The U.S. Food and Drug Administration sent a warning letter to medical device maker Medtronic, saying it lacks adequate complaint procedures and its response to complaints and an FDA investigation were inadequate. Medtronic manufactures implantable drug infusion systems, deep brain stimulation systems, spinal cord neurostimulation systems, nerve monitoring products and other neurological medical/surgical products. The…
DetailsThe U.S. Food and Drug Administration recommends that patients with Riata or Riata ST heart defibrillator implants have X-rays or other scans to check for abnormalities in the lead insulation. The manufacturer, St. Jude Medical of Minnesota, recalled the leads in November 2011 due to premature erosion of the insulation around the electrical conductor wires.…
DetailsA California woman was awarded $5 million and her husband $500,000 after a jury found that transvaginal mesh manufacturer C.R. Bard Inc.’s negligence caused the woman’s injuries including incontinence and chronic pain. The jury ruled on July 23, 2012, that Bard was 60 percent responsible and the surgeon 40 percent responsible for negligent handling of…
DetailsNineteen West Virginia families have filed lawsuits against the drug maker Pfizer, claiming their children suffered birth defects after their mothers took the anti-depressant Zoloft. The lawsuits were filed in Wayne Circuit Court and name Pfizer Inc.; Roerig, a division of Pfizer; and Greenstone LLC. The mothers involved in the separate lawsuits allege they took…
DetailsYou’ve probably heard how taking aspirin can help prevent heart attacks, but one new study shows that daily aspirin use can slightly lower your risk of dying from cancer, especially cancer in the gastrointestinal tract. The study, which was funded by the American Cancer Society in Atlanta, showed that people who took aspirin daily for…
DetailsAmericans spend more than $62 billion each year on pills and diet plans that claim to melt the pounds away – but those promises aren’t guaranteed to work. Most diet pills haven’t even been approved by the U.S. Food and Drug Administration as safe for weight loss. Diet pill makers often claim their products have…
DetailsBayer AG, maker of Yasmin birth control pills, has paid more than $402 million to settle nearly 1,900 lawsuits in the U.S., the company told stockholders. Bayer also reported that it has doubled its reserve to $610.5 million to settle future cases. The settled lawsuits were filed over claims that Yasmin and Yaz contraceptives caused…
DetailsThe Food and Drug Administration is cracking down on the makers of supposedly “all-natural” dietary supplements because many of them are laced with prescription drugs. In a new analysis by Consumer Reports, “Vitamins and Supplements: 10 Dangers That May Surprise You,” the most frequent violators are makers of supplements aimed to enhance male sexual…
DetailsFDA report: Surgical Mesh for Treatment of Women with Pelvic Organ Prolapse and Stress Urinary Incontinence
You might think that it’s safer to use a tanning bed than bake yourself out in the sun. In some respects, it is … but indoor tanning isn’t entirely without its own risks. Experts say melanoma is on the rise, particularly for those under 35 who do their tanning indoors. There’s a 20 percent increased…
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