Posts Tagged ‘
predicate device ’
Mar 22nd, 2013 |
By Jane Akre
March 22, 2013 ~ Friday night, March 22, Public Broadcasting (PBS) looks into the U.S. Food and Drug Administration (FDA) oversight of medical devices and how so many enter the market with little review and oversight. The 510(k) process allows devices on the market after the manufacturer requests clearance from the FDA and names a
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Posted in Media Reports |
7 comments
Tags: 510(k), Linda Gross, medical device, PBS, predicate device, Prolift surgical mesh
Jan 22nd, 2013 |
By Jane Akre
January 22, 2013 ~ Much thanks to Courtroom View Network for access to the live court proceedings and graphics shown to the jury. The Prolift surgical mesh did not undergo any FDA approval before it was marketed in March 2005. Last June Ethicon, a division of Johnson & Johnson announced it was removing Prolift and
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Posted in Legal News |
1 Comment »
Tags: 510(k), adhesion formation, Bladder, Courtroom View Network, David Mazie, Dr. Peggy Pence, dyspareunia, erosions, Ethicon, extrusion, fistula formation, Gynecare Prolift, Gynecare Prolift Pelvic Floor Repair System, Gynemesh PS, IFU (Instructions for Use), inflammatory reaction, Johnson & Johnson, Linda Gross v Ethicon, MAUDE Database, mesh removal, nerves, potentiation inflammation, predicate device, Prolift M, Prolift pelvic organ repair mesh, Prolift surgical mesh, scarring that results in implant contraction. Punctures or lacerations of vessels, the danger of pudendal neuralgia, urethra or bowel
Jan 10th, 2013 |
By Jane Akre
January 10, 2013 ~ Johnson & Johnson was on the defense this afternoon in the trial of a South Dakota woman who claims she is in perpetual pain due to defective transvaginal mesh (TVM). Linda Gross, 47, from Watertown, South Dakota is represented by New Jersey-based attorney Adam Slater in the first of more than
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Posted in Legal News |
3 comments
Tags: Adam Slater, anatomic cure, Butler Snow, Christy D. Jones, Courtroom View Network, dyspareunia, erosion, Ethicon, FDA, fistula formation, Food and Drug Administration, foreign body reaction, Gynecare Prolift polypropylene mesh, Gynemesh, J&J, Johnson & Johnson, Linda Gross, MDND, Mesh medical Device News Desk, pelvic adhesions, polypropylene, predicate device, Prolift M, rectocyle, transvaginal mesh
May 21st, 2012 |
By Jane Akre
Nonie Wideman might be considered one of those angels on earth who pays it forward by taking into her home kids with all sorts of special and emotional needs – those who have suffered trauma and abuse, autism, ADHD, fetal alcohol syndrome, and handicaps, among other issues. Wideman, 57, and her husband Bob, 65, have
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Posted in Patient Profiles |
10 comments
Tags: 510(k), British Columbia, complications, Consumers Union, CTV News, FDA, Gynecare TVT Secur, Health Canada, Incontinence, Institutes of Medicine, Kegel, Mesh medical Device News Desk, Nonie Wideman, pelvic organ prolapse, polypropylene, POP, predicate device, premarket approval, Public Citizen, Rose Prarie, Suffering in Silence, SUI, transvaginal mesh, Truth in Medicine
Mar 13th, 2012 |
By Jane Akre
MARCH 12, 2012 ~ How bad are medical devices approved by the U.S. Food and Drug Administration? Reuters reports (here) that Consumer Reports believes they are very bad. The president of the 76-year-old publication wrote in an email to 1 million subscribers this year that, “The implant that fixed your knee or your heart may
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Posted in Media Reports |
No Comments »
Tags: 510(k), AdvaMed, Consumer Reports, Consumers Union, Fatally flawed, Institute of Medicine, Lana Keeton, medical device, predicate device, Reuters, Safe Patient Project, Truth in Medicine
