Tagged Articles

quality of life 13 articles

FDA panel questions safety, efficacy data for proposed COPD treatment

The Food and Drug Administration (FDA) questioned the validity of an experimental drug for the treatment of chronic obstructive pulmonary disease (COPD), cautioning its panel of advisors that the data is incomplete and may not give a clear picture of efficacy and potential adverse reactions. The treatment, called Anoro Ellipta, is a combination of two drugs, umeclidinium and vilanterol, neither of which has been approved by the FDA as a single therapy. Anoro Ellipta is manufactured by GlaxoSmithKline and Theravance Inc. The two companies in May had secured FDA approval for another COPD drug, Breo Ellipta, and had hoped to keep ... Read More

Dry, itchy skin causes dialysis patients to skip appointments for treatment

Dialysis patients who feel itchy are less likely to keep their appointments, which can make patients more susceptible to serious health complications including heart problems and infections, new research shows. Dry, itchy skin, also known as pruritus, is a problem that affects dialysis patients, but no one really understands why. Because it is not considered a life threatening condition, pruritus has often been overlooked by health care professionals more concerned with more serious complications. However, in the past couple of years dialysis organizations have taken more of an interest in quality of life issues with patients since those issues are ... Read More

Study shows transvaginal mesh removal often requires multiple surgeries

Nearly a quarter of women who have experienced problems with surgical mesh to repair pelvic floor disorders have had to undergo multiple procedures to have the mesh removed in order to alleviate serious pain and other complications caused by the mesh, according to a study conducted by UCLA urologists. The study included data from 236 women who underwent 319 mesh removal procedures during a six-year period from July 2005 to July 2011. Nearly 60 percent of the women had the mesh to treat pelvic organ prolapse (POP), and 86 percent had sling mesh, or a bladder sling, to treat urinary ... Read More

Cancer drug fails to extend life in patients with advanced lung cancer

A drug tested in patients with advanced lung cancer has failed to increase the chances of survival. Nexavar (sorafenib), made by Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals, is already approved by the Food and Drug Administration (FDA) to treat some forms of liver and kidney cancer. Researchers had hoped the medication would also benefit patients with advanced relapsed or refractory non-squamous non-small cell lung cancer whose disease had progressed after previous treatments. The drug, however, did not meet the goal of improving overall survival in patients with late-stage lung cancer. The study involved more than 700 people with the disease, ... Read More

Women who may have been injured by transvaginal mesh can file lawsuit

Women who have received transvaginal mesh or bladder slings to repair pelvic floor disorders such as pelvic organ prolapse (POP) or urinary incontinence and are experiencing problems, may not realize that they may be able hold the manufacturer of the devices liable and receive compensation for their pain and suffering. Transvaginal mesh is a type of surgical mesh that is implanted through the vagina to shore up organs that may have dropped, or prolapsed, due to age, obesity or childbirth. These pelvic floor disorders are relatively common conditions and can cause symptoms such as urinary incontinence, and pain or discomfort. ... Read More

Consumers Union fights for more oversight of medical devices

The Consumers Union (CU) is hoping to close a loophole in the approvals of medical devices that allows them to be cleared for marketing in the United States with almost no government regulation, testing or monitoring. According to its mission statement, CU is an expert, independent, nonprofit organization whose mission is to work for a fair, just, and safe marketplace for all consumers and to empower consumers to protect themselves. CU also publishes the magazine Consumer Reports and the website ConsumerReports.org. Currently, medical devices considered moderate-risk, such as transvaginal mesh and artificial hips, are approved through an accelerated process that ... Read More

Woman files lawsuit against transvaginal mesh manufacturer

For years, Mary Ann McCloskey didn’t know what was wrong with her. It was as if her internal organs were revolting against her body. She endured pain, internal bleeding, and multiple surgeries. Her quality of life plummeted. It wasn’t until February 2010, that Mary Ann discovered her problem wasn’t a medical mystery, but was likely caused by the transvaginal mesh surgically implanted in her pelvis during a medical procedure she received in 2006. The surgical mesh had eroded into her vaginal wall, causing pain and severe complications. Mary Ann is suing C.R. Bard, manufacturer of the Bard pelvi soft acellular ... Read More

FDA wants more data on safety of transvaginal mesh

Manufacturers of surgical mesh used to repair pelvic floor disorders including pelvic organ prolapse (POP) and stress urinary incontinence (SUI) are being asked by the Food and Drug Administration (FDA) to conduct new studies on the safety of the products. The review is in response to mounting complaints associated with the transvaginal use of the mesh. Inserted through the vagina to shore up organs that have slumped from childbirth or obesity, the mesh offers an attractive non-invasive alternative to surgical repair. However, complaints show that the mesh often over time begins to erode into the vaginal wall. This causes pain, ... Read More

One in six women experiences complications with transvaginal mesh

Twelve months after surgery, one in six women who had mesh implants to repair vaginal prolapse experienced complications and many required additional surgeries, according to a study published in the American Journal of Obstetrics & Gynecology. Vaginal prolapse, or pelvic organ prolapse, is a common disorder in women caused by age, childbirth or obesity. It can cause pain during sexual intercourse, urinary incontinence, or a general discomfort. Surgical procedures often but not always involve a type of surgical mesh known as transvaginal mesh. The study involved 65 women with vaginal prolapse who underwent surgical repair for their conditions. Thirty-two of ... Read More

New incontinence treatment offers non-invasive alternative to mesh

A treatment for stress urinary incontinence (SUI) is showing promising results in clinical studies, according to data introduced at two professional society meetings this fall – the annual national Scientific Meeting of the American Urogynecologic Society (AUGS) and the South Central Section of the American Urological Association. The new SUI treatment known as Renessa and developed by Novasys Medical Inc., was put through a prospective three-year clinical trial in women with SUI. The results showed an estimated 71 percent of patients experienced an improvement in quality of life at 36 months post-treatment. “These results confirm that the majority of patients ... Read More