Posts Tagged ‘
ASR ’
Jun 30th, 2012 |
By Jane Akre
June 30, 2012 ~The U.S. Food and Drug Administration (FDA) convened an 18-member expert panel to look at the large number of complications arising from metal-on-metal (MoM) hip replacements in patients. Dr. William Rohr opened the proceedings on June 27 saying they were not there to discuss reclassification of the hip, and the experts
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Posted in FDA |
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Tags: 510(k), ASR, chromium, cobalt, DePuy Orthopaedics, Johnson & Johnson, metal-on-metal, MOM hips, necrosis, orthopaedic, Smith & Nephew
Apr 30th, 2012 |
By Jane Akre
It will be interesting to watch how Alex Gorsky, 51, handles his new job and all that comes with it. As of April 26, he is in charge of Johnson & Johnson (J&J) as its Chief Executive Officer. He also inherited a massive number of lawsuits from surgical mesh and defective metal hip devices.
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Posted in Media Reports |
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Tags: Alex Gorsky, ASR, Ethicon, FDA, Gynemesh, J & J, Janssen Pharmaceuticals, Johnson & Johnson, medical device, medical device recalls, metal-on-metal hips, Novartis, polypropylene, prolene, Risperdal, Secur, surgical mesh, transvaginal mesh, TVT
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 23rd, 2012 |
By Jane Akre
March 23, 2012 ~ This has not been a good week for Johnson & Johnson. First word that it sold the transvaginal surgical mesh, ProLift, without getting any sort of FDA approval in advance (see background story here). Now the New York Times (NYT) (here) is reporting that J&J began phasing out the DePuy defective
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Posted in FDA |
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Tags: Articular Surface Replacement, ASR, DePuy, Johnson & Johnson, Metal hip
Mar 21st, 2012 |
By Jane Akre
March 23, 2012 ~ The SAFETY OF UNTESTED AND NEW DEVICES (SOUND DEVICES) ACT OF 2012 is a critical step to stop others from being harmed by untested, unsafe medical devices like synthetic surgical mesh, say patients harmed by synthetic surgical mesh. The Sound Devices Act, introduced by Rep. Edward Markey (D-MA) will give the
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Posted in Feature |
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Tags: 510(k), ASR, Bay Area Pelvic Surgery, bladder sling, Boston Scientific, DePuy, Edward Markey, FDA, Food and Drug Administration, J&J, pelvic organ prolapse, ProteGen Sling, Sound Devices Act, Tom Margolis, Truth in Medicine