HOLLYWOOD, FLA. — Follow-up data from a study of prolapse repair, which originally found a significant advantage of synthetic mesh over cadaver fascia at 1 year, revealed no significant difference at 5 years based on a new definition of surgical success that included patient-reported symptoms.
“Although fascia did not seem to work as well as mesh using the original definition, the difference did not reach statistical significance with a new definition using a combination of subjective and objective measures of prolapse,” Dr. Susan B. Tate said at the annual meeting of the American Urogynecologic Society.
In the initial study, researchers randomized 100 women with pelvic organ prolapse to receive either mesh or cadaver fascia for abdominal sacral colpopexy (Obstet. Gynecol. 2005;106:29-37). Among the 89 patients assessed at 1-year follow-up, the success rate was significantly higher with mesh (91%) than with fascia (68%), based solely on anatomic changes as assessed using the pelvic organ prolapse quantification (POP-Q) examination.
Dr. Tate and her colleagues attempted to contact all 100 patients for the follow-up study. She presented 5-year findings for 29 women who received mesh repair and 29 who received fascia repair, all of whom underwent assessment of anatomic changes and completed a questionnaire about subjective outcomes. For example, patients were asked about symptoms using questions such as “I feel as though there is a ball between my legs or that I am sitting on a ball,” said Dr. Tate, of the department of obstetrics, gynecology, and women's health, University of Louisville (Ky.).
At 5 years, 100% of the mesh patients and 83% of the fascia patients had achieved success based on a combination of anatomic assessment and patient-reported symptoms. Although all of the failures were in the fascia group, “there was only a trend toward a significant difference,” Dr. Tate said.
During the 5 years, there was one mesh erosion and one fascia erosion. Both were removed without complications, Dr. Tate said.
Dr. Tate noted that the new findings can be viewed in the context of a 2007 American College of Obstetricians and Gynecologists Practice Bulletin that cautions against use of cadaver fascia because of a higher risk of relapse, compared with synthetic mesh (Obstet. Gynecol. 2007;110:717-29).
Strengths of the study include its randomized design and long-term follow-up, Dr. Tate said. A lack of validated questionnaire use at the time of the original study and attrition are potential weaknesses, she added
Disclosures: Dr. Tate, who is a consultant and paid instructor for C.R. Bard, had no relevant disclosures.