Vaginal Mesh Injury Lawyers
Vaginal mesh products, including the Gynecare®, Bard Avaulta®, Uphold®, Pinnacle Product Lines®, Apogee®, Perigee®, Elevate®, and Apical Product Lines® 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 percent of women who have had children are likely to suffer some type of prolapse and nearly 10 percent of women will need surgical repair for pelvic organ prolapse.
Over the past three years, FDA has received over 1,000 reports from nine surgical mesh manufacturers of complications that were associated with surgical mesh devices used to repair POP and SUI" 1
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 Food and Drug Administration (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 POP repair with mesh is more effective than traditional non-mesh repair." Additionally, as recently as Aug. 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 neuropathic pain, infection, urinary trouble, recurrence of prolapse and incontinence, mesh erosion, mesh shrinkage or contraction, mesh migration and exposure, scar tissue formation, dysuria (painful urination), and dyspareunia (painful sexual relations). The failure of vaginal mesh products can also lead to the need for multiple operations to remove the mesh implant and repair damage caused by the mesh implant. 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 be aware that their gynecological problems are caused by the prior implantation of vaginal mesh products.
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.
1 - Source: U.S. Food and Drug Administration