Fatally flawed

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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 [...]

By |2012-10-31T00:27:06-04:00October 31st, 2012|FDA News|1 Comment

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 [...]

By |2012-06-05T14:11:34-04:00June 5th, 2012|Featured|13 Comments

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 [...]

By |2012-05-10T16:05:00-04:00May 10th, 2012|Featured|2 Comments

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 [...]

By |2012-03-13T00:11:54-04:00March 13th, 2012|Media Reports|0 Comments

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 [...]

By |2012-03-08T00:54:38-05:00March 8th, 2012|Legal News|0 Comments