Posts Tagged 'early failure'

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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Use of metal hip implants declining

Use of metal-on-metal hip implants has been declining in recent years, in response to concerns that they may pose a safety risk for patients who receive them.

According to a Bloomberg report, use of the devices peaked in 2006 and 2007, when the metal-on-metal variety accounted for an estimated 30 percent of the market. Now the all-metal implant, with both a ...

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FDA panelists wouldn’t recommend metal implants

According to a story on WLFI out of Indiana, most members of a U.S. FDA panel said they would not recommend metal-on-metal implants for patients who needed hip replacement surgery.

The report quotes a physician on the panel as saying: “I do not use metal-on-metal hips, and I can see no reason to do so.”

At the FDA’s request, the 18-member panel of experts met for two days this week to discuss ...

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