Product News and Recalls

FDA called “sheriff packing a waterpistol”

Amid evidence that Johnson & Johnson continued to sell a dangerous vaginal mesh implant for nine months after the U.S. Food and Drug Administration ordered it to stop, some observers are questioning whether federal regulatory agencies are currently able protect consumers.

A Bloomberg story quotes University of Michigan business professor Erik Gordon as saying that the issue points out “the industry’s ability to shrug off FDA enforcement. If companies can get ...

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New safeguards needed for pharmaceutical companies

An opinion piece in The Atlantic about the $3 billion settlement against GlaxoSmithKline makes the point that even a relatively large financial penalty is unlikely to stop a company that still makes a profit from illegal activities. The solution, The Atlantic says, is to change a system that essentially allows companies to monitor themselves.

The British drugmaker’s agreement with the U.S. Justice Department to pay $3 billion in criminal and civil ...

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Metal hip components recalled

Stryker Corp. of Kalamazoo, Mich., has announced a voluntary recall of components used in metal hip joints.

A report on CBS 62 in Detroit says Stryker’s Rejuvenate and ABG II modular-neck stems, despite their names, are used in hip implants.

Stryker said the recall was based on reports from the field of corrosion and “fretting,” which is corrosion made worse by abrasive wear. A Stryker news release says: “These risks include the ...

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Researchers study computer-related blood clots

British and New Zealand scientists will conduct a study of “e-thrombosis,” or potentially deadly blood clots that can develop when people spend extended periods of time sitting in front of computers.

A Daily Express article on the study characterizes the phenomenon as a “silent killer” that could be affecting thousands of office workers in the U.K. alone.

Deep vein thrombosis occurs when a blood clot forms in one of the deeper veins, usually in the leg. It can be deadly if a ...

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Blood clot diagnosis requires special testing

According to the federal Centers for Disease Control and Prevention, diagnosis of deep vein thrombosis – the formation of a blood clot in one of the deeper veins – can be tricky. So can diagnosis of pulmonary embolism, which occurs when a blood clot breaks off and travels to the lungs.

That’s because other conditions produce similar symptoms. For example, muscle strains and swelling of veins close to the skin can ...

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Mesh implant injures women

A report in the Salt Lake Tribune concerns 50 Utah women who have joined thousands of plaintiffs nationwide in lawsuits against vaginal mesh manufacturers.

The report includes an interview with an unnamed Utah woman in her 50s who had the device implanted in order to treat a leaky bladder. Not only did the device fail to cure problems, but it also caused her constant pain in addition ...

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