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pelvic organ prolapse 179 articles

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

Couple files first morcellator lawsuit against Johnson & Johnson’s Ethicon

The first lawsuit out of what could potentially swell to a body of hundreds or more similar cases was filed against Johnson & Johnson unit Ethicon Endo-Surgery Inc. Thursday by a woman who alleges the company’s morcellator tool, commonly used to remove uterine fibroid tissue and growths, caused her to develop cancer after a 2012 surgical procedure. Plaintiffs Brenda Leuzzi  and her husband George Leuzzi filed the lawsuit in a New York federal court, claiming Ethicon failed to adequately test its Morcelex tool for safety before selling its line of morcellator products. The company began selling morcellators in 1998 as ... Read More

Johnson and Johnson suspends uterine surgery tool amid concerns of cancer risks

Johnson & Johnson is suspending sales of its uterine surgery tool following concerns that the device can cause the spread of deadly cancer. Johnson & Johnson’s subsidiary Ethicon is the largest maker of power morcellators, which are devices commonly used to remove uterine growths, or fibroids. The announcement comes two weeks after the Food and Drug Administration (FDA) warned doctors that 1 in 350 women develop a type of cancer known as uterine sarcoma after undergoing procedures with the device, which can also lessen their odds of long-term survival. Morcellators are typically used with a tube-shaped blade that grinds up and ... 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

Social media campaign takes aim at Johnson & Johnson

An activist group has launched a social media campaign attacking Johnson & Johnson, alleging the company’s transvaginal mesh implants have “hurt women across the country,” and is asking current and former employees to become whistleblowers and investors to divest or not to buy the company’s stock. The Corporate Action Network (CAN), a project of the Action Network Fund founded to address the imbalance of power between corporations and people, launched the campaign in an effort to gather more information against the company to strengthen a complaint the organization filed with the Department of Justice against Johnson & Johnson and its top ... 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

Advocacy group calls for criminal investigation into destruction of documents in transvaginal mesh lawsuit

A consumer advocacy group is asking the U.S. Department of Justice  (DOJ) to investigate whether Johnson & Johnson purposely destroyed documents relevant to multidistrict litigation involving its transvaginal mesh device. Consumer Action Network, a nonprofit organization advocating for consumer and workers’ rights, pushed for the criminal investigation after a West Virginia judge last month found that Johnson & Johnson’s destruction or loss of documents was negligent but not deliberate. The nonprofit argues that the judge was only able to consider a portion of the evidence before making her decision. An attorney general would have a wider scope and the ability ... Read More

European authorities call for review of transvaginal mesh safety

European drug and medical device regulators have asked a scientific committee to review the safety of transvaginal mesh devices and whether the risks outweigh the benefits. The European Commission charged its Scientific Committee on Emerging and Newly Identified Health Risks to conduct the analysis on the surgical mesh products used to treat common pelvic floor disorders such as pelvic organ prolapse and stress urinary incontinence. The request is based on mounting reports of injuries associated with the devices, which range in severity and include complications such as rejection, tissue erosion, mesh exposure and shrinkage resulting in symptoms such as chronic ... Read More

Transvaginal mesh side effects likely caused by defective design

Two women were told they could no longer have sexual intercourse with their partners after suffering complications related to their transvaginal mesh. “We’ve not got a sex life. It’s actually taken a toll on my marriage,” Linda, whose name was changed, told BBC. “I don’t even go to the doctor. I don’t even bother.” Both women were implanted with transvaginal mesh, a type of surgical mesh used to treat pelvic organ prolapse or stress urinary incontinence, common conditions that affect women due to childbirth, age or weight gain. Both women say they were injured by the devices and live in ... Read More

Hundreds of Australian women file transvaginal mesh lawsuit against Johnson and Johnson

Nearly 400 Australian women have filed transvaginal mesh injury lawsuits against Johnson & Johnson in what may be the biggest product liability class action lawsuit in Australian history. The women claim the company’s surgical mesh product used to treat pelvic organ prolapse and stress urinary incontinence caused them to suffer chronic or life threatening injuries. Trish Sara joined the lawsuit after suffering complications leading to multiple surgeries during which she had to have part of her bowel removed. She was implanted with a bladder sling in 2008, confident that it would remedy her embarrassing urinary incontinence. However, from the moment ... Read More