Tagged Articles

pelvic floor disorders 72 articles

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

Transvaginal mesh lawsuits continue three years after FDA warning

It has been three years since the Food and Drug Administration (FDA) issued a Safety Communication warning the public that complications with transvaginal mesh used to treat pelvic floor disorders including pelvic organ prolapse and stress urinary incontinence were not uncommon and could be chronic or life threatening. Since then, lawsuits against manufacturers of the devices have grown exponentially. Trasvaginal mesh, also known as vaginal mesh, pelvic mesh, or bladder sling, is a type of surgical mesh that is inserted through the vagina to support organs that have dropped due to age, childbirth, obesity or other conditions. The mesh is ... Read More

Judge denies Ethicon’s request for new transvaginal mesh trial

Johnson & Johnson subsidiary Ethicon has been denied a new trial that would have struck an $11.1 million verdict in the first bellwether trial over allegedly defective transvaginal mesh. “There was strong evidence presented and multiple sources of evidence that in fact there were many problems with this product,” Atlantic County Superior Court Judge Carol Higbee said in court. Despite the ruling, Ethicon spokesman Matthew Johnson said the company isn’t giving up. “We will be filing an appeal in this case as we believe the jury’s verdict and damage awards were not supported by the evidence presented at trial,” he ... Read More

New Zealand woman demands inquiry into safety of transvaginal mesh

Jen Branje, 45, is petitioning Parliament in New Zealand to investigate injuries caused by transvaginal mesh, claiming the mesh is dangerous and should be banned until an inquiry examines serious risks associated with the devices. Transvaginal mesh, also called vaginal mesh or bladder sling, is a type of surgical mesh used to treat pelvic floor disorders in women, such as pelvic organ prolapse and stress urinary incontinence. Mounting reports of injuries associated with the devices prompted the U.S. Food and Drug Administration (FDA) to conduct an investigation in which the agency found that complications with the device were not uncommon and ... Read More

Maine woman sues makers of transvaginal mesh

Dory Ames from Maine is one of the latest women to file a lawsuit against the makers of transvaginal mesh claiming the device caused serious injuries. Manufacturers of these bladder slings face tens of thousands of lawsuits alleging the companies marketed the devices knowing they were defective and could cause harm to women. Transvaginal mesh is a type of surgical mesh used to treat common pelvic floor disorders known as pelvic organ prolapse and stress urinary incontinence. The mesh is inserted through the vagina to hold up organs that have dropped or protruded due to childbirth, age, weight gain, or ... Read More

Female incontinence treatment linked to serious complications

More than 20 million women in the United States suffer from urinary incontinence, but devices intended to remedy the problem are at the center of thousands of lawsuits by women who claim the treatments ruined their lives. Jennifer Ramirez says her incontinence wasn’t a serious problem for her. She opted to have transvaginal mesh implanted to keep the problem from getting worse following a hysterectomy. Now, she lives in constant pain. Just talking about it brings her to tears. “Now my life has to revolve around having a restroom right there because when you have to go, you have to ... 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

FDA calls for stricter safety guidelines, pre-market approval for transvaginal mesh for incontinence

Stricter safety requirements may be required for the manufacturing of transvaginal mesh under a Food and Drug Administration (FDA) proposal. The surgical mesh used to treat common pelvic floor disorders in women should be reclassified as “high risk,” the agency said in response to mounting reports of complications from the device. Transvaginal mesh, also known as vaginal mesh or a bladder sling, is used to treat pelvic organ prolapse and stress urinary incontinence. It is inserted through the vagina to hold up organs that have dropped causing symptoms such as discomfort and incontinence. The mesh was widely used in women ... Read More

Woman awarded $1.2 million in transvaginal mesh injury lawsuit

A woman was awarded $1.2 million after a Texas jury found Johnson & Johnson liable for design defects in one of its transvaginal mesh devices that caused the plaintiff to suffer pelvic injuries. Linda Batiste, 64, claimed she suffered complications when her TVT-O bladder sling eroded inside her body. It was the first verdict against Johnson & Johnson involving its TVT-O device. Transvaginal mesh is a type of surgical mesh used to treat common pelvic floor disorders such as pelvic organ prolapse and stress urinary incontinence. It is inserted through the vagina to hold up organs that have prolapsed, or dropped, ... Read More