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serious complications 21 articles

Bladder sling market expected to grow despite safety risks

Transvaginal mesh, also called a bladder sling when used to treat stress urinary incontinence, has been linked to serious complications. Manufacturers have shelled out millions to settle lawsuits waged against them by women who claim they have been injured by the devices. But analysts say that the urinary sling market in the United States is expected to grow at a compound annual growth rate of 11.85 percent through 2019. The report published online at MedGadget.com covers the present scenario and the growth prospects of transvaginal mesh as well as male slings in the United States using in-depth market analysis with inputs from industry ... 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 wants to reclassify transvaginal mesh as high-risk medical device

The Food and Drug Administration (FDA) proposed reclassifying transvaginal mesh devices from moderate-risk to high-risk, requiring manufacturers to submit a premarket approval application for the agency to evaluate a device’s safety and efficacy before the device can be approved for marketing. Transvaginal mesh is a type of surgical mesh that is inserted through the vagina to treat common pelvic floor disorders such as pelvic organ prolapse (POP) and stress urinary incontinence (SUI). The mesh holds up organs that have dropped due to the stress of childbirth, obesity or age, causing symptoms such as incontinence, pain during sexual intercourse, and general discomfort. ... Read More

Transvaginal mesh manufacturer should be punished for mishandling documents related to lawsuits

Johnson & Johnson and its subsidiary Ethicon mishandled documents related to its transvaginal mesh devices and should be barred from seeking to throw out lawsuits or using some defense tactics, say attorneys for women who filed lawsuits against the companies. Johnson & Johnson’s unit Ethicon makes the Gynecare Prolift implant, a transvaginal mesh device used to treat pelvic floor disorders such as pelvic organ prolapse and stress urinary incontinence. The devices are inserted through the vagina to hold up organs that have dropped for various reasons, usually from childbirth, obesity or age. The devices have been associated with serious complications including ... Read More

Transvaginal mesh manufacturers face more than 30,000 lawsuits alleging defective design

More than 10,000 lawsuits involving Ethicon Gynecare transvaginal mesh have been filed in the Southern District of West Virginia, all claiming the surgical mesh products were defectively designed and made, and that Ethicon failed to warn doctors and patients of the risks associated with the devices. Ethicon, a subsidiary of Johnson & Johnson, is also facing an additional 4,400 transvaginal mesh lawsuits currently pending in multi-county litigation in New Jersey’s Atlantic County Superior Court. Ethicon is just one of six manufacturers of transvaginal mesh. There are more than 30,000 transvaginal mesh lawsuits currently pending in separate proceedings in just the ... Read More

Recall is just the latest in string of manufacturing mishaps for Hospira

Drug maker Hospira Inc.’s announced this week that it was recalling some injectable drugs because glass strands were found the vials, and if used could cause a host of complications from minor vein inflammation to serious organ failure. The recall is one of nearly a half-dozen manufacturing mishaps involving the company’s products so far this year. This week’s recall involved metoclopramide (Reglan), used to treat severe acid reflux, and ondansetron (Zofran), used to prevent nausea and vomiting in cancer patients. The drugs were distributed nationwide to wholesalers, hospitals and pharmacies from June to September. Hospira blamed the issue on its glass ... Read More

FDA to consider heart device to prevent strokes in atrial fibrillation patients

A heart device designed to prevent strokes in patients with the heart rhythm abnormality atrial fibrillation works just as well as a currently available and widely used drug, a key study found. Patients who have atrial fibrillation experience abnormal heart rhythms that can cause the blood in the chambers of the heart to pool. Clots can form in this pooled blood and travel to the brain, causing a stroke. Patients with the condition are typically given blood thinners to prevent strokes. Warfarin has been the long-used anticoagulant for atrial fibrillation patients, until 2010, when the Food and Drug Administration (FDA) ... 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

FDA approves first four-strain flu vaccine

A new seasonal flu shot that targets four strains of the virus has been approved by the Food and Drug Administration (FDA) to immunize adults and children age 3 and older. Fluarix Quadrivalent, made by GlaxoSmithKline, is the first intramuscular vaccine to protect against four different strains. Current influenza vaccines protect against only three strains. The new vaccine protects against flu virus subtypes A and B. The currently available three-strain flu vaccines protect against the two most common A virus strains and the B strain that public health authorities anticipate to be the predominant one each year. However, since 2000, ... Read More