A gross discrepancy in the number of fetal deaths attributed to the birth control device Essure has prompted the U.S. Food and Drug Administration to analyze the data and decide whether to change the way the product is marketed. The agency has reported five fetal deaths – along with the […]
Ethicon Women’s Health & Urology, maker of the Gynecare Prolift Pelvic Floor Repair System, is appealing an $11 million verdict awarded to a South Dakota women injured by the defective mesh implant. According to the company’s lawyers, the damages should be stricken because of the learned intermediary doctrine. “It’s the […]
Cyber attacks have broken free from their initial molds of carting off with consumer credit card numbers or stealing someone’s identity. The act of digitally digging into cyberspace has hit the U.S. Department of Health & Human Services and some of its 11 government agencies. Instead of hackers hounding out […]
In 2004, North Carolina resident Melanie Cole was implanted with Mentor’s OB Tape, which is a sling device that is used to treat urinary incontinence. Three weeks after the surgery, Ms. Cole visited her surgeon and complained that it was not working properly, and that her incontinence was worse. Ms. […]
The Uphold Vaginal Support System is a transvaginal mesh product used to treat pelvic organ prolapse (“POP”). Marta Carlson sued Boston Scientific Corporation (“Boston Scientific”), the maker of the Uphold Vaginal Support System, and asserted that the device caused her to suffer chronic vaginal pain, difficulty during intercourse and incontinence. […]
The nominee for the top job at the U.S. Food and Drug Administration is being held hostage by Congress until the agency agrees to revamp its approval process for opioid painkillers. Sen. Ed Markey, D-Mass., has led the delay in appointing Robert Califf to the position of commissioner until the […]
One of the foremost father figures in the history of medicine famously said, “There are in fact two things, science and opinion; the former begets knowledge, the latter ignorance.” Hippocrates, the ancient Greek physician revered for high ethical and moral standards that are the reason every doctor in America pledges […]
If the bellwether trial of a plaintiff who suffered complications from a metal-on-metal hip implant is any indication of future verdicts, Wright Medical Technology should be worried. A jury awarded $11 million to a woman suing for damages following surgery to replace her joint with the company’s Conserve system. The […]
A medical device created by Brainlab and marketed as easy-to-use, intuitive, precise and tailored to surgeons’ needs has been recalled by the U.S. Food and Drug Administration. Cranial-navigation systems sold by Brainlab, a German manufacturer that develops software-based applications for brain surgeons in addition to surgeons in other disciplines such […]
In 2004, a Georgia resident was diagnosed with stress urinary incontinence. On July 16, 2004, she was implanted with a Mentor transobturator sling. In December 2010, she began experiencing pain in her thigh and saw an orthopedic surgeon, who diagnosed her with a groin strain. In March 2011, she experienced […]
