Class III

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30 Months is Up! POP Mesh is Officially High Risk, Too Late for Many

Prolift for POP repair Mesh Medical Device News Desk, July 10, 2018 ~ Pelvic Organ Prolapse (POP) polypropylene mesh, that has injured so many, has just suffered another blow. After an initial announcement and a 30 month waiting period, finally this month, the FDA has officially reclassified POP [...]

By |2018-10-22T17:32:39-04:00July 10th, 2018|FDA News|13 Comments

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  [...]

By |2018-07-10T13:10:44-04:00March 29th, 2013|FDA News|13 Comments

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 [...]

By |2012-06-20T00:12:08-04:00June 20th, 2012|FDA News|1 Comment

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. […]

By |2012-01-19T22:30:58-05:00January 19th, 2012|Medical News|1 Comment

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 [...]

By |2012-01-12T20:19:34-05:00January 12th, 2012|Legal News|2 Comments

FDA Panel Wants More Data on Mesh Tx for Incontinence, MedPage Today, September 9

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 [...]

By |2011-09-13T01:50:01-04:00September 13th, 2011|Media Reports|0 Comments

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, [...]

By |2011-08-25T20:34:24-04:00August 25th, 2011|Featured|0 Comments