Transvaginal Mesh: Getting the Facts Straight
By Ian Rosbrugh, MD, FACOG
Transvaginal mesh has been a source of controversy in recent years. With the amount of contradicting information surrounding the safety of meshes used to treat pelvic floor disorders, it can be difficult for primary care physicians to address patients concerns confidently and accurately.
Despite reports about transvaginal mesh complications, relatively few meshes have been recalled. In 2008 and 2011, the Food and Drug Administration (FDA) stated transvaginal mesh procedures have obvious and common complications that are not rare, and cautioned that meshes should be placed judiciously and with adequate training. It did not recall any mesh products.
In 2012, the FDA began requiring mesh manufacturers to start collecting postmarket surveillance data to help more clearly define safety and efficacy standards. The FDA’s statements specifically excluded slings for incontinence and the abdominal placement of vaginal mesh, or sacrocolpoplexy, in the mandated postmarket surveillance studies.
Why Use Mesh?
Mesh complications are not always easy to manage and can, in many cases, require further surgery, making some primary care physicians question why they are placed at all. The answer is because native tissue repair pelvic organ prolapse has a 40% failure rate or higher, depending on the nature of the defect and the vaginal compartment involved.
Transvaginal mesh lowers prolapse treatment failure rates to less than 10% with synthetic products and less than 15% with biological products. However, the reduction in the recurrence rate comes at the cost of increased complications such as painful mesh contraction and mesh erosion into the bowel or bladder. Mesh exposures occur in 10-15% of patients, a modifiable risk that involves the patient's comorbidities, the surgical technique used and the desire to avoid a concomitant hysterectomy.
Therefore, in a patient considering a mesh-augmented procedure, physicians must balance the risks of mesh complications against the risks of pelvic organ prolapse recurrence, and help patients select the most appropriate treatment option.
Sling and Sacrocolpoplexy Procedures
The issues with transvaginal mesh do not pertain to midurethral sling or sacrocolpoplexy procedures. While both treatment methods incorporate synthetic mesh into the pelvis, the complication rates are much lower and success rates much higher.
In 2014, the American Urogynecologic Society (AUGS) released statements clarifying midurethral slings as the standard of care for managing stress urinary incontinence (SUI). Multiple randomized trials have shown that when other surgical techniques are used to manage SUI, cure rates decrease and complication rates increase. There are very few circumstances in which a midurethral sling should not be used to treat SUI.
The sacrocolpoplexy procedure is effective in providing support to the vaginal apex and in repairing pelvic organ prolapse. However, it cannot repair all instances of prolapse. Additionally, it is not always effective in supporting the distal portion of the vagina.
Balancing Risk and Reward
When primary care physicians talk with their patients about transvaginal mesh, they are encouraged to be forthcoming with their information. Use of mesh is determined by weighing the potential benefits versus the potential risks against other pelvic prolapse treatment options.
The goal with any surgical procedure is to provide treatment that helps patients achieve the quality of life they want and avoid hospital readmissions based on recurrence of a previously treated condition or complication. Extensive research and counseling can help physicians and patients reach a safe and effective decision about whether to place transvaginal mesh to treat pelvic floor disorders.
Ian Rosbrugh MD, FACOG
Dr. Rosbrugh earned his medical degree from Loma Linda University School of Medicine and completed his obstetrics and gynecology residency at the University of Kansas Medical Center. He is board certified in obstetrics and gynecology and urogynecology and works for Meritas Health Pavilion for Women.