- Tue, 02/14/2012 - 10:20am
- Comments
According to complaints received by the Food and Drug Administration (FDA), transvaginal mesh has been causing adverse effects to occur in thousands of women. Transvaginal Mesh is a surgical mesh that is generally used to repair weakened or damaged tissue. In urogynecologic procedures, surgical mesh is permanently implanted to reinforce the weakened vagina wall to repair pelvic organ prolapse (POP) or to support the urethra to treat stress urinary incontinence (SUI).
Though the surgical mesh was designed to be beneficial; women who have had the surgery claim that side effects include infection, inflammation, scar tissue, pelvic pain, pelvic floor damage, and more.
Women who have been injured by the transvaginal mesh implants now require medical treatment to locate and remove the mesh and repair pelvic organs, tissue, and nerve damage caused by the mesh.
The FDA issued an updated safety communication on July 13, 2011, due to the increasing concerns about the adverse events associated with Transvaginal Mesh, warning health care providers and patients that surgical placement of mesh through the vagina to repair POP may expose patients to greater risk than other surgical options. According to the FDA, between 2008 and 2010, approximate 2,874 adverse events were reported.
A study was published in the Journal of the American College of Obstetricians and Gynecologists and concluded that there is a 15.6% vaginal mesh erosion rate with Prolift®, a type of surgical mesh, with no difference in overall objective and subjective cure rates.
Manufacturer Johnson & Johnson now faces transvaginal mesh lawsuits from thousands of women who claim that the company underrepresented and withheld information about the tendency of the products to fail and cause injury and complications. Furthermore, it is believed that Johnson & Johnson failed to properly test and research the product to evaluate the risks and benefits associated with the surgical mesh.