Transvaginal Mesh Risks and Lawsuits They Spawn
On September 14, 2011, the FDA proposed to reclassify transvaginal mesh products for pelvic organ prolapse surgery as high-risk medical devices gained support from various product liability experts.
Transvaginal mesh is a surgical device used in the repair of Pelvic Organ Prolapse (POP) and Urinary Stress Incontinence (USI). Promising as it may, the device is alleged to bring complications that include mesh erosion through the vagina, bleeding, pain during sexual intercourse, organ perforation and many others. Because of these risks, transvaginal lawsuits are now being filed and those who are affected must see the expert advice of tranvaginal lawyers in order to protect their rights.
Surgical mesh is used transvaginally in treating two conditions namely pelvic organ prolapse (POP) or stress urinary incontinence (SUI). The former involves the weakening or stretching of internal structures that support organs like the bladder, bowel and uterus which causes the organs to drop to below their normal position and bulge into the vagina. SUI is a leakage of urine during moments of simple physical activity: coughing, sneezing, laughing, or exercise.
On August 25, 2011, the watchdog group founded by Ralph Nader, Public Citizen, said that the U.S. Food & Drug Administration (FDA) must recall transvaginal mesh products due to its well-documented painful side effects.
In latest news, the U.S. Food & Drug Administration (FDA) has drummed up their Transvaginal Mesh Warning on pelvic organ prolapse. This is good reason for transvaginal users to prepare filing a lawsuit against tansvaginal mesh manufacturers.
Lawyers for transvaginal mesh claim that there are about hundreds, perhaps thousands, of women suffering from serious injuries after a surgery with transvaginal mesh to treat pelvic organ prolapse (POP) or stress urinary incontinence (SUI). According to records from the U.S. Food & Drug Administration (FDA), the complications brought by transvaginal devices have caused the death of women in at least three instances. Often, transvaginal mesh complications unfortunately results to a permanent injury and pain.
Transvaginal mesh lawyers have identified the following marketers and/or several manufacturers that include American Medical Systems, Boston Scientific, Caldera, C.R. Bard, Inc., Ethicon, Gynecare, Johnson & Johnson, Mentor, and Sofradim .
Beginning 2008, the FDA has already issued two safety warnings on transvaginal mesh complications. On Oct. 20, 2008 report, the FDA revealed that from 2005 through 2007, there were over 1,000 people who reported having troubles with their mesh and some have considered filing transvaginal mesh lawsuits. The most frequent of their complaints are erosion, urinary problems, infection, pain, and recurrence of prolapse and/or incontinence. Reports of bowel, bladder, and blood vessel perforation during insertion were also made. In other cases, vaginal scarring and mesh erosion may occur that would lead to a decrease in an individual’s quality of life, according to the FDA.
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