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surgical mesh 131 articles

FDA notifies public, Boston Scientific may have used counterfeit raw materials in surgical mesh

The Food and Drug Administration wants health care professionals and patients to be aware that they are in the process of investigating allegations that Boston Scientific used counterfeit raw materials in its urogynecologic surgical mesh products. Additional testing is being done to determine if the mesh manufactured using the raw materials that have come under recent allegations is equivalent to the mesh originally approved by the FDA. The tests will also address the safety and effectiveness of the final product. The FDA anticipates these tests lasting several months and it will update its webpage with new information as it becomes available. It ... Read More

FDA panel recommends increasing risk level for surgical mesh tools

The U.S. Food and Drug Administration (FDA) in January increased surgical mesh for transvaginal pelvic organ prolapse (POP) repair from a class II, moderate-risk, to a class III, high-risk, device. Surgical instruments packaged together with mesh would be considered class III as well, according to Ben Fisher, PhD, director of the FDA’s Division of Reproductive, Gastro-Renal, and Urological Devices in a recent Medscape Medical News article. However, tools that were sold individually would still be considered class I. On Feb. 26 the FDA convened the Gastroenterology-Urology Devices Panel of the Medical Devices Advisory Committee to advise whether instrumentation used to ... Read More

FDA refuses Public Citizen’s request to ban transvaginal mesh from market

The U.S. Food and Drug Administration (FDA) has rejected the request made by Public Citizen in 2011 to recall existing surgical mesh products, specifically transvaginal mesh, and ban them from the market. The FDA says that a rigorous review is sufficient enough. The FDA said it “may consider future action against individual products or this product type as appropriate.” Transvaginal mesh is used to repair conditions such as pelvic organ prolapse (POP) and stress urinary incontinence (SUI). The mesh is implanted through the vagina and is used to shore up pelvic organs that have become displaced due to age, childbirth, ... Read More

Corporate Action Network demands FDA remove transvaginal mesh from the marketplace

The Corporate Action Network has sent a letter to the U.S. Food and Drug Administration (FDA) demanding the immediate ban of the marketing of non-absorbable surgical mesh products specifically designed and labeled for transvaginal repair of pelvic organ prolapse (POP), otherwise known as Transvaginal Mesh (TVM), and asked the agency to order all manufacturers of these products to recall them immediately. Previously, on August 11, 2011, Public Citizen sent a letter to the FDA requesting that TVM be removed from the market. This letter detailed that there were high rates of complications associated with the product, some of which lead to ... 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

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

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

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

Woman files lawsuit against makers of defective transvaginal mesh

“I get stabbed a thousand times a day,” Frances Shulte told The Gazette. The constant pain prevents the Coralville, Iowa, resident from comfortably moving around or going to the bathroom. She never dreamed that the surgery to correct a pelvic floor disorder would cause her chronic pain and disability. “People don’t understand that I’m in pain every day,” she said. Frances’ ordeal began in 2005, when she had surgery to correct her stress urinary incontinence. Doctors inserted a type of surgical mesh, also known as transvaginal mesh or a bladder sling, into her body to hold up organs that had ... Read More