Posts Tagged 'hip implants'

FDA spied on own scientists

The New York Times reports that the U.S. Food and Drug Administration conducted a wide-ranging surveillance operation against its own scientists.

The agency used “spy software” designed to help employers monitor workers, and captured screen images from the government laptops of scientists as they were being used at work or at home.

Though federal agencies have broad discretion to monitor their employees’ computer use, the F.D.A. program may have crossed legal lines ...

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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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Consumers Union applauds medical device proposal

The Consumers Union, the policy and advocacy division of Consumer Reports, has put out a statement applauding the federal Food and Drug Administration’s proposed regulation to establish a “unique identification system” for medical devices marketed in the U.S.

The proposal calls for high-risk devices to carry identification numbers. For most medical devices, the UDI will include a device identifier, which is a unique code tied to a specific device model, and a production identifier, which includes production information for the device.

The ...

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Johnson & Johnson has history of ethical lapses

Johnson & Johnson will reportedly pay a settlement in the neighborhood of $2 billion to settle federal charges that the company used illegal tactics in marketing its antipsychotic drug Risperdal.

The federal probe prompting that settlement included investigations into the company’s alleged kickbacks to Omnicare Inc., a company that dispenses drugs at nursing homes, to boost sales of certain medicines.

In light of Johnson & Johnson’s enormous profits, some observers have questioned ...

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FDA unveils plan to track medical devices

The federal Food and Drug Administration has unveiled a plan to track high-risk medical devices.

A Wall Street Journal report on the policy says that it would require the high-risk devices to carry identification numbers. Jeffrey Shuren, director of the FDA’s medical-device center, described the plan as “a major game-changer” and said the agency plans to ramp up efforts to identify malfunctioning medical devices early.

For a long time, public safety advocates ...

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FDA cautions surgeons implanting all-metal joints

Members of a U.S. Food and Drug Administration panel that recently discussed metal-on-metal artificial hip implants said they wouldn’t recommend that patients get them, although the FDA as a whole has so far stopped short of an official ruling on the devices.

Still, the FDA Website has a section advising orthopedic surgeons who are performing metal-on-metal hip implantation surgery. And the FDA’s recommendations clearly reflect concerns about the devices shedding toxic ...

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