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FDA.gov

Collected by: U.S Food and Drug Administration

Archived since: Oct, 2016

Description:

Snapshot of the www.FDA.gov website

Subject:   Science & Health Government - US Federal

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Page 1 of 8 (155 Total Results)Next Page ►

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FDA strengthens requirements for surgical mesh for the transvaginal repair of pelvic organ prolapse to address safety risks

URL: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm479732.htm

This text was captured  on Feb 08, 2019   Show All Captures

To warn doctors and patients about the use of surgical mesh for transvaginal POP repair, the FDA has: Issued safety communications in 2008 and in 2011 warning doctors and consumers about an increase in

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UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse: FDA Safety Communication

URL: https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm262435.htm

This text was captured  on Apr 06, 2017   Show All Captures

surgical mesh to repair pelvic organ prolapse and/or stress urinary incontinence Health care providers involved in the care of patients with surgical mesh implanted to repair pelvic organ prolapse and/

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FDA strengthens requirements for surgical mesh for the transvaginal repair of pelvic organ prolapse to address safety risks

URL: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm479732.htm

This text was captured  on Jan 11, 2017   Show All Captures

To warn doctors and patients about the use of surgical mesh for transvaginal POP repair, the FDA has: Issued safety communications in 2008 and in 2011 warning doctors and consumers about an increase in

Content: application/xhtml+xml Size: 44 KB

FDA’s Role and Activities

URL: https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/UroGynSurgicalMesh/ucm262301.htm

This text was captured  on Jan 25, 2018   Show All Captures

The FDA previously communicated about serious complications associated with transvaginal placement of surgical mesh to treat pelvic organ prolapse (POP) and SUI in the October 20, 2008 FDA Public Health

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FDA’s Role and Activities

URL: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/UroGynSurgicalMesh/ucm262301.htm

This text was captured  on Jan 11, 2017   Show All Captures

The FDA previously communicated about serious complications associated with transvaginal placement of surgical mesh to treat pelvic organ prolapse (POP) and SUI in the October 20, 2008 FDA Public Health

Content: application/xhtml+xml Size: 43 KB

FDA's Activities: Urogynecologic Surgical Mesh | FDA

URL: https://www.fda.gov/medical-devices/urogynecologic-surgical-mesh-implants/fdas-activities-urogynecologic-surgical-mesh

This text was captured  on Dec 25, 2020   Show All Captures

The FDA previously communicated about serious complications associated with transvaginal placement of surgical mesh to treat pelvic organ prolapse (POP) and SUI in the October 20, 2008 FDA Public Health

Content: text/html Size: 44 KB

FDA: Surgical placement of mesh to repair pelvic organ prolapse poses risks

URL: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm262752.htm

This text was captured  on Jan 11, 2017   Show All Captures

The FDA issued a safety communication in 2008 due to increasing concerns about adverse events associated with the transvaginal placement of mesh .

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Transvaginal Placement of Surgical Mesh

URL: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm079028.htm

This text was captured  on Jan 12, 2017   Show All Captures

[Posted 10/21/2008 ] FDA informed healthcare professionals of serious complications associated with transvaginal placement of surgical mesh in repair of pelvic organ prolapse (POP) and stress urinary incontinence

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OWH-Funded Research: Device Safety

URL: https://www.fda.gov/ScienceResearch/SpecialTopics/WomensHealthResearch/ucm522672.htm

This text was captured  on Apr 06, 2017   Show All Captures

implantation in surgical interventions for the treatment of pelvic floor disorders, Phase III – Cara Krulewitch, CNM, PhD, CDRH (11) Evaluation of Safety and Effectiveness of Mesh Implantation in Surgical

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OWH-Funded Research: Medical Device Safety | FDA

URL: https://www.fda.gov/science-research/womens-health-research/owh-funded-research-medical-device-safety

This text was captured  on Dec 12, 2019   Show All Captures

implantation in surgical interventions for the treatment of pelvic floor disorders, Phase III – Cara Krulewitch, CNM, PhD, CDRH (11) Evaluation of Safety and Effectiveness of Mesh Implantation in Surgical

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OWH-Funded Research: Medical Device Safety | FDA

URL: https://www.fda.gov/node/371329

This text was captured  on Dec 12, 2019   Show All Captures

implantation in surgical interventions for the treatment of pelvic floor disorders, Phase III – Cara Krulewitch, CNM, PhD, CDRH (11) Evaluation of Safety and Effectiveness of Mesh Implantation in Surgical

Content: text/html Size: 56 KB

https://www.fda.gov/media/81123/download

URL: https://www.fda.gov/media/81123/download

This text was captured  on Dec 27, 2020   Show All Captures

Graft use in transvaginal pelvic organ prolapse and urinary incontinence. Obstet Gynecol. 2008 ; 112(5): 1131-1142. 25.

Content: application/pdf Size: 252 KB

https://www.fda.gov/downloads/MedicalDevices/Safety/AlertsandNotices/UCM262760.pdf

URL: https://www.fda.gov/downloads/MedicalDevices/Safety/AlertsandNotices/UCM262760.pdf

This text was captured  on Apr 24, 2018   Show All Captures

Graft use in transvaginal pelvic organ prolapse and urinary incontinence. Obstet Gynecol. 2008 ; 112(5): 1131-1142. 25.

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References

URL: https://www.fda.gov/media/122855/download

This text was captured  on Dec 13, 2019   Show All Captures

Dolen, A randomized comparison of polypropylene mesh surgery with site-specific surgery in the treatment of cystocoele. Int Urogynecol J Pelvic Floor Dysfunct, 2008 . 19(4): p. 467-71. 78.

Content: application/pdf Size: 209 KB

References

URL: https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/ObstetricsandGynecologyDevices/UCM630950.pdf

This text was captured  on Feb 13, 2019   Show All Captures

Dolen, A randomized comparison of polypropylene mesh surgery with site-specific surgery in the treatment of cystocoele. Int Urogynecol J Pelvic Floor Dysfunct, 2008 . 19(4): p. 467-71. 78.

Content: application/pdf Size: 209 KB

https://www.fda.gov/media/122871/download

URL: https://www.fda.gov/media/122871/download

This text was captured  on Dec 13, 2019   Show All Captures

Am J Obstet Gynecol. 2008 Dec;199(6):688.e1-5. Epub 2008 Oct 31. 4. Brubaker L, et al.Am J Obstet Gynecol. 2014 Nov;211(5):554.e1-7.

Content: application/pdf Size: 139 KB

https://www.fda.gov/media/122854/download

URL: https://www.fda.gov/media/122854/download

This text was captured  on Dec 13, 2019   Show All Captures

B. 2008 MAUDE Database Search and Public Health Notification From 2005 – 2008 , the FDA reviewed information regarding the safety of urogynecologic surgical mesh used to repair any type of POP or SUI.

Content: application/pdf Size: 911 KB

FDA issues proposals to address risks associated with surgical mesh for transvaginal repair of pelvic organ prolapse

URL: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm395192.htm

This text was captured  on Jan 12, 2017   Show All Captures

The FDA previously communicated about serious complications associated with transvaginal placement of surgical mesh to treat POP and stress urinary incontinence (SUI) in an Oct. 2008 FDA Public Health

Content: application/xhtml+xml Size: 37 KB

Page 1 of 8 (155 Total Results)Next Page ►