Media Reports

Medical Device Messenger and Fox Failure to Disclose

Oct 1st, 2012 | By
Medical Device Messenger and Fox Failure to Disclose

October 1, 2012 ~ Respect your television audience. In terms of  full disclosure that would require a reporter to  disclose the background of an interview subject, especially if that person is espousing a specific point of view. Journalistic ethics didn’t stop Fox & Friends from practicing bad journalism. Introducing former Senator Evan Bayh (D-IN) on
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What Do We Know About Polypropylene?

Sep 28th, 2012 | By
What Do We Know About Polypropylene?

September 28, 2012 ~ The following was sent from a consultancy group, Frost & Sullivan.  Chemical, Materials and Research Analyst, Tridisha Goswami, provided MDND information on the properties, however nothing on whether or not polypropylene is safe to use for a permanently implanted medical devices. The analyst says more research must be done to determine
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What Do We Know About Polypropylene

Sep 28th, 2012 | By
What Do We Know About Polypropylene

  September 28, 2012 ~ The following was sent from a consultancy group, Frost & Sullivan.  Chemical, Materials and Research Analyst, Tridisha Goswami, provided MDND information on the properties, however nothing on whether or not polypropylene is safe to use for a permanently implanted medical device. The analyst says more research must be done to
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Polypropylene Plastic and Medical Devices

Sep 27th, 2012 | By
Polypropylene Plastic and Medical Devices

September 27, 2012 ~ “Plastics”  said the man to a young Dustin Hoffman in the 1967 film, “The Graduate.” 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?
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Industry-Backed Patient Group Supports Surgery, Treatment

Sep 26th, 2012 | By
Industry-Backed Patient Group Supports Surgery, Treatment

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 Free
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Recalled Bard Avaulta Mesh Sold on EBay

Sep 10th, 2012 | By
Recalled Bard Avaulta Mesh Sold on EBay

September 10, 2012 ~ You can buy almost anything on eBay, right? Even transvaginal mesh that has been taken off the market? DrugWatch (here) reports that the Bard Avaulta polypropylene mesh has shown up on an eBay auction including a Plus Posterior mesh. You could buy it for $50 and two Anterior support System products
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J & J Execs to be Deposed About Vaginal Mesh – What Did They Know – When Did They Know It

Jul 29th, 2012 | By
J & J Execs to be Deposed About Vaginal Mesh – What Did They Know – When Did They Know It

July 29, 2012 ~ Johnson & Johnson’s new CEO is on the hot seat. Alex Gorsky must show up to provide a videotaped deposition concerning the upcoming Ethicon transvaginal mesh lawsuits pending before a New Jersey Superior Court. Ethicon is a wholly owned subsidiary of Johnson & Johnson. The decision to require Gorsky and two
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Campaign Against FDA Whistleblowers Inquiry Heats Up

Jul 16th, 2012 | By
Campaign Against FDA Whistleblowers Inquiry Heats Up

July 16, 2012 ~Most Americans believe the U.S. Food and Drug Administration (FDA)  does a fairly adequate job at least keeping us safe from dangerous pharmaceuticals, medical devices, and food.  However, a story in the New York Times (here) outlines the length to which the FDA went after its own whistleblowers when they tried to
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Hundreds of Utah Women File Lawsuits Alleging Complications for Pelvic Implants

Jul 8th, 2012 | By
Hundreds of Utah Women File Lawsuits Alleging Complications for Pelvic Implants

~Salt Lake Tribune, July 8, 2012 “Lee” had a pelvic mesh sling implanted six years ago to treat incontinence, which was an inconvenience. But after two surgeries and continuing health complications, Lee and about 50 other Utah women have filed lawsuits alleging they are suffering “severe and permanent  bodily injuries” from the pelvic mesh devices
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J&J Continued to Sell Vaginal Mesh Implant After FDA Ordered Halt

Jun 26th, 2012 | By
J&J Continued to Sell Vaginal Mesh Implant After FDA Ordered Halt

June 26, 2012 ~ Johnson & Johnson, the global healthcare company, has once again found itself in the spotlight for failing to follow the rules. J & J was ordered to stop selling a controversial vaginal mesh product, the Gynecare Prolift,  but kept selling it even after being warned by the U.S. Food and Drug
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We hope you find this a helpful resource. National News Editor, Jane Akre, began MDND with the hope of providing the latest news, information and perspective from the regulatory, industry and patient point of view, something that goes under-reported in much of the coverage of medical devices. The public is just now becoming aware that many devices do not undergo the same scrutiny as prescription drugs and are instead grandfathered in under an FDA loophole that has gone largely unchanged since the 1970s. As a result, patients become the post-market clinical trial subjects, and many suffer devastating and permanent injuries.