Posts Tagged ‘ metal-on-metal hips ’

Scotland’s Health Secretary Calls for More Regulation and Informed Consent over Mesh

Nov 13th, 2013 | By
Scotland’s Health Secretary Calls for More Regulation and Informed Consent over Mesh

The Daily Record- the newspaper of Scotland – reports that due to front page headline reports by its sister publication, The Sunday Mail, the country’s Health Secretary, Alex Neil, is calling for tougher regulations concerning transvaginal mesh and more informed consent. The Sunday Mail, and reporter Marion Scott, have done a series of hard-hitting exposes
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FDA Steps Up Medical Device Monitoring – It’s About Time

Sep 24th, 2013 | By
FDA Steps Up Medical Device Monitoring – It’s About Time

Could the entire mesh mesh have been averted much sooner before perhaps one million women were implanted with controversial transvaginal mesh? Yes, if the U.S. tracked medical devices the way it’s done elsewhere. The Food and Drug Administration (FDA) is finally taking a step in that direction. The FDA has just announced a final rule
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Consumers Union: Manufacturers Should Warranty Knees and Hips

Sep 12th, 2013 | By
Consumers Union: Manufacturers Should Warranty Knees and Hips

Your big screen television and new car comes with a warranty- why not the most important medical purchase you will make in your life? Consumers Union, an arm of Consumer Reports, has come up with a novel and common sense approach. Manufacturers of medical devices should warranty their products. They claim they are safe and
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The Scandal of Defective Medical Device Approval in UK

Oct 29th, 2012 | By
The Scandal of Defective Medical Device Approval in UK

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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What Happened to the FDA Request for Transvaginal Mesh Studies?

Sep 19th, 2012 | By
What Happened to the FDA Request for Transvaginal Mesh Studies?

September 19, 2012 ~ Last January, after a five-fold increase in complications was noted by the U.S. Food and Drug Administration (FDA) concerning synthetic mesh used in women to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI), the FDA ordered mesh makers to find out why. At the time, the unprecedented request was
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Coming Up: FDA Expert Panel Weighs in on Metal Hips

Jun 20th, 2012 | By
Coming Up: FDA Expert Panel Weighs in on Metal Hips

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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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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Metal Hip Device Implant Sold in EU After Rejected in U.S.

Feb 15th, 2012 | By
Metal Hip Device Implant Sold in EU After Rejected in U.S.

February 15, 2012 ~ Barry Meier of the New York Times reports that Johnson & Johnson’s DePuy division continued to sell a defective artificial hip overseas even after it was rejected for sale in the U.S. Two related versions of the metal-on-metal hip, DePuy ASR were implanted in about 93,000 patients worldwide with about one-third
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Device Maker Smith & Nephew Pays $22 Million to Settle Bribery Case

Feb 6th, 2012 | By
Device Maker Smith & Nephew Pays $22 Million to Settle Bribery Case

Medical device maker, Smith & Nephew has been in the news lately as one of the manufacturers of metal-on-metal artificial hips. Now AP (here) reports the London-based company has agreed to pay $22.2 million to settle claims that its U.S. and German subsidiaries bribed public doctors in Greece for more than a decade to increase 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.