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 procedure, during which the balloons…
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 range of motion than previous…
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 pose problems to medical professionals…
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 warnings and multiple lawsuits after…
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 power morcellator a high risk…
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 Essure implant. The most common…
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 by tumors, gallstones or other…
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 device was recalled 3 years…
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 the device. The Brainlab Cranial…
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 medical device makers that endanger…