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Peter Angelos Law Legal Blog

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

by | Mar 28, 2017 |

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, […]

FDA Confirms Link Between Breast Implants and Cancer

by | Mar 27, 2017 |

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 […]

Class I Recall: Zimmer Biomet Comprehensive Reverse Shoulder

by | Feb 28, 2017 |

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 […]

Dangerous Infection Associated with Heater-Cooler Devices

by | Feb 28, 2017 |

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 […]

FDA: Adverse Events Reported for Intragastric Balloons

by | Feb 16, 2017 |

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 […]

FDA Warning: Rare but Serious Allergic Reactions from Skin Antiseptic

by | Feb 8, 2017 |

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 […]

Jury Awards Damages to Metal on Metal Hip Victims

by | Feb 8, 2017 |

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 […]

Takata Airbag Recall Grows in 2017

by | Feb 8, 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 […]

Duodenoscope Manufacturer Chose Not to Warn of Risks

by | Jan 25, 2017 |

UPDATE: On January 17, 2017, the United States Food and Drug Administration updated safety information regarding the Pentax ED-3490TK video duodenoscope. Within this update, the FDA warned consumers that the device had the capacity to crack—making the transfer of fluids and bacteria to the device possible. Similar to other duodenoscope devices, the Pentax device can […]

Xarelto®: A Year in Review

by | Jan 11, 2017 |

In November, 2015, the U.S. District Court for the Eastern District of Louisiana announced that the first of the Xarelto® bellwether trials, stemming from the Xarelto® multidistrict litigation, would begin in February, 2017. Since that announcement, there have been many updates in the ongoing legal battle against Xarelto® manufacturer Bayer AG and distributer Janssen Pharmaceuticals. […]

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