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Tag Archives: Food and Drug Administration

FDA Office of the Commissioner, Silver Spring, MD

FDA Covers for Device Makers, Keeps Injuries Under Wraps

By Mesh Medical Device Newsdesk |

Medical Device News Desk, October 20, 2016 ~ The system is supposed to be transparent.   Medical device makers are required to alert the U.S. Food and Drug Administration (FDA) when their products injure consumers or malfunction.  The FDA then theoretically alerts doctors who alert consumers. In rare cases, such as pelvic mesh, the FDA will [continue reading…]

Consumers Union Safe  Patient Project

FDA Funding: Medical Device Makers and Lap Dog Watchdogs

By Mesh Medical Device Newsdesk |

Mesh Medical Device News Desk, August 29, 2016 ~ The medical device industry and the U.S. Food and Drug Administration (FDA) have reached tentative agreement on $1 billion in funding from the very industry it regulates. The Medical Device User Fee Agreement IV (MDUFA IV) will be delivered to Congress in January. It represents [continue reading…]

Alliance for natural health death meter

Report: Deaths Caused by the FDA

By Mesh Medical Device Newsdesk |

Mesh Medical Device News Desk, July 5, 2016 ~ Deaths Caused by the FDA That is the title of a campaign by the Alliance for Natural Health, USA.  Digging into the Food and Drug Administrations (FDA) database, the consumer group, that promotes sustainable natural health, counts 750,659 deaths caused by FDA-approved drugs, vaccines and [continue reading…]


FDA to Consider Reclassifying Trocars Used to Place Surgical Pelvic Mesh

By Mesh Medical Device Newsdesk |

Mesh News Desk, March 14, 2016 ~ When mesh kits were first developed and marketed in the U.S. in the mid 2000’s, they came complete with precut mesh and what’s known as a trocar. What are trocars? A trocar is a stainless steel needle attached generally to a plastic handle that resemble hooks.  A [continue reading…]

Plastics recycling in Guandong Province

Mesh Survivor on the FDA’s Oversight of Chinese Boston Scientific Mesh Controversy

By Mesh Medical Device Newsdesk |

Mesh News Desk, February 26, 2016 ~Written by an anonymous woman in response to the story about Chinese mesh smuggled in by Boston Scientific from China. Judge Goodwin has asked the Food and Drug Administration (FDA) to weigh in as to whether the mesh falls within the regulatory approval Boston Scientific received to sell [continue reading…]

hyman cropped

Biomedical Expert on Regulatory Parellels of Pelvic Mesh to Breast Implants, Federal Preemption and There’s No Medical Grade Mesh

By Mesh Medical Device Newsdesk |

MND, January 13, 2016 ~ Dr.William A. Hyman, a Biomedical expert has been brought in as a consultant in some pelvic mesh cases.  Dr. Hyman compares FDA’s reclassification of POP (pelvic organ prolapse) mesh to class III as a parallel to breast implant reclassification.  It forced them off the market, but they came back after anecdotal [continue reading…]

maude report nov 2014

Have You Filed Your FDA Adverse Event Report Concerning Surgical Mesh?

By Mesh Medical Device Newsdesk |

MND, November 17, 2015 ~ This woman did one year ago. She found the MAUDE database inside the FDA.  Here is the URL for her anonymous report she made after receiving the Gynecare (J&J) Prolift mesh kit.  See it  here.   You can also go to MedWatch and report your adverse event. ADVERSE EVENT [continue reading…]

CRE bacteria, Source: CDC

Faulty design and cleaning procedures in widely used endoscope may have caused superbug outbreak

By Mesh Medical Device Newsdesk |

By Farid Zakaria, Keller, Fishback & Jackson LLP  An outbreak of a drug-resistant strain of bacteria at a major southern California hospital last February has been linked to a medical device used in the treatment of cancers, gallstones, and other ailments of the digestive system. On February 18, the Los Angeles Times reported that [continue reading…]

Mesh Survivors UK- Contact Your GP, MP – Challenge the Information!

By Mesh Medical Device Newsdesk |

A mesh survivor from the UK suggests survivors contact their GP and MP with their mesh survivor stories.  (GP is general practitioner and MP is Member of Parliament. The reason – no one ever gets a letter to confirm it has been reported. Finally, this writer got a report to confirm. It said:  this [continue reading…]

Anonymous woman 200

POWER MORCELLATION and the Risk of Uterine Sarcoma Dissemination

By Mesh Medical Device Newsdesk |

By Dan Bolton, Keller, Fishback & Jackson LLP An estimated 50,000 women a year in the United States undergo a hysterectomy (removal of the uterus) or myomectomy (removal of uterine fibroids) with the use of a medical device known as a power morcellator. Power morcellators typically use a rapidly rotating blade to cut (or [continue reading…]

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