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Tag Archives: 510(k)

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…]

10605n

Noni Wideman to Consumers Union Concerning Pelvic Mesh

By Mesh Medical Device Newsdesk |

Mesh News Desk, March 14, 2016 ~ Noni Wideman, a survivor of a polypropylene mesh implant, writes the following letter to Consumers Union.   CU and specifically Lisa McGiffert have been involved in the pelvic mesh issue through Safe Patient Project, proposing that medical devices carry a warranty not unlike the refrigerator you buy. [continue reading…]

MTMP agency wrapping up mesh

Transvaginal Mesh- Emerging or Resolving?

By Mesh Medical Device Newsdesk |

Mesh News Desk, October 14, 2015 ~ As trial lawyers gather in Las Vegas for the twice-yearly Mass Torts Made Perfect, hosted by Levin Papantonio Law, one cannot help but notice the agenda for the last day – areas ahead for future litigation or areas that are waning. As you might have guessed, transvaginal [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…]

FAVORABLE JURY VERDICTS CONTINUE IN TRANSVAGINAL MESH (TVM) LITIGATION—IS AMS WATCHING?

By Mesh Medical Device Newsdesk |

By Dan C. Bolton, Of Counsel, Keller, Fishback & Jackson LLP                 In recent months, Endo Pharmaceuticals made several announcements concerning global settlements in the transvaginal mesh litigation against American Medical Systems (AMS) pending before Judge Goodwin in federal district court in West Virginia (MDL 2325).  Based on the numbers of women participating, the [continue reading…]

LEGAL THOUGHTS ON THE AMS TRANSVAGINAL MESH (TVM) SETTLEMENT

By Mesh Medical Device Newsdesk |

By Dan C. Bolton, Of Counsel, Keller, Fishback & Jackson LLP                 Recently, Endo Pharmaceuticals announced that it had reached a settlement in principle with four law firms representing plaintiffs in the transvaginal mesh litigation pending before Judge Goodwin in federal district court in West Virginia (MDL 2325).  The Press Release issued by Endo [continue reading…]

Harvard Researchers Take FDA's Device Approvals to Task

By Mesh Medical Device Newsdesk |

Using documents that recently came to light, Harvard researchers have traced a troubling approval process within the Food and Drug Administration that allows medical devices to be sold with little oversight. Essentially the supplemental application resembles the agency’s 510(k) process that allows medical devices to be marketed without clinical trials. The paper is reported [continue reading…]

The 510(k) Process – Safety Forgotten

By Mesh Medical Device Newsdesk |

THE 510(k) PROCESS – SAFETY FORGOTTEN By Dan C. Bolton, Of Counsel, Keller, Fishback & Jackson LLP The 510(k) process is relied upon by the medical device industry, including pelvic mesh manufacturers, such as Ethicon/Johnson & Johnson, Atrium Medical Corporation, and Davol/Bard, to quickly get devices marketed in the United States.  (The term “510(k)” [continue reading…]

AMS new sling RetroArc

FDA Approves New American Medical System Transvaginal Mesh Sling

By Mesh Medical Device Newsdesk |

American Medical Systems (AMS) has just received FDA clearance to market a new incontinence sling, according to a press release that appears in the Wall Street Journal. The RetroArc Retropubic Sling System received the Food the Drug Administration’s 510(k) clearance, a standard that does not require any clinical trials but relies on naming a [continue reading…]

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