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bleeding 56 articles

Lawsuit against Bayer claims Mirena IUD migrated to rectum

Jennifer Martin was shocked when she learned in September 2012 that she was pregnant. Two months earlier she had gotten a Mirena IUD contraceptive device. An ultrasound confirmed the pregnancy but did not offer any clues as to where the IUD had gone. It was a perplexing mystery, and one that had to be resolved. Shortly after, Jennifer had a miscarriage. A month later, her doctor performed surgery to conduct an extensive search for the IUD among her internal organs, including the liver, spleen and stomach. The intrauterine device was eventually found in her rectum. Bayer Healthcare faces more than ... Read More

Federal jury hits Ethicon transvaginal mesh with $3.27 million verdict

Jo Huskey had no idea the turn her life would take after having a 30-minute procedure to implant Ethicon’s transvaginal mesh device in her body to correct urinary incontinence. Plaintiffs attorneys and their witnesses painted a picture for jurors of how the defectively designed device could erode into tissue and puncture neighboring organs causing serious complications from excruciating pain and incontinence to bleeding and infections. The jury responded with a $3.27 million verdict against Johnson & Johnson subsidiary Ethicon, finding the bladder sling was defectively designed and the company failed to warn the public of the potential risks. The product ... Read More

Another transvaginal mesh trial is underway in West Virginia

Another trial is underway in Charleston, W.Va., alleging defectively designed transvaginal mesh products caused serious injuries. The federal lawsuit was filed by Jo Huskey and her husband Allen against Ethicon Inc. and Johnson & Johnson. Transvaginal mesh, also referred to as vaginal mesh or bladder sling, is a type of surgical mesh used to treat pelvic floor disorders including pelvic organ prolapse and stress urinary incontinence. It is inserted through the vagina to hold up organs that have prolapsed out of place, putting pressure in the pelvic cavity and causing symptoms such as pain, discomfort and incontinence. The mesh has ... Read More

FDA approves new at-home colon cancer screening test

The Food and Drug Administration (FDA) has approved a new at-home stool sampling test that can detect colon cancer with more than 90 percent accuracy. The FDA gave unanimous approval to Exact Sciences Corp.’s Cologuard, a DNA-based test, finding it offered patients and physicians another option to screen for colorectal cancer. “Fecal blood testing is a well-established screening tool, and the clinical data showed that the test detected more cancers than a commonly used fecal occult (blood) test,” said Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health at the FDA’s Center for Devices and Radiological Health. ... Read More

Transvaginal mesh lawsuits continue three years after FDA warning

It has been three years since the Food and Drug Administration (FDA) issued a Safety Communication warning the public that complications with transvaginal mesh used to treat pelvic floor disorders including pelvic organ prolapse and stress urinary incontinence were not uncommon and could be chronic or life threatening. Since then, lawsuits against manufacturers of the devices have grown exponentially. Trasvaginal mesh, also known as vaginal mesh, pelvic mesh, or bladder sling, is a type of surgical mesh that is inserted through the vagina to support organs that have dropped due to age, childbirth, obesity or other conditions. The mesh is ... Read More

Judge denies Ethicon’s request for new transvaginal mesh trial

Johnson & Johnson subsidiary Ethicon has been denied a new trial that would have struck an $11.1 million verdict in the first bellwether trial over allegedly defective transvaginal mesh. “There was strong evidence presented and multiple sources of evidence that in fact there were many problems with this product,” Atlantic County Superior Court Judge Carol Higbee said in court. Despite the ruling, Ethicon spokesman Matthew Johnson said the company isn’t giving up. “We will be filing an appeal in this case as we believe the jury’s verdict and damage awards were not supported by the evidence presented at trial,” he ... Read More

Physicians groups recommend six-step evaluation before women undergo bladder sling surgery

Physicians do not need to perform preoperative urodynamic testing, or bladder test functioning, on patients with uncomplicated stress urinary incontinence (SUI) before having surgery to implant a bladder sling to treat symptoms because doing so does not improve surgical outcomes, according to first-time guidelines from the American College of Obstetricians and Gynecologists and the American Urogynecologic Society. Instead, the two medical groups recommend that physicians perform a basic six-step evaluation on women with uncomplicated SUI. This is the first time guidelines have been established to provide consistency in the evaluation of uncomplicated SUI, setting standards for physicians before they operate ... Read More

New Zealand woman demands inquiry into safety of transvaginal mesh

Jen Branje, 45, is petitioning Parliament in New Zealand to investigate injuries caused by transvaginal mesh, claiming the mesh is dangerous and should be banned until an inquiry examines serious risks associated with the devices. Transvaginal mesh, also called vaginal mesh or bladder sling, is a type of surgical mesh used to treat pelvic floor disorders in women, such as pelvic organ prolapse and stress urinary incontinence. Mounting reports of injuries associated with the devices prompted the U.S. Food and Drug Administration (FDA) to conduct an investigation in which the agency found that complications with the device were not uncommon and ... Read More

Low dose aspirin therapy may help prevent pancreatic cancer

A low, daily dose of aspirin has been praised for its cardiovascular benefits, but new research shows that the therapy may also ward off pancreatic cancer, one of the deadliest forms of the disease. The study, conducted by researchers at the Yale School of Public Health, claims daily low-dose aspirin therapy can lower pancreatic cancer risk by up to 48 percent. Low-dose aspirn therapy has already been credited for reducing risk of ovarian, colorectal, stomach, esophageal, prostate, breast, lung, and skin cancers. Researchers studied information on aspirin use and medical histories for 362 people with pancreatic cancer and 690 people ... Read More

Fecal management systems recalled due to serious injuries, death

A recall of all ConvaTec Flexi-Seal CONTROL Fecal Management System Kits has been issued following 12 reports of serious injuries and one death at U.S. health care facilities related to the products. The adverse events were reported from February 2013 through March 2014. The device is not approved by the Food and Drug Administration (FDA) and no application has ever been submitted to the agency for review. The Fecal Management System Kits are used in health care facilities to manage fecal incontinence through the collection of liquid to semi-liquid stool and to provide access to administer medications as prescribed by ... Read More