Posts Tagged ‘ Fatally flawed ’

FDA Follows Industry Lead to Shorten Time to Market

Oct 31st, 2012 | By
FDA Follows Industry Lead to Shorten Time to Market

October 30, 2012 ~    The FDA has issued the new rules for medical device makers to speed up the time it takes for medical devices to make it to market. Earlier this year industry agreed to pay $595 million over 5 years to the FDA as part of its operating budget. In exchange, the
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Four J&J Vaginal Meshes Named – Will Be Removed from Market

Jun 5th, 2012 | By
Four J&J Vaginal Meshes Named – Will Be Removed from Market

June 5, 2012 ~ There is now more detailed information about the move by Johnson & Johnson (J&J) to stop the sale of four vaginal mesh implants. The four named meshes are: TVT Secur Prosima Pelvic Floor Repair System Prolift Pelvic Floor Repair System   Prolift MTM Pelvic Floor Repair System These are the four
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ProPublia: Four Medical Devices that Bypassed FDA Scrutiny

May 10th, 2012 | By
ProPublia: Four Medical Devices that Bypassed FDA Scrutiny

May 10, 2012 ~ ProPublica, an independent journalism organization, reports on four medical devices that are among the thousands pushed into the marketplace every year that do not undergo Food and Drug Administration (FDA) scrutiny. The bottom line – medical devices are big business bringing over $100 billion-a-year to the industry, giving industry the muscle
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Consumer Reports Campaign email Alerts Million About Defective Medical Devices

Mar 13th, 2012 | By
Consumer Reports Campaign email Alerts Million About Defective Medical Devices

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 may
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FDA Denies Legal Group Seeking to Ban IOM Recommendations

Mar 8th, 2012 | By
FDA Denies Legal Group Seeking to Ban IOM Recommendations

March 7, 2012 ~ Bloomberg BNA reported (here) that the Washington Legal Foundation (WLF), had its petition rejected by the Food and Drug Administration February 21 after the industry-tied group tried to have the recommendation of an expert scientific panel barred from FDA consideration and implementation. The WLF is made up of corporate inside-the-beltway attorneys
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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.