Posts Tagged ‘
British Medical Journal ’
Oct 29th, 2012 |
By Jane Akre
October 28, 2012 ~ Working with undercover reporters from The Daily Telegraph in the UK, the British Medical Journal’s (BMJ) Deborah Cohen has exposed, “a fragmented, poorly regulated, market driven system, with financial incentives to prioritize manufacturers’ interests over those of patients, and with no requirement for clinical evaluation of a device’s safety or effectiveness,”
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Posted in Media Reports |
2 comments
Tags: British Medical Journal, Deborah Cohen, defective medical device, faulty medical devices, FDA, MDND, Medical devices, metal-on-metal hips, MHRA, PIP breast implants, regulators, silicone filled breast implants, The Daily Telegraph, total metal hip
Jun 20th, 2012 |
By Jane Akre
Next Wednesday, June 27 and Thursday, June 28, the U.S. Food and Drug Administration (FDA) will convene one of its expert panels – this one on patient complications after a metal-on-metal hip implant. It is a gathering called by the Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee within the FDA. The
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Posted in FDA |
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Tags: 510(k), A.S.R, acetabular component, advisory panel, Ann Morrison, BBC, birmingham Hip Resurfacing, British Medical Journal, chromium, Class II, Class III, cobalt, DePuy, FDA, Howard Sadwin, Johnson & Johnson, Medtronic, metal ions, metal-on-metal hips, MoM, recall, resurfacing system, Smight & Nephew, total hip replacements, transvaginal mesh
Mar 30th, 2012 |
By Jane Akre
The FDA has scheduled a two-day expert panel review of metal-on-metal hips as concerns mount about patient injuries. The June 27-28 gathering (location yet to be announced) will include researchers, patients, doctors and scientists to decide whether or not the agency needs to do a better job protecting patients in light of the high complication
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Posted in FDA |
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Tags: ASR, BBC, British Medical Journal, FDA, Johnson & Johnson, metal-on-metal, MOM hips, Smith & Nepher, Zimmer Holdings
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
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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