Daily Archives: September 22, 2015

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FDA Questions Device Makers about Duodenoscope Cleaning Procedures

Following Deadly Outbreaks, FDA Questions Device Makers about Duodenoscope Cleaning Procedures

In light of a recent outbreak linked to contaminated duodenoscopes, the U.S. Food and Drug Administration (FDA) is questioning manufacturers about their methods for cleaning the devices, the New York Times reports. The specialized scopes, which have been linked to several outbreaks in recent years, most recently infected seven patients ...

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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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Long Island Car Crash Kills 1 Person, Injures 2 More

Long Island Car Crash Kills 1 Person, Injures 2 More

A car accident on LI left one person dead & two more critically injured. The crash occurred Monday in Deer Park on Straight Path, south of Sagamore Lane.

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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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Toxic Nano-Particles from Failing Metal-on-Metal Hip Replacements May Pose Long-Term Health Risks

According to a new study, failing metal-on-metal hip implants generate toxic nano-particles that release Cobalt 2+ ions, which not only cause inflammation in surrounding tissue, but have the potential to cause long-term damage to the genetic material of cells. According to a report published by Medicalxpress.com, this “genotoxicity” could ...

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National Law Firms Calls for More FDA Action on Actos Bladder Cancer Threat

A national law firm is not satisfied with the way the U.S. Food & Drug Administration (FDA) has handled warnings regarding Actos (pioglitazone) bladder cancer risks. In a statement published today, Parker Waichman LLP called on the FDA to compel Takeda Pharmaceuticals, the maker of the type 2 diabetes drug, ...

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Smith & Nephew Says Metal-on-Metal Hip Replacement Controversy Slowing Sales of Birmingham Hip Resurfacing System

Medical device maker Smith & Nephew has reported a drop in sales of its metal-on-metal hip implant devices. According to the company, hip implant sales were down 2 percent during the first quarter of 2012, largely because its Birmingham Hip Resurfacing System suffered from an association with other metal-on-metal hip ...

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Canadian Study Finds Actos Raises Bladder Cancer Risk by 22 Percent

Yet another study is confirming the association between the diabetes drug, Actos, and bladder cancer. This latest research, published today in the Canadian Medical Association Journal, found that taking Actos raised the risk of bladder cancer among diabetics by about one-fifth.

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Zadroga Act Cancer Decision Expected This Week

The federal official tasked with determining what ailments should be covered by the federal Zadroga Act is expected to decide by Saturday if certain cancers will be eligible for compensation. The decision is being eagerly awaited by thousands of first responders who believe they developed cancer due to exposure ...

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FDA Panel to Reevaluate Essure Birth Control Method

Medical experts will meet on Thursday to take a closer look at problems reported with the birth control implant Essure, including chronic pain, bleeding, headaches, and allergic reactions. On September 24, the Obstetrics and Gynecology Devices Panel of the Medical Devices … Continue reading

Posted in Defective Medical Devices, Essure |

New Study Finds Public May Misunderstand FDA “Breakthrough” Designation for New Drugs

In a newly published article in JAMA Internal Medicine, researchers say the U.S. Food and Drug Administration (FDA) should be cautious in using words like “breakthrough” and “promising” when making announcements about new drugs because the public may not understand … Continue reading

Posted in Pharmaceuticals |

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