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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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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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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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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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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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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