Recent News

FDA Updates Guidance for Essure Birth Control

Essure is a hysteroscopic implant method of sterilization that provided a less invasive alternative to other hysteroscopic procedures used. The device is intended to provide women with a permanent form of birth control. However, over the past ten years, thousands of women have filed adverse effect reports with the FDA, detailing complications after receiving the…

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Defective INR Device Used in Xarelto Clinical Trials

In February 2016, BMJ, a medical journal based in the United Kingdom, published a report detailing the use of a faulty device in the Xarelto clinical trials. The Alere international normalized ratio (INR) monitoring device was used to measure blood clotting in patients taking warfarin during the ROCKET-AF clinical trials. The report reveals that the…

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Class I Recall for Cranial Image-Guided Surgery System

The FDA issued a Class I recall for the Brainlab Crainial image-guided surgery system. A Class I recall is the most serious kind issued by the FDA, requiring a manufacturer to take immediate and urgent action to remove affected products from the market.  The recall came after problems were reported regarding the navigation display on…

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Olympus Issues Recall for Unsafe Duodenoscope Devices

Olympus Corporation has issued a voluntary recall for the TJF-Q180V duodenoscope device. Duodenoscopes are used in more than 500,000 gastrointestinal endoscopic procedures each year. These devices are used during endoscopic retrograde cholangiopancreatography (ERCP) procedures to diagnose and treat conditions within the bile duct and main pancreatic duct, such as gallstones and cancer. The duodenoscope can…

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Justice for Victims of Transvaginal Mesh

On January 14, 2016, in Cisson v. C.R. Bard, Inc., the United States Court of Appeals for the Fourth Circuit affirmed a jury’s decision in favor of the plaintiff in a case from the United States District Court for the Southern District of West Virginia.  The ruling is an important step in the fight against…

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