In 2008, the U.S. Food and Drug Administration (FDA) issued an alert about potential complications related to surgical mesh implants in women who underwent transvaginal repair of pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Up to that point in time, the FDA had received approximately 1,000 reports of problems from nine surgical mesh manufacturers. As a result, complications were considered to be rare. With the addition of 2,874 reports over the next two years, the FDA issued a second notification — this time warning that “complications associated with surgical mesh for transvaginal repair of POP are not rare complications.”
From 2008–2010, the most frequent complications reported to the FDA for surgical mesh devices for POP repair included mesh erosion through the vagina (also called exposure, extrusion or protrusion), pain, infection, bleeding, pain during sexual intercourse (dyspareunia), organ perforation and urinary problems. There were also reports of recurrent prolapse, neuromuscular problems, vaginal scarring/shrinkage and emotional problems.
The most common complication reported was mesh exposure into the vagina. It is difficult to estimate the proportion of women who underwent POP and SUI that have or would develop this complication, as the total number of cases in which transvaginal mesh was used is unknown. (Note: Surgical mesh applied abdominally, such as for support extravaginally, has not been associated with a high rate of complications.)
Characteristics of patients at increased risk for complications have not been determined.
Contributing factors may include the overall health of the patient, the mesh material, the size and shape of the mesh, the surgical technique used, concomitant procedures undertaken (e.g. hysterectomy) and possibly estrogen status.
Diagnosis and Treatment
Patients with complications from surgical mesh implants should have a comprehensive evaluation performed to determine whether or not the occurrence of functional complaints, like pain and dyspareunia, is actually related to the mesh implant. This is best done by a multispecialty team of specialists, which may include urologists, gynecologists, colorectal specialists, physical therapists and psychologists. In-depth knowledge of the initial underlying conditions, as well as the complications related to the mesh implant, is critical to obtaining the best treatment plan.
Whether or not surgery is required is determined by the amount of erosion and the site. The site is critical. If the erosion is in the bladder or urethra, then corrective surgery has to be performed.
For best outcomes, seek out the highest level of expertise — a subspecialist, who has had accredited fellowship training in Female Pelvic Surgery. Surgical mesh fuses to natural tissues and, as a result, can be difficult to remove. Perforations and secondary fistulas, where the mesh has eroded and damaged other tissues and organs, are even more complicated to correct and may require a collaborative approach with surgeon-scientists.
Innovative ways to improve pelvic floor conditions before they progress to a stage requiring surgical procedures are being explored. One breakthrough investigational study involves use of cell-based therapy — specifically, the use of stem cells for treatment of stress urinary incontinence and other female pelvic floor disorders. Indications are that this may also be an effective treatment for pelvic organ prolapse.
Clinical and translational research is also being conducted to determine the impact of obesity, diabetes, aging and maternal birth injury on female pelvic floor disorders.
The pace of research is being accelerated because evidence shows that 50% of women over the age of 60, especially if they’ve undergone menopause, have urinary incontinence. So this is a growing problem. Taking a more proactive scientific approach, we need to find alternatives for treatments, and for treatment materials, for pelvic floor conditions.
Dr. Firouz Daneshgari is a board-certified urologist specializing in Female Pelvic Medicine and Surgery. He is the Chairman of the Department of Urology, University Hospitals (UH), and Director of the UH Urology Institute. He is also the Lester Persky Professor and Chairman of the Department of Urology at Case Western Reserve University School of Medicine. In 2008, he was a reviewer for the FDA’s opinion referenced in this article.