The extended CARE study was supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the Office of Research on Women’s Health at the National Institutes of Health. Dr. Nygaard reported no financial conflicts of interest; some of her associates reported ties to Johnson & Johnson, Key Tech, Pelvalon, Astellas, Pfizer, Warner Chilcott, GlaxoSmithKline, Uromedica, IDEO, Xanodyne, and Intuitive Surgical.
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The findings of Nygaard and colleagues have important clinical implications and call into question "the designation of the abdominal sacrocolpopexy as the criterion standard procedure for prolapse repair," said Dr. Cheryl B. Iglesia.
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Moreover, both clinicians and patients "may need to temper their expectations that pelvic floor surgery will last a lifetime. Not enough is known about the long-term outcomes of prolapse surgery; the natural history of prolapse; the effects of aging, hormonal, and weight changes; or the effects of straining and strenuous activity after prolapse repair," she said.
As with surgeries for face-lifts, which carry a 69% rate of partial relapse at 5.5 years, and for abdominal wall incisional hernia, which carry a 28% recurrence rate at 5 years, "operations for pelvic organ prolapse also may be vulnerable to the normal wear and tear of aging and activities of daily living," Dr. Iglesia said.
"Although imperfect, surgery for pelvic organ prolapse is generally safe and effective, and relief of bulge symptoms is associated with high patient satisfaction. Ultimately, patient-reported outcomes of symptom relief is the most important and fundamental goal of surgery," she said.
Dr. Iglesia is in the section of female pelvic medicine and reconstructive surgery at MedStar Washington (D.C.) Hospital Center and in the departments of obstetrics, gynecology, and urology at Georgetown University. She reported no financial conflicts of interest. These comments were taken from her remarks in an editorial accompanying Dr. Nygaard’s report (JAMA 2013;309:2045-6).
FROM JAMA