Posts Tagged ‘ predicate device ’

PBS “Need to Know” Friday, March 22 on FDA and Medical, Surgical Devices

Mar 22nd, 2013 | By
PBS “Need to Know”  Friday, March 22 on FDA and Medical, Surgical Devices

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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Day 8: Linda Gross v Ethicon, Prolift Launched Under FDA Radar

Jan 22nd, 2013 | By
Day 8: Linda Gross v Ethicon, Prolift Launched Under FDA Radar

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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Day One: Linda Gross v. Ethicon over Transvaginal Mesh

Jan 10th, 2013 | By
Day One: Linda Gross v. Ethicon over Transvaginal Mesh

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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Suffering in Silence: Nonie Wideman ~ Canadian Child Advocate and Rancher Sidelined By Transvaginal Mesh

May 21st, 2012 | By
Suffering in Silence: Nonie Wideman ~ Canadian Child Advocate and Rancher Sidelined By Transvaginal Mesh

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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Consumer Reports Campaign email Alerts Million About Defective Medical Devices

Mar 13th, 2012 | By
Consumer Reports Campaign email Alerts Million About Defective Medical Devices

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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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.