Recent News

Government Agency Cites Gaps in FDA’s Reporting System In Power Morcellator Report

In August 2015, The Government Accountability Office (GAO) received requests from 12 US Congress Representatives to investigate the FDA’s handling of adverse event reports regarding laparoscopic power morcellator devices. Such reports claimed that the use of laparoscopic power morcellators spread cancer in those being treated for uterine fibroids. Early this year, the GAO released a…

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CDC Report Suggests Increase in Mesothelioma-Related Mortality Rate

In early March, the Center for Disease Control and Prevention (CDC) released a report that indicated an increase in the mortality and the morbidity of individuals diagnosed with Mesothelioma. Mesothelioma is an aggressive and rare form of cancer that has been linked to asbestos exposure. The disease affects the lining of the lungs, or the…

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FDA Awards Research Grant For Studies Assessing Talc-Ovarian Cancer Risk

Research grants for studies aimed at aiding regulatory decisions and advancing the study of women’s health were awarded by the FDA Office of Women’s Health (OWH). Since 1996, The Office of Women’s Health has funded nine (9) research projects that address medical issues which affect women. The project of the 2016 grant recipient, Nakissa Sadrieh,…

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FDA Confirms Link Between Breast Implants and Cancer

The Food and Drug Administration has announced that those who undergo breast augmentation using breast implants have an increased risk for developing anaplastic large cell lymphoma—a rare form of non-Hodgkins lymphoma. According to safety communications, the FDA identified a possible link between the implants and anaplastic large cell lymphoma (ALCL) in 2011. At the time…

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Dangerous Infection Associated with Heater-Cooler Devices

The medical device liability attorneys at The Law Offices of Peter Angelos provide important health-risk information related to heater-cooler devices. Nearly sixty percent of hospitals in the United States use heater-cooler systems to maintain internal body temperature and consistent blood circulation during invasive surgical procedures—approximately 250,000 procedures each year. However, recent reports suggest that the…

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Class I Recall: Zimmer Biomet Comprehensive Reverse Shoulder

Zimmer Biomet has issued a Class I recall for its Comprehensive Reverse Shoulder as the devices have exhibited higher rates of fracturing than previously stated. In December 2016, Zimmer Biomet issued an Urgent Medical Device Recall Notice to customers who may have undergone surgery in which a Comprehensive Reverse Shoulder was implanted.  This recall has…

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FDA: Adverse Events Reported for Intragastric Balloons

The ReShape Integrated Dual Balloon System and the Orbera Intragastric Balloon System are fluid-filled weight loss systems used to surgically treat obesity. Both systems were approved by the FDA in 2015 to be used by patients in conjunction with diet and exercise programs. Placement of the systems requires patients to undergo a minimally invasive endoscopic…

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Takata Airbag Recall Grows in 2017

Over the past two years, Takata has remained at the center of the largest automobile vehicle recall ever recorded in the United States. This is because the airbags that the manufacturer produces, which are standard in over 45 different models of cars made between 2000 and 2008, were found to be defective and potentially dangerous…

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Jury Awards Damages to Metal on Metal Hip Victims

Last month, a Texas jury awarded more than $1 billion in damages to plaintiffs who claimed they suffered injuries after receiving DePuy Pinnacle metal-on-metal hip implants. Metal-on-metal hip implants, such as the DePuy Pinnacle implants, are surgical devices used during hip replacement surgery that have been claimed to be more durable and provide a greater…

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FDA Warning: Rare but Serious Allergic Reactions from Skin Antiseptic

On February 2, 2017, the Food and Drug Administration (FDA) issued a warning regarding reports of rare but serious allergic reactions on the skin of individuals who have used over-the-counter (OTC) products containing chlorhexidine gluconate. The FDA has requested that manufacturers, which produce antiseptic containing the ingredient, issue a warning detailing the risk on the…

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