predicate device

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

Linda, Jeff Gross 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 Read more

By | 2013-03-22T13:06:04+00:00 March 22nd, 2013|Media Reports|8 Comments

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

Dr. Peggy Pence, Courtesy CVN 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, Read more

By | 2013-01-22T23:07:59+00:00 January 22nd, 2013|Legal News|1 Comment

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). Adam Slater, attny for Linda Gross Linda Gross, 47, from Watertown, South Dakota is Read more

By | 2013-01-10T19:33:22+00:00 January 10th, 2013|Legal News|3 Comments

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

Noni Wideman 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 Read more

By | 2018-01-10T15:13:37+00:00 May 21st, 2012|News, Patient Profiles|11 Comments

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 Read more

By | 2012-03-13T00:11:54+00:00 March 13th, 2012|Media Reports|0 Comments