Transvaginal Surgical Mesh and Bladder Sling
Surgical mesh is a medical device that is generally used to repair weakened or damaged tissue. It is made from porous absorbable or non-absorbable synthetic material or absorbable biologic material. Surgical mesh can be used for urogynecologic procedures, including repair of pelvic organ prolapse “(POP”) and stress urinary incontinence (“SUI”). It is permanently implanted to reinforce the weakened vaginal wall for POP repair or support the urethra or bladder neck for the repair of SUI.
When women suffer from POP or of SUI, they often seek treatment. One of the most popular forms of treatment has been the implantation of pelvic and bladder support products such as transvaginal mesh and sling products. In 2008, however, the FDA began to communicate worry about the health issues that were linked to the implantation of pelvic and bladder support products such as transvaginal mesh and sling products. 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. These mesh devices are usually placed transvaginally utilizing tools for minimally invasive placement. The most frequent complications included but are not limited to erosion through vaginal epithelium, infection, pain, urinary problems, and recurrence of prolapse and/or incontinence. There were also reports of bowel, bladder, and blood vessel perforation during insertion. In some cases, vaginal scarring and mesh erosion led to a significant decrease in patient quality of life due to discomfort and pain, including dyspareunia.
FDA concerns include the following:
- http://www.fda.gov/downloads/MedicalDevices/Safety/AlertsandNotices/UCM262760.pdf (Urogynecologic Surgical Mesh: Update on the Safety and Effectiveness of Transvaginal Placement of Pelvic Organ Prolapse)
- http://www.fda-reports.com/device/transvaginal-mesh.html (FDA Side Effects Report For Transvaginal Mesh)
- http://www.fda.gov/medicaldevices/safety/alertsandnotices/publichealthnotifications/ucm061976.htm
- http://www.fda.gov/medicaldevices/safety/alertsandnotices/ucm262435.htm
If you or someone you know has suffered erosion through vaginal epithelium, infection, pain, urinary problems, and recurrence of prolapse and/or incontinence contact us today to speak to one of our transvaginal mesh lawyers. There were also reports of bowel, bladder, and blood vessel perforation during insertion. In some cases, vaginal scarring and mesh erosion led to a significant decrease in patient quality of life due to discomfort and pain, including dyspareunia. Please contact one of our lawyers immediately.
