Posts Tagged ‘
Safety and Efficacy ’
Oct 31st, 2012 |
By Jane Akre
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
[continue reading...]
Posted in FDA |
1 Comment »
Tags: 510(k), Consumer Union's Safe patient Project, defective devices, fast-tracked medical devices, Fatally flawed, FDA, Institute of Medicine, MDUFA, medical device, Safety and Efficacy, UDI, Unique Device identification
Jun 5th, 2012 |
By Jane Akre
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
[continue reading...]
Posted in Feature |
10 comments
Tags: 510(k), comoplications, Ethicon, Fatally flawed, FDA, GAO, Gynecare Gynemesh PS, Gynemesh, Institutes of Medicine, Johnson & Johnson, Multidistrict Litigation, product recall, Safety and Efficacy, transvaginal mesh, vaginal mesh
Mar 5th, 2012 |
By Jane Akre
Howard Sadwin is 65 years old and lives in Sarasota, Florida. Life has not been the same since a metal-on-metal hip implant in 2007. In fact, during his 10-month hospital stay, Howard’s doctor leaned over and whispered to him that Howard was dying. But Sadwin survived and today is fighting mad about the artificial hip
[continue reading...]
Posted in Patient Profiles |
6 comments
Tags: 510(k), BBC, BHR, Birmingham Hip Resurfacing System, BMJ, British Broadcasting Company, British Medical Journal, FDA, immune response, J & J, medical device, metal on metal hip, metalosis, PMA, premarket approval, pseudotumors, Sadwin, Safety and Efficacy, Smith & Nephew, Zimmer
Feb 2nd, 2012 |
By Jane Akre
February 1, 2012 ~ Bloomberg reports on a bill introduced this week that would put the brakes on the approval of a medical device that claims to be similar to another approved device that’s been recalled or found to be defective. The bill was introduced by Democratic lawmakers including Rep. Edward Markey (D-MA) on
[continue reading...]
Posted in Legal News |
No Comments »
Tags: clinical trials, defective mesh, Markey, medical device recalls, metal hip implants, metal poisoning, PMA, premarket approval, ProteGen, Safety and Efficacy, Sound Devices Act