Recent News
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…
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…
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…
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…
Duodenoscope Manufacturer Chose Not to Warn of Risks
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…
The Fight Against Power Morcellators
Power morcellators are surgical devices that grind uterine fibroids into fragments for removal through small incisions in the abdomen. Unfortunately, there are no reliable methods to determine, prior to surgery, whether a fibroid contains hidden uterine cancer. The inability to rule out cancer prior to using the morcellator makes the laparoscopic supracervical hysterectomy using a…
What Patients Should Know about IVC Filters
What is the issue with IVC filters? IVC filters are implanted into the inferior vena cava vein of patients with deep vein thrombosis, and are intended to be used temporarily to block dangerous blood clots—known as pulmonary embolisms—from reaching a patient’s lungs. However, the filters have become the subject of hundreds of FDA adverse effect…
Update: Unsafe Duodenoscope Devices
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 help to drain fluid from bilary and pancreatic ducts that are blocked…
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…
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…