Senators Call for a Much Broader Recall of Defective Takata Airbags After a Recent Death

With millions of cars containing potentially defective airbags made by Takata still on the road, two senators on Tuesday urged the Obama administration to significantly expand the airbag recalls.

Richard Blumenthal of Connecticut and Edward Markey of Massachusetts, both Democrats, called on the Obama administration in a letter to force the recall of every Takata...

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J&J to Pay $120 Million in Its First Big Mesh Settlement

Johnson & Johnson has made its first serious move to settle thousands of lawsuits filed by women who fault the company’s vaginal-mesh inserts for their injuries, according to people familiar with the matter.

The medical-device maker agreed to pay more than $120 million to resolve 2,000 to 3,000 suits alleging women suffered organ damage and...

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Senate Report Says FDA Fails to Ensure Medical Devices Are Safe

America’s system for ensuring that medical devices are safe failed at every turn when dirty endoscopes began spreading deadly superbugs, according to a Senate investigation released today.

The report, from Senator Patty Murray, a Washington Democrat, blames device manufacturers, hospitals, and the Food and Drug Administration

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FDA Reclassifies Surgical Mesh for Pelvic Organ Prolapse as ‘High Risk’

The FDA has reclassified surgical mesh used to repair pelvic organ prolapse as “high risk,” citing thousands of reports of complications involving its use. The classification requires manufacturers to complete a rigorous application process demonstrating the safety and effectiveness of the implant. Companies with products already on the market have 30 months...
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Keyless Automobile Ignition Systems Are Fatally Flawed, Critics Say

You wouldn't deliberately leave your car running after you pull into the garage, but if that car has a keyless push-button ignition you could forget to turn it off. With an attached garage, the carbon monoxide spewing out of the tailpipe could very easily seep into your house, causing illness or death.

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FDA Tightens Rules for Mesh Device Used in Some Pelvic Surgeries

The Food and Drug Administration is tightening regulations for surgical mesh products used to repair a condition known as pelvic organ prolapse, following years of scrutiny by the U.S. regulator and many lawsuits by women who allege they have suffered harm from such products.

The products will be reclassified as high-risk rather than moderate-risk...

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