Tag Archives: Premarket

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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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Metal-on-Metal Hip Replacement Device

Smith & Nephew’s Birmingham Metal-on-Metal Hip Replacement Device

Wright Medical Inc. took steps in to 2006 to convince the U.S. Food & Drug Administration (FDA) to reject pre-market approval of rival Smith & Nephew’s Birmingham metal-on-metal hip implant. Wright Medical, which makes two metal-on-metal hip replacement devices, the Conserve and the Lieneage device, filed a citizen petition ...

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Government Penalizes 721 Hospitals for High Rates of Infections, Injuries

Medicare is reducing payments to 721 hospitals, one out of every seven hospitals in the nation, for having high rates of “hospital-acquired” conditions (HAC.

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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.

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Whistleblower Wins Retaliation - Canaveral National Seashore

Whistleblower Wins Retaliation Lawsuit

A whistleblower who reported misconduct at Canaveral National Seashore has won a retaliation ruling against the U.S. Department of Interior, Florida Today reports.

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Post -Tonsillectomy Morphine Life-Threatening in Children

Post -Tonsillectomy Morphine can be Life-Threatening in Children, Study Finds

A new study published in Pediatrics suggests that morphine can result in life-threatening respiratory problems when given to children after a tonsillectomy.

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Exposure to Common Pesticide May Increase ADHD Risk

Exposure to Common Pesticide May Increase ADHD Risk

A new study has found that exposure to a common household pesticide may increase the risk of attention deficit hyperactivity disorder (ADHD) in children.

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Stryker Metal Hip Implant Component Recall Bad News for Makers of Metal-on-Metal Hip Replacement Devices

Stryker’s recent recall of two metal hip implant components, the Rejuvenate Modular and ABG II modular-neck hip stems, may have dealt a serious blow to one of the key arguments medical device manufacturers have made to defend their metal-on-metal hip replacements. Facing thousands of lawsuits, the makers of ...

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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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New York Property Owners Challenge Binghamton Fracking Ban

According to a Reuters report, the landowners believe the Binghamton, N.Y., city council and Mayor acted against proper protocol when voting to ban fracking drilling the the city. Instead, they feel the city should have consulted with the Broome County Planning Commission before approving the ban.

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Premarket Approval for Essure Birth Control Device Was Fraudulent, Patients Say

premarket-approval-Essure

Patients involved in the clinical trials conducted in connection with the premarket approval application (PMA) for the Essure birth control device say that patient records were altered to show favorable results despite patient reports of problems. The Food and Drug … Continue reading

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

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