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Tag Archives: substantial equivalent

$8.3 Million Verdict Against J&J's DePuy Unit Over ASR Metal Hip

By Mesh Medical Device Newsdesk |

March 8, 2013 ~ Johnson & Johnson must pay the plaintiff who brought the first DePuy metal hip implant device to trial $8.3 million in damages, a Los Angeles jury decided this afternoon. This is the first of 10,750 product liability lawsuits against J&J’s DePuy unit which makes the ASR XL hip replacement device. [continue reading…]

Teresa Hughes: Demanding Answers and Raising the Profile of Vaginal Mesh Injuries in the UK

By Mesh Medical Device Newsdesk |

Teresa Hughes, 61, a resident of Liverpool, England, and mother of two, has made so much noise about defective vaginal mesh that last year she was profiled in the UK paper, The Daily Mail. It started: “Thousands of women have been left severely damaged as a result of an implantable ‘sling’ operation to treat [continue reading…]

FDA Closer to Funding Goals – Where is Patient Safety?

By Mesh Medical Device Newsdesk |

On May Tuesday, May 8, a House subcommittee unanimously voted to approve its version of the Medical Device User Fee Act (MDUFA) which funds the U.S. Food and Drug Administration’s oversight of medical devices for the next five years. However, the House voted 46-0 without approving legislation that would protect Americans from defective medical [continue reading…]

FDA: Medical Device Complications Growing Faster than Industry

By Mesh Medical Device Newsdesk |

Understanding Barriers to Medical Device Quality is the name of an FDA report issued October 31 by the Center for Devices and Radiological Health (CDRH) and the Food and Drug Administration (FDA) in an attempt to get a handle on why the medical device industry is putting out poorly made, defective medical devices that [continue reading…]

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