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Novel trials aim to speed approval of experimental breast cancer drugs

Two experimental breast cancer drugs showed promising results in a closely watched study designed to enable the accelerated approval of medication that addresses unmet medical need in the treatment of serious or life threatening conditions. The drugs include AbbVie Inc’s veliparib, a treatment for an especially aggressive type of breast cancer known as triple negative, for which there are few effective treatments, and Puma Biotechnology Inc.’s neratinib, designed to treat a different type of breast cancer known as Her2-positive. Both drugs were tested in an unconventional mid-stage trial involving patients with confirmed breast cancer whose disease is considered curable but ... Read More

Nitroglycerin infusion recalled due to possible contamination

One lot of nitrogylcerin infusions used to treat heart patients is being recalled by the manufacturer because of possible contamination that could cause a blockage of blood vessels and other potentially serious health consequences. The recall involves nitroglycerin in 5% dextrose injection made by Baxter. The affected lot may contain particulate matter that if injected has the potential to cause venous and/or arterial thromboembolism, or a blockage of blood vessels. Other potential adverse events that can arise from the contaminated vials include inflammation, particularly in the lungs, and local irritation of blood vessels. Nitroglycerin in 5% dextrose injection is an ... Read More

New IUD insertion device aims to cut down on uterine perforation

New Orleans-based company Bioceptive has created a device that it says makes the insertion of intrauterine devices – or IUDs – simpler, thus cutting down on the technical training required for health providers. The inserter automates some of the insertion process and allows the health care provider to guide the IUD into the intended place and reduce the chance of uterine perforation. IUDs tear through the uterine wall about once or twice for every 1,000 insertions, and the risk is even greater when the device is inserted by an inexperienced health care provider. Women who have had fewer children also ... Read More

Anesthetic vials recalled due to contamination

Two lots of the anesthetic Bupivacaine manufactured by Hospira Inc. have been recalled because small particles were seen floating or embedded in vials of the injectable drug. The recall involves one lot of 0.25% Bupivacaine HCl injection and one lot of 0.75% Bupivacaine HCL injection, both of which come in single-dose vials. The particulate was identified as stainless steel ranging in size from 542 microns to 1,700 microns in the 0.25% vials, and as iron oxide with an average size of 2,000 microns in the 0.75% vials. If medication from contaminated vials are injected into patients the foreign particulates could ... Read More

Texas woman files lawsuit against makers of Mirena IUD

Rachel Coe had no idea the injuries she could suffer from her Mirena interuterine device (IUD) when she received one in 2006 to prevent pregnancy. The insertion of the device was uncomplicated and properly placed, her physician said. However, something went frightfully wrong. Rachel began to suffer from fatigue, abdominal and pelvic pain, abnormal bleeding, ovarian cysts, urinary incontinence and other issues. She returned to her doctor in 2008, who could not locate the IUD by digital examination, nor could she locate the device during two subsequent ultrasounds. Two years later, Rachel sought treatment for her symptoms at a hospital ... Read More

Personal injury lawsuits mount against maker of Mirena IUD

More than 70,000 complaints have been filed with the Food and Drug Administration (FDA) since 2000 regarding the Mirena intrauterine device (IUD), a Scripps investigation reveals. Many of the reports involve serious complications including device dislocation and perforations. Some complications required hospitalizations and/or surgical procedures. The Mirena IUD, made by Bayer Healthcare, is a flexible, T-shaped device that is inserted into the cervix. It releases a steady dose of the hormone levonorgestrel to prevent pregnancy. It is also used to treat heavy menstrual cycles in women who use IUDs for contraception. It is one of two IUDs approved in the United ... Read More

Organization studies effects of anesthesia on infants, young children

Commonly used anesthetics given to children during surgical procedures may be harmful to developing brains, animal studies show. However, experts say that studies on children have mixed results. The human brain goes through significant development during the first few years of life. With more than a million children under the age of 4 requiring anesthesia for surgery in the United States each year, the Food and Drug Administration (FDA) and other health organizations have teamed up to better understand the effects of anesthesia on young brains. The FDA and the Internal Anesthesia Research Society (IARS) started an initiative called SmarTots ... Read More

One-third of women who undergo transvaginal mesh surgeries have complications

A third of patients who undergo surgery to repair common pelvic floor disorders experience complications, according to a new study published in the Journal of the American Medical Association. The surgery, called an abdominal sacrocolpopexy, is used to correct pelvic organ prolapse and stress urinary incontinence. It involves the vaginal insertion of surgical mesh, which is used to hold up organs such as the bladder, rectum or uterus that have fallen out of place due to childbirth, age or obesity. About 25 percent of women suffer from these conditions and about 11 to 19 percent undergo sacrocolpopexy to correct it. Though ... Read More

Woman’s lawsuit claims Mirena IUD caused her serious bodily injury

An Arizona woman has filed a lawsuit against Bayer alleging her intrauterine device for birth control caused her serious bodily injury. Cynthia Solano had a Mirena IUD inserted in her uterus by her doctor in January 2011, and experienced cramping, pain and spotting. Her doctor repeatedly assured her that the device had been implanted properly. However, in December 2012, the day after another doctor visit, Solano vomited and was admitted to the hospital where a CT scan revealed the IUD had become embedded in her body. She was diagnosed with renal failure and a slow heartbeat. Solano had to undergo ... Read More

Canadian women launch website to raise awareness of risks with transvaginal mesh

Canadian Marika English was in so much pain from a bladder sling device to correct urinary incontinence that she paid $30,000 for a doctor in California to remove it. “If this was available in Canada, why would we be paying our own money, borrowing money, putting our families and ourselves in financial jeopardy,” she told News Talk 650. English, along with two other Canadian women, have launched a new website – www.TransvaginalMesh.ca – designed to raise awareness about problems associated with bladder slings, also known as vaginal mesh or transvaginal mesh. “I want to make sure that other women didn’t ... Read More