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Tag Archives: Medtronic

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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…]

Pelvic Floor Disorders Alliance

Industry-Backed Patient Group Supports Surgery, Treatment

By Mesh Medical Device Newsdesk |

September 26, 2012 ~ With all of the news about complications resulting from transvaginal synthetic surgical mesh, and the thousands of product liability lawsuits filed in state and federal court, one might assume industry would push back. That’s exactly what is happening. The Pelvic Floor Disorders Alliance is launching a Public Awareness Campaign, “Break [continue reading…]

Total Hip Replacement, FDA

Coming Up: FDA Expert Panel Weighs in on Metal Hips

By Mesh Medical Device Newsdesk |

Next Wednesday, June 27 and Thursday, June 28, the U.S. Food and Drug Administration (FDA) will convene one of its expert panels – this one on patient complications after a metal-on-metal hip implant. It is a gathering called by the Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee within the FDA. [continue reading…]

Senate on mdufa  200

Senate Passes FDA Funding Bill Minus Major Patient Safety Provisions

By Mesh Medical Device Newsdesk |

May 24, 2012 ~ The U.S. Food and Drug Administration (FDA) is one step closer to being funded for the next five years in a bi-partisan vote considered good for the FDA and industry – but what about patients? The Food and Drug Administration Safety and Innovation Act passed on an unusual bi-partisan vote,  [continue reading…]

Rep. Erik Paulsen ( R-MN)

Industry Doesn’t Want Medical Device Tax, GOP Freshmen Help

By Mesh Medical Device Newsdesk |

An article in DOTmedNews reports that GOP freshmen are aligning with industry to oppose a 2.3 percent excise tax on the medical device industry set to go into effect January 2013. Industry says it will hurt profits and drive jobs and innovation oversees. As the deadline gets closer, the opposition is growing louder. Monday, [continue reading…]

DePuy Hip Implant, J&J, YouTube, Attny Greg Borri

More Monitoring of Medical Device Implants After Market

By Mesh Medical Device Newsdesk |

Artificial hips that fail, surgical mesh that injures – the New York Times reports (here) on December 14, 2011, that amid the growing number of problems with medical devices a bipartisan bill was introduced in the U.S. Senate that would require device makers follow the life of their products after they’re approved for sale.

Medtronic, Fridley MN Headquarters, Wikicommons, Bobak Ha' Eri

Medtronic Pays $23 Million to Settle Doctor Kickback Charges

By Mesh Medical Device Newsdesk |

Medtronic is the world’s top maker of medical devices and it didn’t get that way without help. The U.S. Department of Justice accused the Minnesota-based company of having friends in high places –

Did Medtronic Sell an Unsafe Product?

By Mesh Medical Device Newsdesk |

NOVEMBER 12, 2011 – Fridley, Minnesota is home to Medtronic, the largest medical device company, and an article in the Star Tribune, November 12, Saturday, asks Did Medtronic sell an unsafe product?  (here)

Patients Injured in SErious Adverse Events- FDA report october 31 2011

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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