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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 12 (234 Total Results)Next Page ►

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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

RECOMMENDATION: It is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk.

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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

concerns related to surgical mesh used for transvaginal repair of POP.

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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

Mesh placed abdominally for POP repair may result in lower rates of mesh complications compared to transvaginal POP surgery with mesh .

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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

URL: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm636114.htm

This text was captured  on Apr 22, 2019   Show All Captures

However, the percentage of women undergoing transvaginal POP mesh procedures has decreased in recent years after the FDA began issuing warnings about the risks associated with using transvaginal mesh used

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FDA's Activities: Urogynecologic Surgical Mesh

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

This text was captured  on Apr 23, 2019   Show All Captures

Mesh for Transvaginal Pelvic Organ Prolapse Repair 513(e) Proposed Order for Reclassification of Surgical Mesh for Transvaginal POP Repair and Surgical Instrumentation for Urogynecologic Surgical Mesh

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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

to mini-sling devices for SUI and surgical mesh used for transvaginal repair of POP.

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Urogynecologic Surgical Mesh Implants

URL: https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/UroGynSurgicalMesh/ucm2025152.htm

This text was captured  on Feb 07, 2019   Show All Captures

requirements for surgical mesh for the transvaginal repair of pelvic organ prolapse to address safety risks Final Order for Reclassification of Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair

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Urogynecologic Surgical Mesh Implants

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

This text was captured  on Feb 07, 2019   Show All Captures

requirements for surgical mesh for the transvaginal repair of pelvic organ prolapse to address safety risks Final Order for Reclassification of Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair

Content: application/xhtml+xml Size: 44 KB

Urogynecologic Surgical Mesh Implants

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

This text was captured  on Feb 07, 2019   Show All Captures

requirements for surgical mesh for the transvaginal repair of pelvic organ prolapse to address safety risks Final Order for Reclassification of Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair

Content: application/xhtml+xml Size: 44 KB

Urogynecologic Surgical Mesh Implants

URL: https://www.fda.gov/medicaldevices/productsandmedicalprocedures/implantsandprosthetics/urogynsurgicalmesh/

This text was captured  on Apr 23, 2019   Show All Captures

There are three main surgical procedures performed with surgical mesh to treat pelvic floor disorders with surgical mesh : Transvaginal mesh to treat POP * Transabdominal mesh to treat POP Mesh sling to

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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

compared to transvaginal POP surgery with mesh ; and • Be sure that patients are aware of the risks and benefits of transvaginal POP repair with mesh , and inform patients if mesh is being used.

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Concerns about Surgical Mesh for POP

URL: https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/UroGynSurgicalMesh/ucm345201.htm

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

was issued to inform the medical community and patients that: serious complications associated with surgical mesh for transvaginal repair of POP are not rare ; and it is not clear that transvaginal POP

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Urogynecologic Surgical Mesh Implants | FDA

URL: https://www.fda.gov/medical-devices/implants-and-prosthetics/urogynecologic-surgical-mesh-implants

This text was captured  on Sep 29, 2019   Show All Captures

There are three main surgical procedures performed with surgical mesh to treat pelvic floor disorders with surgical mesh : Transvaginal mesh to treat POP * Transabdominal mesh to treat POP Mesh sling to

Content: text/html Size: 43 KB

Urogynecologic Surgical Mesh Implants | FDA

URL: https://www.fda.gov/node/361082

This text was captured  on Dec 16, 2019   Show All Captures

There are three main surgical procedures performed with surgical mesh to treat pelvic floor disorders with surgical mesh : Transvaginal mesh to treat POP * Transabdominal mesh to treat POP Mesh sling to

Content: text/html Size: 41 KB

Information for Health Care Providers for POP

URL: https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/UroGynSurgicalMesh/ucm345204.htm

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

Requirement for Premarket Approval for Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair Federal Register: Reclassification of Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair More

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Information for Health Care Providers for SUI

URL: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/UroGynSurgicalMesh/ucm345221.htm

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

The patient should understand: the likely success of transvaginal SUI surgery with mesh compared to non-surgical treatment options and non-mesh surgery based on the individual patient factors. the potential

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Information for Health Care Providers for SUI

URL: https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/UroGynSurgicalMesh/ucm345221.htm

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

The patient should understand: the likely success of transvaginal SUI surgery with mesh compared to non-surgical treatment options and non-mesh surgery based on the individual patient factors. the potential

Content: application/xhtml+xml Size: 38 KB

Information for Health Care Providers for POP

URL: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/UroGynSurgicalMesh/ucm345204.htm

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

Requirement for Premarket Approval for Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair Federal Register: Reclassification of Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair More

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Page 1 of 12 (234 Total Results)Next Page ►