Posts Tagged ‘ Class III ’

FDA: Stress Urinary Incontinence (SUI) Surgical Mesh Reports up 36 Percent

Mar 29th, 2013 | By
FDA: Stress Urinary Incontinence (SUI) Surgical Mesh Reports up 36 Percent

March 29, 2013 ~ In September 2011, the U.S. Food and Drug Administration convened a panel of experts to try and get a handle on the concerning number of complications the agency was receiving about surgical mesh used to treat pelvic organ prolapse (POP)  and stress urinary incontinence (SUI).  The experts  suggested that because of the
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Coming Up: FDA Expert Panel Weighs in on Metal Hips

Jun 20th, 2012 | By
Coming Up: FDA Expert Panel Weighs in on Metal Hips

Next Wednesday, June 27 and Thursday, June 28, the U.S. Food and Drug Administration (FDA) will convene one of its expert panels – this one on patient complications after a metal-on-metal hip implant. It is a gathering called by the Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee within the FDA. The
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New England Journal of Medicine – Medical Devices – Balancing Regulation and Innovation

Jan 19th, 2012 | By
New England Journal of Medicine – Medical Devices – Balancing Regulation and Innovation

January 19, 2012 ~ In a letter to the Editor of the New England Journal of Medicine (NEJM), (here) January 19, 2012, Neil Feder, M.D. of the Project on Government Oversight writes about the 510(k) process that allows untested medical devices onto the market without premarket approval. Share this:



Upcoming Miami Hearing on Transvaginal Mesh Litigation and Consolidation

Jan 12th, 2012 | By
Upcoming Miami Hearing on Transvaginal Mesh Litigation and Consolidation

JANUARY 12, 2012 ~ A growing number of women from around the country who are plaintiffs in transvaginal mesh litigation have a court date of Wednesday, January 26 in Miami. The Judicial Panel on Multidistrict Litigation (MDL)  is set to hear requests by plaintiff attorneys to have thousands of defective mesh lawsuits consolidated in the
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FDA Panel Wants More Data on Mesh Tx for Incontinence, MedPage Today, September 9

Sep 13th, 2011 | By

MedPage Today (here)  reports an FDA advisory panel meeting over synthetic mesh used to treat stress urinary incontinence (SUI) said it would like more scientific data on the newer generation of devices but recommended leaving in place the 510(k) approval process. FDA Panel Listens to Industry, Patients, Staff The Obstetrics and Gynecology Devices panel issued
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Public Citizen: Recall Synthetic Surgical Mesh

Aug 25th, 2011 | By
Public Citizen: Recall Synthetic Surgical Mesh

AUGUST 25, 2011 – Synthetic surgical mesh is implanted into women for the treatment of pelvic organ prolapse and incontinence and now Public Citizen is calling for a ban citing the needless exposure of patients to serious, life-altering complications. Synthetic mesh used for pelvic surgeries, and hernia repair in men, is made of a petroleum-based
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Changes Are Afoot in U.S. Medical Device Regulations, Morningstar, August 15, 2011

Aug 15th, 2011 | By

This excellent article by Morningstar reminds us that the Food and Drug Administration (FDA) has been reviewing the regulatory process that allows most medical devices to make their way into the marketplace and the agency plans to have new changes in place by October. This is sparked by the July release of the Institute of
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We hope you find this a helpful resource. National News Editor, Jane Akre, began MDND with the hope of providing the latest news, information and perspective from the regulatory, industry and patient point of view, something that goes under-reported in much of the coverage of medical devices. The public is just now becoming aware that many devices do not undergo the same scrutiny as prescription drugs and are instead grandfathered in under an FDA loophole that has gone largely unchanged since the 1970s. As a result, patients become the post-market clinical trial subjects, and many suffer devastating and permanent injuries.