Do Benefits Outweigh Risks of Mesh for Vaginal Vault Prolapse?

Use of surgical mesh to correct vaginal vault prolapse after a hysterectomy is associated with a lower risk of prolapse recurrence at 1 year than sacrospinous fixation (SSF), according to results of a new study.¹

Vaginal vault prolapse is a common occurrence in women older than 55 years who have had a hysterectomy. Two methods of primary treatment of vaginal vault prolapse after hysterectomy include SSF, which involves lifting the vaginal vault back into place by attaching it to the sacrospinous ligaments and muscle through the vagina, or prolene mesh techniques, which involve supporting the pelvic organs by attaching mesh from the top and back of the vagina to a ligament of the lower back bone. Researchers compared these methods to better understand the recurrence and complication rates associated with each technique by randomizing 168 patients to either SSF (n=83) or mesh repair (n=85). Complications related to the procedures were assessed postoperatively at 3 months and 12 months.

The rate of prolapse recurrence was significantly higher in the SSF group than in the mesh group at 12 months (39.4% vs 16.9%, respectively). The rates of other complications, such as blood loss, bladder injury, and infection, were similar between study groups. Significant improvements in quality of life were noted in both groups for sexual satisfaction, urinary and bowel dysfunction, and harmful effects of prolapse. However, less improvement in bowel symptoms was observed in the SSF group than in the mesh group, and the incidence of de novo stress urinary incontinence in both groups at 12 months was high (25.4%, SSF group; 35.1%, mesh group).

For the mesh group, the vaginal mesh exposure rate was 15.6% at 3 months and 20.8% (16 women) at 12 months, with one fourth of these women experiencing symptoms. Of these 16 erosions, 10 were treated with surgical resection and 6 resolved with local estrogen therapy. Of the 10 cases of erosion that required additional surgery, general anesthesia was used in 6 cases.

In January 2012, the FDA announced that it is considering the recommendation that urogynecological surgical mesh be reclassified to a Class III medical device.² The study authors suggest, however, that physicians interpret this change as well as the risk of mesh extrusion in the context that the mesh procedure is associated with a significantly lower recurrence rate of prolapse.

Pertinent Points:
- Women with vaginal vault prolapse that was corrected with mesh surgery had a lower rate of prolapse recurrence at 1 year than women whose prolapse was corrected with sacrospinous fixation.
- The study authors found that the risk of mesh exposure was balanced against the lower rate of prolapse recurrence.

References:

1. Halaska M, Maxova K, Sottner O, et al. A multicenter, randomized, prospective, controlled study comparing sacrospinous fixation and transvaginal mesh in the treatment of posthysterectomy vaginal vault prolapse. Am J Obstet Gynecol. 2012;207:301.e1-7.
2. U.S. Food and Drug Administration. Urogynecological surgical mesh implants. Available at: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/UroGynSurgicalMesh/default.htm. Accessed October 25, 2012.