Stress urinary incontinence is a condition characterized by the inability to hold urine while under physical stress, even as mild as coughing or sneezing. One method of treating such cases, which has rapidly grown more popular recently, involves the use of a sling. The sling is used in order to avoid complications associated with the process of grafting autologous tissues (tissues from another part of the patient’s body). On the other hand, purely synthetic materials are known to be durable, but put the patient at risk of suffering vaginal and urethral erosion. Therefore, hybrid systems have been created to avoid such problems. “The BioArc sling system (American Medical Systems, Minnetonka, Minn) is a hybrid sling system that uses polypropylene mesh for fixation and a biological graft for suburethral support.”
Gary Bong and Eric Rovner published a study titled “Vaginal Erosion After Hybrid Midurethral Sling Placement” through the Department of Urology in the Medical University of South Carolina. The report is a case study, covering the first case of vaginal erosion after implantation of the midurethral hybrid sling.
The patient was a healthy 31 year old woman without any unusual prior medical or surgical history. She had undergone a previous procedure and suffered from dyspareunia (painful sexual intercourse due to medical or physiological causes) and persistent sensation of a vaginal “bulge” 5 months after sling placement. The doctors observed tenderness along the vaginal wall and visible erosion of the mesh sling. After re-intervention, in which the previous sling was removed and replaced with a new one, the patient’s symptoms no longer persisted. She was continent and had resumed normal intercourse with her husband.
Given that this was the first reported case study of its nature, the authors could not come to any definite conclusions. They did note, however, that “The hybrid BioArc system has been marketed as a technique for the treatment of female stress urinary incontinence that combines the ease of placement and durability of polypropylene mesh with the biologically compatible nature of autologous fascia and its low erosion rates.” However, the combined use of autologous materials with polypropylene mesh did not prevent erosion “it is likely that it was the polypropylene component that was responsible for the erosion seen in this case”. The authors concluded, in part, by asserting that future clinical trials are necessary to further evaluate the safety and efficacy of this system.
Since the risks associated with TVM use have gone undisclosed to patients and doctors alike, a number of lawsuits have been filed against the manufacturers of some TVM products. If you or a loved one used TVM and believe you may have a case, please do not hesitate to contact our team of TVM lawyers. We have the experience, resources, and skills required to win the justice you deserve, even from the largest of pharmaceutical companies.