Vaginal Mesh Repair Receives FDA Warning
The American Urogynecologic Society Foundation (AUGS) estimates that half of all women between the ages of 50 and 79 suffer some form of pelvic organ prolapse (POP). Stress urinary incontinence (SUI), often related to POP, affects another estimated 15 million. These conditions can cause pain, pressure, bleeding, sexual problems, and embarrassment, sometimes severely limiting quality of life.
In 2010, an estimated 100,000 women opted for vaginal mesh repair, a surgical process meant to help reduce symptoms of POP and SUI. Unfortunately, thousands experienced vaginal mesh complications that required additional surgeries, and sometimes caused lasting damage. Many women filed a vaginal mesh lawsuit, claiming they were not adequately warned about the procedure’s high risk of complications. The Food and Drug Administration (FDA) recently issued a warning that supports this claim, and will prove useful to a vaginal mesh lawyer seeking compensation for clients.
What is Vaginal Mesh Repair?
When a woman’s pelvic muscles weaken—often as a result of childbirth, hysterectomy, or menopause—they can no longer completely support organs like the bladder, urethra, bowel, and uterus. As a result, these organs may “drop” and bulge into the vagina, resulting in POP. SUI, which causes urine to leak when a woman is physically active, laughs, or sneezes, is often related to POP, as the drop of the bladder or urethra can increase the risk of incontinence.
Vaginal mesh repair is a surgical technique performed through the vagina that uses a synthetic mesh to anchor and reinforce weakened connective tissues in the vaginal wall, or to support the urethra or bladder, reducing urine leakage. For many women, the surgery is effective. Thousands of others, however, suffer serious vaginal mesh complications.
Surgery Complications Lead to Vaginal Mesh Lawsuits
On July 13, 2011, the FDA updated their former warnings 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.” This warning came after the department had received more than 1,500 reports of problems with the mesh between 2008 and 2010, a five-fold increase from the number of reports received between 2005 and 2007.
Consumer watchdog group Public Citizen urges women to seek alternative treatments, as vaginal mesh repair has been associated with risk of pain, infection, urinary problems, erosion of the mesh into the vagina, bleeding, difficulty during sex, hardening of the mesh, and a risk of organ perforation during surgery.
A Vaginal Mesh Lawsuit Could Recover Damages
Several manufacturers have been involved in vaginal mesh lawsuits, most notably Johnson & Johnson, which paid vaginal mesh settlements to plaintiffs suffering vaginal mesh complications from Mentor ObTape meshes. The product was pulled from the market in 2006. Women have also seen problems with the Bard Avaulta mesh, with allegations that it has a defective design.
If you’ve suffered from vaginal mesh complications, a vaginal mesh lawyer can help you determine if you have a legal claim to compensation for your medical expenses, pain, and suffering. Dedicated to upholding women’s rights, Chaffin Luhana LLP is happy to provide a free, confidential case evaluation by calling us at 1-888-480-1123.