity in detail and provides a basis for why the FDA Safety Communication was issued. Physicians should be aware of these details.

Urogynecologic Surgical Mesh Implants. The US Food and Drug Administration (FDA). 1/4/2012 http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/UroGynSurgicalMesh/default.htm.

Medical Devices—FDA’s Roles and Activities. The US Food and Drug Administation. http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/UroGynSurgicalMesh/ucm262301.htm.

Premarket notification (510k). The US Food and Drug Administration (FDA). 6/18/2009. http://www.fda.gov/medicaldevices/productsandmedicalprocedures/deviceapprovalsandclearances/510kclearances/default.htm.

6.•

Considerations about Surgical Mesh for SUI. March 2013. The US Food and Drug Administration (FDA). http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/UroGynSurgicalMesh/ucm345219.htm. This Web site helps clarify the differences between the FDA considerations of TVM for POP versus SUI.

7.•

FDA Safety Communication: UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse. The US Food and Drug Administration (FDA). July 13, 2011 http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm262435.htm. Physicians need to be aware of the details of the FDA Safety Communication, with special attention to how it pertains to patient selection and counseling.

2011 Meeting Materials of the Obstetrics and Gynecology Devices Panel. FDA. 10/7/2011 http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/ObstetricsandGynecologyDevices/ucm262488.htm.

24-hr Summary—OB/GYN Devices Panel. September 8–9, 2011. The US Food and Drug Administration. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/ObstetricsandGynecologyDevices/UCM271769.pdf.

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Chamberlain J, Rosoff J, Kaufman MR, et al. The media and patient perception of transvaginal mesh. Abstract presented at American Urologic Association, San Diego May 2013

12.

Brown L, Fenner DE, Berger MB, et al. Defining patient knowledge and perceptions of vaginal mesh surgery. Oral Poster presented at SGS 2013, Charleston SC, April 8–10 2013.

13.

Google Search, search term “Transvaginal Mesh,” May 2, 2013

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Feeley J. Bard, Doctor ordered to pay $5.5 million over implant. July 25 2012. http://www.bloomberg.com/news/2012-07-24/bard-must-pay-5-5-million-over-vaginal-mesh-implants.html.

15.

Moylan T. Jury Awards $7.76 Million in Punitive Damages in New Jersey’s 1st Pelvic Mesh Trial. Lexis Nexis Communities. February 28, 2013. http://www.lexisnexis.com/community/litigationresourcecenter/blogs/litigationblog/archive/2013/02/28/jury-awards-7-76-million-in-punitive-damages-in-new-jersey-s-1st-pelvic-mesh-trial.aspx.

16.

Mucowski SJ, Jurnalov C, et al. Use of vaginal mesh in the face of recent FDA warnings and litigation. Am J Obstet Gynecol. 2010;203:103.PubMedCrossRef

17.

American Urologic Association (AUA) position statement on the use of vaginal mesh for repair of pelvic organ prolapse. 2012. http://www.auanet.org/content/aua-policies/position-statements/pelvic-organ-prolapse.cfm.

18.

American Urologic Association (AUA) position statement on the use of vaginal mesh for the surgical treatment of stress urinary incontinence. 2012 http://www.auanet.org/content/aua-policies/position-statements/stress-urinary-incontinence.cfm.

19.••

Society for Female Urology and Urodynamics (SUFU) Response: FDA Safety Communication: UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse (July 2011). http://www.sufuorg.com/pdf/SUFU%20FDA%20response%207%2018%2011.pdf. This document outlines the current stance of leadership in female urology on the use of TVM and the FDA Safety Communication.

20.

The American Urogynecologic Society (AUGS) response: FDA Safety Communication, 2011 http://www.augs.org/p/cm/ld/fid=163.

21.

The American College of Obstetricians and Gynecologists (ACOG). Committee Opinion. Vaginal Placement of Synthetic Mesh for Pelvic Organ Prolapse. 2011 http://www.acog.org/Resources_And_Publications/Committee_Opinions/Committee_on_Gynecologic_Practice/Vaginal_Placement_of_Synthetic_Mesh_for_Pelvic_Organ_Prolapse.

22.

The Society of Gynecologic Surgeons (SGS) Executive Committee Statement Regarding the FDA Communication: surgical placement of mesh to repair pelvic organ prolapse imposes risks. http://www.sgsonline.org/sgsinc/sgsmeetings/pdf/SGS_Statement.pdf.

23.

Shveiky D, Hants Y. Biomaterials in obstetrics and gynecology. P161. In: Biomaterials science: an integrated clincial and engineering approach. Boca Raton: CRC Press; 2012.

24.

Davila GW, Baessler K, Cosson M, et al. Selection of patients in whom vaginal graft use may be appropriate. 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):7.CrossRef

25.

Miller D, Milani AL, Sutherland SE, et al. 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.CrossRef

26.

Winters JC, Jacquetin B, Castro R. Credentialing for transvaginal mesh placement—a case for “added qualification” in competency. 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):27.CrossRef

27.

Visco AG. AUGS releases guidelines of privileging and credentialling physicians for sacrocolpopexy for POP. http://www.augs.org/p/bl/et/blogid=6&blogaid=156.

28.

American Urogynecologic Association. Guidelines and Statements. http://www.augs.org/p/cm/ld/fid=202.

29.

Koski ME, Rovner ES. The use of mesh for pelvic organ prolapse and stress urinary incontinence. AUA Update Series, Lesson 19. June 2013.

30.•

Keys T, Campeau L, Badlani G. Synthetic mesh in the surgical repair of pelvic organ prolapse: current status and future directions. Urology. 2012;80:237. This article provides an overview of the basis of use of TVM and future directions.PubMedCrossRef

31.

Lee U, Wolff EM, Kobashi KC. Native tissue repairs in anterior vaginal prolapse surgery: examining definitions of surgical success in the mesh era. Curr Opin Urol. 2012;22:265.PubMedCrossRef

Titel: Implications of the FDA Statement on Transvaginal Placement of Mesh: The Aftermath
verfasst von: Michelle E. Koski
Eric S. Rovner
Publikationsdatum: 01.02.2014
Verlag: Springer US
Erschienen in: Current Urology Reports / Ausgabe 2/2014
Print ISSN: 1527-2737
Elektronische ISSN: 1534-6285
DOI: https://doi.org/10.1007/s11934-013-0380-3

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