Daily Archives: August 25, 2016

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Scientist Calls for Federal Regulations for Fracking Pollution

Hydraulic fracturing (fracking) drilling should be governed by federal regulations because its pollution has no awareness of state boundaries.

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FDA Warning for Bone Graft Products in Patients Under 18

FDA Safety Warning for Bone Graft Products in Patients Under 18

FDA issued safety alerts to patients, parents & guardians, bone graft devices w/recombinant proteins or synthetic peptides not to be the first treatment for 18 & under.

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Smith & Nephew Recalls Metal-on-Metal Hip Implant Component

Medical device maker, Smith & Nephew, just issued a recall for a metal-on-metal hip implant component, a part of one of its all-metal hip replacement systems.

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FDA Urged to Ban Powdered Caffeine

FDA Urged to Ban Powdered Caffeine

Pennsylvania Senator Robert Casey has written to the Food and Drug Administration (FDA) to urge the agency to ban powdered caffeine, a dietary supplement.

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Smokers More Vulnerable to Joint Replacement Failures

People who smoke cigarettes before and after receiving a total joint replacement, such as a hip replacement device or knee implant, are far more likely to endure revision surgeries on those implants than people who don’t smoke.

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Medtronic Sprint Fidelis Leads Vulnerable to Fracture after ICD Switch

Medtronic Sprint Fidelis leads are vulnerable to fracture following ICD switch, says a new study published in the June issue of the journal Heart Rhythm.

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FDA Advisory Panel Wrestling with Metal-on-Metal Hip Replacement Safety

An advisory panel for the U.S. Food & Drug Administration (FDA) began a highly-anticipated meeting yesterday to discuss the safety of metal-on-metal hip implants. Among other things, the panel of outside experts is being asked to make recommendations regarding the best practices for monitoring patients with metal-on-metal hip replacements. ...

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FDA Advisors Set to Examine Metal-on-Metal Hip Implant Safety Concerns

Thousands of people with metal-on-metal hip implant devices could soon get some answers from the U.S. Food & Drug Administration (FDA) about the dangers they face. Tomorrow, the agency will convene a panel of outside medical experts to examine the safety record of metal-on-metal hip replacements, and recommend the ...

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First Bard Avaulta Transvaginal Mesh Lawsuit Scheduled for February Trial in MDL

The first test trials in the federal C.R. Bard Avaulta transvaginal mesh litigation will most likely start next year, according to a report from Bloomberg News. About 600 lawsuits involving Bard Avaulta transvaginal mesh products are currently pending in the multidistrict litigation underway Charleston, West Virginia. U.S. District Judge Joseph ...

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New York City Council Calls for Zadroga Act to be Renewed

New York City Council Calls for Zadroga Act to be Renewed

New York City Council members are calling for the Zadroga Act, which provides compensation and medical treatment to 9/11 victims, to be renewed. According to press release issued Jan. 7, a resolution was introduced by Council Member Margaret Chin, Council Speaker Melissa Mark-Viverito and Council Members Paul Vallone and I. ...

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McDonald’s Recalls 29 Million Fitness Bands Due to Reports of Skin Irritation

McDonald’s Recalls 29M Fitness Bands Due to Skin Irritation

Following reports of skin irritation and burns, McDonald’s is recalling 29 million “Step It!” fitness trackers included in some Happy Meals. According to a statement from the U.S. Consumer Product Safety Commission, McDonald’s received more than 70 reports of adverse … Continue reading

Posted in Defective Products, Health Concerns, Product Recalls | Tagged , , , , , |

Analysis Raises Questions about How Device Makers Label Patient Deaths

Questions Rise about How Device Makers Label Patient Deaths

Medical device manufacturers are required to report any event that “reasonably suggests a device may have caused or contributed to a death or serious injury.” Madris Tomes, a former FDA consultant, conducted an analysis showing that 4,000 patient deaths were … Continue reading

Posted in Defective Medical Devices, Health Concerns | Tagged , , , , , , , |

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