A jury in California has returned a $5.7 million dollar verdict against the manufacturers of a transvaginal mesh device that was defectively designed. The jury also determined that the manufacturers failed to warn physicians of the risks of using the product on their patients.
Trans-vaginal mesh devices are marketed by manufacturers to permanently fix pelvic organ prolapse (POP) and stress urinary incontinence, conditions that cause great discomfort and embarrassment to women post child birth, hysterectomy and menopause. Unfortunately, not all of these devices are safe and reliable. The danger of some of these devises is that they may cause infection, erosion of the vaginal tissues, and can actually become embedded in the internal organs of the patient, causing permanent and painful damage.
The FDAs literature review found that erosion of mesh through the vagina is the most common and consistently reported mesh-related complication from transvaginal POP surgeries using mesh. Mesh erosion can require multiple surgeries to repair and can be debilitating for some women. In some cases, even multiple surgeries will not resolve the complication.
Mesh contraction (shrinkage) is a previously unidentified risk of transvaginal POP repair with mesh that has been reported in the published scientific literature and in adverse event reports to the FDA since the Oct. 20, 2008 FDA Public Health Notification. Reports in the literature associate mesh contraction with vaginal shortening, vaginal tightening and vaginal pain.
Both mesh erosion and mesh contraction may lead to severe pelvic pain, painful sexual intercourse or an inability to engage in sexual intercourse.
The complications associated with the use of surgical mesh for POP repair have not been linked to a single brand of mesh.
If you or a loved one has experienced complications following a transvaginal mesh procedure, please contact a qualified attorney as soon as possible.
FDA Update on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Transplant: FDA Safety Communication July 13, 2011