Posts Tagged ‘ ASR ’

FDA Panel – No Decision on Metal Hips

Jun 30th, 2012 | By
FDA Panel – No Decision on Metal Hips

  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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New J & J CEO Plans to Expand Medical Device Industry

Apr 30th, 2012 | By
New J & J CEO Plans to Expand Medical Device Industry

  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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FDA Expert Panel to Assess Metal Hips

Mar 30th, 2012 | By
FDA Expert Panel to Assess Metal Hips

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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Johnson & Johnson Began Phasing out DePuy Defective Hip Prior to Recall

Mar 23rd, 2012 | By
Johnson & Johnson Began Phasing out DePuy Defective Hip Prior to Recall

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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Call to Action: Citizens Lend Support to Sound Devices Act

Mar 21st, 2012 | By
Call to Action: Citizens Lend Support to Sound Devices Act

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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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.