On 7-13-2011, the FDA issued an update to warn of further complications and adverse effects connected to the transvaginal placement of surgical mesh. A previous warning was issued in 2008, but the emergence of new complications in numerous patients necessitated an official update to the original warning. The most up to date FDA warning also acknowledges that the complications associated with transvaginal mesh are not rare, which is a modification from the previous warning. The number of complaints regarding vaginal mesh almost tripled in the past 3 years, and is currently approaching a shocking 3000. Vaginal mesh has been found to expose patients to greater risk than other more traditional forms of non-mesh methods of vaginal repair. According to the FDA warning, the use of vaginal mesh is “an area of continuing serious concern.”
Vaginal mesh and bladder slings along with ObTape are medical device composed of synthetic material implanted surgically for the treatment of stress urinary incontinence (SUI) and pelvic organ prolapsed (POP). Vaginal mesh treats stress urinary incontinence by supporting the urethra to prevent unexpected bladder leakage, and strengthens weakened vaginal walls for the treatment of pelvic organ prolapse. The mesh is supposed to be a permanent solution to these conditions, however for many women the distressing consequences result in further surgery for its removal. Often times, these patients were not adequately warned of the possible complications and had they been aware, they might have chosen an alternative device or treatment method. In many cases stress urinary incontinence and pelvic organ prolapsed can be treated successfully without the use of mesh. Furthermore, using vaginal mesh, bladder slings and Ob Tape can make further surgical repairs more challenging.
Vaginal mesh erosion happens when the vaginal mesh, bladder sling and Ob Tape actually grinds through the fragile tissue of the vaginal walls. Also referred to as extrusion or protrusion, mesh erosion is the most regular and repeatedly reported mesh-related concern. According to the FDA warning, expulsion is a complication limited to transvaginal mesh and can be avoided through the use of conventional non-mesh surgical methods. Mesh erosion can require multiple invasive surgeries to fix and can be incapacitating for some women. In a number of severe cases, multiple surgeries will not even fully resolve the complication. Other potential risks associated with vaginal mesh include, but are not limited to, pain during sexual intercourse, recurring vaginal discharge, and persistent vaginal bleeding.
Many patients suffering from vaginal mesh, bladder sling or Ob Tape complications wish that they had been adequately warned of the risks and potential complications before undergoing the operation. If you or a loved one is suffering from vaginal mesh injuries please call the Willis Law Firm. We have female consultants standing by, trained to discuss these sensitive issues confidentially. We are currently accepting vaginal mesh injury lawsuits nationwide. Our product liability law team at the Willis Law Firm is committed to getting you answers and financial compensation for your medical expenses, loss of income, physical pain, and emotional suffering. These cases are handled on a Contingency Fee Basis, which means that no attorney’s fees or any other expenses will be charged unless we recover for you. Call us toll free at 1-800-883-9858 for a free case evaluation about Filing a Lawsuit.