A California jury has awarded $5.5 million in the first verdict to be reached in a transvaginal mesh lawsuit. Christine Scott and her husband had filed suit against C.R. Bard after she developed complications from the company’s Avaulta Mesh device.
Transvaginal surgical mesh products are used to treat women with stress urinary incontinence (SUI) and pelvic organ prolapse. Patients with pelvic organ prolapse (POP) suffer from a weakening of the tissue that holds the pelvic organs in place. In some cases, these organs may bulge (prolapse) past into the vagina or past the vaginal opening. SUI is a condition in which urine can leak involuntarily from the bladder during some physical activities, including coughing, sneezing, or exercise.
Christine Scott underwent surgery with Avaulta transvaginal mesh to treat SUI. According to her lawsuit, Scott experienced severe complications after undergoing transvaginal mesh surgery, including damage to her colon and pain during sex with her husband. She has already undergone eight repair surgeries to fix problems with the transvaginal mesh, and may be forced to undergo additional surgeries.
Commenting on the verdict, Scott’s attorney said that C.R. Bard had falsely advertised Avaulta Mesh as being “FDA-approved.” Like many surgical mesh products, Avaulta Mesh was allowed to go on sale in the U.S. under the FDA’s 501(k) process, which allows the sale of medical devices that are deemed “substantially similar” to products that are already on the market. However, these products do not require pre-market approval from the FDA, meaning that they may not receive the same level of safety testing as other medical products.
The FDA issued a warning in July 2011 about the safety of surgical mesh products used for transvaginal repair. According to the agency, patients who undergo surgical repair with transvaginal mesh are at risk of complications that are not found with traditional surgical repair, including vaginal mesh erosion. The FDA warned that the complications from transvaginal mesh surgery were more common than experts had previously suspected.
At least 650 surgical mesh lawsuits have already been filed by women who have suffered complications from these products. Patients who have received a surgical mesh product and experienced problems with the device—including pain, sexual problems, bleeding, or erosion of the mesh into the vagina—may still be eligible to file a lawsuit and receive compensation for their injuries.
To speak with a lawyer about your case, contact the law firm of Heygood, Orr & Pearson to receive a free legal consultation. You can reach us by calling our toll-free hotline at 1-877-446-9001, or by completing our free case evaluation form.