Vaginal Mesh Litigation
Vaginal mesh products, including the Gynecare® and Bard Avaulta® line of vaginal mesh products, are medical devices, commonly referred to as pelvic mesh, vaginal mesh, and bladder slings, which are used in the treatment of pelvic organ prolapse (POP) and stress urinary incontinence (SUI).
As a result of childbirth, hysterectomy, or menopause, a woman’s uterus, bladder or rectum may slip out of place due to weakened muscles or ligaments. As a result of these organs “dropping”, increased stress is placed on the woman’s vagina, causing pain and discomfort, as well as urinary incontinence in some cases. Although this is a sensitive condition, it impacts millions of women nationwide. Approximately 50% of women who have had children will suffer some type of prolapse and nearly 10% of women will need surgical repair for pelvic organ prolapse.
These products, predominantly made of polyprophylene mesh, are used in a procedure called “vaginal mesh repair.” Vaginal mesh repair is a surgical technique where synthetic mesh is used to anchor weakened connective tissues in the vaginal wall, or to support the urethra or bladder, thus reducing urine leakage.
On October 20, 2008, the FDA issued a warning to both medical professionals and consumers regarding vaginal mesh products. At the time the warning was issued, there were over 1,000 reports of complications relating to surgical mesh products. On July 13, 2011, the FDA issued an updated warning to alert physicians and women that vaginal mesh complications are not rare, as previously believed, and that “it is not clear that transvaginal repair with mesh is more effective than traditional non-mesh repair.” Additionally, as recently as August 25, 2011, Public Citizen, a consumer advocacy group, submitted a petition to the FDA urging a ban on the marketing of vaginal mesh products.
Complications and injuries associated with vaginal mesh products include: pelvic and/or neuropathic pain, infection, urinary trouble, recurrence of prolapse and/or incontinence, mesh erosion into the vagina, bladder, intestines and uterus, mesh shrinkage or contraction, mesh migration and/or exposure, scar tissue formation, dysuria (painful urination), and dyspareunia (painful sexual relations). The failure of the vaginal mesh products can also lead to the need for multiple operations in an attempt to remove the mesh and/or repair damage caused by the mesh. Because vaginal mesh is a permanent implant, surgeons may be unable to fully remove it, permanently compromising a woman’s health. Further, women who are currently experiencing vaginal mesh complications may not immediately link current gynecological problems with an older surgery.
If you or a loved one has suffered complications or injuries as a result of Gynecare® or Bard Avaulta® vaginal mesh products, please contact our experienced attorneys at Schlichter, Bogard & Denton for a free legal consultation by calling toll-free 1-800-873-5297.