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Tag Archives: Safe Patient Project

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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…]

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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…]

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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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MDUFA for Another Five Years

By Mesh Medical Device Newsdesk |

August 6, 2012 ~ The U.S. Food and Drug Administration (FDA) has a renewed source of funding for the review of medical devices, at least for the next five years. On October 1, 2012 the Medical Device User Fee Amendments of 2012 or MDUFA III will go into effect. It will expire October 1, [continue reading…]

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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…]

Sick of Suffering in Silence

By Mesh Medical Device Newsdesk |

MARCH 19, 2012 ~ By Jane Akre    A story before I tell this story.  I was commissioned to write a 2,100 word piece for the Chicago-based magazine “In These Times.”  I had pitched the long-time editor and he said they were very interested. Great I thought. The money wasn’t much but the exposure for [continue reading…]

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Consumer Reports Campaign email Alerts Million About Defective Medical Devices

By Mesh Medical Device Newsdesk |

MARCH 12, 2012 ~ How bad are medical devices approved by the U.S. Food and Drug Administration? Reuters reports (here) that Consumer Reports believes they are very bad. The president of the 76-year-old publication wrote in an email to 1 million subscribers this year that, “The implant that fixed your knee or your heart [continue reading…]

Call to Action This Week!

By Mesh Medical Device Newsdesk |

Call to Action The stories in Patient Profiles show something within the FDA is clearly broken, and needs to be fixed. Most blame the 510(k) process which is sort of an ‘honor system’ allowing medical device makers to market their products, while the FDA and consumers hope the devices are safe and effective. We [continue reading…]

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