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Tag Archives: Medical devices

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…]

Melayna Lokosky

Whistleblower Wants Prison Time for Convicted J&J Med Device Execs

By Mesh Medical Device Newsdesk |

Mesh Medical Device News Desk, July 25, 2016 ~ Whistleblower Wants J&J Subsidiary Execs To Be Imprisoned Following $18 Million Fine and Federal Conviction   Melayna Lokosky is not shy. The former Acclarent Inc. medical device sales rep worked for a Johnson & Johnson subsidiary until 2011 when she filed a whistleblower lawsuit against the [continue reading…]

Plastic mesh

European Union Cracks Down on Toxins in Plastic Used for Medical Devices

By Mesh Medical Device Newsdesk |

Mesh Medical Device News Desk, June 13, 2016 ~ Using Plastic for Permanent Implants Is Not the Ideal Material Mr. McGuire: I just want to say one word to you – just one word. Ben: Yes sir. Mr. McGuire: Are you listening? Ben: Yes I am. Mr. McGuire: ‘Plastics.’ Ben: Exactly how do you mean? Mr. McGuire: There’s a great future [continue reading…]

Power morcellator, Contemporary ObGyn

Study: Insufficient Science to FDA Allows Med Devices On the Market

By Mesh Medical Device Newsdesk |

Mesh Medical Device News Desk, May 22, 2016 ~  The U.S. Food and Drug Administration (FDA) has put safety in the back seat in approving several high risk devices for obstetric and gynecological procedures, according to a study by researchers at Northwestern University. Citing the problems with transvaginal mesh, power morcellators, and the Essure [continue reading…]

Essure Facebook page

Bill Would Have Essure Birth Control Removed from Market

By Mesh Medical Device Newsdesk |

MND, Nov. 3, 2015 ~ There has been a lot of organized attention by consumers harmed by the Essure birth control device made by Bayer Healthcare Pharmaceuticals. Metal coils are implanted in the fallopian tubes with the goal of having them scar over, therefore preventing pregnancy. The coils contain polyethylene fibers and are held in place [continue reading…]

Power morcellator graphic, WSJ

*New* Power Morcellator Controversy Spurs FDA Proposal – But Does it Go Far Enough?

By Mesh Medical Device Newsdesk |

The Wall Street Journal (WSJ) reports on Friday the House passed a bill that would improve the safety monitoring of medical devices. It was inspired by a gynecological device – the power morcellator. The morcellator is a tool that is used to grind up growths in the uterus, however a woman has a one [continue reading…]

Consumers Union Safe Patient project logo 218

Consumers Union: Manufacturers Should Warranty Knees and Hips

By Mesh Medical Device Newsdesk |

Your big screen television and new car comes with a warranty- why not the most important medical purchase you will make in your life? Consumers Union, an arm of Consumer Reports, has come up with a novel and common sense approach. Manufacturers of medical devices should warranty their products. They claim they are safe [continue reading…]

FDA medwatch form 200

FDA Asks Consumers to Report Product Failures

By Mesh Medical Device Newsdesk |

June 10, 2013 ~ New and Improved? The U.S. Food and Drug Administration (FDA) is celebrating 20 years of the MedWatch program by providing consumers with a new form that should encourage consumers and medical professionals to report adverse events, complications and bad outcomes with drugs and medical devices, cosmetics, medical equipment, food or [continue reading…]

Medical Device Innovation Consortium logo

FDA Helps Industry Push Medical Device Innovation

By Mesh Medical Device Newsdesk |

December 4, 2012 ~ The FDA will collaborate with the medical device industry it regulates in a public-private collaboration, all to speed up the approval of new devices. The newly formed nonprofit group,  Medical Device Innovation Consortium (MDIC), has a goal of speeding up and simplifying the design and testing of medical devices, reports [continue reading…]

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