Synthetic Mid-Urethral Slings for Stress Urinary Incontinence in Women
Synthetic Mesh Sling
Stress Urinary Incontinence
Vanderbilt University Medical Center, Lahey Hospital & Medical Center, Mayo Clinic, Weill-Cornell, Yale-New Haven Hospital
The objectives of this project are to assess the capacity of routinely collected electronic health record (EHR) data to be used to evaluate long-term (>2 years) adverse events following synthetic surgical mesh implantation (mid-urethral slings) for female stress urinary incontinence (SUI). Synthetic surgical mesh used in transvaginal pelvic organ prolapse (POP) repair surgeries are Class III devices, and synthetic surgical mesh for all other gynecological indications (i.e., transabdominal POP repair and SUI) are Class II devices.
Stress urinary incontinence (SUI) is a common condition among women, and negatively impacts patient quality of life, with an estimated 50% of patients experiencing some symptoms during their lifetime. When conservative treatments are inadequate, implantation of a mesh mid-urethral sling is a recognized minimally invasive surgical treatment for SUI. There is uncertainty about adverse event rates for this procedure and indication, with reports of chronic pain, urethral fistula, voiding problems, and mesh breaking through the skin. Because of adverse outcomes, re-operation rates can reach 8% to 9%.
NESTcc was approached by the U.S. Food and Drug Administration (FDA) to engage in a collaborative consortium to pursue concerns around the risk of mesh use for SUI. Multiple academic medical centers, including Vanderbilt University Medical Center, Lahey Hospital & Medical Center, Mayo Clinic, Weill-Cornell, and Yale-New Haven Health, were recruited to collect and analyze patient data regarding mesh implantations for SUI for the outcomes of re-operation, mesh erosion, all-cause chronic pain, and continued voiding symptoms that occur past one year after the surgery.
This study has the potential to increase medical knowledge regarding the safety of SUI devices. Working with the NESTcc is important for this project in order to coordinate multiple data sites for execution of the study. In addition, NESTcc is operating as a central point of contact between FDA and other sponsors to find the appropriate data sites and investigators to pursue the use case of interest.
This project seeks to provide a proof of concept for post-market medical device surveillance utilizing electronic health record data, in a use case of substantial public health safety interest to the FDA, patients, and health care providers: mid- and long-term adverse outcomes related to synthetic surgical mesh implantation for stress urinary incontinence. The study protocol outlines the study rationale, objectives, design, target population, procedures, outcomes, statistical analysis plan, administration, and results dissemination, as well as NESTcc solicited public comments from May 1 to June 12, 2020.