Tag Archives: Safety Reviews

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Pradaxa Associated with more Complications than Warfarin, According to Early Study Findings

Early results from the largest study to date to compare Pradaxa and warfarin indicate that in a real-world setting, Pradaxa causes more complications than decades-old warfarin. The preliminary study results were announced last week, during the 2012 Thrombosis and Hemostasis Summit of North America.

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Stryker Issues Voluntary Recall for Rejuvenate Modular and ABG II Hip Implant Components

Stryker Orthopedics is recalling two metal-on-metal hip implant components, its Rejuvenate Modular and ABG II modular-neck hip stems. According to a notice posted on Stryker’s website, risks associated with the Rejuvenate Modular and ABG II modular-neck hip stems include the potential for fretting and/or corrosion at or about ...

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U.K. Regulators Issue Additional Guidance for Metal-on-Metal Hip Implant Recipients

Regulators in the U.K. are once again issuing advice to doctors and other healthcare professionals involved in the follow-up of patients with metal-on-metal hip replacement devices. In an alert issued by the Medicines and Healthcare products Regulatory Agency (MHRA), guidance is provided for four groups of metal-on-metal hip implant ...

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Birth Control Shot Depo-Provera may Increase HIV Risk

Birth Control Shot Depo-Provera may Increase HIV Risk, Study Suggests

A new study has linked the use of Depo-Provera (medroxyprogesterone acetate), an injectable type of birth control, to an increased risk of HIV infection.

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What Action Will the FDA Take on E-cigarettes?

What Action Will the FDA Take on E-cigarettes?

As health and quality concerns trouble the e-cigarette industry, experts and the public await the Food and Drug Administration (FDA)’s action to regulate the devices.

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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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Johnson & Johnson’s Ethicon Division to End Sales of Gynecare Prolift, Three Other Transvaginal Mesh Devices

Johnson & Johnson’s Ethicon Inc. division revealed yesterday that it will end sales of its Gynecare Prolift device and three other transvaginal mesh products. The plan to stop selling the four products was set forth in a letter filed by the company in the Ethicon transvaginal mesh multidistrict litigation ...

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Johnson & Johnson Marketing of Gynecare Prolift Transvaginal Mesh Raises More Questions

Johnson & Johnson and its Ethicon unit are again coming under scrutiny for the way it marketed its Gynecare ProLift transvaginal mesh product. According to a new report from Bloomberg News, Johnson & Johnson continued marketing the Gynecare ProLift device for months after it received a warning from the ...

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Bisphosphonate Study Confirms Atypical Thigh Fracture Risk

New research has confirmed the link between bisphoshonates, such as Fosamax, and atypical femur fractures, a type of thigh fracture that occurs spontaneously, without any major leg injury. The study, published in the Archives of Internal Medicine, also found that the risk of atypical thigh fractures increases the longer a ...

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New Legislation Outsources Medical Device Safety Reviews

Medical-Device-Safety-Reviews

Consumer groups and health advocates are concerned about legislation just passed by the House of Representatives that would make it easier for medical devices to reach the market and would put safety determinations in the hands of subcontractors paid by … Continue reading

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

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