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Tag Archives: predicate device

Linda, Jeff Gross

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

By Mesh Medical Device Newsdesk |

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 [continue reading…]

Dr. Peggy Pence, Courtesy CVN

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

By Mesh Medical Device Newsdesk |

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 [continue reading…]

Adam Slater

Day One: Linda Gross v. Ethicon over Transvaginal Mesh

By Mesh Medical Device Newsdesk |

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 [continue reading…]

Nonie  300  in 2011

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

By Mesh Medical Device Newsdesk |

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, [continue reading…]

Consumers Union Safe Patient project logo 218

Consumer Reports Campaign email Alerts Million About Defective Medical Devices

By Mesh Medical Device Newsdesk |

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 [continue reading…]

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