Search Results for transvaginal mesh

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Asia Regulatory Roundup: Australia Bans Transvaginal Mesh Products (5 December 2017) By Nick Paul Taylor - Published 05 December 2017

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

Categories: News, China, Oceania, CFDA, TGA, Biologics and biotechnology, Drugs, Medical Devices

Tags: transvaginal mesh, confidential information, medicine naming

Use of Transvaginal Mesh Fell After Strongly-Worded FDA Safety Alert, Study Finds By Michael Mezher - Published 15 February 2016

Two safety communications issued by the US Food and Drug Administration (FDA) had different impacts on the use of surgical mesh to treat pelvic organ prolapse (POP), according to a recent study appearing in JAMA Internal Medicine.

Categories: News, US, FDA, Communication, Medical Devices, Postmarket surveillance

Tags: Surgical mesh, Transvaginal mesh, Pelvic organ prolapse, Safety communication

FDA Increases Regulatory Requirements for Transvaginal Mesh By Michael Mezher - Published 04 January 2016

The US Food and Drug Administration (FDA) announced Monday that it is increasing regulatory oversight of transvaginal mesh after receiving thousands of reports of injuries, including pelvic pain and bleeding, caused by the devices.

Categories: News, US, CDRH, Medical Devices, Postmarket surveillance, Submission and registration

Tags: Transvaginal mesh, surgical mesh, pelvic organ prolapse

FDA Cracks Down on Transvaginal Mesh, Will Require Companies to Submit Data or Pull Products By Alexander Gaffney, RAC - Published 29 April 2014

Categories: US, FDA, CDRH

Tags: Device Reclassification, POP, Transvaginal Mesh, Class II, Latest News, Class III, PMA, medical device

EU Launches Probe into Safety of Transvaginal Mesh By Alexander Gaffney,RAC - Published 24 March 2014

Categories: EC

Tags: SCENIHR, Transvaginal Mesh, European Commission, Latest News, safety, EU

FDA Orders Surgical Mesh Manufacturers to Study Risks By Alexander Gaffney - Published 05 January 2012

Categories: FDA, CDRH

Tags: POP, Transvaginal Mesh, Surgical Mesh, Bill Maisel, Latest News, studies, safety