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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

Creator:   FDA Office of the Commissioner, Office of External Affairs

Date:   October 21 2016

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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

Concerns about Surgical Mesh for POP

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

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

repair with mesh is more effective than traditional non-mesh repair Additional Information Federal Register: Effective Date of Requirement for Premarket Approval for Surgical Mesh for Transvaginal

Content: application/xhtml+xml Size: 37 KB

Recommendations for Health Care Providers Treating Stress Urinary Incontinence | FDA

URL: https://www.fda.gov/medical-devices/urogynecologic-surgical-mesh-implants/recommendations-health-care-providers-treating-stress-urinary-incontinence

This text was captured  on Dec 25, 2020   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: text/html Size: 35 KB

Information for Patients for POP

URL: https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/UroGynSurgicalMesh/ucm345205.htm

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

for transvaginal repair of pelvic organ prolapse (POP).

Content: application/xhtml+xml Size: 41 KB

Information for Patients for POP

URL: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/UroGynSurgicalMesh/ucm345205.htm

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

for transvaginal repair of pelvic organ prolapse (POP).

Content: application/xhtml+xml Size: 40 KB

FDA Reclassifies Surgical Instrumentation For Use With Urogynecologic Surgical Mesh From Class I to Class II

URL: https://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm559862.htm

This text was captured  on Jul 22, 2017   Show All Captures

All urogynecologic surgical mesh instrumentation – whether used for transvaginal POP repair or other urogynecologic surgical mesh procedures – falls under this reclassification.

Content: application/xhtml+xml Size: 36 KB

Urogynecologic Surgical Mesh Implants

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

This text was captured  on Jan 11, 2017   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: 45 KB

Urogynecologic Surgical Mesh Implants

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

This text was captured  on Jan 13, 2017   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: 45 KB

Urogynecologic Surgical Mesh Implants

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

This text was captured  on Jan 11, 2017   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: 45 KB

Considerations about Surgical Mesh for SUI

URL: https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/UroGynSurgicalMesh/ucm345219.htm

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

The use of mesh slings in transvaginal SUI repair introduces a risk not present in traditional non-mesh surgery for SUI repair, which is mesh erosion, also known as extrusion.

Content: application/xhtml+xml Size: 39 KB

Considerations about Surgical Mesh for SUI

URL: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/UroGynSurgicalMesh/ucm345219.htm

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

The use of mesh slings in transvaginal SUI repair introduces a risk not present in traditional non-mesh surgery for SUI repair, which is mesh erosion, also known as extrusion.

Content: application/xhtml+xml Size: 39 KB

Pelvic Organ Prolapse (POP) | FDA

URL: https://www.fda.gov/medical-devices/urogynecologic-surgical-mesh-implants/pelvic-organ-prolapse-pop

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

If you have had transvaginal POP surgery but do not know whether your surgeon used mesh , ask your surgeon at your next scheduled visit.

Content: text/html Size: 39 KB

Pelvic Organ Prolapse (POP)

URL: https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/UroGynSurgicalMesh/ucm262299.htm

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

If you have had transvaginal POP surgery but do not know whether your surgeon used mesh , ask your surgeon at your next scheduled visit.

Content: application/xhtml+xml Size: 42 KB

Statement from FDA Commissioner Scott Gottlieb, M.D. and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on FDA’s updates to Medical Device Safety Action Plan to enhance post-market safety

URL: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm626286.htm?utm_campaign=Women%27s%20Health%20Update%20-%20December%202018&utm_medium=email&utm_source=Eloqua&elqTrackId=57c04dc566f347e1b6861aedcb763624&elq=3a1dfe79d54d41f8b986873635bd8a4c&elqaid=6172&elqat=1&elqCampaignId=5012

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

mesh intended for transvaginal pelvic organ prolapse (POP) repair.

Content: application/xhtml+xml Size: 58 KB

Statement from FDA Commissioner Scott Gottlieb, M.D. and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on FDA’s updates to Medical Device Safety Action Plan to enhance post-market safety

URL: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm626286.htm

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

mesh intended for transvaginal pelvic organ prolapse (POP) repair.

Content: application/xhtml+xml Size: 58 KB

Considerations about Surgical Mesh for SUI | FDA

URL: https://www.fda.gov/medical-devices/urogynecologic-surgical-mesh-implants/considerations-about-surgical-mesh-sui

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

The use of mesh slings in transvaginal SUI repair introduces a risk not present in traditional non-mesh surgery for SUI repair, which is mesh erosion, also known as extrusion.

Content: text/html Size: 37 KB

Statement from FDA Commissioner Scott Gottlieb, M.D. and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on FDA’s updates to Medical Device Safety Action Plan to enhance post-market safety | FDA

URL: https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-and-jeff-shuren-md-director-center-devices-and-2

This text was captured  on Dec 26, 2020   Show All Captures

mesh intended for transvaginal pelvic organ prolapse (POP) repair.

Content: text/html Size: 57 KB

May 2019 Office of Women's Health e-Update | FDA

URL: https://www.fda.gov/consumers/collaborate-and-connect/may-2019-office-womens-health-e-update

This text was captured  on Dec 23, 2020   Show All Captures

Last month, we also shared an update on FDA actions ordering manufacturers to stop selling surgical mesh products intended for transvaginal repair of pelvic organ prolapse.

Content: text/html Size: 49 KB

February 25-26, 2016: Gastroenterology and UrologyDevices Panel of the Medical Devices Advisory Committee Meeting Announcement

URL: https://www.fda.gov/AdvisoryCommittees/Calendar/ucm480045.htm

This text was captured  on Apr 05, 2017   Show All Captures

aid in insertion, placement, fixation, or anchoring of surgical mesh for procedures including transvaginal pelvic organ prolapse repair, sacrocolpopexy (transabdominal pelvic organ prolapse repair), treatment

Content: application/xhtml+xml Size: 47 KB

February 25-26, 2016: Gastroenterology and UrologyDevices Panel of the Medical Devices Advisory Committee Meeting Announcement

URL: http://www.fda.gov/AdvisoryCommittees/Calendar/ucm480045.htm

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

aid in insertion, placement, fixation, or anchoring of surgical mesh for procedures including transvaginal pelvic organ prolapse repair, sacrocolpopexy (transabdominal pelvic organ prolapse repair), treatment

Content: application/xhtml+xml Size: 47 KB

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