A 2011 internal report from Johnson & Johnson concluded that the company’s metal-on-metal hip implants would fail within five years in nearly 40 percent of patients, requiring them to undergo painful and costly replacement procedures.
A story in the New York Times says Johnson & Johnson recalled the device, made by subsidiary DePuy Orthopaedics, in 2010. Yet even as the company ...
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A Pennsylvania woman has filed a federal lawsuit against Bayer over complaints that the German drugmaker failed to provide adequate warning of health risks associated with its contraceptive Mirena, Bloomberg reports.
Mirena is an intrauterine device that prevents pregnancy for as long as five years. According to the lawsuit that Tricia Prendergast filed in Philadelphia, Bayer doesn’t warn that it can become embedded in the body or cause an ectopic pregnancy. Prendergast claims she required surgery to remove ...
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Legal documents released in Johnson & Johnson’s trial regarding all-metal hip implants reveal that the company was aware of problems with the devices in 2008 – two years before recalling them, the Wall Street Journal reports.
For example, the company was in possession of clinical data showing “extreme” levels of metal ions in patients who received the devices, compared to patients who received a product from a rival company. The all-metal ...
continue reading...The U.S. Food and Drug Administration has sent a warning letter to medical device manufacturer St. Jude Medical, warning of problems with manufacturing and quality control at the California plant where the company makes implantable heart defibrillators.
A story in the New York Times notes that the St. Paul-based company has been struggling to deal with problems involving wires that are used to attach the defibrillator to the heart. The wires ...
continue reading...The U.S. Food and Drug Administration is proposing a policy that could prevent manufacturers from selling dangerous metal-on-metal hip implants, according to a story in the New York Times.
The story says all-metal hips – which have both a ball and a socket coated with a combination of cobalt and chromium – have been plagued by high early failure rates.
Traditional hip ...
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The U.S. Food and Drug Administration says metal-on-metal hip implants, which feature both a ball and a socket coated in a mixture of cobalt and chromium, can cause soft-tissue damage. According to a Reuters story, the agency warns that the implant defects can make further surgery necessary.
The problem, according to the FDA, is that the implants can shed metal debris when the ball and socket slide against each other during ...
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