Between 2003 and 2006, over 35,000 women were treated for female stress urinary incontinence with the implantation of an ObTape vaginal sling, manufactured and designed by Mentor Corporation. The sling was designed to support weakened pelvic muscles at the bladder and urethra to prevent involuntary leakage. Due to a defective design, slings were manufactured with a non-woven surgical mesh that blocked nutrients and oxygen from passing through, potentially causing serious complications that will surface months or even years after the procedure. A study, published in the “Journal of Urology” in October, 2006, reported that more than 13% of women who received the Mentor Sling for incontinence suffered vaginal extrusions. There were also a number of cases involving chronic vaginal discharge and abscess. Following the release of this study, some medical institutions stopped using the device.
In a letter to healthcare practitioners issued in October, 2008, the FDA reported that in the last three years they have received over 1000 adverse reports from surgical mesh manufacturers on complications associated with mesh devices implanted transvaginally to treat Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI). The most frequently reported complications include:
- Erosion through vaginal epithelium
- Urinary problems
- Recurrence of prolapsed and/or incontinence
- Perforation of bowel, bladder or blood vessel during insertion
- Vaginal scarring
- Mesh erosion
- Severe pain and discomfort
Treatments for various complications include IV therapy, blood transfusions, drainage of abscesses and additional surgeries to remove the mesh. Specific characteristics of patients who may be more at risk for complications are still unknown but several factors may contribute to the erosion and extrusion of the sling which include the size and placement of the sling, bacterial infection, incompatibility, attachment of sling to mobile structures, and the material of the sling. Solid or excessively woven materials were associated with higher instances of complications than meshed slings, most likely because they are not porous enough to allow tissue and capillaries to grow though and be fully incorporated into the body.
The FDA recommended physicians to be vigilant of potential adverse events and to inform patients about the serious effects of complications that may alter the patient’s quality of life. Symptoms of complications from sling surgery include:
- High fever
- Vaginal pain
- Pelvic pain
- Pain during intercourse
- Chronic infections
- Perineal cellulitis
- Severe pain in the back, hips and legs
Any individual who is experiencing symptoms of complications from sling surgery should contact a healthcare professional immediately.