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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

Physicians groups recommend six-step evaluation before women undergo bladder sling surgery

Physicians do not need to perform preoperative urodynamic testing, or bladder test functioning, on patients with uncomplicated stress urinary incontinence (SUI) before having surgery to implant a bladder sling to treat symptoms because doing so does not improve surgical outcomes, according to first-time guidelines from the American College of Obstetricians and Gynecologists and the American Urogynecologic Society. Instead, the two medical groups recommend that physicians perform a basic six-step evaluation on women with uncomplicated SUI. This is the first time guidelines have been established to provide consistency in the evaluation of uncomplicated SUI, setting standards for physicians before they operate ... 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

New treatment for pelvic organ prolapse less risky than transvaginal mesh

Women who suffer from common pelvic floor disorders such as pelvic organ prolapse (POP) or stress urinary incontinence (SUI) can experience uncomfortable or embarrassing symptoms including pain and incontinence. Unfortunately, in 2011, the Food and Drug Administration (FDA) warned that the most popular surgical procedure used to treat the condition – a process in which surgical mesh is inserted through the vagina to hold up prolapsed organs – was associated with a large number of complications. Problems involved the mesh eroding in tissue causing infections, pain, disability, and hemorrhaging. Some women had to undergo repeated surgeries to remove the mesh, and some ... Read More

Man sues maker of surgical mesh

A Texas man is suing the manufacturer of the surgical mesh used to repair his hernia, alleging the device was defective and caused infections. The lawsuit was filed against C.R. Bard, maker of surgical mesh and other medical devices. The man claims that shortly after surgery his pain became worse and his surgical site became infected. He underwent a second surgery, where surgeons found that the problem stemmed from the mesh dislodging and eroding. Surgical mesh is a woven fabric used for chest wall reconstruction, strengthening tissues, providing for support for internal organs, and treating surgical or traumatic wounds. The fabric ... Read More

Study shows transvaginal mesh removal often requires multiple surgeries

Nearly a quarter of women who have experienced problems with surgical mesh to repair pelvic floor disorders have had to undergo multiple procedures to have the mesh removed in order to alleviate serious pain and other complications caused by the mesh, according to a study conducted by UCLA urologists. The study included data from 236 women who underwent 319 mesh removal procedures during a six-year period from July 2005 to July 2011. Nearly 60 percent of the women had the mesh to treat pelvic organ prolapse (POP), and 86 percent had sling mesh, or a bladder sling, to treat urinary ... Read More

Woman warns others about dangers of transvaginal mesh

“One night I emailed my sons and told them goodbye,” Teresa Sawyer told The Press. “I really thought I was going to die. I made them promise me that if something happened to me they would spread the word and tell other women not to get the mesh.” In February 2011, Teresa had surgery to implant Transvaginal Ethicon Mesh to treat stress urinary incontinence (SUI), a common condition in women in which urine unintentionally leaks after physical movement or activity (coughing, heavy lifting) that puts pressure on the bladder. It can be caused by childbirth, pelvic surgery, age and obesity. ... Read More

Consumers Union fights for more oversight of medical devices

The Consumers Union (CU) is hoping to close a loophole in the approvals of medical devices that allows them to be cleared for marketing in the United States with almost no government regulation, testing or monitoring. According to its mission statement, CU is an expert, independent, nonprofit organization whose mission is to work for a fair, just, and safe marketplace for all consumers and to empower consumers to protect themselves. CU also publishes the magazine Consumer Reports and the website ConsumerReports.org. Currently, medical devices considered moderate-risk, such as transvaginal mesh and artificial hips, are approved through an accelerated process that ... Read More